Form 8-K CURIS INC For: Nov 11

 

 

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): November 11, 2016

 

 

Curis, Inc.

(Exact name of registrant as specified in charter)

 

 

 

Delaware		000-30347		04-3505116
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

4 Maguire Road, Lexington, MA (Address of principal executive offices)		02421 (Zip Code)

Registrant’s telephone number, including area code: (617) 503-6500

Not Applicable

(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 ( see General Instruction A.2. below):

 

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

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Item 5.02.

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

(d) Director Election

On November 11, 2016, the Board of Directors (“Board”) of Curis, Inc. (the “Company”) elected Lori A. Kunkel, M.D., to serve as a class II director until the 2019 Annual Meeting of Stockholders and thereafter until her successor is duly elected and qualified.

Dr. Kunkel will receive compensation for her board service as a non-employee director commensurate with the Company’s previously-disclosed director compensation program, including a one-time nonqualified stock option under the Amended and Restated 2010 Stock Incentive Plan, as amended (the “2010 Plan”) to purchase 25,000 shares of the Company’s Common Stock with an exercise price equal to the closing price of the Company’s Common Stock on the Nasdaq Global Market on the grant date. The option will become exercisable as to 25% of the shares underlying the option on the first anniversary of the grant date and as to an additional 6.25% of the shares underlying the option at the end of each three-month period thereafter, until the option is fully exercisable on the fourth anniversary of the grant date. Exercisability is subject to Dr. Kunkel’s continued service on the Board. The option will expire 10 years from the date of grant.

In addition, on November 11, 2016, Dr. Kunkel entered into an indemnification agreement (the “Indemnification Agreement”) with the Company. The Indemnification Agreement is substantially identical to the form of indemnification agreement that the Company has entered into with its other non-employee directors and provides that Dr. Kunkel:

 

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shall be indemnified by the Company against all expenses, including attorney’s fees, and, to the extent permitted by law, amounts paid in settlement incurred in connection with any litigation or other legal proceeding, other than an action by or in the right of the Company, brought against her by virtue of her position as a director if she acted in good faith and in a manner she reasonably believed to be in, or not opposed to, the Company’s best interests, and, with respect to any criminal action or proceeding, had no reasonable cause to believe her conduct was unlawful; and

 

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shall be indemnified by the Company against all expenses, including attorneys’ fees, and, to the extent permitted by law, amounts paid in settlement incurred in connection with any action by or in the right of the Company brought against her by virtue of her position as a director of the Company if she acted in good faith and in a manner she reasonably believed to be in, or not opposed to, the Company’s best interests, except that no indemnification shall be made with respect to any matter as to which such person shall have been adjudged to be liable to the Company, unless a court determines that, despite such adjudication but in view of all of the circumstances, she is entitled to indemnification of such expenses.

Notwithstanding the foregoing, to the extent that Dr. Kunkel has been successful, on the merits or otherwise, she is required to be indemnified by the Company against all expenses, including attorneys’ fees, incurred in connection with defending any proceeding to the extent that the Company does not assume the defense of such proceeding. Expenses shall be advanced to Dr. Kunkel, provided that she undertakes to repay the amount advanced if it is ultimately determined that she is not entitled to indemnification for such expenses.

Indemnification is required to be made unless the Company determines that the applicable standard of conduct required for indemnification has not been met. As a condition precedent to the right of indemnification, Dr. Kunkel must give notice to the Company of the action for which indemnity is sought and the Company has the right to participate in such action or assume the defense thereof.

The foregoing description of the Indemnification Agreement is qualified in its entirety by the full text of the form of indemnification agreement by and between the Company and each non-employee member of its Board of Directors, which is incorporated herein by reference to Exhibit10.9 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the SEC on February 29, 2016.

Pursuant to the terms of a Consulting Agreement dated August 21, 2013 by and between the Company and D2D, LLC, a limited liability company owned by Dr. Kunkel (as amended, the “D2D Consulting Agreement”), Dr. Kunkel served as a consultant to the Company in the area of oncology clinical evaluation and development. The Company and Dr. Kunkel terminated the D2D Consulting Agreement on June 30, 2015, and entered into a Consulting Agreement by and between the Company and Dr. Kunkel on July 1, 2015 (the “Kunkel Consulting Agreement”). The Company and Dr. Kunkel terminated the Kunkel Consulting Agreement in connection with her election as a member of the Board of Directors. From January 1, 2015 through the date of this report, pursuant to the D2D Consulting Agreement and the Kunkel Consulting Agreement, Dr. Kunkel has received aggregate payments from the Company of $185,400 and received options in connection with the Kunkel Consulting Agreement to purchase an aggregate of 150,000 shares of the Company’s common stock at a weighted average exercise price of $3.33 per share.

 

Item 8.01.

Other Events.

On November 14, 2016, the Company issued a press release announcing the appointment of Dr. Kunkel. The full text of the press release issued in connection with this announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

 

Item 9.01.

Financial Statements and Exhibits.

 

(d)

Exhibits

The Exhibits to this Current Report on Form 8-K are listed in the Exhibit Index attached hereto.

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SIGNATURE

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.

 

				By:		/s/ James E. Dentzer
Date: November 14, 2016						James E. Dentzer Chief Financial Officer and Chief Administrative Officer

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EXHIBIT INDEX

 

Exhibit No.		Description
99.1		Press Release issued by Curis, Inc., dated November 14, 2016.

Exhibit 99.1

 

FOR IMMEDIATE RELEASE

For More Information:

James E. Dentzer

Chief Financial Officer & Chief Administrative Officer

Curis, Inc.

617-503-6500

[email protected]

Media Contact

David Schull

Russo Partners

(212) 845-4271

[email protected]

Curis Announces Appointment of Lori A. Kunkel, M.D. to Board of Directors

LEXINGTON, Mass., November 14, 2016 (GLOBENEWSWIRE) — Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of human cancers, today announced the appointment of Lori A. Kunkel, M.D. to its Board of Directors.

Dr. Kunkel currently serves on the Board of Directors at Loxo Oncology, where she was formerly Acting Chief Medical Officer. Prior to Loxo Oncology, Dr. Kunkel served as Chief Medical Officer at Pharmacyclics, Inc. leading integrated clinical development highlighted by the approval of IMBRUVICA^®. She has also served as Chief Medical Officer at Proteolix Inc. (acquired by Onyx), Syndax, and ACT Biotech.

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Prior to joining the biotechnology industry in 1995, Dr. Kunkel spent ten years in academic/clinical medicine and served as a faculty member in the Division of Hematology/Oncology’s Bone Marrow Transplant Unit at University of California, Los Angeles.

She trained in internal medicine at Baylor College of Medicine, hematology at USC and oncology at UCLA, earning board certifications in these specialties.

“We are delighted to welcome Lori to the Board of Curis and we will benefit tremendously from her depth of experience and instincts as we develop our drug candidates and place the company on a path for approval and commercialization of our products,” said CEO Ali Fattaey. “Lori is well known and respected in the biotechnology community and we have benefited from her role as an advisor to the company in the past.”

“I am pleased to join the Curis Board and look forward to working closely with the Board and management team as we collectively advance Curis as a leading oncology company,” said Dr. Kunkel.

IMBRUVICA^® is a registered trademark of Pharmacyclics LLC

About Curis, Inc.

Curis is a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of human cancers. The Company’s clinical drug candidates include CUDC-907, which is being investigated in a Phase 2 trial in patients with Diffuse Large B Cell Lymphoma, or DLBCL, and in a separate Phase 1 trial in patients with solid tumors. As part of a broad collaboration with Aurigene, Curis has an exclusive license to CA-170, an oral small molecule PD-L1/VISTA antagonist that is currently being investigated in a Phase 1 trial in patients with solid tumors or lymphoma. Curis also has an exclusive license to oral small molecule antagonists of the PD-1 and TIM-3 pathways, including PD-L1/TIM-3 antagonist CA-327, as well as to molecules designed to inhibit the IRAK4 kinase, including CA-4948. Curis is also party to a collaboration with Genentech, a member of the Roche Group, under which Genentech and Roche are commercializing Erivedge^® for the treatment of advanced basal cell carcinoma, and are further developing Erivedge in other diseases including idiopathic pulmonary fibrosis and myelofibrosis. For more information, visit Curis’s website at www.curis.com.

Cautionary Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the potential advantages and benefits of small molecule checkpoint inhibitors and the Company’s plans and expectations for the collaboration with Aurigene, including its plans to discover and develop multiple first-in-class oral, small molecule checkpoint inhibitors for the treatment of patients with cancer. Forward-looking statements may contain the words “believes,” “expects,” “anticipates,” “plans,” “seeks,” “estimates,” “assumes,” “will,” “may,” “could” or similar

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expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements. For example, Curis may experience adverse results, delays and/or failures in its drug development programs and may not be able to successfully advance the development of its drug candidates in the time frames it projects, if at all. Curis’s drug candidates may cause unexpected toxicities, fail to demonstrate sufficient safety and efficacy in clinical studies and/or may never achieve the requisite regulatory approvals needed for commercialization. Favorable results seen in preclinical studies and early clinical trials of Curis’s drug candidates may not be replicated in later trials. There can be no guarantee that the collaboration agreement with Aurigene will continue for its full term, that Curis or Aurigene will each maintain the financial and other resources necessary to continue financing its portion of the research, development and commercialization costs, or that the parties will successfully discover, develop or commercialize drug candidates under the collaboration. Regulatory authorities may determine to delay or restrict Genentech’s and/or Roche’s ability to continue to develop or commercialize Erivedge in BCC. Erivedge may not demonstrate sufficient or any activity to merit its further development in disease indications other than BCC. Competing drugs may be developed that are superior to Erivedge. Curis faces risks relating to its wholly-owned subsidiary’s royalty-collateralized loan transaction, including the risk that it may not receive sufficient levels of royalty revenue from sales of Erivedge to satisfy the debt obligation or may otherwise lose its rights to royalties and royalty-related payments as a result of a foreclosure of the loan. Curis will require substantial additional capital to fund its business and such capital may not be available on reasonable terms, or at all. Curis faces substantial competition. Curis also faces risks relating to potential adverse decisions made by the FDA and other regulatory authorities, investigational review boards, and publication review bodies. Curis may not obtain or maintain necessary patent protection and could become involved in expensive and time-consuming patent litigation and interference proceedings. Unstable market and economic conditions and unplanned expenses may adversely affect Curis’s financial conditions and its ability to access the substantial additional capital needed to fund the growth of its business. Important factors that may cause or contribute to such differences include the factors set forth under the caption “Risk Factors” in our in our most recent Form 10-K and Form 10-Q and the factors that are discussed in other filings that we periodically make with the Securities and Exchange Commission (“SEC”).

In addition, any forward-looking statements represent the views of Curis only as of today and should not be relied upon as representing Curis’s views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by law.

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