ecyt_Current_Folio_8K

 

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): May 3, 2018

 

 

 

 

 

Endocyte, Inc. 

 

 

(Exact name of registrant as specified in its charter)

 

 

 

 

 

 

 

 

Delaware

 

001-35050

 

35-1969-140

(State or other jurisdiction

 

(Commission

 

(I.R.S. Employer

of incorporation)

 

File Number)

 

Identification No.)

 

 

 

 

 

3000 Kent Avenue, Suite A1-100, 
West Lafayette, Indiana

 

47906

(Address of principal executive offices)

 

(Zip Code)

 

 

 

 

Registrant’s telephone number, including area code:

765-463-7175

 

 

 

 

 

 

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:

 

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))

 

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

 

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.

 

 

 

 

 

 


 

 

ITEM 2.02 Results of Operations and Financial Condition.

 

On May 9, 2018, Endocyte, Inc. (the “Company”) announced its results of operations for the three months ended March 31, 2018. A copy of the Company’s earnings release is furnished herewith as Exhibit 99.1.

 

The information in this Item 2.02 and in Item 9.01 of this Current Report (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Item 2.02 and in Item 9.01 of this Current Report (including Exhibit 99.1) shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing. 

 

ITEM 5.07 Submission of Matters to a Vote of Security Holders.

 

The Company held its 2018 annual meeting of stockholders on May 3, 2018. The Company’s stockholders took the following actions on the business items which were set forth in the notice for the meeting:

 

Proposal 1 – Election of Directors: elected three (3) directors for three-year terms ending at the 2021 annual meeting of stockholders;

 

Proposal 2 – Ratification of Independent Registered Public Accounting Firm: ratified the Audit Committee’s appointment of Ernst & Young LLP as the Company’s independent registered public accounting firm for 2018;

 

Proposal 3 – Advisory Vote on Executive Compensation (“Say-on-Pay”): approved the compensation of the Named Executive Officers.

 

The vote tabulation for each proposal is as follows:

 

Proposal 1 – Election of Directors

 

 

 

 

 

 

 

 

 

 

 

 

Nominee

 

For

 

 

Withhold

 

 

Broker
Non-Votes

Patrick Machado

 

 

36,471,268

 

 

 

83,550

 

 

 

13,199,282

Lesley Russell

 

 

36,470,775

 

 

 

84,043

 

 

 

13,199,282

Dawn Svoronos

 

 

36,465,278

 

 

 

89,540

 

 

 

13,199,282

 

 

Proposal 2 – Ratification of Independent Registered Public Accounting Firm

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For

 

 

Against

 

 

Abstain

 

 

Broker Non-Votes

 

49,455,655

 

 

 

45,402

 

 

 

253,043

 

 

 

0

 

 

Proposal 3 – Advisory Vote on Executive Compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For

 

 

Against

 

 

Abstain

 

 

Broker Non-Votes

 

36,268,657

 

 

 

129,907

 

 

 

156,254

 

 

 

13,199,282

 

 


 

ITEM 9.01 Financial Statements and Exhibits.

 

A copy of the Company’s earnings release is furnished, but not filed, as Exhibit 99.1 hereto.

 

(d)         Exhibits

Exhibit Index

 

 

Exhibit No.     

Description                                                      

99.1

Press release issued on May 9, 2018

 

 

 


 

 

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.

 

 

 

 

 

Endocyte, Inc.

 

 

 

May 9, 2018

By:

/s/ Beth A. Taylor

 

 

Name: Beth A. Taylor

 

 

Title: Vice President of Finance and Chief Accounting Officer

 

 


ecyt_Ex99_1

Exhibit 99.1

 

Contact:

Stephanie Ascher, Stern Investor Relations, Inc., (212) 362-1200, stephanie@sternir.com

 

NEWS RELEASE

 

Endocyte Provides First Quarter 2018 Financial Results and Operational Update

 

– Recently Updated Phase 2 Data on 177Lu-PSMA-617 Published in The Lancet Oncology Favorable to Preliminary Data Presented at 2017 ESMO Congress –

 

– Positive End of Phase 2 FDA Meeting Set Stage for Successful Financing in First Quarter –

 

– Phase 3 VISION Trial on Track for First Patient Visit in Q2 2018 –

 

– Conference Call Today at 8:30 a.m. EDT –

 

WEST LAFAYETTE, Ind., May 9, 2018 (GLOBE NEWSWIRE) – Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, today announced financial results for the first quarter ending Mar. 31, 2018 and provided an operational update.

 

“We made important progress during the first quarter in establishing the design of our phase 3 VISION trial of 177Lu-PSMA-617, securing clinical supply of no-carrier-added Lutetium, and raising sufficient capital to fund the company through expected completion of the trial,” said Mike Sherman, president and CEO of Endocyte. “We continue to expect the first patient visit in the VISION trial in the second quarter and are working to advance EC17/CAR T-cell therapy, our folate-targeted CAM-based therapy, for which we expect to have an IND submitted in the fourth quarter of 2018.”

 

Mr. Sherman continued, “In addition, we are encouraged by the updated 30 patient data from the ongoing phase 2 trial at Peter MacCallum Cancer Centre in Melbourne, Australia, published today in The Lancet Oncology. We anticipate an update at the American Society of Clinical Oncology Annual Meeting in June with early data on the additional 20 patients dosed in the expansion phase of that trial. Enrollment also continues in the phase 2 TheraP trial in Australia comparing 177Lu-PSMA-617 to cabazitaxel in 200 patients.”

 

First Quarter and Recent Highlights

 

·

Finalized the design for the phase 3 VISION trial evaluating 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC) following a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration.

·

Announced an agreement with ITM Isotopen Technologien München AG to supply no-carrier-added Lutetium (177Lu) to support the phase 3 VISION trial.

·

Presented data on the chimeric antigen receptor T-cell (CAR T) adaptor molecule (CAM) platform at the American Association for Cancer Research Annual Meeting 2018 confirming the anti-tumor activity of Endocyte’s folate-targeted EC17/CAR T-cell therapy.

·

Completed an underwritten registered public offering of 20,535,714 shares of its common stock, including full exercise of the underwriters’ option to purchase additional shares of common stock, at a public offering price of $4.20 per share. Endocyte received aggregate net proceeds from the offering of approximately $80.9 million.

·

Hired additional experienced clinical trial professionals to ensure strong execution and support the success of its clinical programs.

·

Elected Patrick Machado, J.D., co-founder and former chief business and financial officer of Medivation, and Dawn Svoronos, former president of Merck’s Europe/Canada region, to serve on the Board of Directors, bringing significant commercial leadership and understanding of the prostate cancer market to the Board.

 

 


 

Expected 2018 Milestones

 

·

First patient visit for phase 3 VISION trial of 177Lu-PSMA-617 in mCRPC (2Q 2018).

·

50-patient response rate data readout of investigator-initiated trial of 177Lu-PSMA-617 in mCRPC patients at Peter MacCallum Cancer Centre in Melbourne, Australia, to be presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO)  (June 2018).

·

Publications on additional ongoing investigator-initiated clinical trials of 177Lu-PSMA-617 in prostate cancer patients (2018).

·

IND for phase 1 trial of EC17/CAR T-cell therapy in patients with osteosarcoma (4Q 2018).

 

First Quarter 2018 Financial Results

 

Endocyte reported a net loss of $8.6 million, or $0.16 per basic and diluted share, for the first quarter of 2018, compared to a net loss of $11.5 million, or $0.27 per basic and diluted share for the same period in 2017.

 

Research and development expenses were $5.3 million for the first quarter of 2018, compared to $8.0 million for the same period in 2017. The decrease was primarily attributable to a strategic portfolio review announced in June 2017 which led to a reduction in workforce and the discontinuation of certain research and development activities, including: a decrease of $1.4 million in expenses related to pre-clinical work and general research, including the development of EC2629; a decrease of $0.8 million in EC1169 trial expenses; a decrease of $0.6 million in EC1456 trial expenses; a decrease of $0.5 million in compensation expense as a result of employee terminations since March 31, 2017, and a decrease of $0.4 million in manufacturing expense for EC1169 and EC1456. These decreases were partially offset by: an increase of $0.8 million in expenses related to development of PSMA-617; and an increase of $0.2 million related to our CAR T-cell therapy program.

 

General and administrative expenses were $3.8 million for the first quarter of 2018, which were consistent with the $3.7 million of expenses for the same period in 2017.

 

Cash, cash equivalents and investments were $173.1 million at Mar. 31, 2018, compared to $127.6 million at Mar. 31, 2017, and $97.5 million at Dec. 31, 2017. Cash, cash equivalents and investments of $173.1 million at Mar. 31, 2018 included $80.9 million of net proceeds from our public offering of 20,535,714 shares of our common stock that closed in March 2018.

 

Financial Expectations

 

The company anticipates its cash, cash equivalents and investments balance at the end of 2018 to exceed $130 million. Based on current operational assumptions, Endocyte has sufficient cash to fund its activities through the expected end of the VISION trial and potential proof of concept of its EC17/CAR T-cell therapy.

 

Conference Call

 

Endocyte management will host a conference call today at 8:30 a.m. EDT.

U.S. and Canadian participants:(877) 845-0711

International:(760) 298-5081

 

A live, listen-only webcast of the conference call may be accessed by visiting the Investors & News section of the Endocyte website,  www.endocyte.com.

 

The webcast will be recorded and available on the company's website for 90 days following the call.

 

Website Information

 

Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the “Investors & News” section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the “Investors & News” section of

2


 

Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document.

 

About Endocyte

 

Endocyte is a biopharmaceutical company and leader in developing targeted therapies for the personalized treatment of cancer. The company's drug conjugation technology targets therapeutics and companion imaging agents specifically to the site of diseased cells. Endocyte's lead program is a prostate specific membrane antigen (PSMA)-targeted radioligand therapy, 177Lu-PSMA-617, entering phase 3 for metastatic castration-resistant prostate cancer (mCRPC). Endocyte also expects to have an Investigational New Drug application submitted in the fourth quarter of 2018 for its adaptor-controlled CAR T-cell therapy which will be initially studied in osteosarcoma. For additional information, please visit Endocyte's website at www.endocyte.com.

 

Forward Looking Statements

 

Certain of the statements made in this press release are forward looking, such as those, among others, relating to future spending, future cash balances, future use of capital, sufficiency of cash, the timing of initiation, interim assessments and completion of clinical trials, the enrollment period for, and availability and reporting of data from, ongoing and future clinical trials, the occurrence and timing of actions by regulatory agencies, estimates of the potential market opportunity for the company’s product candidates, and the company's future development plans including those relating to the completion of pre-clinical development in preparation for possible future clinical trials and future sources of supply of product candidates to support clinical and commercial activities. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that the company or independent investigators may experience delays in the initiation or completion of clinical trials (whether caused by competition, adverse events, patient enrollment rates, shortage of clinical trial materials, regulatory issues or other factors); risks that suppliers or other third party contractors may not fulfill their contractual obligations on a timely basis or at all;  risks that data from prior clinical trials may not be indicative of subsequent clinical trial results; risks related to the safety and efficacy of the company’s product candidates; risks that early stage pre-clinical data may not be indicative of subsequent data when expanded to additional pre-clinical models or to subsequent clinical data; risks that evolving competitive activity and intellectual property landscape may impair the company's ability to capture value for the technology; risks that expectations and estimates turn out to be incorrect, including estimates of the potential markets for the company’s product candidates, estimates of the capacity of manufacturing and other facilities required to support its product candidates, projected cash needs, and expected future revenues, operations, expenditures and cash position. More information about the risks and uncertainties faced by Endocyte, Inc. is contained in the company’s periodic reports filed with the Securities and Exchange Commission. Endocyte, Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Endocyte, Inc.

Statements of Operations

(dollars in thousands, except per share amounts)

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the Three Months
Ended March 31,

 

 

 

 

2017

 

 

2018

 

 

 

 

 

Collaboration revenue

 

 

 

$

12

 

 

$

16

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

 

 

7,994

 

 

 

5,255

 

General and administrative

 

 

 

 

3,745

 

 

 

3,778

 

Total costs and expenses

 

 

 

 

11,739

 

 

 

9,033

 

Loss from operations

 

 

 

 

(11,727

 

 

(9,017

 

 

 

 

 

 

 

 

 

 

 

Interest income, net

 

 

 

 

235

 

 

 

413

 

Other income, net

 

 

 

 

3

 

 

 

1

 

Net loss

 

 

 

$

(11,489

 

$

(8,603

 

 

 

 

 

 

 

 

 

 

 

Net loss per share - basic and diluted

 

 

 

$

(0.27

)

 

$

(0.16

)

 

 

 

 

 

 

 

 

 

 

 

Comprehensive loss

 

 

 

$

(11,501

)

 

$

(8,617

)

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of common shares used in net loss per share – basic and diluted:

 

 

 

 

42,434,709

 

 

 

55,000,743

 

 

 

4


 

Endocyte, Inc.

Balance Sheets

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

As of
December 31,

 

 

As of
March 31,

 

 

2017

 

 

2018

 

 

 

 

 

(unaudited)

Assets

 

 

 

 

 

 

 

Cash, cash equivalents and investments

 

$

97,471

 

 

$

173,125

Other assets

 

 

3,291

 

 

 

3,553

Total assets

 

$

100,762

 

 

$

176,678

 

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

Current liabilities

 

$

4,546

 

 

$

4,613

Deferred revenue and other liabilities, net of current portion

 

 

732

 

 

 

363

Total stockholders’ equity

 

 

95,484

 

 

 

171,702

Total liabilities and stockholders’ equity

 

$

100,762

 

 

$

176,678

 

5