Endocyte, Inc.
ENDOCYTE INC (Form: 8-K, Received: 05/10/2017 08:16:40)

 

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 10, 2017

 

 

 

 

 

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 10, 2017, Endocyte, Inc. (the “Company”) announced its results of operations for the three months ended March 31, 2017. A copy of the Company’s earnings release is furnished herewith as Exhibit 99.1.

 

ITEM 9.01 Financial Statements and Exhibits.

 

(d)         Exhibits

99.1       Press Release dated May 10, 2017 relating to Endocyte’s first quarter 2017 results of operations.

 

The information in 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 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.


 

 

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 10, 2017

By:

/s/ Beth A. Taylor

 

 

Name: Beth A. Taylor

 

 

Title:  Vice President of Finance and Chief Accounting Officer

 

 


 

Exhibit Index

 

 

 

 

Exhibit No.

 

Description

99.1

 

Exhibit 99.1 Earnings Release

 


Exhibit 99.1

 

Contact:

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

NEWS RELEASE

 

 

Endocyte Reports First Quarter Financial Results and Provides Clinical and Pipeline Update

 

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

 

West Lafayette, Ind., May 10, 2017 – Endocyte, Inc. (NASDAQ Global Market: ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, today announced financial results for the first quarter ending March 31, 2017, and provided a clinical and pipeline update.

 

“We look forward to providing safety and efficacy updates for our clinical trials of both EC1169 and EC1456 at the Annual Meeting of the American Society of Clinical Oncology (ASCO) next month,” said Mike Sherman, president and CEO at Endocyte. “In addition, we continue to discover compelling applications of the SMDC platform and are working to more rapidly bring assets toward clinical development in several exciting areas, to drive more value from our pipeline. These include our dual-targeted DNA crosslinker drug that can attack both tumor associated macrophages (TAMs) and cancer cells, EC2629, and our chimeric antigen receptor T-cell (CAR T-cell) SMDC adaptor platform.”

 

“Enrollment in the expansion phase of the EC1169 trial in prostate cancer continues to progress well, and we recently completed our work with EC1456 exploring multiple dosing schedules,” added Dr. Alison Armour, Endocyte’s chief medical officer. “We also enrolled the first patient in the study of EC1456 in ovarian cancer patients undergoing surgery to provide tissue-based characterization following drug administration.”

 

Lead SMDC Programs

 

EC1169 (PSMA-targeted tubulysin) : Enrolling patients in the expansion phase of the EC1169 trial in up to 50 taxane-exposed metastatic castration-resistant prostate cancer (mCRPC) patients and up to 50 taxane-naïve mCRPC patients at a maximum clinical dose of 6.5 mg/m 2 once per week. The primary endpoint of this expansion phase is radiographic progression-free survival (rPFS), with a target of 5 months for taxane-naïve mCRPC patients and 3 months for taxane-exposed mCRPC patients. Secondary endpoints, which will provide earlier insight into drug activity, include overall response rates as measured by response evaluation criteria in solid tumors (RECIST) 1.1 and prostate-specific antigen (PSA). Enrollment is not limited based on the results of the scan with EC0652, but primary endpoints of the trial are to be assessed on PSMA positive patients.

 

EC1456 (folate receptor-targeted tubulysin) : Enrolling expansion cohort of up to 40 folate receptor-positive (FR-positive) non-small cell lung cancer (NSCLC) patients, as determined by an etarfolatide scan, to receive the maximum clinical dose of 6.0 mg/m 2 twice per week. Patients included in this expansion phase of the trial will have received first-line chemotherapy and may have also been treated with anti-programmed death-1 (anti-PD-1) therapy. Endocyte is also conducting an ovarian cancer surgical study to characterize EC1456 at the tumor level through a multifaceted analysis of collected tissue samples after administration of the drug.

 

Immuno-oncology Pipeline

 

EC2629 : Pre-clinical development currently underway with a potential Investigational New Drug (IND) filing in mid-2017. EC2629 leverages a proprietary warhead with a dual mechanism of action: targeting both TAMs and FR-positive cancer cells.

 

CAR T-Cell Development Program : Continued progress with next-generation CAR T-cell therapeutic platform, in collaboration with leading experts in the field at Seattle Children's Research Institute. Endocyte announced new research in a late-breaking poster session at the American Association for Cancer Research (AACR) Annual Meeting in April 2017, on the application of Endocyte's SMDC technology. Data demonstrated that Endocyte’s bi-specific adaptor molecules can mitigate or eliminate cytokine storms in animal models and could meaningfully improve the safety and tolerability of CAR T-cell therapies. Pre-clinical evaluations for the CAR T-cell program by Dr. Michael Jensen are expected to be completed in the second half of 2017, in anticipation of a potential IND filing in 2018.

 

First Quarter 2017 Financial Results

 

Endocyte reported a net loss of $11.5 million, or $0.27 per basic and diluted share, for the first quarter of 2017, compared to a net loss of $10.2 million, or $0.24 per basic and diluted share for the same period in 2016.

 

Research and development expenses were $8.0 million for the first quarter of 2017, compared to $6.5 million for the same period in 2016. The increase was primarily attributable to increases in expenses related to the EC1169 phase 1 trial, including drug manufacturing


 

expenses, expenses related to the development of EC2629 and other pre-clinical work and general research, and expenses related to the EC1456 phase 1 trial, which were partially offset by a decrease related to non-cash stock-based compensation expenses.

 

General and administrative expenses were $3.7 million for the first quarter of 2017, compared to $3.8 million for the same period in 2016. The slight decrease was primarily attributable to a decrease in compensation expense, which was partially offset by an increase in expenses related to professional fees.    

 

Cash, cash equivalents and investments were $127.6 million at March 31, 2017, compared to $163.3 million at March 31, 2016, and $138.2 million at December 31, 2016.

 

Financial Expectations

 

The company anticipates its cash balance at the end of 2017 to be approximately $100 million.

 

About EC1169 and EC0652

 

EC1169 is an investigational therapeutic SMDC constructed of a high affinity prostate specific membrane antigen (PSMA)-targeting ligand conjugated through a bioreleasable linker system to a potent microtubule inhibitor, tubulysin B hydrazide (TubBH). Patient PSMA-status is determined using the investigational companion imaging agent, EC0652.

 

About EC1456 and etarfolatide

 

EC1456 is an investigational therapeutic SMDC constructed of a high affinity FR-targeting ligand conjugated through a spacer and bioreleasable linker system to a potent cytotoxic microtubule inhibitor, TubBH. Patient FR-status is determined using the investigational companion imaging agent, etarfolatide. 

 

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 also 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 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 treatment of cancer and other serious diseases. Endocyte uses its proprietary drug conjugation technology to create novel SMDCs and companion imaging agents for personalized targeted therapies. The company’s SMDCs actively target receptors that are over-expressed on diseased cells relative to healthy cells. This targeted approach is designed to enable the treatment of patients with highly active drugs at greater doses, delivered more frequently and over longer periods of time than would be possible with the untargeted drug alone. The companion imaging agents are designed to identify patients whose disease over-expresses the target of the therapy and who are therefore more likely to benefit from treatment. 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, the successful completion of current and future clinical trials, the enrollment period for, and availability and reporting, of data from ongoing and future clinical trials, and the company's future development plans including those relating to the completion of pre-clinical development in preparation for possible future clinical trials. 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 may experience delays in the completion of its clinical trials (whether caused by competition, adverse events, patient enrollment rates, shortage


 

of clinical trial materials, regulatory issues or other factors); risks that data from its 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.


 

Endocyte, Inc.

Statements of Operations

(dollars in thousands, except per share amounts)

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the Three Months
Ended March 31,

 

 

 

 

 

2016

 

 

2017

 

 

 

 

 

 

 

Collaboration revenue

 

 

 

$

12

 

 

$

12

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

 

 

6,531

 

 

 

7,994

 

General and administrative

 

 

 

 

3,820

 

 

 

3,745

 

Total costs and expenses

 

 

 

 

10,351

 

 

 

11,739

 

Loss from operations

 

 

 

 

(10,339)

 

 

 

(11,727

)

 

 

 

 

 

 

 

 

 

 

 

Interest income, net

 

 

 

 

189

 

 

 

235

 

Other income (expense), net

 

 

 

 

(3)

 

 

 

3

 

Net loss

 

 

 

$

(10,153

 

$

(11,489

)

 

 

 

 

 

 

 

 

 

 

 

Net loss per share - basic and diluted

 

 

 

$

(0.24)

 

 

$

(0.27

)

 

 

 

 

 

 

 

 

 

 

 

Comprehensive loss

 

 

 

$

(10,043)

 

 

$

(11,501

)

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

42,109,828

 

 

 

42,434,709

 

 


 

Endocyte, Inc.

Balance Sheets

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

As of
December 31,

 

 

As of
March 31,

 

 

 

2016

 

 

2017

 

 

 

 

 

 

(unaudited)

 

Assets

 

 

 

 

 

 

 

 

Cash, cash equivalents and investments

 

$

138,207

 

 

$

127,562

 

Other assets

 

 

5,287

 

 

 

4,825

 

Total assets

 

$

143,494

 

 

$

132,387

 

 

 

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities

 

$

5,562

 

 

$

4,915

 

Deferred revenue and other liabilities, net of current portion

 

 

785

 

 

 

770

 

Total stockholders’ equity

 

 

137,147

 

 

 

126,702

 

Total liabilities and stockholders’ equity

 

$

143,494

 

 

$

132,387