UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 8-K

 

CURRENT REPORT PURSUANT TO

SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Date of Report: March 15, 2016

(Date of earliest event reported)

 

LOXO ONCOLOGY, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware

(State or Other Jurisdiction of Incorporation)

 

001-36562

 

46-2996673

(Commission File Number)

 

(IRS Employer Identification No.)

 

281 Tresser Blvd, 9th Floor
Stamford, CT

 

06901

(Address of Principal Executive Offices)

 

(Zip Code)

 

(203) 653-3880

(Registrant’s Telephone Number, Including Area Code)

 

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):

 

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))

 

 

 



 

Item 2.02 Results of Operations and Financial Condition.

 

On March 15, 2016, Loxo Oncology, Inc. (“Loxo Oncology”) issued a press release announcing its financial results for the year ended December 31, 2015. A copy of the press release is attached as Exhibit 99.01 to this Current Report on Form 8-K.

 

The information in this Item 2.02, including Exhibit 99.01 to this Current Report on Form 8-K, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended.  The information contained in this Item 2.02 and in the accompanying Exhibit 99.01 shall not be incorporated by reference into any registration statement or other document filed by Loxo Oncology with the Securities and Exchange Commission, whether made before or after the date of this Current Report on Form 8-K, regardless of any general incorporation language in such filing (or any reference to this Current Report on Form 8-K generally), except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

99.01

 

Press release issued by Loxo Oncology regarding its financial results for the year ended December 31, 2015, dated March 15, 2016.

 

2



 

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.

 

 

 

Loxo Oncology, Inc.

 

 

 

 

Date: March 15, 2016

By:

/s/ Jennifer Burstein

 

 

Name: Jennifer Burstein

 

 

Title: Vice President, Finance

 

 

 

3



 

EXHIBIT INDEX

 

Number

 

Description

99.01

 

Press release issued by Loxo Oncology regarding its financial results for the year ended December 31, 2015, dated March 15, 2016.

 

4


Exhibit 99.01

 

 

Loxo Oncology Reports Fourth Quarter and Year-End 2015 Financial Results and Provides Program Updates

 

— Updated LOXO-101 Phase 1 Clinical Data Accepted for Oral Plenary Session Presentation at 2016 AACR Annual Meeting —

 

— LOXO-195, Next-Generation Selective TRK Inhibitor Addressing Potential Acquired Resistance, to Enter the Clinic in 2017 —

 

— Cash Position Funds Operations Well Into 2018 —

 

STAMFORD, Conn., March 15, 2016 — Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today reported fourth quarter and year-end 2015 financial results and provided an update on its drug development programs. Loxo Oncology will not be conducting a conference call in conjunction with this earnings release.

 

“We ended 2015 with great momentum behind LOXO-101 and our pipeline programs,” said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. “We are excited to announce that updated LOXO-101 adult Phase 1 data have been selected for an oral plenary session at AACR in April. This presentation will provide further follow-up on the first three enrolled patients with TRK fusions that responded to LOXO-101, and will provide initial response assessment and follow-up on the next three enrolled patients with TRK fusions. We are also pleased to announce that we have developed a next-generation selective TRK inhibitor, LOXO-195, in collaboration with our partner Array BioPharma. Last year, we supported academic research to anticipate potential mechanisms of acquired resistance to TRK inhibition and we have continued to follow published literature reports that corroborate and add to those results. Should a patient progress on LOXO-101 or another compound, we hope LOXO-195 will be able to induce a new response in the patient and functionally extend time on therapy.”

 

Dr. Bilenker continued, “We are fortunate that our financing in November allows us to fund operations well into 2018, which we believe will provide ample runway for potentially meaningful clinical data events for LOXO-101, LOXO-195, our RET program and other possible Array collaboration projects.”

 

New Announcements

 

·                  Updated LOXO-101 Phase 1 Data at AACR: Loxo Oncology announced today that updated clinical data from the ongoing LOXO-101 Phase 1 trial were accepted for oral plenary session presentation at the 2016 American Association for Cancer Research (AACR) Annual Meeting in New Orleans, taking place April 16-20, 2016. This presentation will be an update to data presented at the AACR-NCI-EORTC meeting in November 2015, with a focus on enrolled patients with

 



 

TRK fusions. The abstract title will be posted online at 4:30 p.m. ET on Wednesday, March 16.

 

·                  Next-Generation Selective TRK Inhibitor: Acquired resistance to targeted therapies has proven to be an important component of long-term cancer care and targeted therapy drug development. In anticipation of potential resistance to LOXO-101, and in light of recent published literature regarding emerging mechanisms of resistance to TRK inhibition, Loxo Oncology today unveiled its next-generation selective TRK inhibitor, LOXO-195, which is capable of addressing potential mechanisms of acquired resistance that may emerge in patients receiving LOXO-101 or multikinase inhibitors with anti-TRK activity. With the LOXO-195 program, Loxo Oncology has an opportunity to strengthen its leadership position in the field of TRK inhibition and clinically extend the duration of disease control for patients with TRK-driven cancers. Loxo Oncology will begin IND-enabling activities in 2016 that should enable initiation of a LOXO-195 Phase 1 study in 2017.

 

·                  2015 Financial Results and 2016 Cash Guidance. As of December 31, 2015, Loxo Oncology had cash, cash equivalents and investments of $153.9 million. The company expects a cash burn of $48 to $52 million in 2016. The company believes that based upon its current operating plan, its existing capital resources will be sufficient to fund its anticipated operations well into 2018.

 

Recent Highlights

 

LOXO-101 Program

 

·                  LOXO-101 Phase 1 Pediatric Trial Initiated: In December, Loxo Oncology enrolled the first patient in the LOXO-101 pediatric Phase 1 trial, a multicenter, open-label trial in pediatric patients with advanced solid or primary CNS tumors.

 

·                  LOXO-101 Phase 1 Data Presented at AACR-NCI-EORTC: Results from the Phase 1 study of LOXO-101 were reported in a late-breaking oral presentation at the 27th AACR-NCI-EORTC Symposium on Molecular Targets and Cancer Therapeutics in November. As of the October 20, 2015 cutoff date, six patients with cancers harboring TRK fusions had been enrolled and treated. Three of the six patients with TRK fusion cancers had been on study long enough for their first efficacy assessment, and all three had achieved an objective response at the first response assessment, as defined by standard RECIST criteria. See the full data here.

 

·                  LOXO-101 Phase 2 Basket Trial Initiated: In October, Loxo Oncology enrolled the first patient in the LOXO-101 Phase 2 trial, a global, multi-center, single-arm, open-label basket trial in adult patients with solid tumors that harbor a TRK fusion.

 

·                  LOXO-101 Selected for NCI-MATCH Trial: In October, the independent committee of the National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) clinical trial chose LOXO-101 as the sole, dedicated treatment arm for patients with TRK gene fusions. Loxo Oncology anticipates that the NCI will activate the TRK fusion arm of this study later in 2016.

 



 

Pipeline: RET and FGFR Pre-clinical Programs

 

·                  Data on RET and FGFR Programs Presented at AACR-NCI-EORTC: Loxo Oncology presented two preclinical posters at AACR-NCI-EORTC containing the first publicly disclosed data for its Rearranged during Transfection (RET) and Fibroblast Growth Factor Receptor (FGFR) programs showing potential best-in-class selectivity and target coverage.

 

·                  RET Clinical Trial Initiation: Consistent with prior guidance, the company plans to initiate a Phase 1 study of its RET inhibitor in late 2016 or early 2017.

 

Corporate Activities

 

·                  Strengthened Balance Sheet: Loxo Oncology raised $76.2 million in gross proceeds in an equity financing in November 2015. Loxo Oncology’s cash, cash equivalents and marketable securities are expected to be sufficient to fund operations well into 2018.

 

Fourth Quarter and Year-End 2015 Financial Results

 

Cash, cash equivalents and investments totaled $153.9 million as of December 31, 2015, compared to $112.9 million as of December 31, 2014. The increase was attributable to $71.3 million in net proceeds from our November 2015 equity financing offset by $30.3 million in cash burn.

 

Research and development expenses were $9.8 million for the fourth quarter of 2015 compared to $4.6 million in the fourth quarter of 2014. The increase was primarily attributable to expanded Phase 1 and Phase 2 clinical development activities for LOXO-101 and additional full-time equivalents and other support dedicated to discovery, preclinical, and manufacturing activities at Array BioPharma or third-party vendors.

 

Research and development expenses were $25.6 million for the year ended December 31, 2015, compared to $14.5 million for the year ended December 31, 2014.  The increase was primarily due to expanded Phase 1 and Phase 2 clinical development activities for LOXO-101 and additional full-time equivalents and other support dedicated to discovery, preclinical, and manufacturing activities at Array BioPharma or third-party vendors.  The company also recognized R&D-related stock-based compensation expense of $3.3 million during the year ended December 31, 2015 compared to $2.0 million for the year ended December 31, 2014.

 

General and administrative expenses were $3.2 million for the fourth quarter of 2015 compared to $2.6 million in the fourth quarter of 2014. The increase was primarily due to additional full-time equivalents, increased compensation costs and increased costs associated with operating as a public company.

 

General and administrative expenses were $10.5 million for the year ended December 31, 2015, compared to $6.2 million for the year ended December 31, 2014. The increase was primarily due to additional full-time equivalents, increased compensation costs and increased costs associated with operating as a public company. The company also recognized G&A-related stock-based compensation expense of $2.8 million during the

 



 

year ended December 31, 2015 compared to $1.0 million for the year ended December 31, 2014.

 

Net loss attributable to common stockholders was $12.9 million for the fourth quarter of 2015, compared to $7.1 million for the fourth quarter of 2014. Net loss attributable to common stockholders was $35.9 million for the year ended December 31, 2015, compared to $20.7 million for the year ended December 31, 2014.

 

About LOXO-101

 

LOXO-101 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, LOXO-101 has demonstrated encouraging preliminary efficacy. LOXO-101 is also being evaluated in a global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions, and a Phase 1 dose escalation trial in pediatric cancer patients. For additional information about both the LOXO-101 clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123.

 

About Loxo Oncology

 

Loxo Oncology is a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers. Our pipeline focuses on cancers that are uniquely dependent on single gene abnormalities, such that a single drug has the potential to treat the cancer with dramatic effect. We believe that the most selective, purpose-built medicines have the highest probability of maximally inhibiting the intended target, thereby delivering best-in-class disease control and safety. Our management team seeks out experienced industry partners, world-class scientific advisors and innovative clinical-regulatory approaches to deliver new cancer therapies to patients as quickly and efficiently as possible. For more information, please visit the company’s website at www.loxooncology.com.

 

Forward Looking Statements

 

This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, statements we make regarding the timing and success of our clinical trials, success in our collaborations and the potential therapeutic benefits and economic value

 



 

of our lead product candidate or other product candidates. Further information on potential risk factors that could affect our business and its financial results are detailed in our most recent Quarterly Report on Form 10-Q, and other reports as filed from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

 



 

Financials

 

Loxo Oncology, Inc.

Balance Sheets

(in thousands, except share and per share amounts)

 

 

 

December
31,
2015

 

December
31,
2014

 

 

 

 

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

68,177

 

$

43,930

 

Short-term investments

 

85,715

 

62,362

 

Prepaid expenses with related party

 

922

 

663

 

Other prepaid expenses and current assets

 

1,830

 

821

 

Total current assets

 

156,644

 

107,776

 

Long-term investments

 

 

6,648

 

Property and equipment, net

 

88

 

12

 

Other assets

 

726

 

23

 

Total assets

 

$

157,458

 

$

114,459

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

269

 

$

239

 

Accrued expenses and other current liabilities

 

2,584

 

1,548

 

Total liabilities

 

2,853

 

1,787

 

Commitments and contingencies

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Common stock, $0.0001 par value; 125,000,000 shares authorized; 19,577,707 shares issued and outstanding at December 31, 2015; and 16,644,229 shares issued and 16,634,063 shares outstanding at December 31, 2014

 

2

 

2

 

Additional paid-in capital

 

221,457

 

143,660

 

Accumulated deficit

 

(66,838

)

(30,962

)

Accumulated other comprehensive loss

 

(16

)

(28

)

Total stockholders’ equity

 

154,605

 

112,672

 

Total liabilities and stockholders’ equity

 

$

157,458

 

$

114,459

 

 



 

Loxo Oncology, Inc.

Statements of Operations

(in thousands, except share and per share amounts)

 

 

 

Year Ended
December
31, 2015

 

Year Ended
December
31, 2014

 

Operating expenses:

 

 

 

 

 

Research and development with related party

 

$

11,611

 

$

7,568

 

Research and development

 

13,956

 

6,947

 

General and administrative

 

10,508

 

6,175

 

Total operating expenses and loss from operations

 

(36,075

)

(20,690

)

Interest income, net

 

199

 

18

 

Net loss

 

$

(35,876

)

$

(20,672

)

Accretion of redeemable convertible preferred stock

 

 

(34

)

Net loss attributable to common stockholders

 

$

(35,876

)

$

(20,706

)

Per share information:

 

 

 

 

 

Net loss per share of common stock, basic and diluted

 

$

(2.12

)

$

(3.06

)

Weighted average shares outstanding, basic and diluted

 

16,894,549

 

6,773,673

 

 

###

 

Contacts

 

Loxo Oncology, Inc.

 

Company:

Jacob S. Van Naarden

Chief Business Officer

jake@loxooncology.com

 

Investors:

Peter Rahmer

The Trout Group, LLC

646-378-2973

prahmer@troutgroup.com

 

Media:

Dan Budwick

Pure Communications, Inc.

973-271-6085

dan@purecommunicationsinc.com