– Larotrectinib Rolling NDA Submission on Track
for Completion in March –
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 2017 financial results.
“2017 was a remarkable year for the company,” said Josh
Bilenker, M.D., chief executive officer of Loxo Oncology. “Our TRK
franchise partnership with Bayer brings capital and commercial
expertise to an NDA-stage opportunity in larotrectinib and an
acquired resistance solution in LOXO-195. Continued progress in the
Phase 1 trial for LOXO-292, our highly selective RET inhibitor, has
positioned the program for a clinical update in the first half of
2018. Finally, our acquisition of LOXO-305, a selective and
reversible BTK inhibitor intended for patients with acquired
resistance or intolerance to covalent BTK inhibitors, brings a
fourth program to our pipeline, with a clinical start planned for
the second half of 2018.”
Recent Highlights
TRK Inhibitor Franchise
- Global Development and Commercialization Partnership
with Bayer: On November 14, 2017, Loxo Oncology announced
a global collaboration with Bayer to develop and commercialize
larotrectinib and LOXO-195. The company received a $400.0 million
upfront payment and is eligible for an additional $1.15 billion in
milestones, of which Loxo Oncology believes $425.0 million are
achievable in 2018 and 2019. In the U.S., where Loxo Oncology and
Bayer will co-promote the products, the parties will share
commercial costs and profits on a 50/50 basis. More information on
the collaboration can be found here.
Larotrectinib
- New England Journal of Medicine (NEJM)
Publication: On February 22, 2018, the NEJM
published results for larotrectinib in the treatment of pediatric
and adult patients with TRK fusion cancers. The publication
included central radiology results and additional patient follow-up
from the 2017 American Society of Clinical
Oncology (ASCO) Annual Meeting presentation, employing a July
17, 2017 data cutoff. As previously reported, the overall response
rate (ORR) was 75% by central assessment and 80% by investigator
assessment. As of the July 17, 2017 data cutoff, 86% of responding
patients remained on treatment or had undergone surgery with
curative intent. The publication can be found here.
- New Drug Application (NDA) Rolling Submission:
On December 20, 2017, Loxo Oncology announced that the company
initiated a rolling NDA submission to the U.S. Food and Drug
Administration (FDA) for larotrectinib for the treatment of
unresectable or metastatic solid tumors with NTRK-fusion proteins
in adult and pediatric patients who require systemic therapy and
who have either progressed following prior treatment or who have no
acceptable alternative treatments. The company expects to complete
the submission by the end of March. More information can be found
here.
- Clinical Data in Thyroid (TC) and Salivary Gland
Cancers (SGC): On February 15, 2018, a poster presentation
at the 2018 Multidisciplinary Head and Neck Cancers Symposium
outlined data in 19 patients (age 15-75 years) with TRK fusion TC
or SGC who were treated in the ongoing larotrectinib clinical
trials. In 17 patients with measurable disease (5 TC and 12 SGC),
treatment with larotrectinib led to an ORR of 88%, by both central
and investigator assessment. Adverse events were consistent with
data previously reported from these trials. The presented poster
can be found here.
- Clinical Data from the Phase 1 SCOUT Clinical
Trial: On December 4, 2017, an oral presentation at the
American Association for Cancer Research (AACR) Special Conference
on Pediatric Cancer Research outlined data in 17 pediatric patients
with TRK fusion cancers who were treated in the larotrectinib
pediatric Phase 1 SCOUT clinical trial. Treatment with
larotrectinib led to an ORR of 93%, by both central and
investigator assessment. An overview of the data can be found
here.
Upcoming Milestones
- Larotrectinib (TRK)
- Completion of the rolling NDA submission is expected in
March
- Marketing Authorisation Application submission by Bayer in the
European Union is expected in 2018
- Presentation of updated TRK fusion clinical data is expected in
the second half of 2018
- LOXO-195 (next-generation TRK)
- Presentation of updated clinical data is expected in the second
half of 2018
- LOXO-292 (RET)
- Presentation of updated clinical data is expected in the first
half of 2018
- LOXO-305 (BTK)
- Initiation of a Phase 1 clinical trial is expected in the
second half of 2018
Fourth Quarter and Full Year 2017 Financial
Results
As of December 31, 2017, Loxo Oncology had aggregate cash, cash
equivalents and investments of $626.2 million, compared to $141.8
million as of December 31, 2016. Loxo Oncology received $250
million of the $400 million upfront payment related to the Bayer
collaboration in the fourth quarter of 2017 and the remaining $150
million is payable in first quarter of 2018.
Revenue from the collaboration agreement was $21.3 million for
the fourth quarter and full year of 2017, compared to none for the
fourth quarter and full year of 2016. This represents the partial
revenue recognition of the $400 million upfront payment from the
Bayer collaboration. Loxo Oncology is recognizing revenue on a
proportional performance basis utilizing a calculation based on
quarterly research and development spending associated with
larotrectinib and LOXO-195, relative to cumulative and forecasted
research and development spending on larotrectinib and LOXO-195
over the course of the collaboration agreement. As a result, the
quarterly revenue recognized for the upfront payment will vary from
quarter to quarter.
Research and development expenses were $30.7 million for the
fourth quarter of 2017 compared to $23.4 million for the fourth
quarter of 2016. This increase was primarily due to expanded
larotrectinib development activities including clinical costs, as
well as additional development expenses related to our other
programs. Loxo Oncology also recognized research and
development-related stock-based compensation expense of $1.5
million during the fourth quarter of 2017 compared to $1.4 million
for the fourth quarter of 2016.
Research and development expenses were $140.0 million for the
year ended December 31, 2017, compared to $58.3 million for the
year ended December 31, 2016. This increase was primarily due to a
non-recurring charge related to the $40.0 million asset acquisition
of the BTK inhibitor program from Redx, expanded larotrectinib
development activities, as well as additional development expenses
related to our other programs. We also had higher employment costs
primarily due to increased headcount. Loxo Oncology also recognized
research and development-related stock-based compensation expense
of $9.5 million during the year ended December 31, 2017, compared
to $3.5 million for the year ended December 31, 2016.
General and administrative expenses were $12.7 million for the
fourth quarter of 2017 compared to $4.0 million for the fourth
quarter of 2016. The increase was primarily due to preparation
activities for the potential commercialization of larotrectinib,
additional headcount and associated employment costs and general
and administrative professional fees. Loxo Oncology also recognized
general and administrative-related stock-based compensation expense
of $3.3 million during the fourth quarter 2017 compared to $1.2
million for the fourth quarter of 2016.
General and administrative expenses were $33.7 million for the
year ended December 31, 2017, compared to $14.9 million for the
year ended December 31, 2016. The increase was primarily due to
preparation activities for the potential commercialization of
larotrectinib, additional headcount and associated employment costs
and general and administrative professional fees. Loxo Oncology
also recognized general and administrative-related stock-based
compensation expense of $9.9 million during the year ended December
31, 2017, compared to $4.5 million for the year ended December 31,
2016.
Net loss was $20.6 million for the fourth quarter of 2017,
compared to $27.2 million for the fourth quarter of 2016. Net loss
was $148.9 million for the year ended December 31, 2017, compared
to $72.4 million for the year ended December 31, 2016. This
increase in net loss is primarily driven by the increases in
operating expenses.
Non-GAAP net loss was $37.2 million for the fourth quarter of
2017, compared to $24.6 million for the fourth quarter of
2016. Non-GAAP net loss was $110.8 million for the year ended
2017, compared to $64.4 million for the year ended 2016. This
non-GAAP net loss measure, more fully described below under
“Non-GAAP Financial Measures,” excludes the recognition of
collaboration revenue related to an upfront payment, acquisition of
an in-process R&D asset and share-based compensation expenses.
A reconciliation of the GAAP financial results to non-GAAP
financial results is included with the attached financial
statements.
Conference Call Information Loxo
Oncology will host a conference call today at 8:00 a.m.
ET to discuss the fourth quarter and full-year 2017 financial
results and program updates. To participate in the conference call,
please dial (877) 930-8065 (domestic) or (253) 336-8041
(international) and refer to conference ID 7395447. A replay will
be available shortly after the conclusion of the call and archived
on the company's website for 30 days following the call.
About Loxo OncologyLoxo 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, the reporting, timing and success of our
clinical trials. Further information on potential risk factors that
could affect our business and its financial results are detailed in
our most recent Annual Report on Form 10-K, 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.
Non-GAAP Financial MeasuresThis press release
includes financial results prepared in accordance with accounting
principles generally accepted in the United States (GAAP), and also
certain historical non-GAAP financial measures. In particular, we
have provided non-GAAP net loss, adjusted to exclude recognized
collaboration revenue related to an upfront payment, the
acquisition of an in process R&D asset and share-based
compensation expenses. Non-GAAP financial measures are not an
alternative for financial measures prepared in accordance with
GAAP. For a reconciliation of these non-GAAP financial measures to
their most directly comparable GAAP financial measure, see the
table below. Non-GAAP financial measures may not be comparable to
similarly titled measures reported by other companies, since not
all companies may calculate these measures in an identical manner
and, therefore, it is not necessarily an accurate measure of
comparison between companies. However, we believe the presentation
of non-GAAP net loss, when viewed in conjunction with our GAAP
results, provides investors and management with a more complete
understanding of our ongoing and projected operating performance
because this measure excludes the recognition of collaboration
revenue from an upfront payment that is a non-recurring event,
acquisition of an in process R&D asset that is a non-recurring
event and non-cash charges that are substantially dependent on
changes in the market price of our common stock. We believe our
non-GAAP net loss measure helps indicate underlying trends in our
business and is important in comparing current results with prior
period results.
Financials
LOXO ONCOLOGY, INC. |
|
Condensed Consolidated Balance
Sheets |
|
(in thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
|
|
|
|
|
2017 |
|
|
2016 |
|
Assets |
|
|
(Unaudited) |
|
|
|
Cash, cash
equivalents and investments |
|
|
$ |
626,200 |
|
$ |
141,810 |
|
Receivable
from collaboration partner |
|
|
|
150,000 |
|
|
— |
|
Other
prepaid expenses and current assets |
|
|
|
5,607 |
|
|
2,483 |
|
Property
and equipment, net |
|
|
|
912 |
|
|
248 |
|
Other
assets |
|
|
|
723 |
|
|
771 |
|
|
|
Total assets |
|
|
|
783,442 |
|
|
145,312 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Accounts
payable |
|
|
|
3,996 |
|
|
1,061 |
|
Accrued
expenses and other current liabilities |
|
|
22,537 |
|
|
14,083 |
|
Deferred
revenue |
|
|
378,699 |
|
|
— |
|
|
|
Total liabilities |
|
|
|
405,232 |
|
|
15,144 |
|
Commitments
and contingencies |
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
Common
stock, $0.0001 par value; 125,000,000 shares authorized; 29,991,884
and 21,681,236 shares issued and outstanding at December 31, 2017
and December 31, 2016, respectively |
|
3 |
|
|
2 |
|
|
Additional
paid-in capital |
|
|
|
666,891 |
|
|
269,423 |
|
|
Accumulated
deficit |
|
|
|
(288,112 |
) |
|
(139,236 |
) |
|
Other
comprehensive loss |
|
|
|
(572 |
) |
|
(21 |
) |
|
|
Total stockholders'
equity |
|
|
|
378,210 |
|
|
130,168 |
|
|
|
Total
liabilities and stockholders' equity |
|
$ |
783,442 |
|
$ |
145,312 |
|
LOXO ONCOLOGY, INC. |
|
Consolidated Statements of
Operations |
|
(unaudited) |
|
(in thousands, except share and per share
amounts) |
|
|
|
|
Three Months
EndedDecember 31, |
|
Year EndedDecember
31, |
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from
collaboration agreement |
$ |
21,300 |
|
$ |
— |
|
$ |
21,300 |
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
30,718 |
|
|
23,358 |
|
|
140,039 |
|
|
58,275 |
|
General
and administrative |
|
12,689 |
|
|
4,044 |
|
|
33,657 |
|
|
14,903 |
|
Total operating
expenses |
|
(43,407 |
) |
|
(27,402 |
) |
|
(173,696 |
) |
|
(73,178 |
) |
Loss from
operations |
|
(22,107 |
) |
|
(27,402 |
) |
|
(152,396 |
) |
|
(73,178 |
) |
Interest income,
net |
|
1,479 |
|
|
208 |
|
|
3,520 |
|
|
780 |
|
Net loss |
$ |
(20,628 |
) |
$ |
(27,194 |
) |
$ |
(148,876 |
) |
$ |
(72,398 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share
information: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of
common stock, basic and diluted |
$ |
(0.69 |
) |
$ |
(1.26 |
) |
$ |
(5.31 |
) |
$ |
(3.46 |
) |
Weighted average shares
outstanding, basic and diluted |
|
29,948,706 |
|
|
21,634,295 |
|
|
28,035,697 |
|
|
20,905,448 |
|
LOXO ONCOLOGY, INC. |
|
Reconciliation of GAAP Net Loss to Non-GAAP
Net Loss |
|
(unaudited) |
|
(in thousands, except share and per share
amounts) |
|
|
|
|
Three Months
EndedDecember 31, |
|
Year EndedDecember
31, |
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss |
$ |
(20,628 |
) |
$ |
(27,194 |
) |
$ |
(148,876 |
) |
$ |
(72,398 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from
collaboration agreement |
|
(21,300 |
) |
|
— |
|
|
(21,300 |
) |
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition of
in-process R&D (IPR&D) asset |
|
|
|
|
|
|
|
|
|
|
|
|
included
in R&D expenses |
|
— |
|
|
— |
|
|
40,000 |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based
compensation expenses |
|
|
|
|
|
|
|
|
|
|
|
|
included
in R&D expenses |
|
1,492 |
|
|
1,369 |
|
|
9,502 |
|
|
3,471 |
|
Share-based
compensation expenses |
|
|
|
|
|
|
|
|
|
|
|
|
included
in G&A expenses |
|
3,252 |
|
|
1,197 |
|
|
9,920 |
|
|
4,489 |
|
Total share-based
compensation expenses |
|
4,744 |
|
|
2,566 |
|
|
19,422 |
|
|
7,960 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total adjustments |
|
(16,556 |
) |
|
2,566 |
|
|
38,122 |
|
|
7,960 |
|
Non-GAAP net loss |
$ |
(37,184 |
) |
$ |
(24,628 |
) |
$ |
(110,754 |
) |
$ |
(64,438 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share
information: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of
common stock, basic and diluted |
$ |
(1.24 |
) |
$ |
(1.14 |
) |
$ |
(3.95 |
) |
$ |
(3.08 |
) |
Weighted average shares
outstanding, basic and diluted |
|
29,948,706 |
|
|
21,634,295 |
|
|
28,035,697 |
|
|
20,905,448 |
|
Contacts for 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 1AB Media 973-271-6085 dan@1abmedia.com
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