- LOXO-292 Phase 1 Oral Presentation Upcoming at
2018 ASCO Annual Meeting -
Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company
innovating the development of highly selective medicines for
patients with genetically defined cancers, today reported first
quarter 2018 financial results.
“In the first quarter, we delivered against all of our planned
corporate goals. We completed the rolling NDA submission for
larotrectinib, enrolled well on the LOXO-292 Phase 1 trial and
moved LOXO-305 toward a clinical start in the second half of
2018. We also entered into an important collaboration with
Illumina to develop a companion diagnostic test for larotrectinib
and LOXO-292,” said Josh Bilenker, M.D., chief executive officer of
Loxo Oncology. “We look forward to providing a comprehensive update
on the Phase 1 study of LOXO-292 at ASCO on June 2nd.”
Recent Highlights
Companion Diagnostic (CDx) Partnership
- Global Development and Commercialization Partnership
with Illumina: On April 10, 2018, Loxo Oncology announced
a global strategic partnership with Illumina to develop and
commercialize a CDx version of Illumina’s TruSight Tumor 170 for
NTRK fusions and RET fusions/mutations as a Class III FDA-approved
companion diagnostic in conjunction with larotrectinib and
LOXO-292, respectively. The companies are also planning to broaden
the clinical utility of the full panel by seeking approval for the
rest of the assay content as a Class II cancer genomic profiling
test. More information can be found here.
Larotrectinib
- Completion of New Drug Application (NDA) Rolling
Submission to FDA: On March 26, 2018, Loxo Oncology
completed the rolling submission of an NDA to the U.S. Food and
Drug Administration (FDA) for larotrectinib for the treatment of
adult and pediatric patients with locally advanced or metastatic
solid tumors harboring an NTRK gene fusion. More information can be
found here.
- The Lancet Oncology
Publication: On March 29, 2018, The Lancet
Oncology published results for larotrectinib in the treatment of
pediatric patients with TRK fusion cancer. The publication included
results from the ongoing pediatric Phase 1/2 trial. In this trial,
larotrectinib induced an objective response rate (ORR) of 93
percent in pediatric patients with TRK fusion-positive solid
tumors. The publication can be found here.
LOXO-292
- Annals of Oncology
Publication: On April 18, 2018, the Annals of
Oncology published a manuscript illustrating the preclinical
profile of LOXO-292, preclinical work supporting LOXO-292’s
selective inhibition of RET, and continued evidence of clinical
proof-of-concept. The publication included two patient cases who
both presented with RET-altered, multikinase (MKI)
inhibitor-resistant cancers. One patient harbored RET M918T-mutant
medullary thyroid cancer with an acquired RET V804M gatekeeper
resistance mutation, and the other patient harbored KIF5B-RET
fusion-positive non-small cell lung cancer with brain metastases.
The latter case was previously reported on in October 2017 in a
presentation at the International Association for the Study of Lung
Cancer 18th World Conference on Lung Cancer. Due to clinical
urgency, both were treated with LOXO-292 on intra-patient dose
escalation single patient protocols. Both patients achieved RECIST
confirmed partial responses. This represents the first clinical
report of the predicted RET V804M gatekeeper mutation arising in a
patient previously treated with MKIs, and the first successful
treatment of a patient in that setting. In this two-patient
dataset, LOXO-292 was well-tolerated with no adverse events
attributed to LOXO-292. The publication can be found here.
- LOXO-292 Oral Presentation Accepted at the American
Society of Clinical Oncology (ASCO) Annual Meeting: On
April 4, 2018, Loxo Oncology announced that LOXO-292 interim
clinical data from the ongoing Phase 1 clinical trial will be
presented in an oral presentation at the ASCO Annual Meeting held
June 1 - 5, 2018 in Chicago, Illinois. The presentation is entitled
“A Phase 1 Study of LOXO-292, A Potent and Highly Selective RET
Inhibitor, in Patients with RET-Altered Cancers.” Loxo Oncology
will host a conference call and live webcast on Saturday, June 2,
2018 at 4:00 p.m. CT to discuss the clinical data after they are
presented at ASCO. Information on how to access the call and
webcast can be found below.
Upcoming Milestones
- Larotrectinib (TRK)
- FDA is expected to accept the filing of the New Drug
Application in the first half of 2018
- 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 at the ASCO Annual
Meeting
- LOXO-305 (BTK)
- Initiation of a Phase 1 clinical trial is expected in the
second half of 2018
First Quarter 2018 Financial Results
As of March 31, 2018, Loxo Oncology had aggregate cash, cash
equivalents and investments of $735.6 million, compared to $626.2
million as of December 31, 2017. Loxo Oncology received the
remaining $150 million of the $400 million upfront payment related
to the Bayer collaboration in the first quarter of 2018.
Revenue from the collaboration agreement was $38.4 million for
the first quarter of 2018, compared to none for the first quarter
of 2017. This represents $42.9 million in revenue recognized from
the $400 million upfront payment from the Bayer collaboration
offset by $4.4 million, Loxo Oncology’s share of the joint
larotrectinib co-promotion costs. Loxo Oncology recognizes revenue
from the upfront payment 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 varies from quarter to quarter. A supporting
schedule that shows the different components of revenue from the
collaboration agreement is included with the attached financial
statements.
Research and development expenses were $32.0 million for the
first quarter of 2018 compared to $20.2 million for the first
quarter of 2017. This increase was primarily due to expanded
larotrectinib development activities including clinical costs, as
well as additional development expenses related to our other
programs, and higher employment costs primarily due to increased
headcount. These numbers are net of 50/50 cost-sharing with Bayer
for larotrectinib and LOXO-195 development costs. Loxo Oncology
recognized research and development-related stock-based
compensation expense of $4.3 million during the first quarter of
2018 as compared to $2.4 million for the first quarter of 2017.
General and administrative expenses were $12.2 million for the
first quarter of 2018 compared to $4.8 million for the first
quarter of 2017. The increase was primarily due to additional
headcount and associated employment costs and general and
administrative professional fees. Loxo Oncology recognized general
and administrative-related stock-based compensation expense of $5.4
million during the first quarter 2018 compared to $1.6 million for
the first quarter of 2017.
Net loss was $3.6 million for the first quarter of 2018,
compared to $24.5 million for the first quarter of 2017. This
decrease in net loss is primarily driven by the revenue recognized
from the $400.0 million upfront payment from the Bayer
collaboration, the larotrectinib and LOXO-195 development
reimbursement from the Bayer collaboration, offset by increases in
operating expenses.
Non-GAAP net loss was $36.8 million for the first quarter of
2018, compared to $20.6 million for the first quarter of
2017. This non-GAAP net loss measure, more fully described
below under “Non-GAAP Financial Measures,” excludes the recognition
of collaboration revenue related to the Bayer upfront payment and
share-based compensation expenses. A reconciliation of the GAAP
financial results to non-GAAP financial results is included with
the attached financial statements.
Earnings Conference Call Information Loxo
Oncology will host a conference call today at 8:00 a.m. ET to
discuss the first quarter 2018 financial results and company
updates. To participate in the conference call, please dial (877)
930-8065 (domestic) or (253) 336-8041 (international) and refer to
conference ID 1979239. 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.
ASCO Conference Call and Webcast Information
Loxo Oncology will be hosting a conference call and live webcast
with slides and Q&A on Saturday, June 2, 2018 at 4:00 p.m. CT
to discuss the interim LOXO-292 clinical data after they are
presented at ASCO. To participate in the conference call, please
dial (877) 930-8065 (domestic) or (253) 336-8041 (international)
and refer to conference ID 3597058. A live webcast of the
presentation will be available at http://ir.loxooncology.com/. 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 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 StatementsThis 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, and the timing or success of regulatory approvals
in the U.S. and in the E.U. 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 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 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) |
|
|
|
|
|
|
|
|
March 31, |
|
|
|
December 31, |
|
|
|
2018 |
|
|
|
2017 |
|
Assets |
(Unaudited) |
|
|
|
Cash, cash equivalents
and investments |
$ |
735,584 |
|
|
$ |
626,200 |
|
Receivable from
collaboration partner |
|
4,529 |
|
|
|
150,000 |
|
Other prepaid expenses
and current assets |
|
5,891 |
|
|
|
5,607 |
|
Property and equipment,
net |
|
1,578 |
|
|
|
912 |
|
Other assets |
|
1,027 |
|
|
|
723 |
|
Total
assets |
|
748,609 |
|
|
|
783,442 |
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
Accounts payable |
|
5,796 |
|
|
|
3,996 |
|
Accrued expenses and
other current liabilities |
|
22,546 |
|
|
|
22,537 |
|
Deferred revenue |
|
335,846 |
|
|
|
378,699 |
|
Total
liabilities |
|
364,188 |
|
|
|
405,232 |
|
Commitments and
contingencies |
|
|
|
|
Stockholders’
equity |
|
|
|
|
Common
stock, $0.0001 par value; 125,000,000 shares authorized; 30,055,380
and 29,991,884 shares issued and outstanding at March 31, 2018 and
December 31, 2017, respectively |
|
3 |
|
|
|
3 |
|
Additional paid-in capital |
|
676,771 |
|
|
|
666,891 |
|
Accumulated deficit |
|
(291,670 |
) |
|
|
(288,112 |
) |
Other
comprehensive loss |
|
(683 |
) |
|
|
(572 |
) |
Total
stockholders' equity |
|
384,421 |
|
|
|
378,210 |
|
Total
liabilities and stockholders' equity |
$ |
748,609 |
|
|
$ |
783,442 |
|
|
|
|
|
|
|
|
|
|
|
LOXO ONCOLOGY, INC. |
|
Consolidated Statements of
Operations |
|
(unaudited) |
|
(in thousands, except share and per share
amounts) |
|
|
|
|
|
Three Months EndedMarch
31, |
|
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
Revenue from
collaboration agreement |
$ |
38,429 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research
and development |
|
31,990 |
|
|
|
20,169 |
|
General
and administrative |
|
12,194 |
|
|
|
4,773 |
|
Total operating
expenses |
|
44,184 |
|
|
|
24,942 |
|
Loss from
operations |
|
(5,755 |
) |
|
|
(24,942 |
) |
Interest income,
net |
|
2,197 |
|
|
|
414 |
|
Net loss |
$ |
(3,558 |
) |
|
$ |
(24,528 |
) |
|
|
|
|
|
|
|
|
Per share
information: |
|
|
|
|
|
|
|
Net loss per share of
common stock, basic and diluted |
$ |
(0.12 |
) |
|
$ |
(0.96 |
) |
Weighted average shares
outstanding, basic and diluted |
|
30,025,461 |
|
|
|
25,668,052 |
|
|
|
|
|
|
|
|
|
|
LOXO ONCOLOGY, INC. |
Reconciliation of GAAP Net Loss to Non-GAAP Net
Loss |
(unaudited) |
(in thousands, except share and per share
amounts) |
|
|
Three Months EndedMarch
31, |
|
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
GAAP net loss |
$ |
(3,558 |
) |
|
$ |
(24,528 |
) |
Adjustments: |
|
|
|
|
|
|
|
Revenue from
collaboration agreement |
|
|
|
|
|
|
|
Revenue
recognized from $400M upfront payment |
|
(42,853 |
) |
|
|
— |
|
|
|
|
|
|
|
|
|
Share-based compensation expenses |
|
|
|
|
|
|
|
included
in R&D expenses |
|
4,283 |
|
|
|
2,406 |
|
Share-based compensation expenses |
|
|
|
|
|
|
|
included
in G&A expenses |
|
5,368 |
|
|
|
1,568 |
|
Total share-based
compensation expenses |
|
9,651 |
|
|
|
3,974 |
|
|
|
|
|
|
|
|
|
Total adjustments |
|
(33,202 |
) |
|
|
3,974 |
|
Non-GAAP net loss |
$ |
(36,760 |
) |
|
$ |
(20,554 |
) |
|
|
|
|
|
|
|
|
Per share
information: |
|
|
|
|
|
|
|
Net loss per share of
common stock, basic and diluted |
$ |
(1.22 |
) |
|
$ |
(0.80 |
) |
Weighted average shares
outstanding, basic and diluted |
|
30,025,461 |
|
|
|
25,668,052 |
|
|
|
|
|
|
|
|
|
|
LOXO ONCOLOGY, INC. |
Calculation of Revenue from Collaboration
Agreement |
(unaudited) |
(in thousands) |
|
|
Three Months EndedMarch
31, |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
Upfront payment |
|
|
|
|
|
|
Revenue
recognized from $400M upfront payment |
$ |
42,853 |
|
|
$ |
— |
|
|
|
|
|
|
|
Milestones |
|
— |
|
|
|
— |
|
|
|
|
|
|
|
Royalties |
|
— |
|
|
|
— |
|
|
|
|
|
|
|
Co-promote |
|
|
|
|
|
|
Product
revenue subject to profit sharing (as recorded by Bayer) |
|
— |
|
|
|
— |
Combined
cost of goods sold, distribution, selling, general and |
|
|
|
|
|
|
administrative expenses |
|
(8,848 |
) |
|
|
— |
Combined
collaboration co-promotion profit/(loss) |
|
(8,848 |
) |
|
|
— |
|
|
|
|
|
|
|
Loxo
Oncology’s 50/50 share of collaboration co-promotion
profit/(loss) |
|
(4,424 |
) |
|
|
— |
|
|
|
|
|
|
|
Total revenue from
collaboration agreement |
$ |
38,429 |
|
|
$ |
— |
|
|
|
|
|
|
|
Contacts for Loxo Oncology, Inc.
Company: Lauren CohenDirector, Corporate
Communicationslcohen@loxooncology.com
Investors:Peter Rahmer Endurance Advisors, LLC 415-515-9763
prahmer@enduranceadvisors.com
Media:Dan Budwick1AB Media973-271-6085dan@1abmedia.com
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