- LOXO-292 New Drug Application (NDA) Submission
to FDA Expected in Late 2019 -
Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company
developing highly selective medicines for patients with genomically
defined cancers, today reported second quarter 2018 financial
results.
“We made significant progress across our pipeline in the second
quarter,” said Josh Bilenker, M.D., chief executive officer of Loxo
Oncology. “In May, our NDA for larotrectinib was accepted by FDA
and granted Priority Review. In June, initial clinical data from
the ongoing LIBRETTO-001 Phase 1/2 study of LOXO-292 were presented
at ASCO. These data enabled a subsequent FDA meeting, which
established a path forward for the program. And lastly, we
completed important enabling studies and manufacturing activities
for the LOXO-305 IND. In the second half of the year, we are
focused on continuing to advance our pipeline, as well as aiding
and advising our partners at Bayer in anticipation of a possible
larotrectinib regulatory approval. Operationally, we aim to lay the
groundwork for the long-term adoption of tumor genomic testing
capable of detecting TRK fusions alongside other clinically
actionable alterations.”
LOXO-292 Regulatory Update
Loxo Oncology recently conducted a meeting with the U.S. Food
and Drug Administration (FDA) for LOXO-292. Based on written
minutes from FDA, Loxo Oncology expects to submit a new drug
application (NDA) for LOXO-292 in late 2019, utilizing data
generated from the ongoing LIBRETTO-001 clinical trial. This
timeline integrates standard NDA activities which are ongoing and
planned, including clinical pharmacology studies, non-clinical
studies, and manufacturing. Loxo Oncology expects to file for
separate potential indications for two populations of patients:
those with RET fusion-positive solid tumors such as lung and
thyroid cancer, and those with RET-mutant medullary thyroid cancer
(MTC). In both cases, Loxo Oncology expects that patients
will be required to have received systemic therapy, progressed
following prior treatment and have no satisfactory alternative
treatment options.
Recent Highlights
Larotrectinib
- Abstract Accepted for Oral Presentation at the European
Society for Medical Oncology (ESMO) 2018 Congress:
Clinical data for larotrectinib will be presented at the ESMO 2018
Congress to be held October 19-23, 2018, in Munich, Germany. The
presentation will provide updated clinical follow-up for the 55
patients who comprise the primary efficacy analysis population that
has supported global regulatory filings. The presentation will also
include new data for TRK fusion patients subsequently
enrolled.
- Abstract Accepted for Poster Presentation at the
Molecular Analysis for Personalised Therapy 2018 Congress:
On September 15, 2018, Ventana Medical Systems, Inc., a member of
the Roche Group, and Loxo Oncology, will present a co-authored
poster on the analytical validation of Ventana’s pan-TRK IHC assay
at the Molecular Analysis for Personalised Therapy 2018 Congress,
to be held September 14-15, 2018 in Paris, France.
- Acceptance of NDA by FDA: On May 29, 2018,
Loxo Oncology announced FDA acceptance of the larotrectinib NDA and
granting of Priority Review for the treatment of adult and
pediatric patients with locally advanced or metastatic solid tumors
harboring an NTRK gene fusion. The FDA has set a target action date
of November 26, 2018, under the Prescription Drug User Fee Act
(PDUFA). More information can be found here.
- International Symposium on Pediatric Neuro-Oncology
(ISPNO) Poster Presentation: On July 1, 2018, a poster
presentation at ISPNO 2018 detailed a case report of a pediatric
patient with TRK fusion high-grade glioma treated with
larotrectinib on a single patient protocol. The poster can be found
here.
- World Congress on Gastrointestinal Cancer Oral
Presentation: On June 22, 2018, an oral presentation at
the ESMO World Congress on Gastrointestinal Cancer detailed
larotrectinib data in patients with TRK fusion gastrointestinal
(GI) cancers enrolled to the pivotal larotrectinib program. The
presentation can be found here.
- Journal of Clinical Investigation
Publication: On June 19, 2018, an article was
published online in the peer-reviewed Journal of Clinical
Investigation detailing the occurrence of TRK fusions in
hematologic malignancies, including a case report of a patient with
TRK fusion acute myeloid leukemia (AML) treated with larotrectinib
on a single patient protocol. The publication can be found
here.
- Pediatric Blood & Cancer
Publication: On June 12, 2018, a case report was
published in the online edition of the peer-reviewed journal
Pediatric Blood & Cancer detailing a pediatric patient with
metastatic TRK fusion congenital mesoblastic nephroma (CMN) treated
with larotrectinib on the SCOUT trial. The publication can be found
here.
LOXO-292
- Interim Clinical Data Presented at the American Society
of Clinical Oncology (ASCO) Annual Meeting: In June,
interim clinical data from the LOXO-292 global LIBRETTO-001 trial
were presented in an oral presentation at ASCO. The presentation
included 82 patients enrolled across eight dose escalation cohorts
and employed an April 2, 2018 data cut-off. The data demonstrated a
77 percent (95% CI: 61-89%) overall response rate (ORR) in RET
fusion cancers and a 45 percent (95% CI: 24-68%) ORR in RET mutated
MTC as evaluated by RECIST 1.1 criteria. Patients had received a
median of three prior treatments with two-thirds having been
treated with at least one prior multi-kinase inhibitor. All
responding patients across all tumor types remained on therapy as
of the data cut-off. LOXO-292 was well tolerated with most
treatment-emergent adverse events Grade 1 in severity. The
treatment-emergent adverse events observed in ≥10% of patients,
regardless of relationship to LOXO-292, were fatigue, diarrhea,
constipation, dry mouth, nausea, and dyspnea. Phase 2 cohorts are
open and enrolling at the 160mg BID dose. See the presented data
here.
LOXO-305
- Presentation Accepted at the Society of Hematologic
Oncology (SOHO) Annual Meeting: In September 2018, Loxo
Oncology authors will present LOXO-305 preclinical characterization
data in oral and poster presentations at the SOHO Annual Meeting
taking place September 12-15 in Houston, Texas.
Upcoming Milestones
- Larotrectinib (TRK)
- Presentation of updated clinical data at the ESMO Congress
- Submission of a Marketing Authorisation Application in the
European Union, by Bayer, is expected in the second half of
2018
- NDA PDUFA date of November 26, 2018
- LOXO-195 (next-generation TRK)
- Updated clinical data is now expected in the first half of
2019
- LOXO-292 (RET)
- Updated clinical data is expected in the second half of
2018
- LOXO-305 (BTK)
- Presentation of preclinical data at the SOHO Annual
Meeting
- Initiation of a Phase 1 clinical trial is expected in the
fourth quarter of 2018
Second Quarter 2018 Financial Results
As of June 30, 2018, Loxo Oncology had aggregate cash, cash
equivalents and investments of $706.4 million, compared to $626.2
million as of December 31, 2017.
Revenue from the collaboration agreement was $42.6 million for
the second quarter of 2018, compared to none for the second quarter
of 2017. This represents $51.2 million in revenue recognized from
the $400 million upfront payment from the Bayer collaboration
offset by $8.6 million, Loxo Oncology’s share of the joint
larotrectinib co-promotion costs.
Revenue from the collaboration agreement was $81.0 million for
the six months ended June 30, 2018, compared to none for the six
months ended June 30, 2017. This represents $94.1 million in
revenue recognized from the $400 million upfront payment from the
Bayer collaboration offset by $13.1 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 $41.6 million for the
second quarter of 2018 compared to $24.4 million for the second
quarter of 2017. This increase was primarily due to expanded
development expenses across our LOXO-292 and LOXO-305 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 $5.8
million during the second quarter of 2018 as compared to $3.5
million for the second quarter of 2017.
Research and development expenses were $73.5 million for the six
months ended June 30, 2018 compared to $44.6 million for the six
months ended June 30, 2017. This increase was primarily due to
expanded development expenses across our LOXO-292 and LOXO-305
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 $10.1 million during the six months ended
June 30, 2018 as compared to $5.9 million for the six months ended
June 30, 2017.
General and administrative expenses were $15.7 million for the
second quarter of 2018 compared to $6.5 million for the second
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 $6.5
million during the second quarter of 2018 compared to $2.0 million
for the second quarter of 2017.
General and administrative expenses were $27.9 million for the
six months ended June 30, 2018 compared to $11.3 million for the
six months ended June 30, 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 $11.9 million during the six months ended June 30, 2018 compared
to $3.5 million for the six months ended June 30, 2017.
Net loss was $11.7 million and $15.3 million for the three and
six months ended June 30, 2018, respectively, compared to $30.4
million and $54.9 million for the three and six months ended June
30, 2017, respectively. 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 $50.6 million and $87.4 million for the
three and six months ended June 30, 2018, respectively, compared to
$25.0 million and $45.5 million for the three and six months ended
June 30, 2017, respectively. 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 and Webcast
Information Loxo Oncology will host a conference call
today at 8:00 a.m. ET to discuss the second quarter 2018 financial
results and company updates. A live webcast can be accessed under
"Events & Presentations" in the Investors & Media section
of the company's website at www.loxooncology.com. The conference
call can be accessed by dialing (877) 930-8065 (domestic) or (253)
336-8041 (international) and referring to conference ID 7291605.
The webcast will be archived and made available for replay on the
company's website beginning approximately two hours after the
event.
About Loxo Oncology Loxo Oncology is
a biopharmaceutical company developing highly selective medicines
for patients with genomically 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, with the intention of
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, the success of our efforts to commercialize
larotrectinib, 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) |
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2018 |
|
2017 |
|
Assets |
(Unaudited) |
|
|
|
Cash, cash equivalents
and investments |
$ |
706,401 |
|
$ |
626,200 |
|
Receivable from
collaboration partner |
|
— |
|
|
150,000 |
|
Other prepaid expenses
and current assets |
|
5,749 |
|
|
5,607 |
|
Property and equipment,
net |
|
3,333 |
|
|
912 |
|
Other assets |
|
1,027 |
|
|
723 |
|
Total
assets |
|
716,510 |
|
|
783,442 |
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
Accounts payable |
|
4,789 |
|
|
3,996 |
|
Payable due to
collaboration partner |
|
593 |
|
|
— |
|
Accrued expenses and
other current liabilities |
|
34,386 |
|
|
22,537 |
|
Deferred revenue |
|
284,618 |
|
|
378,699 |
|
Total
liabilities |
|
324,386 |
|
|
405,232 |
|
Commitments and
contingencies |
|
|
|
|
Stockholders’
equity |
|
|
|
|
Common
stock, $0.0001 par value; 125,000,000 shares authorized; 30,426,546
and 29,991,884 shares issued and outstanding at June 30, 2018 and
December 31, 2017, respectively |
|
3 |
|
|
3 |
|
Additional paid-in capital |
|
695,996 |
|
|
666,891 |
|
Accumulated deficit |
|
(303,396 |
) |
|
(288,112 |
) |
Other
comprehensive loss |
|
(479 |
) |
|
(572 |
) |
Total
stockholders' equity |
|
392,124 |
|
|
378,210 |
|
Total
liabilities and stockholders' equity |
$ |
716,510 |
|
$ |
783,442 |
|
LOXO ONCOLOGY, INC. |
|
Consolidated Statements of
Operations |
|
(unaudited) |
|
(in thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
Three Months EndedJune
30, |
|
Six Months EndedJune
30, |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from
collaboration agreement |
$ |
42,601 |
|
$ |
— |
|
$ |
81,030 |
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
41,555 |
|
|
24,398 |
|
|
73,545 |
|
|
44,567 |
|
General
and administrative |
|
15,742 |
|
|
6,515 |
|
|
27,936 |
|
|
11,288 |
|
Total operating
expenses |
|
57,297 |
|
|
30,913 |
|
|
101,481 |
|
|
55,855 |
|
Loss from
operations |
|
(14,696 |
) |
|
(30,913 |
) |
|
(20,451 |
) |
|
(55,855 |
) |
Interest income,
net |
|
2,970 |
|
|
512 |
|
|
5,167 |
|
|
926 |
|
Net loss |
$ |
(11,726 |
) |
$ |
(30,401 |
) |
$ |
(15,284 |
) |
$ |
(54,929 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share
information: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of
common stock, basic and diluted |
$ |
(0.39 |
) |
$ |
(1.14 |
) |
$ |
(0.51 |
) |
$ |
(2.10 |
) |
Weighted average shares
outstanding, basic and diluted |
|
30,156,986 |
|
|
26,586,610 |
|
|
30,091,587 |
|
|
26,129,869 |
|
LOXO ONCOLOGY, INC. |
|
Reconciliation of GAAP Net Loss to Non-GAAP
Net Loss |
|
(unaudited) |
|
(in thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
Three Months EndedJune
30, |
|
Six Months EndedJune
30, |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss |
$ |
(11,726 |
) |
$ |
(30,401 |
) |
$ |
(15,284 |
) |
$ |
(54,929 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from
collaboration agreement |
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
recognized from $400M upfront payment |
|
(51,228 |
) |
|
— |
|
|
(94,081 |
) |
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based
compensation expenses included in R&D expenses |
|
5,825 |
|
|
3,456 |
|
|
10,108 |
|
|
5,862 |
|
Share-based
compensation expenses included in G&A expenses |
|
6,521 |
|
|
1,979 |
|
|
11,889 |
|
|
3,548 |
|
Total share-based
compensation expenses |
|
12,346 |
|
|
5,435 |
|
|
21,997 |
|
|
9,410 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total adjustments |
|
(38,882 |
) |
|
5,435 |
|
|
(72,084 |
) |
|
9,410 |
|
Non-GAAP net loss |
$ |
(50,608 |
) |
$ |
(24,966 |
) |
$ |
(87,368 |
) |
$ |
(45,519 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share
information: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of
common stock, basic and diluted |
$ |
(1.68 |
) |
$ |
(0.94 |
) |
$ |
(2.90 |
) |
$ |
(1.74 |
) |
Weighted average shares
outstanding, basic and diluted |
|
30,156,986 |
|
|
26,586,610 |
|
|
30,091,587 |
|
|
26,129,869 |
|
LOXO ONCOLOGY, INC. |
|
Calculation of Revenue from Collaboration
Agreement |
|
(unaudited) |
|
(in thousands) |
|
|
|
|
|
|
|
Three Months EndedJune
30, |
|
Six Months EndedJune
30, |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Upfront payment |
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
recognized from $400M upfront payment |
$ |
51,228 |
|
$ |
— |
|
$ |
94,081 |
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
(17,254 |
) |
|
|
|
|
(26,102 |
) |
|
|
|
Combined
collaboration co-promotion profit/(loss) |
|
(17,254 |
) |
|
|
|
|
(26,102 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loxo
Oncology’s 50/50 share of collaboration co-promotion
profit/(loss) |
|
(8,627 |
) |
|
|
|
|
(13,051 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue from
collaboration agreement |
$ |
42,601 |
|
$ |
|
|
$ |
81,030 |
|
$ |
|
|
Contacts for Loxo Oncology, Inc.Company:Lauren
CohenDirector, Corporate Communicationslcohen@loxooncology.com
Investors:Peter RahmerEndurance Advisors,
LLC415-515-9763prahmer@enduranceadvisors.com
Media:Dan Budwick1AB Media973-271-6085dan@1abmedia.com
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