ACTIVE Phase 3 trial results published in Journal
of American Medical Association and Journal of Bone Mineral
Research
Radius Health, Inc. (“Radius” or the “Company”) (Nasdaq:RDUS), a
science-driven biopharmaceutical company that is committed to
developing innovative therapeutics in the areas of osteoporosis,
oncology and endocrine diseases, reported its financial results for
the third quarter ended September 30, 2016, and provided a business
update. As of September 30, 2016, Radius had $369.8 million
in cash, cash equivalents and marketable securities.
“We are working closely with the U.S. Food and Drug
Administration and the European Medicines Agency as they review our
regulatory submissions for abaloparatide-SC, and building our
commercial capabilities for a successful launch, pending favorable
review,” said Robert Ward, President and Chief Executive Officer of
Radius. “We are positioning our company for sustainable
growth, and pleased to have made substantial progress in the
development of a transdermal patch line extension for abaloparatide
and in advancing our two oncology programs.”
Pipeline Updates
Abaloparatide-SC
Radius’ new drug application (NDA) in the United
States for abaloparatide-SC for the treatment of postmenopausal
women with osteoporosis was accepted for filing by the FDA and was
granted a Prescription Drug User Fee Act (PDUFA) date of March 30,
2017. Radius’ marketing authorisation application (MAA) to the
European Medicines Agency (EMA), was validated in December 2015 and
is currently undergoing regulatory review. We anticipate receiving
a CHMP scientific opinion in late 2016 or 2017.
In August 2016, the Phase 3 ACTIVE (Abaloparatide Comparator
Trial In Vertebral Endpoints) trial results were published in the
Journal of the American Medical Association (JAMA) in a manuscript
titled “Effect of Abaloparatide vs Placebo on New Vertebral
Fractures in Postmenopausal Women With Osteoporosis”.
In September 2016, additional analyses from the Phase 3 ACTIVE
trial were published in the Journal of Bone and Mineral Research
(JBMR) in an article titled "Effects of Abaloparatide-SC on
Fracture and Bone Mineral Density in Subgroups of Postmenopausal
Women with Osteoporosis and Varying Baseline Risk
Factors".
Also in September 2016 at the American Society for Bone and
Mineral Research (ASBMR) 2016 Annual Meeting, Radius presented
three abstracts on data from the Phase 3 ACTIVE trial demonstrating
that abaloparatide provides patients with early reductions in the
risk of vertebral, nonvertebral, major osteoporotic and clinical
fracture, irrespective of their baseline 10 year fracture
probability. The titles for the abstracts presented are:
- “Abaloparatide-SC is an Effective Treatment Option for
Postmenopausal Women with Osteoporosis: Review of the Number Needed
to Treat (NNT) Compared with Teriparatide”
- “Effect of Investigational Treatment Abaloparatide-SC
for Prevention of Major Osteoporotic Fracture or Any Fracture is
Independent of Baseline Fracture Probability”
- "Abaloparatide-SC has Minimal Effects in Subjects with
Mild or Moderate Renal Impairment: Results from the ACTIVE
trial”.
On Sunday, November 13, 2016, additional data on abaloparatide
will be presented at the 2016 American College of
Rheumatology/Association of Rheumatology Health Professionals
(ACR/ARHP) Annual Meeting in Washington, D.C. in a poster titled
“Abaloparatide-SC Significantly Reduces Vertebral and
Nonvertebral Fractures and Increases Bone Mineral Density (BMD)
Regardless of Age, BMD T-Score, or Prior Fracture at
Baseline”.
Abaloparatide-SC as a treatment for postmenopausal women with
osteoporosis is an investigational product and its safety and
efficacy have not been established.
Abaloparatide-TD
In December 2015, Radius commenced a human replicative clinical
evaluation of the optimized abaloparatide-TD patch with the goal of
achieving comparability to abaloparatide-SC. Radius reported
results of this pilot pharmacokinetic (PK) study in an oral
presentation titled “Clinical Development of an Optimized
Abaloparatide Transdermal Patch” at the Late-Breaking
Abstract Session at the ASBMR 2016.
The pilot PK study of the second-generation transdermal patch in
postmenopausal women was successful in demonstrating the ability to
modify the PK profile with respect to time to peak concentration
(Tmax), half life (T1/2) and area under the curve (AUC). The
results of this clinical evaluation will inform the design of a
formal bioequivalence study that will be initiated following
completion of activities required for the study.
RAD1901
During the third quarter of 2016, we completed enrollment with
20 patients at the 400 mg dose in the Phase I Part B expansion
cohort for RAD1901 in ER+, HER2-negative advanced breast cancer.
Radius has disclosed that multiple confirmed clinical
responses have been reported in this study of heavily pretreated
patients, and to date, no dose limiting toxicities have been
reported in the RAD1901 program.
We continue to enroll patients in the European Phase I FES-PET
trial – the first three-patient dosing cohort at 400 mg has been
enrolled and these 3 patients achieved a reduction equal to or
greater than 75% in FES-PET signal intensity.
On December 8, 2016, Radius will present three abstracts from
the RAD1901 program at the San Antonio Breast Cancer Symposium
(SABCS) titled:
- “A phase 1 study of RAD1901, a novel, oral selective
estrogen receptor degrader, for the treatment of ER-positive
advanced breast cancer”
- “A phase 1 study of RAD1901, an oral selective estrogen
receptor degrader, to determine changes in the 18F-FES uptake and
tumor responses in ER-positive, HER2-negative, advanced breast
cancer patients”
- “RAD1901 demonstrates anti-tumor activity in multiple
models of ER-positive breast cancer treatment
resistance”.
RAD140
We have reported that RAD140 in preclinical xenograft models of
breast cancer has demonstrated potent tumor growth inhibition when
administered alone or in combinations with CDK4/6 inhibitors. It is
estimated that 77% of breast cancers show expression of the
androgen receptor. Our preclinical data suggest that RAD140
activity at the androgen receptor stimulates up-regulation of a
tumor suppression pathway.
On December 1, 2016, at the EORTC-NCI-AACR
Molecular Targets and Cancer Therapeutics Meeting in Munich,
Germany, Radius will present new nonclinical data on RAD140 in a
poster titled “RAD140, an orally available
selective androgen receptor modulator, exhibits potent anti-tumor
activity in ER+AR+ breast cancer
models”.
Radius Expects the Following Upcoming
Milestones
- Abaloparatide-SC
- Receive scientific opinion from the Committee for Medicinal
Products for Human Use regarding the EMA’s review of the
abaloparatide-SC MAA in late 2016 or 2017
- FDA PDUFA date of March 30, 2017
- Enter into a collaboration for the commercialization of
abaloparatide-SC prior to commercial launch
- RAD1901
- Expect to report additional clinical results from the ongoing
Phase I expansion cohort and FES-PET studies in metastatic breast
cancer at SABCS on December 8, 2016
- Radius will host an investor panel presentation with Key
Opinion Leaders in San Antonio, Texas on December 8, 2016 to
provide an update on the progress of its oncology programs. Details
for this event can be found under Events & Presentations on the
IR section of the company’s website at
www.radiuspharm.com.
- RAD140
- Expect to submit an IND in 2016 and initiate first-in-human
study in 2017.
Radius Expects To Make Presentations at the Following
Upcoming Conferences
- On November 6-7, 2016, Radius President and CEO, Robert E. Ward
will make a presentation and will host one-on-ones at the 25th
Annual Credit Suisse Healthcare Conference, at the Phoenician in
Scottsdale, Arizona.
- On Sunday, November 13, 2016 Radius will present a poster at
the 2016 American College of Rheumatology/Association of
Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in
Washington, D.C.
- On November 29, 2016, Radius President and CEO, Robert E. Ward,
will make a presentation and company management will host
one-on-ones at the Nasdaq 35th Investor Program in London.
- On December 1, 2016, at the EORTC-NCI-AACR Molecular Targets
and Cancer Therapeutics Meeting in Munich, Germany, Radius will
present new nonclinical data on RAD140.
- On December 8, 2016, at the SABCS, Radius will present three
posters on RAD1901.
- On December 14, 2016, Radius President and CEO, Robert Ward,
will make a presentation and host one-on-ones at the BMO Healthcare
Conference in New York.
- On December 14, 2016, Radius Chief Commercial Officer, David
Snow, will host one-on-one meetings at the Bank of America Merrill
Lynch Midwest Healthcare Conference in Chicago, Illinois.
Third Quarter 2016 Financial Results
For the three months ended September 30, 2016, Radius reported a
net loss of $46.2 million, or $1.07 per share, as compared to a net
loss of $28.3 million, or $0.68 per share for the three months
ended September 30, 2015. The increase in net loss for the three
months ended September 30, 2016 as compared to the three months
ended September 30, 2015 was primarily due to an increase in
research and development and general and administrative expenses,
partially offset by a decrease in loss on retirement of note
payable, a decrease in interest expense and an increase in interest
income.
Research and development expenses for the three months ended
September 30, 2016 were $27.5 million, compared to $18.2 million
for the same period in 2015. This increase was primarily driven by
higher research and development costs associated with the
development of RAD1901 to support a Phase 1 study in metastatic
breast cancer that commenced in late 2014 and a Phase 2b study in
postmenopausal vasomotor symptoms that commenced in December 2015.
This increase was also a result of an increase in compensation
expense, including stock-based compensation, due to an increase in
headcount from September 30, 2015 to September 30, 2016.
General and administrative expenses for the three months ended
September 30, 2016 were $19.2 million, compared to $8.5 million for
the same period in 2015. This increase was primarily attributable
to an increase in professional support costs, including the costs
associated with increasing headcount and preparing for the
potential commercialization of abaloparatide-SC, subject to a
favorable regulatory review.This increase was also driven by an
increase in compensation expense, including stock-based
compensation, due to an increase in headcount from
September 30, 2015 to September 30, 2016.
As of September 30, 2016, Radius had $369.8 million in cash,
cash equivalents and marketable securities. Based upon
Radius’ cash, cash equivalents and marketable securities balance,
Radius believes that, prior to the consideration of revenue from
the potential future sales of any of its investigational products
that may receive regulatory approval or proceeds from collaboration
activities, it has sufficient capital to fund its development
plans, U.S. commercial scale-up and other operational activities
into 2018.
Conference Call and Webcast
In connection with the earnings release, Radius will host a
conference call and live audio webcast at 8:00 a.m. ET on Thursday,
November 3, 2016 to discuss the financial results, and give an
update on the Company’s progress.
Conference Call Information: Date: Thursday, November 3, 2016
Time: 8:00 a.m. ET Domestic Dial-in Number: 1-877-705-6003
International Dial-in Number: 1-201-493-6725 Live webcast:
http://public.viavid.com/index.php?id=121469
For those unable to participate in the conference call or live
webcast, a replay will be available until November 17 at 11:59 p.m.
ET. To access the replay, dial domestic 1-844-512-2921,
international 1-412-317-6671. The replay passcode is
13647502.
A live audio webcast of the call will also be
available on the Investors section of the Company's website,
www.radiuspharm.com. A webcast replay will be available for two
weeks on the Radius website, www.radiuspharm.com.
About Radius
Radius is a science-driven biopharmaceutical company that is
committed to developing innovative therapeutics in the areas of
osteoporosis, oncology and endocrine diseases. Radius' lead product
candidate, the investigational drug abaloparatide for subcutaneous
injection, has completed Phase 3 development for potential use in
the reduction of fracture risk in postmenopausal women with
osteoporosis. Radius' Marketing Authorisation Application (MAA) for
abaloparatide-SC for the treatment of postmenopausal women with
osteoporosis is under regulatory review in Europe and a New Drug
Application (NDA) has been accepted for filing by the FDA with a
PDUFA date of March 30, 2017. The Radius clinical pipeline also
includes an investigational abaloparatide transdermal patch for
potential use in osteoporosis and the investigational drug RAD1901
for potential use in hormone-driven and/or hormone-resistant breast
cancer, and vasomotor symptoms in postmenopausal women. Radius'
preclinical pipeline includes RAD140, a non-steroidal, selective
androgen receptor modulator (SARM) under investigation for
potential use in cancer. For more information, please visit
www.radiuspharm.com
About Abaloparatide
Abaloparatide is an investigational therapy for the potential
treatment of women with postmenopausal osteoporosis who are at an
increased risk for a fracture. Abaloparatide is a novel synthetic
peptide that engages the parathyroid hormone receptor (PTH1
receptor) and was selected for clinical development based on its
favorable bone building activity.
Abaloparatide has completed Phase 3 development for potential
use as a daily self-administered injection (abaloparatide-SC). In
the fourth quarter of 2015, Radius’ Marketing Authorisation
Application (MAA) for abaloparatide-SC for the treatment of
patients with postmenopausal osteoporosis was validated and is
currently undergoing regulatory review by the European Medicines
Agency (EMA). Radius submitted a New Drug Application (NDA) for
abaloparatide-SC to the US Food and Drug Administration (FDA) at
the end of the first quarter of 2016, which has been accepted for
filing with a PDUFA date of March 30, 2017. Radius also is
developing abaloparatide-transdermal (abaloparatide-TD) based on
3M's patented Microstructured Transdermal System technology for
potential use as a treatment for osteoporosis.
About RAD1901
RAD1901 is a selective estrogen receptor down-regulator/degrader
(SERD), which at high doses is being evaluated for potential use as
an oral non-steroidal treatment for hormone-driven, or
hormone-resistant, breast cancer. RAD1901 is currently being
investigated for potential use in postmenopausal women with
estrogen receptor positive (ER+), HER2-negative advanced breast
cancer, the most common form of the disease. Studies completed to
date indicate that the compound has the potential for use as a
single agent or in combination with other therapies for the
treatment of breast cancer.
RAD1901 also is being evaluated in a Phase 2b study at low doses
for potential relief of the frequency and severity of moderate to
severe hot flashes in postmenopausal women with vasomotor symptoms.
Additional information on the clinical trial program of RAD1901 is
available on www.clinicaltrials.gov.
RAD140
RAD140 is a nonsteroidal selective androgen receptor modulator.
The androgen receptor (AR) is highly expressed in many estrogen
receptor (ER)-positive, ER-negative, and triple-negative receptor
breast cancers. Because of its receptor and tissue selectivity,
potent activity, oral bioavailability, and long half-life, RAD140
could have clinical potential in the treatment of breast cancer.
RAD140 resulted from an internal drug discovery program focused on
the androgen receptor pathway, which is highly expressed in many
breast cancers.
Forward Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. All statements contained in this press
release that do not relate to matters of historical fact should be
considered forward-looking statements, including without limitation
statements regarding the progress of abaloparatide-SC in the
regulatory process with the FDA and the EMA and the timing of
potential regulatory actions, the timing of potential collaboration
agreements, the progress in development of abaloparatide-TD and in
the development of RAD1901 and RAD140, each of the statements under
the heading “Radius Expects The Following Upcoming Milestones,”
upcoming events and presentations, the sufficiency of cash, cash
equivalents and marketable securities and the potential clinical
uses for RAD1901 and RAD140.
These forward-looking statements are based on
management’s current expectations. These statements are neither
promises nor guarantees, but involve known and unknown risks,
uncertainties and other important factors that may cause our actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements, including, but not
limited to, the following: we have no product revenues and may need
to raise additional funding, which may not be available; risks
related to raising additional capital; our limited operating
history; quarterly fluctuation in our financial results; our
dependence on the success of abaloparatide-SC, and our inability to
ensure that abaloparatide-SC will obtain regulatory approval or be
successfully commercialized; any collaboration agreements failing
to be successful; risks related to clinical trials, including our
reliance on third parties to conduct key portions of our clinical
trials and uncertainty that results will support our product
candidate claims; the risk that adverse side effects will be
identified during the development of our product candidates; and
the risk of litigation regarding our intellectual property rights.
These and other important factors discussed under the caption “Risk
Factors” in our most recent Annual Report on Form 10-K filed with
the Securities and Exchange Commission, or SEC, on February 25,
2016, and our other reports filed with the SEC could cause actual
results to differ materially from those indicated by the
forward-looking statements made in this press release. Any
such forward-looking statements represent management’s estimates as
of the date of this press release. While we may elect to
update such forward-looking statements at some point in the future,
we disclaim any obligation to do so, even if subsequent events
cause our views to change. These forward-looking statements
should not be relied upon as representing our views as of any date
subsequent to the date of this press release.
Condensed Consolidated Balance
Sheets(In thousands, except share and per share
amounts) |
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
(unaudited) |
|
|
|
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
198,565 |
|
|
$ |
159,678 |
|
|
|
Marketable securities |
|
|
171,267 |
|
|
|
313,661 |
|
|
|
Prepaid
expenses and other current assets |
|
|
3,661 |
|
|
|
6,969 |
|
|
Total current assets |
|
|
373,493 |
|
|
|
480,308 |
|
|
Property and equipment, net |
|
|
4,057 |
|
|
|
1,897 |
|
|
Other assets |
|
|
551 |
|
|
|
260 |
|
|
Total assets |
|
$ |
378,101 |
|
|
$ |
482,465 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts
payable |
|
$ |
2,665 |
|
|
$ |
6,228 |
|
|
|
Accrued
expenses and other current liabilities |
|
|
22,642 |
|
|
|
14,952 |
|
|
Total current liabilities |
|
|
25,307 |
|
|
|
21,180 |
|
|
|
|
|
|
|
|
|
|
Other non-current liabilities |
|
402 |
|
|
|
- |
|
|
|
Total
liabilities |
|
$ |
25,709 |
|
|
$ |
21,180 |
|
|
Commitments and contingencies |
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
Common stock, $.0001
par value; 200,000,000 shares authorized, 43,109,927 shares and
42,984,243 shares issued and outstanding at September 30, 2016 and
December 31, 2015, respectively |
|
|
4 |
|
|
|
4 |
|
|
|
Additional paid-in-capital |
|
|
928,184 |
|
|
|
907,040 |
|
|
|
Accumulated other comprehensive income (loss) |
|
|
52 |
|
|
|
5 |
|
|
|
Accumulated deficit |
|
|
(575,848 |
) |
|
|
(445,764 |
) |
|
Total stockholders' equity |
|
|
352,392 |
|
|
|
461,285 |
|
|
Total liabilities and stockholders' equity |
|
$ |
378,101 |
|
|
$ |
482,465 |
|
|
|
|
|
|
|
|
|
Condensed Consolidated Statements of
Comprehensive Loss(Unaudited)(In thousands, except share
and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
|
|
|
|
|
September 30, |
|
September 30, |
|
|
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
27,453 |
|
|
$ |
18,217 |
|
|
$ |
81,827 |
|
|
$ |
46,054 |
|
|
|
|
|
|
General and
administrative |
|
|
19,240 |
|
|
|
8,456 |
|
|
|
50,079 |
|
|
|
19,212 |
|
|
|
|
|
|
|
Loss
from operations |
|
|
(46,693 |
) |
|
|
(26,673 |
) |
|
|
(131,906 |
) |
|
|
(65,266 |
) |
|
|
|
OTHER
(EXPENSE) INCOME: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
(expense) income, net |
|
|
(78 |
) |
|
|
1 |
|
|
|
(174 |
) |
|
|
(127 |
) |
|
|
|
|
|
Loss on
retirement of note payable |
|
|
- |
|
|
|
(1,572 |
) |
|
|
- |
|
|
|
(1,572 |
) |
|
|
|
|
|
Interest income |
|
|
585 |
|
|
|
274 |
|
|
|
1,996 |
|
|
|
564 |
|
|
|
|
|
|
Interest
expense |
|
|
- |
|
|
|
(294 |
) |
|
|
- |
|
|
|
(1,885 |
) |
|
|
|
NET LOSS |
|
$ |
(46,186 |
) |
|
$ |
(28,264 |
) |
|
$ |
(130,084 |
) |
|
$ |
(68,286 |
) |
|
|
|
OTHER COMPREHENSIVE LOSS, NET OF TAX: |
|
|
|
|
|
Unrealized (loss) gain from available-for-sale securities |
|
|
(136 |
) |
|
|
89 |
|
|
|
47 |
|
|
|
120 |
|
|
|
|
COMPREHENSIVE LOSS |
|
$ |
(46,322 |
) |
|
$ |
(28,175 |
) |
|
$ |
(130,037 |
) |
|
$ |
(68,166 |
) |
|
|
|
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS - BASIC AND
DILUTED |
|
$ |
(46,186 |
) |
|
$ |
(28,264 |
) |
|
$ |
(130,084 |
) |
|
$ |
(68,286 |
) |
|
|
|
LOSS PER
SHARE: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
$ |
(1.07 |
) |
|
$ |
(0.68 |
) |
|
$ |
(3.02 |
) |
|
$ |
(1.77 |
) |
|
|
|
WEIGHTED
AVERAGE SHARES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
|
43,092,921 |
|
|
|
41,331,612 |
|
|
|
43,049,734 |
|
|
|
38,525,827 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Radius Health
Investor Relations Contact:
Barbara Ryan
Email: bryan@radiuspharm.com
Phone: 203-274-2825
Media Contact:
Lori Gorski
Email: lgorski@radiuspharm.com
Phone: 617-551-4096
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