- Both ENVISION and ATLAS Phase 3 trials of UGN-102 met primary
endpoints in treating low-grade intermediate-risk
non‐muscle‐invasive bladder cancer (LG-IR-NMIBC).
- Reported record JELMYTO® net product revenues in Q2 2023 of
$21.1 million, an increase of ~27% from the same period last
year
- Significantly strengthened balance sheet via $120 million
private placement of ordinary shares and pre-funded warrants
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated
to developing and commercializing innovative solutions that treat
urothelial and specialty cancers, today announced financial results
for the second quarter ended June 30, 2023, and provided an
overview of recent developments.
“We are in a transformative period for UroGen,” said Liz
Barrett, President and Chief Executive Officer of UroGen Pharma.
“Recently, we announced positive topline results from the ATLAS and
ENVISION Phase 3 clinical trials of UGN-102 in LG-IR-NMIBC. Both
trials met their primary endpoints, demonstrating consistent,
compelling results for UGN-102. If approved, we believe UGN-102’s
promising efficacy and safety profile across multiple trials
support a potential shift from frequent surgeries to a minimally
invasive, non-surgical option for the more than 82,000 underserved
LG-IR-NMIBC patients diagnosed annually in the U.S. alone,
positioning it as a potential key growth driver for UroGen.”
“Furthermore, increased adoption and expansion of JELMYTO use in
a diverse LG-UTUC population, supported by a growing database of
real-world outcomes data, translated to notable revenue growth
during the second quarter of 2023,” continued Ms. Barrett.
“Building on these achievements, the recently announced $120
million private placement of ordinary shares and pre-funded
warrants with a select group of biotech investors provides us with
the resources to support our business, including our prospective
pre-commercialization and launch strategy for UGN-102.”
Business Highlights:
UGN-102 (mitomycin) for intravesical solution:
- The ENVISION Phase 3 clinical trial met its primary endpoint by
demonstrating a 79.2% rate of complete response among ~240
LG-IR-NMIBC patients at 3-months after the first UGN-102
instillation.
- Additional data evaluating the secondary endpoint of duration
of response from ENVISION, and the submission of a New Drug
Application (NDA) (assuming additional positive findings) to the
U.S. Food and Drug Administration (FDA) are anticipated in
2024.
- The Journal of Urology published a peer-reviewed article
highlighting that the ATLAS Phase 3 clinical trial met its primary
endpoint of disease-free survival, with topline results
demonstrating a reduced risk of recurrence, progression, or death
of 55% for UGN-102 + TURBT compared to
TURBT monotherapy.
- Patients who only received UGN-102 showed a 64.8% complete
response rate at three months, compared to a 63.6% complete
response rate at three months for patients who only received
TURBT.
- The estimated probability of remaining disease free 15-months
after randomization was 72% for UGN-102 ± TURBT and 50% for TURBT
monotherapy (hazard ratio 0.45).
- UroGen hosted an event to discuss and highlight topline results
from the Phase 3 ATLAS and ENVISION clinical trials on July 27th,
2023. A replay of the event is available on the UroGen website at
https://investors.urogen.com.
JELMYTO (mitomycin) for pyelocalyceal solution in low-grade
upper tract urothelial cancer (LG-UTUC):
- Generated record quarterly net product revenue of $21.1 million
for the second quarter of 2023, representing ~27% growth over the
second quarter of 2022.
- Activated sites on August 1, 2023 were 1,058, compared to 1,009
on May 1, 2023, while repeat accounts on August 1, 2023 were 267,
compared to 235 on May 1, 2023.
- Results from a retrospective study investigating whether
patients with higher-volume low-grade disease could achieve
disease-free status using partial ablation or biopsy before JELMYTO
treatment during initial ureteroscopy (URS) showed no significant
difference in rendered disease-free rates between complete ablation
(78.6%), partial ablation (57.6%), or biopsy-only (66.7%) groups
during initial URS (p=0.15). The analysis also showed that tumor
size prior to JELMYTO induction did not have a significant impact
on rendered disease free (RDF) rates (p=0.09). The study aimed to
find alternatives to nephroureterectomy for preserving kidney
function and to assess JELMYTO's efficacy in managing larger volume
disease.
Private Placement of Ordinary Shares
- Completed a private placement of ordinary shares and pre-funded
warrants with gross proceeds of approximately $120 million before
deducting placement agent commissions and other offering expenses
to select institutional and accredited investors.
Second Quarter 2023 Financial Results:
JELMYTO Revenue: UroGen reported net product revenue of
JELMYTO for the second quarter 2023 of $21.1 million, compared to
$16.6 million in the second quarter of 2022.
R&D Expense: Research and development expenses for
the second quarter 2023 were $11.6 million, including non-cash
share-based compensation expense of $0.5 million as compared to
$12.6 million, including non-cash share-based compensation expense
of $0.7 million, for the same period in 2022.
SG&A Expense: Selling, general and administrative
expenses for the second quarter 2023 were $22.5 million, including
non-cash share-based compensation expense of $1.7 million. This
compares to $20.8 million, including non-cash share-based
compensation expense of $2.2 million, for the same period in
2022.
Financing on Prepaid Forward Obligation: UroGen reported
non-cash financing expense related to the prepaid forward
obligation to RTW Investments of $5.3 million for the second
quarter 2023, compared to $5.8 million for the same period in 2022.
The rate applied to cash payments incurred in 2023 is 13% based on
global net product sales of JELMYTO in 2022.
Interest Expense on Long-Term Debt: Interest expense
related to the $100 million term loan facility with funds managed
by Pharmakon Advisors was $3.8 million for the second quarter of
2023, compared to $2.2 million for the same period last year due to
the transaction closing in March 2022 and the final $25 million
draw down under the term loan facility in December 2022.
Net Loss: UroGen reported a net loss of $24.1 million, or
basic and diluted net loss per ordinary share of $1.03, for the
second quarter 2023 as compared to $26.7 million, or basic and
diluted net loss per ordinary share of $1.18, for the same period
in 2022.
Cash & Cash Equivalents: As of June 30, 2023, cash,
cash equivalents and marketable securities totaled $55.3 million.
This figure does not include proceeds from the recent $120 million
private placement of ordinary shares and pre-funded warrants.
2023 Revenue, Operating Expense and RTW Expense Guidance:
The Company reiterates anticipated full year 2023 net product
revenues from JELMYTO to be in the range of $76 to $86 million. The
Company also reiterates anticipated full year 2023 operating
expenses in the range of $135 to $145 million, including non-cash
share-based compensation expense of $6.0 to $11.0 million, subject
to market conditions. The Company also reiterates anticipated full
year 2023 non-cash financing expense related to the prepaid
obligation to RTW Investments in the range of $21.0 to $26.0
million. Of this amount approximately $9.9 to $11.2 million is
expected to be in cash.
Conference Call & Webcast Information: Members of
UroGen’s management team will host a live conference call and
webcast today at 10:00 AM Eastern Time to review UroGen’s financial
results and provide a general business update.
The live webcast can be accessed by visiting the Investors
section of the Company’s website at http://www.urogen.com. Please
connect at least 15 minutes prior to the live webcast to ensure
adequate time for any software download that may be needed to
access the webcast.
UROGEN PHARMA LTD.
SELECTED CONSOLIDATED BALANCE
SHEETS
(U.S. dollars in thousands)
(Unaudited)
June 30, 2023
December 31, 2022
Cash and cash equivalents and marketable
securities
$
55,271
$
99,963
Total assets
$
95,361
$
135,619
Total liabilities
$
233,795
$
224,980
Total shareholders' deficit
$
(138,434
)
$
(89,361
)
UROGEN PHARMA LTD.
CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS AND COMPREHENSIVE LOSS
(U.S. dollars in thousands,
except share and per share data)
(Unaudited)
Three months ended June 30,
Six months ended June 30,
2023
2022
2023
2022
Revenue
$
21,139
$
16,604
$
38,331
$
30,168
Cost of revenue
2,443
1,846
4,708
3,371
Gross profit
18,696
14,758
33,623
26,797
Operating expenses:
Research and development expenses
11,584
12,640
24,082
25,336
Selling, general and administrative
expenses
22,494
20,833
46,968
42,133
Total operating expenses
34,078
33,473
71,050
67,469
Operating loss
(15,382
)
(18,715
)
(37,427
)
(40,672
)
Financing on prepaid forward
obligation
(5,344
)
(5,833
)
(10,568
)
(11,659
)
Interest expense on long-term debt
(3,761
)
(2,239
)
(7,314
)
(2,521
)
Interest and other income (expense),
net
405
128
1,035
126
Loss before income taxes
$
(24,082
)
$
(26,659
)
$
(54,274
)
$
(54,726
)
Income tax expense
(54
)
(32
)
(75
)
(357
)
Net loss
$
(24,136
)
$
(26,691
)
$
(54,349
)
$
(55,083
)
Net loss per ordinary share basic and
diluted
$
(1.03
)
$
(1.18
)
$
(2.33
)
$
(2.43
)
Weighted average shares outstanding, basic
and diluted
23,462,016
22,703,572
23,371,878
22,667,825
About JELMYTO®
JELMYTO® (mitomycin) for pyelocalyceal solution is a
mitomycin-containing reverse thermal gel containing 4 mg mitomycin
per ml gel indicated for primary chemoablative treatment of LG-UTUC
in adults. It is recommended for primary treatment of biopsy-proven
LG-UTUC in patients deemed appropriate candidates for renal-sparing
therapy. JELMYTO is a viscous liquid when cooled and becomes a
semi-solid gel at body temperature. The drug slowly dissolves over
four to six hours after instillation and is removed from the
urinary tract by normal urine flow and voiding. It is approved for
administration in a retrograde manner via ureteral catheter or
antegrade through nephrostomy tube. The delivery system allows the
initial liquid to coat and conform to the upper urinary tract
anatomy. The eventual semisolid gel allows for chemoablative
therapy to remain in the collecting system for four to six hours
without immediately being diluted or washed away by urine flow.
APPROVED USE FOR JELMYTO
JELMYTO® is a prescription medicine used to treat adults with a
type of cancer of the lining of the upper urinary tract including
the kidney called low-grade Upper Tract Urothelial Cancer
(LG-UTUC).
IMPORTANT SAFETY
INFORMATION
You should not receive JELMYTO if you have a hole or tear
(perforation) of your bladder or upper urinary tract.
Before receiving JELMYTO, tell
your healthcare provider about all your
medical conditions, including
if you:
- are pregnant or plan to become pregnant. JELMYTO can harm your
unborn baby. You should not become pregnant during treatment with
JELMYTO. Tell your healthcare provider right away if you become
pregnant or think you may be pregnant during treatment with
JELMYTO. Females who are able to become pregnant: You should
use effective birth control (contraception) during treatment with
JELMYTO and for 6 months after the last dose. Males being
treated with JELMYTO: If you have a female partner who is able
to become pregnant, you should use effective birth control
(contraception) during treatment with JELMYTO and for 3 months
after the last dose.
- are breastfeeding or plan to breastfeed. It is not known if
JELMYTO passes into your breast milk. Do not breastfeed during
treatment with JELMYTO and for 1 week after the last dose.
- Tell your healthcare provider if you take water pills
(diuretic).
How will I receive
JELMYTO?
- Your healthcare provider will tell you to take a medicine
called sodium bicarbonate before each JELMYTO treatment.
- You will receive your JELMYTO dose from your healthcare
provider 1 time a week for 6 weeks. It is important that you
receive all 6 doses of JELMYTO according to your healthcare
provider’s instructions. If you miss any appointments, call your
healthcare provider as soon as possible to reschedule your
appointment. Your healthcare provider may recommend up to an
additional 11 monthly doses.
- JELMYTO is given to your kidney through a tube called a
catheter.
- During treatment with JELMYTO, your healthcare provider may
tell you to take additional medicines or change how you take your
current medicines.
After receiving JELMYTO:
- JELMYTO may cause your urine color to change to a violet to
blue color. Avoid contact between your skin and urine for at least
6 hours.
- To urinate, males and females should sit on a toilet and
flush the toilet several times after you use it. After going to the
bathroom, wash your hands, your inner thighs, and genital area well
with soap and water.
- Clothing that comes in contact with urine should be washed
right away and washed separately from other clothing.
JELMYTO may cause serious side effects, including:
- Swelling and narrowing of the tube that carries urine from
the kidney to the bladder (ureteric obstruction). If you
develop swelling and narrowing, and to protect your kidney from
damage, your healthcare provider may recommend the placement of a
small plastic tube (stent) in the ureter to help the kidney drain.
Tell your healthcare provider right away if you develop side pain
or fever during treatment with JELMYTO.
- Bone marrow problems. JELMYTO can affect your bone
marrow and can cause a decrease in your white blood cell, red blood
cell, and platelet counts. Your healthcare provider will do blood
tests prior to each treatment to check your blood cell counts
during treatment with JELMYTO. Your healthcare provider may need to
temporarily or permanently stop JELMYTO if you develop bone marrow
problems during treatment with JELMYTO.
- The most common side effects of JELMYTO include: urinary
tract infection, blood in your urine, side pain, nausea, trouble
with urination, kidney problems, vomiting, tiredness, stomach
(abdomen) pain.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You may
also report side effects to UroGen Pharma at
1-855-987-6436.
Please see JELMYTO Full Prescribing Information, including
the Patient Information, for additional information.
About Upper Tract Urothelial Cancer (UTUC)
Urothelial cancer is the ninth most common cancer globally and
the eighth most lethal neoplasm in men in the U.S. Between five
percent and ten percent of primary urothelial cancers originate in
the ureter or renal pelvis and are collectively referred to as
upper tract urothelial cancers (UTUC). In the U.S., there are
approximately 6,000 - 7,000 new or recurrent low-grade UTUC
patients annually. Most cases are diagnosed in patients over 70
years old, and these older patients often face comorbidities. There
are limited treatment options for UTUC, with the most common being
endoscopic surgery or nephroureterectomy (removal of the entire
kidney and ureter). These treatments can lead to a high rate of
recurrence and relapse.
About UGN-102
UGN-102 (mitomycin) for intravesical solution is an
investigational drug formulation of mitomycin in Phase 3
development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s
proprietary RTGel® technology, a sustained release, hydrogel-based
formulation, UGN-102 is designed to enable longer exposure of
bladder tissue to mitomycin, thereby enabling the treatment of
tumors by non-surgical means. UGN-102 is delivered to patients
using a standard urinary catheter in an outpatient setting.
Assuming positive secondary endpoint findings from the ENVISION
Phase 3 study, UroGen anticipates submitting a New Drug Application
(NDA) for UGN-102 in 2024. If approved, UGN-102 would be the first
non-surgical primary therapeutic to treat a subset of bladder
cancer characterized by high recurrence rates and multiple
surgeries.
About the Phase 3 ENVISION Trial
The Phase 3 ENVISION trial is a single-arm, multinational,
multicenter study evaluating the efficacy and safety of UGN-102
(mitomycin) for intravesical solution as primary chemoablative
therapy in patients with low-grade, intermediate-risk NMIBC. The
Phase 3 ENVISION trial completed target enrollment with
approximately 240 patients across 56 sites. Study participants
received six once-weekly intravesical instillations of UGN-102. The
primary endpoint evaluated the complete response rate at the
3-month assessment after the first instillation, and the key
secondary endpoint will evaluate durability over time in patients
who achieved a complete response at the three-month assessment.
Based on discussions with the FDA, and assuming positive secondary
endpoint findings, UroGen anticipates submitting an NDA for UGN-102
in 2024. Learn more about the Phase 3 ENVISION trial at
www.clinicaltrials.gov (NCT05243550).
About the Phase 3 ATLAS Trial
ATLAS was a global, open-label, randomized controlled Phase 3
trial designed to assess the efficacy and safety of UGN-102, with
or without TURBT, vs. TURBT alone in patients diagnosed with
LG-IR-NMIBC. The trial enrolled 282 patients in clinical sites in
the U.S., Europe and Israel. Patients were randomized 1:1 to either
UGN-102 + / - TURBT or TURBT. Patients in the UGN-102 arm were
treated with six weekly intravesical instillations of UGN-102. At
the 3-month time point, patients were assessed for response.
Patients who demonstrated a complete response to either UGN-102 or
TURBT, were assessed for long-term follow-up for evidence of
recurrence. Patients who demonstrated presence of persistent
disease at 3-months, in either arm, underwent a TURBT and continued
for long-term follow-up for evidence of recurrence. The primary
endpoint of the study is disease-free survival. Learn more about
the ATLAS trial at www.clinicaltrials.gov (NCT04688931).
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and
commercializing innovative solutions that treat urothelial and
specialty cancers because patients deserve better options. UroGen
has developed RTGel® reverse-thermal hydrogel, a proprietary
sustained release, hydrogel-based platform technology that has the
potential to improve therapeutic profiles of existing drugs.
UroGen’s sustained release technology is designed to enable longer
exposure of the urinary tract tissue to medications, making local
therapy a potentially more effective treatment option. JELMYTO®
(mitomycin) for pyelocalyceal solution and investigational
treatment UGN-102 (mitomycin) for intravesical solution for
patients with low-grade non-muscle invasive bladder cancer are
designed to ablate tumors by non-surgical means. UroGen is
headquartered in Princeton, NJ with operations in Israel. Visit
www.urogen.com to learn more or follow us on Twitter,
@UroGenPharma.
Forward-Looking Statements
This press release contains forward-looking statements as that
term is defined in the Private Securities Litigation Reform Act of
1995, including, without limitation, statements regarding: plans
with respect to a regulatory submission for UGN-102 and the timing
thereof; our belief that UGN-102, if approved, will support a
potential shift from frequent surgeries to UGN-102, positioning it
as a potential key growth driver for UroGen; financial guidance for
2023; the potential of UroGen’s proprietary RTGel technology to
improve therapeutic profiles of existing drugs and UroGen’s
sustained release technology making local delivery potentially more
effective as compared to other treatment options. These statements
are subject to a number of risks, uncertainties and assumptions,
including, but not limited to: preliminary results may not be
indicative of results that may be observed in the future; the
timing and success of clinical trials and potential safety and
other complications thereof; unforeseen delays that may impact the
timing of progressing clinical trials and reporting data; the
ability to obtain regulatory approval within the timeframe
expected, or at all; the ability to maintain regulatory approval;
complications associated with commercialization activities; the
labeling for any approved product; competition in UroGen’s
industry; the scope, progress and expansion of developing and
commercializing UroGen’s product candidates; the size and growth of
the market(s) thereof and the rate and degree of market acceptance
thereof vis-à-vis alternative therapies; UroGen’s ability to
attract or retain key management, members of the board of directors
and personnel; UroGen’s RTGel technology may not perform as
expected; UroGen may not successfully develop and receive
regulatory approval of any other product that incorporates RTGel
technology; market conditions and third-party performance; UroGen’s
financial condition and need for additional capital in the future.
In light of these risks and uncertainties, and other risks and
uncertainties that are described in the Risk Factors section of
UroGen’s Form 10-Q filed with the SEC on May 11, 2023, as well as
in the Risk Factors section of UroGen’s Quarterly Report on Form
10-Q being filed with the SEC later today (which are available at
http://www.sec.gov), the events and
circumstances discussed in such forward-looking statements may not
occur, and UroGen’s actual results could differ materially and
adversely from those anticipated or implied thereby. Any
forward-looking statements speak only as of the date of this press
release and are based on information available to UroGen as of the
date of this release.
JELMYTO®, RTGel® and UroGen® are registered trademarks of UroGen
Pharma Ltd.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230810124339/en/
INVESTOR CONTACT: Vincent Perrone vincent.perrone@urogen.com
609-460-3588 ext. 1093 MEDIA CONTACT: Cindy Romano
cindy.romano@urogen.com 609-460-3583 ext. 1083
UroGen Pharma (NASDAQ:URGN)
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