On May 7, 2020 Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to developing and commercializing new medicines for patients battling cancer, reported financial results for the three months ending March 31, 2020, and provided an overview of recent corporate highlights (Press release, Verastem, MAY 7, 2020, View Source [SID1234557361]).

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"The early part of 2020 was marked most importantly by the strategic in-licensing of the novel RAF/MEK inhibitor VS-6766 which is being investigated in combination with defactinib, our lead FAK inhibitor, in KRAS mutant tumors," commented Brian Stuglik, Chief Executive Officer of Verastem Oncology. "The encouraging preliminary Phase 1 results from the investigator-initiated FRAME study recently reported at AACR (Free AACR Whitepaper) in KRAS mutant low-grade serous ovarian cancer (LGSOC) will form the basis of our upcoming discussions with the U.S. Food and Drug Administration (FDA) and other regulatory authorities. We look forward to identifying the path forward for this novel combination and to embarking on a registration-directed clinical trial in LGSOC as rapidly as possible."

RAF/MEK and FAK Inhibition in KRAS Mutant Solid Tumors

Presented Preliminary Results from investigator-initiated Phase 1 FRAME Study Investigating the Combination of VS-6766 and Defactinib in KRAS Mutant Solid Tumors at AACR (Free AACR Whitepaper) 2020 Virtual Meeting I. In a virtual poster presentation, Udai Banerji, MBBS, MD, DNB, PhD, FRCP, NIHR, Professor of Molecular Cancer Pharmacology at The Institute of Cancer Research and Honorary Consultant in Medical Oncology at The Royal Marsden NHS Foundation Trust, highlighted data from this ongoing, open-label, dose-escalation and expansion investigator-initiated study investigating the combination of VS-6766, Verastem Oncology’s RAF/MEK inhibitor, with defactinib, the Company’s FAK inhibitor, in patients with KRAS mutant advanced solid tumors, including LGSOC and non-small cell lung cancer (NSCLC).

The VS-6766/defactinib combination was well tolerated by the patients in the trial. The recommended Phase 2 dose has now been established. In the patients with KRAS mutant LGSOC (n=6), 4 patients responded for an overall response rate (ORR) of 67%. The median time on treatment for these 4 patients was 20.5 months. In the patients with KRAS mutant NSCLC (n=10), 1 patient responded (partial response) for an ORR of 10% and a total of 8 patients achieved disease control for a disease control rate (DCR) of 80%. Additionally, in patients with KRAS mutant NSCLC, 8 remained on therapy for at least 12 weeks and 3 remained on therapy for at least 24 weeks. Expansion cohorts remain ongoing in LGSOC and NSCLC.

Verastem Oncology plans to initiate discussions with the FDA during second quarter of 2020, with the goal of commencing a registration-directed clinical trial investigating the VS-6766/defactinib combination in patients with LGSOC by the end of 2020.

Subsequent Analysis

Based on an observation of higher response rates seen in patients with KRASG12V mutations in the investigator-initiated Phase 1 combination study, Verastem Oncology conducted a post-hoc combined analysis with data from the combination study and the prior single-agent study that utilized a twice-weekly dosing schedule of VS-6766 to get a more complete picture of activity in KRASG12V mutations. This analysis showed early signals of activity in patients with KRASG12V mutated NSCLC. The Company plans to evaluate this finding further in a prospective NSCLC clinical trial.
New Strategic Direction. Verastem Oncology recently licensed exclusive global development and commercialization rights to VS-6766 (CH5126766), a unique and promising inhibitor of the RAF/MEK signaling pathway. The Company then announced its plans to accelerate development of VS-6766 in combination with defactinib for the treatment of KRAS mutant solid tumors. The rationale for investigating the combinations of VS-6766 and defactinib is supported by single-agent Phase 1 and Phase 2 studies which investigated defactinib in KRAS mutant NSCLC1 and VS-6766 in KRAS mutant NSCLC and LGSOC2.
COPIKTRA (Duvelisib)

First Patient Dosed in Chinese Study Evaluating Duvelisib in Patients with Relapsed or Refractory Follicular Lymphoma (FL). Verastem Oncology’s partner, CSPC Pharmaceutical Group Limited, has dosed the first patient in a single-arm, open-label, multi-center pivotal study designed to evaluate the antitumor activity and safety of duvelisib in patients with relapsed or refractory FL. This study is expected to serve as a bridging study based on the efficacy and safety observed in Verastem Oncology’s Phase 2 DYNAMO study. The results of this study will form the basis of a regulatory submission for duvelisib for the treatment of relapsed or refractory FL in China.
Ongoing U.S. Commercial Rollout of COPIKTRA. COPIKTRA, the Company’s marketed oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first FDA-approved dual inhibitor of PI3K-delta and PI3K-gamma generated $5.0 million in net product revenues during the first quarter of 2020, a 194% increase over the first quarter of 2019 and a 39% increase over the fourth quarter of 2019.
Corporate and Financial

Strengthened the Balance Sheet Through a Private Placement with Premier Life Science Investors. On March 3, 2020, Verastem Oncology completed a private placement offering of approximately 46.5 million shares of its common stock to certain institutional investors, including RA Capital Management, Vivo Capital, Venrock Healthcare Capital Partners, Farallon Capital Management, Acuta Capital, EcoR1 Capital LLC, Avidity Partners and Logos Capital at a price of $2.15 per share, a 12.6% premium to the February 27, 2020 closing price. The gross proceeds to Verastem Oncology were $100 million. After deducting the underwriting discounts and commissions and other estimated offering expenses, net proceeds to the Company were approximately $93.8 million.
Convertible Senior Second Lien Notes (2019 Notes) Fully Converted to Common Stock. During the first quarter of 2020, all of the remaining 2019 Notes were converted into shares of common stock. As of March 31, 2020, the Company had approximately $63.3 million in outstanding debt.
Appointed John H. Johnson to the Board of Directors. In April, Verastem Oncology announced the appointment of John H. Johnson to its Board of Directors. Mr. Johnson’s career spans multiple executive management roles at leading global corporations where he was responsible for overseeing oncology and immunology drug development initiatives and commercialization. Mr. Johnson will serve on the Compensation and Nominating and Governance Committees.
First Quarter 2020 Financial Results

Net product revenue for the three months ending March 31, 2020 (2020 Quarter) was $5.0 million, compared to $1.7 million for the three months ending March 31, 2019 (2019 Quarter). COPIKTRA demand units for the 2020 Quarter increased 178% compared to the 2019 Quarter. License and collaboration revenue for the 2020 Quarter was less than $0.1 million. There was no license and collaboration revenue for the 2019 Quarter. 2020 Quarter license and collaboration revenue was comprised of duvelisib shipments to our partner, CSPC Pharmaceutical Group Limited.

Total operating expenses for the 2020 Quarter were $31.4 million, compared to $36.3 million for the 2019 Quarter. Included within operating expenses for the 2020 Quarter is a non-recurring charge of $3.0 million related to an up-front non-refundable payment to Chugai Pharmaceutical Co. Ltd. (Chugai) for the VS-6766 license, $1.8 million of severance expense and $1.4 million of non-cash stock-based compensation expense.

Research and development (R&D) expense for the 2020 Quarter was $10.9 million, compared to $9.8 million for the 2019 Quarter. The increase of $1.1 million, or 11%, was primarily related to the up-front non-refundable payment of $3.0 million to Chugai for the VS-6766 license. This was partially offset by a decrease of $1.3 million in contract research organization costs and a decrease of $0.6 million in costs for clinical supply, drug substance and drug product.

Selling, general and administrative (SG&A) expense for the 2020 Quarter was $19.6 million, compared to $26.0 million for the 2019 Quarter. The decrease of $6.4 million, or 25%, primarily resulted from a decrease of $2.8 million in consulting and professional fees, principally related to the support of commercial launch activities in the 2019 Quarter, a decrease of $2.3 million in personnel related costs, including non-cash stock-based compensation as a result of reduced headcount, and a decrease of $1.3 million in reduced travel and other costs.

Net loss for the 2020 Quarter was $38.0 million, or $0.35 per share (basic and diluted), compared to $38.1 million, or $0.52 per share (basic and diluted), for the 2019 Quarter. The 2020 Quarter includes $8.1 million of non-cash interest expense related to conversions of Convertible Senior Notes into shares of common stock.

For the 2020 Quarter, non-GAAP adjusted net loss was $21.3 million, or $0.20 per share (diluted), compared to non-GAAP adjusted net loss of $33.8 million, or $0.46 per share (diluted), for the 2019 Quarter. Please refer to the GAAP to Non-GAAP Reconciliation attached to this press release.

Verastem Oncology ended the first quarter of 2020 with cash, cash equivalents and short-term investments of $170.7 million.

Financial Guidance for Fiscal 2020

As a result of its new strategic direction, Verastem Oncology expects to reduce its operating expenses by approximately 40% for 2020 compared to 2019. Based on its current operating plans, the Company expects its R&D and SG&A expenses for the full year 2020 to be in the range of $70 million to $85 million. The company is guiding that 2020 COPIKTRA revenues may be approximately $16 million.

On May 7, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported financial results for the first quarter ended March 31, 2020 (Press release, Personalis, MAY 7, 2020, View Source [SID1234557360]).

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First Quarter Highlights

Reported record revenues of $19.2 million in the first quarter of 2020 versus $14.1 million in the first quarter of 2019, an increase of 36%
A total of 26 customers have placed orders for NeXT as of March 31, 2020, with 7 of those customers placing their orders in the first quarter of 2020
Received a new order outside of oncology to deliver neoantigen prediction, which will leverage the Company’s proprietary technology platform
"I’m proud to say that we were able to report record revenues once again this quarter, in spite of the initial impact from the COVID-19 pandemic, and continued to see strong ordering levels from both our existing and new customers," said John West, Chief Executive Officer. "Also, while our laboratory operations have been scaled down due to the COVID-19 shelter-in-place orders, and will be at least through May, we feel well-positioned to work through our VA MVP samples and also service our biopharma customers when they are able to send us their samples."

First Quarter 2020 Financial Results

Revenues were $19.2 million in the three months ended March 31, 2020, up 36% from $14.1 million in the same period of the prior year. First quarter revenue growth was driven by an increase in volume for testing and analytical services provided to the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP). In the first quarter, the VA MVP accounted for $14.8 million, or 77%, of revenues and the remaining $4.4 million, or 23%, was from biopharmaceutical and all other customers.

Gross margin was 21.1% for the three months ended March 31, 2020, compared with 28.3% in the same period of the prior year.

Operating expenses were $13.7 million for the three months ended March 31, 2020, compared with $9.4 million in the same period of the prior year.

Net loss was $9.1 million for the three months ended March 31, 2020 and net loss per share was $0.29 based on a weighted-average basic and diluted share count of 31.3 million, compared with a net loss of $5.7 million and a net loss per share of $1.84 on a weighted-average basic and diluted share count of 3.1 million in the same period of the prior year.

Cash, cash equivalents, and short-term investments were $120.0 million as of March 31, 2020.

Outlook and COVID-19

Due to uncertainty surrounding the COVID-19 pandemic, Personalis will not provide an outlook for fiscal 2020 at this time, and will plan to give an update during its second quarter earnings announcement and press release, to the extent practicable, based on available information at that time.

Webcast and Conference Call Information

Personalis will host a conference call to discuss the first quarter financial results after market close on Thursday, May 7, 2020 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using conference ID: 9370329. The live webinar can be accessed at View Source

On May 7, 2020 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported financial results for the first quarter of 2020 (Press release, NanoString Technologies, MAY 7, 2020, View Source [SID1234557359]).

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First Quarter Financial Highlights

Product and service revenue of $24.5 million, 15% year-over-year growth. Pro forma growth was 23% and reflects the impact of the Veracyte transaction on revenue recorded for Prosigna IVD kits
Instrument revenue of $9.8 million, including $6.5 million of GeoMx Digital Spatial Profiler (DSP) instrument revenue, 128% year-over-year growth
Total consumables revenue of $11.5 million, 20% year-over-year decline. Pro forma decline was 11%
Service revenue of $3.2 million, 23% year-over-year growth
"Our team has risen to the challenges presented by the COVID-19 pandemic. The momentum of the GeoMx DSP launch continues, and we are particularly pleased with the substantial early interest from discovery researchers interested in reading out GeoMx results using next generation sequencing," said Brad Gray, President and CEO of NanoString. "In contrast, the COVID-19 related challenges have slowed the pace of research and reduced our current nCounter revenue visibility. With our strong balance sheet and powerful technology platforms, we remain focused on achieving our strategic objectives and expect to be well-positioned to capture demand when customers return to their research activities."

Recent Business Highlights

GeoMx DSP Platform

Generated more than 15 GeoMx DSP instrument orders in the first quarter, bringing cumulative orders received to more than 105 instruments since launch
Shipped 27 GeoMx DSP instruments in the first quarter, bringing cumulative shipments to 71 instruments since launch
Highlighted new peer-reviewed papers utilizing GeoMx DSP technology, including two publications from the lab of Dr. David Rimm of Yale University in Laboratory Investigation and Clinical Cancer Research, bringing the cumulative total to 17 peer-reviewed publications
Generated substantial interest in GeoMx DSP from discovery researchers, who represented approximately one-third of GeoMx Technology Access Program (TAP) orders in the first quarter
nCounter Platform

Grew installed base to approximately 880 nCounter Analysis Systems at March 31, 2020, as compared to approximately 760 systems at March 31, 2019
Surpassed 3,300 cumulative peer-reviewed publications utilizing nCounter technology
Financial

Issued $230 million aggregate principal amount of 2.625% Convertible Senior Notes due 2025. Approximately $89 million was used to repay borrowings and fees owed under the Company’s 10.5% senior term loan facility and its senior revolving credit facility, with the remaining net proceeds to be used for general corporate purposes
Concluded the quarter with over $268 million in cash, cash equivalents and short-term investments
First Quarter Financial Results

The Company has elected to present selected non-GAAP, or adjusted, financial measures, including Adjusted EBITDA. These adjusted financial measures are calculated excluding certain items that may make it more challenging to compare the Company’s GAAP operating results across periods. Such items may include collaboration revenue, stock-based compensation or one-time charges such as transaction related fees and expenses or restructuring charges and severance costs. A reconciliation of adjusted financial measures to the nearest comparable GAAP financial measure can be found in the notes and table at the end of this press release.

Fiscal Year 2020

On April 6, 2020, as a result of ongoing disruption relating to the COVID-19 pandemic and uncertainty as to the timing of the return of normalized levels of customer activity, the Company announced it was withdrawing its financial guidance for fiscal year 2020. As of the date of this release, management cannot predict the extent or the duration of the impact of the COVID-19 outbreak on our full year operating results.

Supplemental Information

As a supplement to the table above, the Company has posted to the investor relations section of the Company’s website, at www.nanostring.com, adjusted financial measures as compared to the nearest comparable GAAP financial measures for the first quarter of 2020 and for each quarter of and the full year 2019.

Conference Call

Management will host a conference call today beginning at 1:30 pm PT / 4:30 pm ET to discuss these results and answer questions. Individuals interested in listening to the conference call may do so by dialing (866) 211-0364 for domestic callers, or (647) 689-6861 for international callers. Please reference Conference ID 4699305. To listen to a live webcast, please visit the investor relations section of the Company’s website at www.nanostring.com. A replay of the call will be available beginning May 7, 2020 at 7:30pm ET through midnight ET on May 14, 2020. To access the replay, dial (800) 585-8367 or (416) 621-4642 and reference Conference ID: 4699305. The webcast will also be available on the Company’s website for one year following the completion of the call.

On May 7, 2020 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that Jim Clemmer, President and Chief Executive Officer, and Stephen Trowbridge, Executive Vice President and Chief Financial Officer, will participate in a virtual fireside chat at the UBS Virtual Global Healthcare Conference at 9:10 a.m. ET on Monday, May 18, 2020 (Press release, AngioDynamics, MAY 7, 2020, View Source [SID1234557358]).

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A live webcast of the fireside chat will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.

On May 7, 2020 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, reported financial results for the first quarter ended March 31, 2020 and provided an overview of the Company’s recent developments (Press release, X4 Pharmaceuticals, MAY 7, 2020, View Source [SID1234557357]).

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"The first quarter of 2020 was marked by flawless execution by our team as we prepared for the landmark FDA approval of Jelmyto, the first and only non-surgical treatment for patients with low-grade upper tract urothelial cancer. It has been our mission to pioneer novel treatments for patients in areas of unmet need, and our team has developed innovative solutions to engage key stakeholders so we can bring this effective, kidney-sparing therapy to patients who have been waiting for new treatment options," said Liz Barrett, President and Chief Executive Officer of UroGen. "Our momentum continues as we advance our portfolio of product candidates, highlighted by our recent UGN-102 data readout for the treatment of patients with low-grade intermediate-risk non-muscle invasive bladder cancer, a disease associated with high rates of recurrence and the need for repetitive surgical intervention. The recently published positive interim UGN-102 data, combined with pivotal data for Jelmyto, further supports our confidence in the broad potential of our pipeline. We remain on track to initiate a pivotal Phase 3 study later this year."

Recent Highlights and Upcoming Milestones

Jelmyto (mitomycin) for pyelocalyceal solution, formerly known as UGN-101, for adult patients with low-grade upper tract urothelial cancer (LG-UTUC)

UroGen announced the U.S. FDA granted approval of Jelmyto for the treatment of patients with LG-UTUC on April 15, 2020. Jelmyto is the first and only FDA approved non-surgical treatment option for patients with LG-UTUC.
The most commonly reported adverse events (≥ 20%) were ureteric obstruction, flank pain, urinary tract infection, hematuria, renal dysfunction, fatigue, nausea, abdominal pain, dysuria, and vomiting. No treatment-related deaths occurred.
The Lancet Oncology published pivotal results from the Phase 3 OLYMPUS trial, reporting that 59% of LG-UTUC patients treated with Jelmyto achieved a Complete Response (CR). Durability at 12-months (based on interim data) was estimated to be 84% by Kaplan-Meier analysis.
At the 12-month time point for assessment of durability, 19 patients remained in CR, seven had experienced recurrence of disease, nine patients continued to be followed for the 12-month duration of response, and median duration of response was not reached as of the FDA-approval date.
Jelmyto Commercial Readiness

The Company expects to commence the official commercial launch of Jelmyto on June 1, 2020.
To maximize engagement with health care professionals and key stakeholders in this current environment, the Company has developed innovative solutions, including a virtual platform, to allow for an effective launch.
The team has completed the application for submission of the C-code, and submission of the J-code application to CMS is in process. The company continues to expect a C-code will be secured by October and a J-code by the end of the year.
UGN-102 (mitomycin) for intravesical solution for patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC)

UroGen announced a positive interim data analysis of UGN-102 in patients with LG-IR-NMIBC, featured in a late-breaking abstract published in the April Supplement to The Journal of Urology.
The Phase 2b OPTIMA II trial demonstrated a CR rate at three months following onset of treatment of 65% (41/63 patients). In this subset of patients, 31/32 patients (97%) and 17/20 patients (85%) remained free of disease at six- and nine-months follow-up, respectively.
The most commonly reported adverse events seen to date (≥ 10%) were reported as mild to moderate and include dysuria, hematuria, urinary frequency, fatigue, urgency and urinary tract infection.
The detailed results presentation from the Phase 2b OPTIMA II trial will be available online via the American Urological Association (AUA) in mid-May 2020.
The Company remains on track to initiate a pivotal Phase 3 trial in 2H 2020.
There are no drugs currently approved by the FDA as first-line treatment for LG-IR-NMIBC. UGN-102 has the potential to provide a non-surgical treatment alternative for approximately 80,000 patients diagnosed with LG-IR-NMIBC in the United States alone.
First Quarter 2020 Financial Results; 2020 Guidance

As of March 31, 2020, cash, cash equivalents and marketable securities totaled $159.2 million, excluding restricted cash.
Research and development expenses for the three months ended March 31, 2020 were $16.6 million, including non-cash share-based compensation expense of $1.9 million, and a one-time payment of $6.6 million to unwind our obligation to the IIA.
Selling, general and administrative expenses for the three months ended March 31, 2020 were $22.0 million, including non-cash share-based compensation expense of $5.7 million.
UroGen reported a net loss of $37.8 million, or basic and diluted net loss per ordinary share of $1.79, for the three months ended March 31, 2020.
The 2020 financial guidance set forth during the Company’s full year and fourth quarter 2019 quarterly call on March 2, 2020 remains the same based on current business goals and anticipated activities.
Conference Call & Webcast Information

Members of UroGen’s management team will host a live conference call and webcast today at 8:30 AM Eastern Time to review the Company’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 View Source 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. Alternatively, please call (855) 765-5685 (U.S.) or (615) 247-5916 (International) to listen to the live conference call. The conference ID number for the live call will be 4575088. An archive of the webcast will be available for two weeks on the Company’s website.

About the Phase 3 OLYMPUS Trial

OLYMPUS (Optimized DeLivery of Mitomycin for Primary UTUC Study) is an open-label, single-arm Phase 3 clinical trial of UGN-101, Jelmyto (mitomycin) for pyelocalyceal solution, to evaluate the safety, tolerability and tumor ablative effect of Jelmyto in patients with low-grade UTUC. Seventy-one patients were treated at clinical sites across the United States and Israel. Study participants were treated with six weekly instillations of Jelmyto administered via a standard catheter. Four to six weeks following the last instillation, patients underwent a Primary Disease Evaluation (PDE) to determine Complete Response (CR), the primary endpoint of the study. PDE involved a ureteroscopy and wash cytology, a standard microscopic test of cells obtained from the urine to detect cancer and for cause biopsy. Patients who achieved a CR at the PDE timepoint were then followed for up to 12 months to determine the durability of response with Jelmyto.

About JelmytoTM

Jelmyto (mitomycin) for pyelocalyceal solution, is a drug formulation of mitomycin indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC). Utilizing the RTGel technology platform, UroGen’s proprietary sustained release, hydrogel-based formulation, Jelmyto is designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. Jelmyto is delivered to patients using standard ureteral catheters or nephrostomy tube. The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC. On April 15, 2020, the FDA approved Jelmyto, making it the first drug approved for the treatment of LG-UTUC in adult patients.

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.

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: side pain, urinary tract infection, blood in your urine, kidney problems, tiredness, nausea, stomach pain, trouble with urination, vomiting, low red blood cell count, frequent urination, itching, chills, and fever.