On May 13, 2022 Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Ocuphire Pharma, MAY 13, 2022, View Source [SID1234614527]).

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"We have kicked off 2022 with a high level of productivity and execution resulting in multiple positive clinical data readouts across our late-stage programs," said Mina Sooch, MBA, founder and CEO of Ocuphire Pharma. "Year to date, we presented at 10 conferences and met with many KOLs, reinforcing the growing awareness and enthusiasm for our programs, particularly among doctors anticipating an eye drop treatment to reverse dilation. We recently reported positive data from the MIRA-3 and MIRA-4 trials, marking completion of the clinical activities to support the planned NDA filing for Nyxol in the Reversal of Mydriasis (RM) indication later this year. In our retinal program, we look forward to reporting top-line Phase 2b data in the second half of the year for APX3330, an novel oral treatment option for the large unmet need of over 7 million diabetic retinopathy patients who are generally asymptomatic with a progressive vision-threatening disease and are not routinely treated with approved anti-VEGF injections. With the approval of the first artificial-intelligence-based screening of diabetic retinal diseases, we expect an increase in the identification of DR patients."

Key Anticipated Future Milestones

Reversal of Mydriasis (RM): Planned New Drug Application (NDA) with the FDA for Nyxol in RM indication in late 2022, with potential launch as first dilation reversal drop in 2H 2023
Presbyopia: Initiate VEGA Phase 3 program in mid-2022 investigating Nyxol alone and Nyxol with 0.4% low-dose pilocarpine (LDP) as adjunctive therapy and, if successful, expect to file an NDA in 2023
Night Vision Disturbances (NVD): Report top-line results from the Nyxol Phase 3 LYNX-1 trial in 2Q 2022
Diabetic Retinopathy (DR) and Diabetic Macular Edema (DME): Report top-line results from the APX3330 Phase 2b ZETA-1 trial in 2H 2022
First Quarter and Recent Business Highlights

Clinical Development

In January, the Company announced new positive data from the VEGA-1 Phase 2 trial for Nyxol as a single agent in presbyopia, showing that one drop of Nyxol had statistically significant improvement in 3 lines of near vision efficacy at 12-hours compared to placebo.
In January, the Company completed enrollment of the LYNX-1 Phase 3 Trial investigating Nyxol for the treatment of night vision disturbances in 145 patients (target of 140).
In February, Ocuphire held a Type-C meeting with the FDA from which it obtained guidance regarding the design of pivotal studies for filing an NDA to seek approvals of Nyxol for the treatment of presbyopia, both as a single agent and with LDP as adjunct therapy eye drops.
In March, the Company announced successful results from the MIRA-3 Phase 3 registration trial of Nyxol for RM, demonstrating significant and rapid reversal of mydriasis. In addition, multiple key secondary endpoints met statistical significance, including early onset of action, durable response over 24 hours, similar efficacy with one or two drops, and efficacy regardless of iris color or mydriatic agent used.
In March, the Company completed enrollment of 103 (target of 90-100) diabetic retinopathy patients in the ZETA-1 Phase 2b trial of first-in-class oral APX3330. Masked safety data from the trial, first announced during the R&D Day event in January 2022 and later presented through May at medical conferences, demonstrated a favorable safety profile, consistent with prior studies.
In April, the Company completed the last clinical trial supporting a planned NDA submission with the announcement of positive results from the MIRA-4 Phase 3 pediatric study evaluating Nyxol for RM. The study met its primary safety endpoint, demonstrating a favorable safety and tolerability profile with no adverse events reported.
Presentations, Publications, and Conferences

In January through May 2022, Ocuphire was represented at conferences by Mina Sooch and several prominent key thought leaders, including David Boyer, MD, David Lally, MD, Jay Pepose, MD, Inder Paul Singh, MD, Douglas Devries, OD, and James Katz, MD, who presented updates on Nyxol in Presbyopia and RM, as well as masked safety data for APX3330 in DR. In total, 16 papers, posters, and panel talks were presented across 10 medical and industry conferences.
Corporate

In January, the Company held an Investor R&D Day webinar that featured six ophthalmic Key Opinion Leaders: Jay Pepose, MD, PhD, James Katz, MD and Mitchell Jackson, MD from refractive surgery, Paul Karpecki, OD from optometry, and David Boyer, MD, and Peter Kaiser, MD, from retina practice areas who discussed the unmet needs in RM, presbyopia and DR addressed by Ocuphire’s two late-stage clinical drug assets, Nyxol and APX3300. A replay of the event can be found on the Company’s corporate website here.

In March, the Company appointed Jay Pepose, MD, PhD, as its Chief Medical Advisor.
First Quarter Ended March 31, 2022 Financial Highlights

As of March 31, 2022, Ocuphire had cash and cash equivalents of approximately $19.2 million. Based on current projections, management believes the current cash on hand will be sufficient to fund operations into the second quarter of 2023. Cash and cash equivalents as of March 31, 2022 was $5.3 million lower than on December 31, 2021.

General and administrative expenses were $1.7 million for each of the three months ended March 31, 2022 and March 31, 2021.

Research and development expenses for the three months ended March 31, 2022 were $4.8 million compared to $3.5 million for the three months ended March 31, 2021. The $1.3 million increase was primarily attributable to an increased activity level associated with clinical trials and manufacturing activities for Nyxol and APX3330 period over period as well as additional preclinical and other development activities during the current period.

The loss from operations for the quarter ended March 31, 2022 was $6.5 million, compared to $5.2 million for the quarter ended March 31, 2021.

Net loss for the quarter ended March 31, 2022 was $6.6 million or ($0.35) per share, compared to $39.0 million or ($3.57) per share for the quarter ended March 31, 2021 which included a non-cash fair value change in warrant liabilities of $33.8 million.

For further details on Ocuphire’s financial results, refer to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 to be filed with the Securities and Exchange Commission.

On May 13, 2022 Pyxis Oncology, Inc. (Nasdaq: PYXS), a multi-asset, multi-modality company focused on developing next-generation therapeutics for difficult to treat cancers, reported financial results for its first quarter ended March 31, 2022 (Press release, Pyxis Oncology, MAY 13, 2022, View Source [SID1234614526]). The Company ended the quarter with approximately $247 million in cash and cash equivalents.

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Pyxis Oncology remains on target to file INDs for anti-EDB, PYX-201, and anti-Siglec-15, PYX-106, in the second half of 2022 and INDs for anti-CD123, PYX-203, and anti-KLRG1, PYX-102, in the second half of 2023. Further, as previously disclosed, the Company expects to provide an update on its anti-DLK1 ADC, PYX-202, in mid-2022.

Financial Update

As of May 13, 2022, Pyxis Oncology had cash and cash equivalents of approximately $231 million (preliminary, unaudited), which is expected to fund operations into the third quarter of 2024.

Research and development expenses were $20.1 million for the three months ended March 31, 2022, compared to $32.8 million for the three months ended March 31, 2021. The period-over-period decrease was primarily due to a lower license fee partially offset by increased expenses associated with cell line development and an increase in employee headcount to support research and development activities.

General and administrative expenses were $11.3 million for the three months ended March 31, 2022, compared to $2.9 million for the three months ended March 31, 2021. The period-over-period increase was primarily due to a higher personnel-related expenses (including stock-based compensation), and increase in legal, professional, recruiting and consulting fee to support our growth and operations.

Net loss was $31.4 million, or $0.97 per common share, for the three months ended March 31, 2022, compared to $36.8 million, or $27.26 per common share, for the three months ended March 31, 2021.The reduction in net loss is primarily due to a one-time license fee for the addition of three antibody-drug conjugates to the Company’s portfolio in the first quarter of 2021.

As of May 13, 2022, the outstanding number of shares of Common Stock of Pyxis Oncology was 32,817,062.

On May 13, 2022 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence (AI) and data mining platform to discover and develop cell and gene therapies with a therapeutic focus on immuno-oncology, reported financial results for the first quarter ended March 31, 2022 (Press release, Kiromic, MAY 13, 2022, View Source [SID1234614525]).

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"This past quarter has seen tremendous progress inside the Company, particularly within the research, development, and manufacturing functions. As an organization, we have achieved important goals, from optimizing and validating our ALEXIS Gamma Delta T (GDT) cell platform, enhancing our GDT cell banking technology, to expanding and redesigning our cGMP manufacturing facility and deploying a master cell bank strategy. These are all critical activities for achieving our milestone of beginning the activation of the clinical trial for our first oncology cell therapy candidate Procel by the end of the fourth quarter later this year," stated Pietro Bersani, Kiromic BioPharma’s Chief Executive Officer. "We have been intensely preparing for this milestone, and we believe that we now have the right team, the right capabilities, and the right processes in place to achieve this objective. We have a tremendous opportunity ahead of us, with incredible science that we are looking forward to ultimately making available to patients."

Quarter 1 Fiscal Year 2022 Financial Highlights:

Cash Position: Cash and cash equivalents were $15,123,100 as of March 31, 2022, compared to $25,353,900 as of December 31, 2021. The difference is attributable to cash outflows of $7,520,200, $2,541,800, and $168,800 for operating, investing, and financing activities, respectively.
R&D Expenses: Our research and development expenses increased by $1,040,200, or 55.17%, to $2,925,800 for the three months ended March 31, 2022, from $1,885,600 for the three months ended March 31, 2021. The increase was attributable to increased headcount, manufacturing, and experimentation costs for the development of our ALEXIS clinical platform.
G&A Expenses: Our general and administrative expenses increased by $2,368,200, or 114.35%, to $4,439,200 for the three months ended March 31, 2022, from $2,071,000 for the three months ended March 31, 2021. This increase was primarily due to increases in professional services fees, personnel, and recruiting costs.
Net Loss: Our net loss increased to $7,019,400 during the three months ended March 31, 2022, compared to $3,854,500 during the three months ended March 31, 2021.
Recent Business Highlights:

New Company Leadership:

As previously announced, we appointed our Chief Executive Officer, a new Chair of our Board, and two new independent Board members.
ALEXIS (Gamma Delta CAR-T cell Platform) Research & Development:

Continued to improve and enhance the manufacturing efficiencies of the ALEXIS platform, optimizing both cellular function and cost containment
Progressed a Master Cell Bank strategy for retro-viral vector (RVV) production
Performed additional studies on supplementary target tumor cell lines, thereby providing additional pre-clinical validation of the potency and specificity of the ALEXIS platform of products.
Further optimized Kiromic’s Diamond AImediated pooled donor Gamma Delta T cell banking technology. The method of manufacturing GDT cells from pooled allogenic donors has been validated and confirmed with post-freezing, thawing, recovery, stability, and potency. As a next step, the pooled donor GDT cell banks will be tested in vivo for tolerability and efficacy.
Confirmed a quantitative methodology to determine the residual helper plasmid DNA in RVV preparations, which is an important RVV release test used in manufacturing Procel and Isocel.
cGMP Manufacturing:

We have expanded and redesigned our in-house current Good Manufacturing Practices (cGMP) facility.
DIAMONDAI 2.0 Platform for Drug Discovery and Development: NOEMI (NeurO Evolutive) Machine Learning Enabled Antibody Design)

Kiromic’s DIAMONDAI 2.0 identifies and validates cancer-specific proteins on the surface of cancer cells that can be targeted by engineered T-cells. Typically, a year of laboratory work in animal models and significant expense is then required to develop a chimeric antigen receptor (CAR) for our GDT cells so they will attack that cancer target.
Consistent with Kiromic’s mission to apply cutting edge techniques to improve immunotherapy, we believe we have created a groundbreaking system, NOEMI, to dramatically accelerate CAR development.
NOEMI is a machine learning and genetic algorithm trained to provide the sequence of a chimeric antigen receptor (CAR) receptor that will bind a Diamond AI target. This software can do in hours what would normally take a year.

On May 13, 2022 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, reported financial results for the quarter ended March 31, 2022 and provided a corporate update (Press release, Tempest Therapeutics, MAY 13, 2022, View Source [SID1234614524]).

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"The team continued to execute well throughout the first quarter of this year, enabling us to present the first clinical data from a Tempest program at the ASCO (Free ASCO Whitepaper) Annual Meeting in June," said Stephen R. Brady, chief executive officer of Tempest. "We look forward to the upcoming oral presentation, which will highlight the clinical profile and responses observed in the monotherapy and combination Phase 1 study of TPST-1120, our novel PPARa antagonist."

________________________
1 If approved by the FDA

Recent Highlights

TPST-1120 (clinical PPARα antagonist): (i) completed enrollment in the Phase 1 monotherapy and combination dose escalation arms; (ii) announced that the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) accepted for an oral presentation at its 2022 Annual Meeting an abstract containing the TPST-1120 Phase 1 monotherapy and combination data; and (iii) continued enrollment in first-line, randomized global Phase 1b/2 study in patients with hepatocellular carcinoma (HCC), under a collaboration with F. Hoffmann La Roche.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) continued enrollment in a Phase 1 study evaluating both monotherapy and combination (with anti-PD-1 checkpoint inhibitor, pembrolizumab) dose and schedule optimization arms, towards establishing an RP2D; (ii) presented preclinical data further differentiating TPST-1495 from other approaches targeting the prostaglandin E2 (PGE2) pathway at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting; and (ii) announced that ASCO (Free ASCO Whitepaper) accepted for a poster presentation a "trials in progress" for the ongoing TPST-1495 Phase 1 clinical monotherapy and combination therapy clinical trial.
TREX1 Inhibitor (preclinical tumor-selective STING pathway activator): presented the first data with proprietary targeted molecules demonstrating therapeutic benefit in tumor-bearing mice at the AACR (Free AACR Whitepaper) 2022 Annual Meeting.
Planned Near-Term Milestones

TPST-1120 (clinical PPARα antagonist): (i) first presentation of clinical data from a Tempest program at the oral presentation of the Phase 1 monotherapy and combination data at the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting; and (ii) objective response data from the first 40 HCC patients in the first-line randomized study expected by year end or early 2023.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) selection of monotherapy RP2D expected in the first half of 2022; (ii) presentation of "trial in progress" poster at ASCO (Free ASCO Whitepaper) 2022 Annual Meeting; and (iii) data from Phase 1 monotherapy and combination dose and schedule optimization arms expected by year end or early 2023.
TREX1 Inhibitor (preclinical tumor-selective STING pathway activator): planned selection of development candidate in the second half of 2022.
PIPE Financing

On April 27, we announced a $15 million private investment in public equity (PIPE) financing to EcoR1 Capital, LLC and Versant Venture Capital.
Financial Results

First Quarter

Tempest ended the first quarter of 2022 with $45.8 million in cash and cash equivalents, compared to $51.8 million at December 31, 2021. The decrease was primarily due to cash used in operations of $7.1 million offset by proceeds from sales under our ATM program of $1.4 million. Cash balance does not reflect $15 million raised in April from PIPE financing.
Net cash used in operations for the quarter ended March 31, 2022 was $7.1 million compared to $6.3 million for the same period in 2021.
Net loss and net loss per share for the quarter ended March 31, 2022 were $8.5 million and $1.18, respectively, compared to $5.4 million and $10.55, respectively, for the first quarter of 2021.
Research and development expenses for the first quarter of 2022 were $5.1 million compared to $3.6 million for the same period in 2021. The $1.5 million increase was primarily attributable to expanded research and development efforts and increased fees for consulting services and compensation expenses.
For the three months ended March 31, 2022, general and administrative expenses were $3.0 million compared to $1.5 million for the same period in 2021. The increase of $1.5 million was primarily due to higher professional and consulting fees, insurance, and compensation expenses.

On May 13, 2022 UroGen Pharma Ltd. (Nasdaq: URGN) reported that highlighted four presentations of interest featuring data on JELMYTO (mitomycin) for pyelocalyceal solution for patients with low-grade upper tract urothelial cancer (LG-UTUC) and investigational agent UGN-102 (mitomycin) for intravesical solution in Phase 3 clinical development as primary non-surgical therapy for low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) at the upcoming 2022 American Urological Association (AUA) Annual Meeting, May 13-16 in New Orleans, Louisiana (Press release, UroGen Pharma, MAY 13, 2022, View Source [SID1234614523]). The presentations will be published in the June 2022 issue of The Journal of Urology and will be accessible via the AUA website.

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Details on AUA Presentations:

Podium Presentation
Abstract #: PD26-08
Session: Low-grade urothelial carcinoma recurs at a tempo that naturally accelerates from Adagio to Allegro
Presenter: Alex Sankin, M.D., Associate Professor Department of Urology, Albert Einstein College of Medicine
Date and Time: Saturday, May 14, 2022 at 2:10-2:20 PM CT
Location: Room 252

ICU Theater
Session: Chemoablation as primary treatment: Transforming the paradigm for low grade UTUC with JELMYTO
Presenter: Jennifer Linehan, M.D. Associate Professor of Urology and Urologic Oncology at the Saint John’s Cancer Institute
Date and Time: Sunday, May 15, 2022 at 12:00-1:00 PM CT
Location: S&T Hall: Booth 1043

Moderated Poster
Abstract #: MP54-06
Session: Longitudinal Health-Related Quality of Life Outcomes in Adults with Non-Muscle-Invasive Bladder Cancer Receiving a Chemoablative Gel as a Primary Treatment (Optima II: Phase 2b, single arm, open-label trial)
Presenter: Angela Smith, M.D., M.S. Associate Professor at the University of North Carolina (UNC) Department of Urology in Chapel Hill, North Carolina
Date and Time: Monday, May 16, 2022 at 8:45-10:00 AM CT
Location: Room 228

Podium Presentation
Abstract #: PD58-06
Session: Antegrade Administration of Reverse Thermal Mitomycin Gel for Primary Chemoablation of Upper Tract Urothelial Carcinoma via Percutaneous Nephrostomy Tube: a Multi-Institutional Real-World Experience
Presenter: Kyle Rose, M.D., Urologic Oncology Fellow at Moffitt Cancer Center in Tampa, Fla.
Date and Time: Monday, May 16, 2022 at 1:50-2:00 PM CT
Location: Room 252

UroGen will be hosting Booth #837 at the Ernest N. Morial Convention Center during AUA 2022.

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 U.S. Food and Drug Administration. 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.