On April 30, 2023 Pulse Biosciences, Inc. (the "Company") reported to have entered into a Securities Purchase Agreement (the "Purchase Agreement") with Robert W. Duggan ("Investor"), the Company’s Executive Chairman of the Board of Directors and majority stockholder of the Company (Filing, 8-K, Pulse Biosciences, APR 30, 2023, View Source [SID1234630781]). Pursuant to the Purchase Agreement, the Company agreed to issue and sell to the Investor 10,022,937 shares of the Company’s common stock, par value $0.001 per share, in a private placement (the "Private Placement"), at a price per share of $6.51 (the "Shares"), a greater than 1% premium over the last closing price on NASDAQ of $6.44 per share on Friday, April 28, 2023.

The Shares will be paid for through the cancellation of $65 million aggregate principal amount, together with all accrued and unpaid interest outstanding, pursuant to that certain Loan Agreement (the "Loan Agreement"), dated as of September 20, 2022, as amended on March 17, 2023 by that certain First Amendment to Loan Agreement (the "Amendment"), by and between the Company and the Investor, as previously disclosed on a Current Report on Form 8-K filed with the Securities and Exchange Commission (the "SEC") on September 23, 2022 and March 21, 2023, respectively. At the time of Mr. Duggan’s original loan to the Company in September 2022, the Company’s stock was trading under $1.50 per share. Upon closing of the Private Placement and satisfaction of the outstanding debt, the Loan Agreement will terminate, without early termination fees or penalties being owed by the Company, and no additional amounts will be owed to the Investor under the Loan Agreement.

The foregoing description of the Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Purchase Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by this reference.

The representations, warranties and covenants contained in the Purchase Agreement were made solely for the benefit of the parties to the Purchase Agreement and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Purchase Agreement is incorporated herein by reference only to provide investors with information regarding the terms of the Purchase Agreement and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the U.S. Securities and Exchange Commission.

The Investor, who is already the majority holder of the Company, will have a beneficial ownership interest in the Company of approximately 69%, after the closing of the Private Placement.

Termination of a Material Definitive Agreement.

The description of the termination of the Loan Agreement set forth in Item 1.01 of this Current Report on Form 8-K is incorporated by reference into this Item 1.02 in its entirety. The terms of the Loan Agreement and the Amendment were previously disclosed in a Current Report on Form 8-K filed with the SEC on September 23, 2022 and March 21, 2023, respectively, which disclosures are incorporated herein by this reference.

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On May 1, 2023 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported additional positive results from its completed pivotal Phase III ZIRCON study of TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118) (Press release, Telix Pharmaceuticals, APR 30, 2023, View Source [SID1234630712]).

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The results were featured in a late-breaking oral presentation delivered on Sunday, 30 April 2023 (CST) by Associate Professor Brian Shuch, MD, Director, Kidney Cancer Program, UCLA Institute of Urologic Oncology (Los Angeles, California) and a principal investigator in the Phase III ZIRCON study, at the American Urological Association’s (AUA) Annual Meeting in Chicago.

New data presented demonstrates the high value of TLX250-CDx PET/CT imaging in detecting ccRCC, with secondary analysis confirming utility and effectiveness in very small renal masses, which are prevalent and present a significant diagnostic challenge.

In very small renal lesions (≤2cm, a secondary endpoint), sensitivity was 84% for all three readers, with specificity 92.3% to 100%. This reinforces the accuracy of this investigational diagnostic imaging agent across all analyses, with previously presented data showing an overall sensitivity and specificity of 86% and 87%, respectively.1,2

Dr Colin Hayward, Chief Medical Officer at Telix stated, "The excellent sensitivity and specificity for small lesions considerably expands the clinical utility and potentially the commercial opportunity for TLX250-CDx. We expect that the ability to diagnose even very small lesions as ccRCC will be an important factor in driving market adoption, subject to product approval."

Associate Professor Brian Shuch, MD commented, "It is a great pleasure to be showcasing new data from Telix’s Phase III ZIRCON study at AUA, the largest gathering of urologists in the world. We now have analyses on the outcome for very small renal masses, where the data set still shows outstanding sensitivity and specificity, far exceeding confirmatory trial success targets. This data is meaningful for surgeons to help them improve management by aiding risk stratification, selecting appropriate patients for treatment or in those where further imaging/biopsy could be indicated."

Telix is in the process of implementing an expanded access program in the United States and establishing named patient programs for TLX250-CDx in Europe.

On April 30, 2023 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the first results from the open-label Phase 2 SunRISe-1 study evaluating the efficacy and safety of TAR-200 monotherapy (a novel investigational intravesical drug delivery system) and cetrelimab monotherapy (an investigational anti-PD-1 monoclonal antibody administered intravenously) in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC), who are ineligible for, or decline, radical cystectomy (Press release, Johnson & Johnson, APR 30, 2023, View Source;pd-1-antibody-cetrelimab-in-patients-with-bacillus-calmette-guerin-unresponsive-non-muscle-invasive-bladder-cancer-301811583.html [SID1234630711]). The study demonstrated that 72.7 percent of patients treated with TAR-200 alone (95 percent confidence interval [CI] 49.8-89.3) and 38.1 percent of patients treated with cetrelimab alone (CI 18.1-61.6) achieved the primary endpoint of a complete response (CR). These data were featured today in a Late Breaker Podium Presentation Session (Abstract #LBA02-03) at the American Urological Association Annual Meeting (AUA).

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"We continue to see significant unmet need among high-risk patients with non-muscle-invasive bladder cancer, who often experience negative outcomes and poor quality of life with existing standard of care treatments, such as radical cystectomy," said Siamak Daneshmand*, M.D., Professor of Urology, Director of Urologic Oncology at the Norris Comprehensive Cancer Center, Keck School of Medicine of University of Southern California and SunRISe-1 study principal investigator. "As a clinician, my ultimate treatment goal is to achieve deep and durable responses in these patients. It is encouraging to see an improvement among those treated with TAR-200 alone, as well as cetrelimab alone, and we look forward to reporting on results from the study cohort that is evaluating these two treatments in combination in the future."

HR-NMIBC includes lesions confined to the bladder mucosa and has a higher likelihood of local recurrence and distant progression to other parts of the body.1 HR-NMIBC is typically treated with BCG – a type of intravesical immunotherapy – as the standard of care. BCG involves injecting a weakened form of tuberculosis bacteria into the bladder, stimulating the immune system to attack the cancer cells; however, approximately one-third of HR-NMIBC patients will not respond to the treatment. For BCG-unresponsive patients, there is an anti-PD-1 monoclonal antibody as an alternate, approved treatment option.2,3,4 NMIBC represents some 70 percent of newly diagnosed bladder cancer cases, of which 10 percent are carcinoma in situ (CIS), early cancer cells confined within the innermost layer of the bladder lining; 50 percent of all cases of CIS will progress to muscle-invasive bladder cancer (MIBC) within 5 years if left untreated.5,6

TAR-200 is a novel investigational intravesical drug delivery system designed to provide sustained local release of gemcitabine into the bladder urine. Cetrelimab is an investigational anti-PD-1 monoclonal antibody administered intravenously. The SunRISe-1 study evaluated patients with histologically confirmed CIS, with or without concomitant high-grade Ta (CIS) or T1 (CIS cases with higher risk of progressing to MIBC) papillary disease, a type of NMIBC. Patients were randomized to one of three cohorts: treatment with TAR-200 in combination with cetrelimab (Cohort 1 [C1]), TAR-200 alone (Cohort 2 [C2]) or cetrelimab alone (Cohort 3 [C3]). C2 and C3 results were reported at AUA with C1 results to be reported at a future date. The primary endpoint of CR at any time was determined by cystoscopy, central cytology, and central pathology (Weeks 24 and 48). Secondary endpoints included duration of response (DOR), overall survival (OS), pharmacokinetics, quality of life, safety, and tolerability.

Preliminary results of the SunRISe-1 study included 23 evaluable patients in C2 and 24 evaluable patients in C3. After median follow-up of 10.6 months, 15 of 16 responses in C2 are still ongoing; median DOR was not reached. Additionally, six of the patients in C2 maintained their response beyond 12 months and none of the complete responders had documented recurrence or progression.

The initial findings from SunRISe-1 showed low rates of grade three or higher adverse events (AEs) and a limited number of treatment discontinuations due to adverse events were observed with TAR-200. The most common AEs were pollakiuria (34.8 percent), micturition urgency (34.8 percent), dysuria (26.1 percent), and noninfective cystitis (21.7 percent) in C2; pruritus (20.8 percent) and diarrhea (20.8 percent) occurred in patients in C3. Seven patients in C2 (30.4 percent) and two patients in C3 (8.3 percent) had AEs that were grade three or higher.

"Our ambition is to improve the lives of patients living with non-muscle and muscle-invasive bladder cancers and redefine the treatment of this disease in the future," said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Janssen Research & Development, LLC. "With the innovative TAR-200 intravesical drug delivery system, we are committed to advancing bladder cancer treatment across the spectrum of this disease, and we look forward to providing further updates from our robust SunRISe clinical program."

Bladder cancer is the sixth most common cancer in the United States, with more than 80,000 patients diagnosed annually, and is the tenth most common cancer worldwide, with more than 600,000 patients diagnosed each year.6,7 Bladder cancer occurs when cells in the bladder tissue grow uncontrollably, often forming a tumor that can then spread to other parts of the body if left untreated. Non-muscle-invasive bladder cancers are limited to the urothelium, the innermost layer of the bladder, and may be less aggressive than muscle-invasive bladder cancer, a type of cancer that arises from the muscular layer of the bladder or has grown beyond the urothelium and is more likely to spread to other parts of the body.8

About SunRISe-1
SunRISe-1 (NCT04640623) is a Phase 2 randomized, parallel-assignment, open-label clinical study evaluating the safety and efficacy of TAR-200 in combination with cetrelimab, TAR-200 alone, or cetrelimab alone for BCG-unresponsive HR-NMIBC CIS patients who are ineligible for, or decline, radical cystectomy. Participants are randomized to one of three cohorts: treatment with TAR-200 in combination with cetrelimab (C1), TAR-200 alone (C2), or cetrelimab alone (C3). The primary endpoint is CR rate at any time point. Secondary endpoints include DOR, OS, pharmacokinetics, quality of life, safety, and tolerability.

About TAR-200
TAR-200 is an investigational drug delivery system, enabling controlled release of gemcitabine into the bladder, increasing dwell time and local drug exposure. The safety and efficacy of TAR-200 are being evaluated in Phase 2 and Phase 3 studies in patients with muscle-invasive bladder cancer in SunRISe-2 and SunRISe-4 and NMIBC in SunRISe-1 and SunRISe-3.

About Cetrelimab
Administered intravenously, cetrelimab is an investigational programmed cell death receptor-1 (PD-1) monoclonal antibody being studied to treat bladder cancer, prostate cancer, melanoma, and multiple myeloma as part of a combination treatment. Cetrelimab is also being evaluated in multiple other combination regimens across the Janssen Oncology portfolio.

About High-risk Non-Muscle-Invasive Bladder Cancer
High-risk non-muscle-invasive bladder cancer (HR-NMIBC) is a type of non-invasive bladder cancer that is more likely to recur or spread beyond the lining of the bladder, called the urothelium, and progress to invasive bladder cancer compared to low-risk NMIBC. HR-NMIBC makes up 15-44 percent of patients with NMIBC and is characterized by a high-grade, large tumor size, presence of multiple tumors, and CIS. Radical cystectomy is currently recommended for NMIBC patients who fail BCG therapy, with over 90 percent cancer-specific survival if performed before muscle-invasive progression. Given that NMIBC typically affects older patients, many may be unwilling or unfit to undergo radical cystectomy. The high rates of recurrence and progression can pose significant morbidity and distress for these patients.

On April 30, 2023 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported the results of a sub-analysis from the first and largest post-commercial utilization review of JELMYTO (mitomycin) for pyelocalyceal solution presented at the American Urological Association Meeting 2023 in Chicago, IL (Press release, UroGen Pharma, APR 30, 2023, View Source [SID1234630707]). The study titled, First Analysis of the Safety and Efficacy of UGN-101 in the Treatment of Ureteral Tumors (Abstract PD24-07) is the first to assess JELMYTO in treating ureteral tumors. The investigators reported no difference in outcomes at first endoscopic evaluation based on UTUC tumor location (ureter vs. renal pelvis) (p=0.644). JELMYTO is approved for the treatment of low-grade upper tract urothelial cancer (LG-UTUC) in adult patients.

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"These results are encouraging and suggest that JELMYTO could be an effective treatment option for patients with low grade ureteral carcinoma," said Joseph Jacob, M.D., Director of The Bladder Cancer Program, Upstate Medical University, Syracuse, NY. "This is particularly important for patients who may have limited options."

In this analysis, 47 patients had UTUC tumors involving the ureter, with 12 cases of ureteral tumor only (8.8%) and 35 cases of ureteral plus renal pelvic tumors (25.7%). In addition to similar efficacy and safety results at first endoscopic evaluation, there was also no difference in recurrence rate or progression based on tumor location. Fourteen patients (37.8%) with ureteral tumor had significant ureteral stenosis at first post-treatment evaluation, however, only 5.4% of patients developed new clinically significant stenosis when excluding patients with pre-existing hydronephrosis (excess fluid in a kidney due to a backup of urine) or ureteral stenosis.

"These data are promising for LG-UTUC patients with ureteral tumors," said Mark Schoenberg, M.D., Chief Medical Officer, UroGen. "The Phase 3 OLYMPUS study only included patients with tumors in the renal pelvis, so these real-word data provide important insights about the utility of JELMYTO in treating LG-UTUC patients with multifocal disease."

The limitations of this study include the retrospective design, lack of a control group, the lack of a centralized pathology review, and lack of standardized clinicopathologic assessment.

To further explore the full potential of JELMYTO for the treatment of patients with UTUC, investigators are in the process of enrolling the prospective and retrospective uTRACT Registry to capture data in a large scale, standardized manner to report further on patient outcomes following JELMYTO treatment including longitudinal follow-up.

About UTUC

Approximately 5-7% of urothelial cancer occurs in the upper lining of the kidney, called the calyx and renal pelvis. It could also occur in one or both of the ureter(s), the tubes that lead from the kidneys to the bladder. Cancer in the renal pelvis or ureter(s) is called upper tract. LG-UTUC is usually not very aggressive and is slow to spread but has a high recurrence rate. High-grade UTUC can be more aggressive. It may spread to other parts of the urinary tract, or to other parts of the body.

JELMYTO is approved for the treatment of adults with LG-UTUC. LG-UTUC is a rare disease managed by endoscopic methods and radical nephroureterectomy. Endoscopic resection and laser ablation attempt to preserve the kidney, though there is a high risk of recurrence that may eventually necessitate removal of the kidney. Although kidney removal is the gold standard for treatment of high-grade UTUC, it may be over-treatment in LG-UTUC, as kidney removal offers similar five-year survival as kidney-sparing procedures but is associated with significant morbidity. JELMYTO is efficacious as a primary chemoablative therapy in patients with LG-UTUC.

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.

Please click here for JELMYTO Full Prescribing Information, including the Patient Information, for additional information and here for the Nephrostomy Administration Guide.

On April 29, 2023 (the "Signing Date"), FibroGen, Inc. (the "Company") reported to have entered into a financing agreement ("Financing Agreement") with investment funds managed by Morgan Stanley Tactical Value, as lenders (the "Lenders"), and Wilmington Trust, National Association, as the administrative agent (the "Administrative Agent"), providing for senior secured term loan facilities consisting of (i) a $75,000,000 initial term loan (the "Initial Term Loan"), (ii) a $37,500,000 delayed draw term loan that will be funded upon the achievement of certain clinical development milestones ("Delayed Draw Term Loan 1") and, (iii) an uncommitted delayed draw term loan of up to $37,500,000, to be funded at the Lenders sole discretion, ("Delayed Draw Term Loan 2" and, together with the Initial Term Loan and Delayed Draw Term Loan 1, the "Term Loans") (Filing, 8-K, FibroGen, APR 29, 2023, View Source [SID1234630771]).

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Pursuant to the Financing Agreement, the Lenders (i) shall fund the Initial Term Loan by May 8, 2023, (ii) shall fund the Delayed Draw Term Loan 1 within 24 business days from the date of achievement of certain clinical development milestones but no later than August 31, 2023 and, (iii) at their discretion, shall provide Delayed Draw Term Loan 2 on or prior to August 31, 2023, whether or not such milestones are achieved.

The Term Loans shall accrue interest at a rate of 14.0% per annum, payable monthly in arrears. The Term Loans shall mature on May 8, 2026. The Term Loans will not be subject to amortization payments. The Company is permitted to prepay the Term Loans from time to time, in whole or in part, subject to payment of a make-whole amount equal to the unpaid principal amount of the portion of the Term Loans being repaid or prepaid, plus accrued and unpaid interest of the portion of the Term Loans being repaid or prepaid, plus an amount equal to the remaining scheduled interest payments due on such portion of the Term Loans being repaid or prepaid as if such Term Loans were to remain outstanding until the scheduled maturity date.

During the term of the Term Loans, the Company is required to maintain a minimum balance of $30 million of unrestricted cash and cash equivalents held in accounts in the United States, tested monthly on each interest payment date (after netting the monthly interest payment then due). In addition, while any portion of the Term Loans or any other obligations under the Financing Agreement remain outstanding, the Company must comply with certain customary affirmative and negative covenants set forth in the Financing Agreement and related loan documents, including, without limitation, restrictions or limitations on: incurrence of further indebtedness or liens, acquisitions and other investments, breach or material default under certain material contracts, dividends, distributions and stock buy-backs, negative pledges, sales, transfers, licenses or other disposition of assets (including core intellectual property), prepayment of other indebtedness, and transactions with affiliates, in each case, subject to thresholds and exceptions set forth in the Financing Agreement and related loan documents.

The Financing Agreement provides for customary events of default triggers, including, without limitation, non-payment, breach of covenants (including the minimum cash covenant described above), material misrepresentation, cross-default to other material indebtedness of the Company or its subsidiaries (or the imposition of a material event of default fee or similar payment under a royalty monetization transaction), commencement of voluntary or involuntary bankruptcy proceedings, material judgments, change of control, invalidity of loan documents, certain ERISA events, certain regulatory events and failure to draw any portion of the Delayed Draw Term Loan 1 when funded by the Lenders. Upon an event of default, the Administrative Agent may, and at the direction of the majority Lenders shall, accelerate all outstanding obligations of the Company under the Financing Agreement and related loan documents, terminate all outstanding funding commitments and/or exercise remedies available at law or equity or under contract for secured creditors.

The Term Loans and all other obligations of the Company under the Financing Agreement and related loan documents are guaranteed by each of the Company’s current and future, direct and indirect, subsidiaries, with certain exceptions (including an exclusion for any Chinese subsidiary of the Company). The Term Loans are secured by substantially all assets of the Company and the guarantors, subject to customary exceptions.

The foregoing description of the Financing Agreement is not a complete description thereof, and is qualified in its entirety by reference to the full text of the Financing Agreement, which will be filed with the Securities and Exchange Commission as an exhibit to FibroGen’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2023.