On July 28, 2021 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, and Neopharm group ("Neopharm"), reported an exclusive license for Neopharm to market and sell Jelmyto (mitomycin) for pyelocalyceal solution in Israel, subject to regulatory approval (Press release, UroGen Pharma, JUL 28, 2021, View Source [SID1234585293]). Jelmyto is the first and only U.S. Food and Drug Administration approved medicine for adult patients with low-grade upper tract urothelial cancer (LG-UTUC).

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Neopharm will lead the regulatory process in Israel, which is supported by the results from the Phase 3 OLYMPUS trial that showed Jelmyto achieved clinically significant disease eradication in adults with LG-UTUC.

"We are excited to work with Neopharm and take the first step in making Jelmyto available to patients in Israel," said Liz Barrett, President and Chief Executive Officer of UroGen. "As we begin the process of geographic expansion for Jelmyto, it was important for us to prioritize Israel as the first opportunity to bring this innovative treatment to patients outside of the United States. Beyond the fact that our company was founded in Israel, and we continue to have a significant presence there, physicians and patients in Israel played a key role in the pivotal study that supported Jelmyto’s approval in the United States."

Jelmyto, which received expedited approval in the United States in April 2020, is an innovative therapy utilizing UroGen’s proprietary sustained release RTGel technology in combination with mitomycin, an established chemotherapy that inhibits DNA synthesis. It has been designed to dwell in the cavity, enabling mitomycin to have longer exposure to and broader coverage of urinary tract tissue, thereby allowing the treatment of tumors by non-surgical means.

"We look forward to working with UroGen to move Jelmyto through the regulatory process in Israel and to make this novel, non-surgical treatment available to appropriate patients as quickly as possible," said Efi Shnaidman, general manager of Neopharm Israel. "We are proud to be the first company outside the US to have started the regulatory approval and commercialization process for Jelmyto, demonstrating Israel’s importance in geographic expansion. Moreover, it is exciting to work with another company who has deep roots in Israel. I am confident that our well-established expertise and heritage of collaboration with innovative biopharmaceutical companies will make Jelmyto a success in Israel."

In addition to Israel, UroGen continues to work with regulators and potential collaborators in key markets to explore opportunities for geographic expansion. UroGen is committed to bringing the promise of Jelmyto to as many patients as possible, as quickly as feasible.

About Jelmyto

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.

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.

On July 28, 2021 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported the closing of its previously announced private placement with a single healthcare-focused institutional investor for 4,629,630 shares of its common stock (or common stock equivalents) at a purchase price per share of $2.70, priced at-the-market under Nasdaq rules (Press release, Xenetic Biosciences, JUL 28, 2021, View Source [SID1234585292]). The gross proceeds to Xenetic totaled approximately $12.5 million before deducting placement agent fees and other offering expenses.

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H.C. Wainwright & Co. acted as exclusive placement agent for the offering.

Additionally, Xenetic issued to the investor warrants to purchase up to 4,629,630 shares of common stock. The warrants to purchase 4,629,630 shares of common stock have an exercise price of $3.30 per share, will be immediately exercisable and will expire three and one half years from the earlier of (a) the six month anniversary of the initial exercise date and (b) the date that the registration statement registering all of the warrant shares underlying the warrants is declared effective. The potential gross proceeds from the exercise of the warrants, if fully exercised on a cash basis, will be approximately $15.3 million. No assurance can be given that any of the warrants will be exercised. Xenetic intends to use the net proceeds from the offering for general working capital purposes.

The securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and Regulation D promulgated thereunder, and the securities have not been registered under the Act or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. Pursuant to a registration rights agreement with the investor, the Company has agreed to file a resale registration statement covering the shares of common stock, common stock equivalents, and shares of common stock underlying the warrants described above within 30 days.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 28, 2021 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness a patient’s innate immune system to fight disease, reported that it will host a conference call on Wednesday, August 4, 2021 at 4:30 PM Eastern Time to discuss results for its second quarter ended June 30, 2021 and to provide a corporate update (Press release, INmune Bio, JUL 28, 2021, https://inmunebio.com/index.php/en/news-2/2021/464-muneionctoeporteconduarter2021inanciale20210728 [SID1234585291]).

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Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Second Quarter Conference Call when reaching an operator.

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through August 11 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13721921.

On July 28, 2021 Prescient Therapeutics (ASX:PTX) reported its cancer-fighting drug candidate has exhibited an excellent safety in an early clinical trial – and seemed to benefit two patients with aggressive, hard-to-treat lymphoma (Press release, Prescient Therapeutics, JUL 28, 2021, View Source;utm_medium=rss&utm_campaign=very-encouraging-two-cancer-patients-see-partial-remission-and-long-lasting-benefits-after-treatment-with-prescients-ptx-100 [SID1234585290]).

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Prescient says it is encouraged by a Phase 1b trial evaluating PTX-100 in ten patients: five with solid tumours — pancreatic and colorectal cancer – and five patients with blood cancer, namely multiple myeloma and T cell lymphomas.

The drug was well-tolerated, even at the highest doses, Prescient says. An intravenous infusion, PTX-100 works by blocking an important protein known as GGT-1 that is involved in cancer-causing pathways in cells.

The safety profile of the drug means it might have utility in fragile patients unable to tolerate more toxic therapies, or as a combination agent with other treatments, says Prescient chief executive and managing director Steven Yatomi-Clarke.

And while the primary goal of the study was to evaluate safety, clinical benefit was observed in two patients with aggressive T cell lymphoma.

One patient had tried five different therapies to control their peripheral T cell lymphoma, but none had worked for more than a few months at a time.

Treated with PTX-100, the patient experienced a partial remission in their cancer that has lasted 17 months so far. The patient has undergone 24 cycles of therapy and is still receiving PTX-100.

The other patient also had partial remission, seeing reduced cancerous lesions and relief from their cutaneous T cell lymphoma during 12 months of therapy. This patient had tried three prior treatments that had failed to control their cancer.

Both patients could have expected disease progression within four months using currently available treatments, highlighting the benefits of PTX-100.

"It was surprising to not only see clinical responses in these patients, but for these benefits to endure for a year or longer, together with symptomatic relief," says principal study investor, Professor H. Miles Prince, who called the early results "very encouraging".

A possible quick route to market
Given the success of the Phase 1b study, Prescient plans to progress development of PTX-100 with another study into refractory T cell lymphoma, with a particular focus on peripheral T-cell lymphoma.

There’s a considerable unmet need in treating that aggressive, rare form of non-Hodgkin’s lymphoma with poor survival rates.

The study will evaluate PTX-100 as a monotherapy, meaning the infusion won’t be administered in combination with other drugs.

The company plans to enrol eight to 12 patients in the expansion of the study, which will again be led by Professor Prince at Epworth Hospital in Melbourne.

If that study successfully demonstrates a clinical benefit for PTX-100, the drug could advance directly into another study that could be suitable for registration.

Compared to the usual large Phase 3 studies, a comparatively smaller trial might be all that’s needed to register the drug, Prescient says.

Yatomi-Clarke says the company is pursuing the quickest route to market for PTX-100 by pursuing areas of unmet clinical need.

On July 28, 2021 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ: IPA) (TSX VENTURE: IPA) a leader in full-service, therapeutic antibody discovery and development, reported financial results for the full fiscal year 2021 ended April 30, 2021 (Press release, ImmunoPrecise Antibodies, JUL 28, 2021, View Source [SID1234585289]).

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Fiscal 2021 Financial Summary*

Earned revenues of $17.9 million, a 27% increase which includes a sale through Talem of an internally generated therapeutic antibody for $1.2 million, core CRO business up 19%
Research and development costs increased to $2.0 million from $446,280 in 2020 due to the extensive research work the Company is undertaking, including COVID-19 related research projects
The Company recorded a net loss of $7.3 million during the year ended April 30, 2021, compared to $5.0 million in 2020
Adjusted EBITDA** of $2.3 million as compared to $52,000 in 2020
As of April 30, 2021, the Company held cash of $41.8 million
*Expressed in Canadian dollars unless otherwise noted.
**For additional information regarding Adjusted EBITDA (a non-IFRS measure) see the Forward Looking Information section below.

Dr. Jennifer Bath, CEO of ImmunoPrecise, stated, "We are pleased with our solid fiscal year end results, with consistently strong and growing recurring revenue. Looking ahead, we will continue to transform IPA, both strategically and operationally. We continue to execute on strategy including ongoing technology innovation and accelerated discovery of internal and partnered novel antibodies. We also continue to work towards becoming a leading CRO of choice and industry consolidator in the antibody discovery and development markets. As it stands, we have partnered with over 500 clients resulting in very strong recurring revenues following client onboarding for services."

"As we begin the new fiscal year, we actively seek expansion of our global footprint and push to broaden our diverse portfolio of technologies, while moving pipeline programs further toward functional and pre-clinical development. While in vitro non-clinical evaluation of four programs is currently ongoing, an additional set of five programs in development by Talem Therapeutics are at the stage of final in vitro (functional) characterization and are anticipated to enter in vivo proof of concept studies later this year. Each of these advanced assets are wholly owned by ImmunoPrecise and we look forward to completing functional and in vivo analyses with the aim of maximizing their value prior to any potential out-licensing events," concluded Dr. Bath.

Recent and Fiscal 2021 Operational Highlights

Successfully demonstrated pre-clinical in vivo results for TATX-03 PolyTope Therapy, a multi-membered monoclonal antibody cocktail designed to retain efficacy against SARS-CoV-2 variants. Results demonstrated strong efficacy for prophylactic and therapeutic use in a well-established SARS-CoV-2 animal model
Pre-released publication in Biorxiv outlining IPA’s approach to the design and development of TATX-03, also demonstrating potent pseudovirus neutralizing activity against the SARS-CoV-2 Delta (B.1.617.2) variant
New co-marketing partnership wherein Eurofins Discovery and ImmunoPrecise co-market non-overlapping service offerings to Eurofins’ global clients, providing greater access to IPA’s end-to-end antibody discovery capabilities
Presented data on TATX-21, investigational antibodies aimed to prevent low density lipid (LDL) uptake with the goal of preventing and treating Atherosclerosis Cardiovascular Disease (ACVD)
Added Dr. Ilse Roodink to the role of Chief Scientific Officer and Dr. Dion Neame to Strategic Advisory Board
Identified a unique antibody with in vivo efficacy in animal model, utilizing an alternative mechanism of action, and which binds all tested SARS-CoV-2 variants of concern
Successfully launched TATX-112 candidate antibody program, for the treatment of cancer and Alzheimer’s disease
Established separate development partnerships with Genmab and LiteVax
Announced the comprehensive screening of twenty-seven proprietary therapeutic antibodies against SARS-CoV-2, identifying antibodies that retained binding to emerging variants of concern including U.K. (B1.1.7 lineage), S. African (B.1.351 lineage) and Brazilian (P.1 lineage) strains
Solidified research partnership with Mila, a world-renowned research institute dedicated to artificial intelligence (AI) development and focused on deep learning optimization for AI and machine language learning
Successfully dual listed to NASDAQ global markets stock exchange
IPA Europe significantly expanded capabilities, releasing its second-generation B cell Select
Entered separate collaborations with Twist Bioscience and Zymeworks
Financial Results

Revenue

The Company achieved revenues of $17.9 million during the year ended April 30, 2021, consisting of an increase in its core CRO business of $2.7 million (19%) and a sale through Talem of an internally generated therapeutic antibody for $1.2 million. This represents a 27% increase over 2020 revenues of $14.1 million. The continued growth trend in CRO revenue is due to increases in both volume and financial values of client contracts due to a continued focus on expanding the breadth and depth of service offerings available in-house, new client onboarding and the sustained growth of its core existing business.

Gross Profit

During the year ended April 30, 2021, gross profit was $11.5 million (64% gross profit margin) compared to gross profit of $8.0 million (57% gross profit margin) in 2020. The increase in gross profit is, in part, a result of the sale of an internally generated asset that was expensed as research and development in prior years. Excluding the internally generated asset sale gross profit margin would have been 62%.

Research & Development

Research and development increased to $2.0 million from $446,280 in 2020, due to the extensive R&D work the Company is undertaking, including COVID-19 related research projects.

Other Income (Expenses)

The Company recorded other income of $1.6 million during the year ended April 30, 2021, compared to other expense of ($739,756) in 2020. The increase is primarily related to 2020 government grant income of $1.9 million and subsidies of $844,417 related to COVID-19, a $553,836 reduction in accretion expense related to its obligations, offset by $1.1 million unrealized foreign exchange losses on cash held in US dollars.

Net Loss

The Company recorded a net loss of $7.3 million during the year ended April 30, 2021, compared to net loss of $5 million for the year ended April 30, 2020. The Company achieved higher gross profits and received grant and subsidy income while investing in research and development, and incurring higher share-based payments, salaries, and Nasdaq uplist related costs.

Non-IFRS Measures*

Adjusted EBITDA for the year ended April 30, 2021, was $2.3 million compared to $52,311 for the same period last year. Adjusted EBITDA is management’s view of operating earnings. The significant improvement in Adjusted EBITDA is primarily the result of increased gross profits and awards of government research grants and subsidies related to COVID-19 partially offset by higher research costs, salaries, and expenses related to the Nasdaq uplist.

Cash Position

As of April 30, 2021, the Company held cash of $41.8 million as compared to $2.7 million as of April 30, 2020 and had working capital of $42.8 million. The increase in cash is primarily due to the public offering of the Company’s stock and proceeds from the exercise of warrants and stock options. The Company’s internal forecast indicates the cash on hand will sustain its existing operations, support its Nasdaq and TSXV on-going listing costs and satisfy its obligations through at least fiscal year ending 2023.

The conference call will be webcast live and available for replay via the same link found on the main page of the Company’s Investors section at: View Source

If you are dialing into the call, please call the conference telephone number five minutes prior to the start time. An operator will register your name and organization.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Toronto Stock Exchange and Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

About IPA’s PolyTope Platform.

IPA’s SARS-CoV-2 PolyTope monoclonal therapies currently in preclinical development are designed to protect against mutagenic escape with an emphasis on efficacy for every patient, variant, and strain of SARS-CoV-2. They are created with the goal of sustainable efficacy in the face of an evolving virus, combining extensively characterized, potently neutralizing, synergistic antibodies exhibiting richly diverse epitope coverage.