On July 14, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported that it has entered into a global settlement and license agreement with Clarus Therapeutics Inc. ("Clarus") to resolve all outstanding claims in the on-going intellectual property litigation between the two companies as well as the on-going interference proceeding between the two companies (Press release, Lipocine, JUL 14, 2021, View Source [SID1234584842]).

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Under the terms of the settlement announced today, Lipocine and Clarus have agreed to dismiss the Lipocine Inc. v Clarus Therapeutics, Inc., No 19-cv-622 (WCB) litigation presently pending in the U.S. District Court for the District of Delaware. Additionally, both parties have reached an agreement on the interference proceedings captioned Clarus Therapeutics, Inc. v. Lipocine Inc., Interference No. 106,128 presently pending in the U.S. Patent and Trademark. The terms of the settlement remain confidential.

On July 14, 2021 INmune Bio, Inc. (NASDAQ: INMB) (the "Company" or "INmune Bio"), a clinical-stage immunology company focused on developing treatments that harness a patient’s innate immune system to fight disease, reported that it has entered into a definitive agreement with one healthcare focused institutional investor and one family office for the purchase and sale of 1,818,182 shares of its common stock at a price of $22.00 per share for gross proceeds of approximately $40 million in a registered direct offering (Press release, INmune Bio, JUL 14, 2021, View Source [SID1234584841]). The closing of the offering is expected to occur on or about July 16, 2021, subject to the satisfaction of customary closing conditions.

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A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering.

INmune Bio intends to use the net proceeds from this offering for working capital and general corporate purposes and to advance the development of its product candidates and expand its pipeline. This includes the completion and data readout from the Company’s planned Phase 2 clinical trial of its lead clinical candidate, XPro1595, in patients suffering from Alzheimer’s disease, which is expected to commence by the end of 2021. "With this investment, we expect the Company’s Phase II program in Alzheimer’s disease is completely funded" said RJ Tesi MD, CEO of Inmune Bio.

The securities described above will be offered by the Company pursuant to an effective "shelf" registration statement on Form S-3 (File No. 333-254221) previously filed with the Securities and Exchange Commission (the "SEC") on March 12, 2021 and declared effective by the SEC on May 5, 2021. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the offering will be filed with the SEC. Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, 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 the registration or qualification under the securities laws of any such state or jurisdiction.

On July 14, 2021 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, reported that it expects net product revenue from Jelmyto sales for the second quarter ended June 30, 2021, to be approximately $13.0 million, representing an increase of over 70% compared to the first quarter of 2021 and the highest quarterly sales since Jelmyto was launched in June 2020 (Press release, UroGen Pharma, JUL 14, 2021, View Source [SID1234584836]). Additionally, operating expenses in the second quarter of 2021 are anticipated to be in the range of $33 to $38 million. Cash, cash equivalents and marketable securities as of June 30, 2021, are expected to be approximately $129.0 million.

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"Our strong, preliminary top line results for the second quarter of 2021 have validated our belief that increased vaccination rates and the general re-opening of activities throughout the United States would correlate to increased adoption of Jelmyto as an innovative treatment for patients with low-grade upper tract urothelial cancer," said Liz Barrett, President and Chief Executive Officer of UroGen. "The momentum in Jelmyto sales gives us increased confidence in physician adoption of this paradigm shifting therapy. We are optimistic that this trend will continue as our commercial team actively engages in-person with healthcare providers to activate new sites and increase usage at existing sites. We look forward to reporting our full results for the second quarter of 2021 in early August."

The Company expects to report full financial results for the second quarter ended June 30, 2021, and host a conference call on Wednesday, August 4, 2021. A press release with the details for the conference call will be issued approximately one week prior to the planned reporting date.

Preliminary Financial Results

The preliminary financial results set forth above are based on management’s initial review of the Company’s results as of and for the quarter ended June 30, 2021, and are subject to revision based upon the Company’s quarter-end closing procedures and the completion of the review by the Company’s external auditors of the Company’s quarter-end financial statements. Actual results may differ materially from these preliminary results as a result of the completion of quarter-end closing procedures, final adjustments, and other developments arising between now and the time that the Company’s financial results are finalized. In addition, these preliminary results are not a comprehensive statement of the Company’s financial results for the quarter ended June 30, 2021, should not be viewed as a substitute for complete financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the Company’s results for any future period.

2021 Operating Expense Guidance

The Company affirms its previously announced guidance for full-year operating expenses in the range of $155 to $165 million, including non-cash share-based compensation expense of $24 to $28 million, subject to market conditions.

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 takewater 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 14, 2021 Kriya Therapeutics, Inc., a fully integrated platform company pioneering novel technologies and therapeutics in gene therapy, reported the closing of a $100 Million Series B financing to support its mission of transforming the design, development and manufacturing of gene therapies (Press release, Kriya Therapeutics, JUL 14, 2021, View Source [SID1234584835]).

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The financing was led by Patient Square Capital, with participation from new investors Woodline Partners LP, CAM Capital, Hongkou, Alumni Ventures and others. All existing institutional investors also participated in this round, including QVT, Dexcel Pharma, Foresite Capital, Bluebird Ventures, Transhuman Capital, Narya Capital, Amplo and JDRF T1D Fund. Proceeds from the financing will be used to further develop Kriya’s core technology platforms, expand its therapeutic pipeline and advance its current programs in metabolic disease, ophthalmology and oncology.

"In recent years we have seen the promise of gene therapy become a reality for the treatment of a number of devastating diseases. However, the field has been constrained by critical limitations in manufacturing technology, vector design capabilities and cost," said Shankar Ramaswamy, M.D., Co-Founder and Chief Executive Officer of Kriya Therapeutics. "Kriya was formed with the mission of revolutionizing how gene therapies are designed, developed and produced by fully integrating advanced manufacturing technologies, computational tools and development capabilities within a single company. With the support of our new and existing investors, we believe that Kriya is well positioned to deliver transformative improvements in cost, scale and efficiency that will help the gene therapy field achieve its full potential across a range of therapeutic areas."

Concurrent with the financing, Jim Momtazee, Managing Partner of Patient Square Capital, will join Kriya’s Board of Directors. Prior to Patient Square, Mr. Momtazee spent over 21 years at KKR, where he helped establish the firm’s health care industry group in 2001 and subsequently was head of the Americas Heath Care Investment Team for over 10 years. Mr. Momtazee has spent years on the board of directors of Jazz Pharmaceuticals, HCA, PRA Health Sciences and BridgeBio Pharma, among other companies, and more recently joined the board of directors of Apollo Therapeutics.

"We believe that gene therapy will have transformative impact on medicine over time, and companies that are able to integrate platform capabilities delivering better treatments, lower cost and broader applications of the technology are going to drive that innovation," said Mr. Momtazee. "With that vision, we are incredibly excited to partner with the management team at Kriya to bring multiple important medicines to patients."

By combining advances in computer science and vector biology, Kriya is developing its SIRVE (System for Intelligent Rational Vector Engineering) platform for de novo vector design, sequence modification and data analysis. SIRVE is deployed to advance Kriya’s internally discovered gene therapy programs and improve first-generation products, with a goal of reducing immunogenicity and improving expression and packaging efficiency. Kriya is also developing STRIPE (System to Realize Improved Production Efficiency), a proprietary high-efficiency manufacturing platform integrating advances in cell line technology and upstream and downstream process to achieve exponential reductions in production costs at scale. STRIPE is being developed at Kriya’s 51,000 square foot manufacturing facility in Research Triangle Park, North Carolina, and can support simultaneous manufacturing of multiple products from early research through commercialization. The company’s full cGMP manufacturing infrastructure is expected to be online this year.

On July 14, 2021 Ribon Therapeutics, a clinical stage biotechnology company developing therapeutics targeting stress support pathways in cancer and inflammation, reported the closing of a $65 million financing (Press release, Ribon Therapeutics, JUL 14, 2021, View Source [SID1234584833]). The financing was led by Deerfield Management and U.S. Venture Partners, with support from new investors Avego BioScience Capital, GV (formerly Google Ventures), Monashee Investment Management and Peregrine Ventures, along with existing investors AbbVie Ventures, Bristol Myers Squibb, Euclidean Capital, Johnson & Johnson Innovation – JJDC, Inc., Novartis Venture Fund, Osage University Partners, Takeda Ventures and The Column Group. Ribon will use the proceeds to support the clinical development of its novel precision medicine candidates.

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"We are excited to have this terrific group of new investors join our strong group of existing investors to enable Ribon to develop novel precision drugs targeting stress support pathways," said Victoria Richon, Ph.D., President and Chief Executive Officer, Ribon Therapeutics. "The additional capital will enable the advancement of our lead programs, RBN-2397 in cancer and RBN-3143 in inflammation, through key clinical milestones as well as support additional drug discovery and validation from our proprietary BEACON+ platform. We look forward to realizing our mission to bring novel small molecule therapeutics to patients and families in need."

"Ribon is pioneering the development of first-in-class precision development candidates targeting stress support pathways in cancer and inflammation and has made notable progress advancing its lead candidates," said Cameron Wheeler, Ph.D., Partner, Deerfield Management and Board Director for Ribon Therapeutics. "This funding represents a commitment to the compelling science that marks the foundation of Ribon and we look forward to working with management on continued clinical, preclinical and platform discovery execution."