On July 14, 2021 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported it will host a webcast and conference call to discuss corporate updates and financial results for its first fiscal quarter 2021, ended June 30, 2021 (Press release, Myovant Sciences, JUL 14, 2021, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-host-first-fiscal-quarter-2021-earnings [SID1234584855]). The webcast and conference call will be held at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time on July 28, 2021.

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Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovant’s website at investors.myovant.com. Institutional investors and analysts may also participate in the conference call by dialing 1-800-532-3746 in the U.S. or +1-470-495-9166 from outside the U.S.

A replay of the webcast, along with the earnings press release and presentation materials, will be archived on Myovant’s investor relations website.

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 Transcenta Holding Limited ("Transcenta"), a clinical stage global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, reported that the first US patient has been dosed in the global Phase I clinical trial of PD-L1/TGF-β bi-functional antibody TST005 (Press release, Transcenta, JUL 14, 2021, View Source;bi-functional-antibody-tst005-301334343.html [SID1234584856]).

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TST005 is the second bi-functional anti-PD-L1 and TGF-β trap fusion protein entering the global clinical stage. It simultaneously targets two immuno-suppressive pathways, transforming growth factor -β (TGF-β) and programmed cell death ligand-1 (PD-L1), that are commonly used by cancer cells to evade the immune system. TST005 consists of a high affinity PD-L1 antibody fused with an engineered TGF-β Receptor Type II protein in its C-terminal. TST005 lacks FcR binding activity and thus has reduced FcR mediated killing of PD-L1 expressing effector T cells. TST005’s high PD-L1 binding activity and enhanced TGF-β trap stability enables the targeted delivery of TGF-β trap into PD-L1 expressing tumors, thereby minimizing off-target toxicities of systemic inhibition of TGF-β signaling. TST005 displayed potent activity in vitro in reversing TGF-β induced T-cell suppression. In multiple syngeneic tumor models, TST005 induced significant increase of CD8 T-cell infiltration into PD-L1 expressing tumors and displayed dose-dependent tumor growth inhibition in tumor model not sensitive to PD-(L)1 treatment due to high level TGF-β. TST005 is well tolerated in non-human primates and displayed a linear PK profile. TST005 is a potential novel bi-functional immunotherapy candidate with improved therapeutic window.

"TST005 has potential application for the treatment of a large number of tumor types. It is expected to be effective in the patient populations who are either naïve or progressed after treatment with PD-(L)1 inhibitor." said Dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta, "TST005 will be one of the company’s key competitive products, considering that there are huge worldwide unmet needs in patients who failed checkpoint inhibitor therapies, by targeting PD-L1/TGF-β pathways."

"Primary and acquired resistance to immune checkpoint inhibitors represent a significant unmet need in cancer treatment." said Anthony W. Tolcher, M.D., FRCPC, FACP, Medical Oncologist, Co-founder of NEXT Oncology and current study’s investigator. "TST005 demonstrated potent antitumor efficacy in multiple pre-clinical models while maintaining wide safety margins, and I look forward to evaluating this novel bi-functional antibody in patients with advanced solid tumors."

On July 14, 2021 Immunic, Inc. (the "Company") (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, Immunic, JUL 14, 2021, View Source [SID1234584857]). All the shares to be sold in the offering will be offered by the Company. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. In addition, the Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% percent of shares of its common stock offered in the public offering.

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Piper Sandler is acting as sole book-runner for the offering.

The Company intends to use the net proceeds of the offering to fund the ongoing clinical development of its three lead product candidates, IMU-838, IMU-935 and IMU-856, and for other general corporate purposes.

The securities described above are being offered by the Company pursuant to an effective shelf registration statement on Form S-3 (File No. 333-250083) previously filed with the Securities and Exchange Commission ("SEC") on November 13, 2020, which registration statement was declared effective on November 24, 2020. The securities will be offered by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may also be obtained, when available, from Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by email at [email protected], or by telephone at (800) 747-3924.

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 14, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and Ascentage Pharma (6855.HK), reported a multifaceted strategic collaboration (Press release, Innovent Biologics, JUL 14, 2021, https://www.prnewswire.com/news-releases/innovent-and-ascentage-pharma-reach-multifaceted-strategic-agreement-including-joint-commercialization-of-olverembatinib-in-china-joint-clinical-development-on-multiple-products-and-equity-investment-301333902.html [SID1234584858]). This collaboration includes: i) the joint commercialization of HQP1351 (olverembatinib) in China; ii) the collaborative clinical development of Bcl-2 inhibitor APG-2575 (lisaftoclax) with the anti-CD20 monoclonal antibody HALPRYZA (rituximab biosimilar injection) and the anti-CD47 monoclonal antibody letaplimab (IBI188); and iii) the equity investment in Ascentage Pharma.

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HQP1351, the core drug candidate of Ascentage Pharma, is the first China-developed third-generation BCR-ABL TKI targeting drug-resistant chronic myeloid leukemia (CML). At present, an NDA for HQP1351 has been submitted and subsequently granted Priority Review status and a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) in China. According to the agreement, Innovent and Ascentage Pharma will be jointly responsible for the subsequent R&D of HQP1351 in China. Upon being granted a New Drug Application (NDA) approval, the two companies will jointly commercialize HQP1351 in China and equally split the profit generated by the joint commercialization. Innovent will leverage its advantage of broad commercial channel and experienced oncology commercial team to roll out HQP1351 to hospitals and pharmacies at various tiers, in aims to make this novel therapeutic available to the cancer patients in China.

After signing the agreement, Ascentage Pharma will receive an upfront payment of US$30 million from Innovent. Upon achieving certain pre-specified milestones in development, registration and annual sales performance of HQP-1351, Ascentage Pharma is eligible to receive up to US$115 million in milestone payments.

In addition, the two companies agree to jointly explore the possibility of developing the Bcl-2 TKI APG-2575 with the anti-CD20 monoclonal antibody HALPRYZA (rituximab biosimilar injection) and the anti-CD47 monoclonal antibody letaplimab (IBI188), in certain indications.

Furthermore, Innovent will subscribe to Ascentage Pharma’s common shares for a total consideration of US$50 million at HK$44.0 per share, and be granted stock warrants that will allow it to acquire additional Ascentage Pharma’s common shares for a total consideration of US$50 million at subscription price of HK$57.2 per share within the next two years.

Dr. Michael Yu, Founder, Chairman and CEO of Innovent Biologics, stated, "We are excited to form this strategic collaboration with Ascentage Pharma, a pioneer in the field of innovative R&D of apoptosis-targeted therapies. Innovent is deeply engaged in the oncology area having built up a robust oncology pipeline of nearly 20 clinical stage assets, an industry-leading medical operations and regulatory affairs team, a broad commercial channel and a professional commercial team of over 2000 people. The collaboration with Ascentage pharma adds another near-to-launch innovative medicine HQP1351 to our pipeline, and we will leverage our advantage in the joint commercialization after the drug is approved. In addition, this collaboration creates potential synergy with our oncology pipeline such as CD47 and CD20 antibodies. Meanwhile, we are impressed with Ascentage Pharma’s strong R&D capability and rich pipeline, and we hope to join in our partner’s growth potential realization through the strategic equity investment. We look forward to partnering with Ascentage Pharma and bringing the innovative therapies of both parties to patients as soon as possible.

The strategic collaboration represents a new model for China biopharmaceutical companies to work together to bring additional benefit to patients. Innovent has been exploring diversified and innovative strategic partnership models with outstanding pharmaceutical companies globally with the aim to make more innovative therapies available. This collaboration proves once again that Innovent is an ideal partner to help expand pipeline development and product commercialization."

Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma, stated, "Innovent is a leading biopharmaceutical company with outstanding integrated capabilities in the R&D and commercialization of innovative therapies. It is our great pleasure to enter into this multifaceted and comprehensive landmark partnership with Innovent. HQP1351 is a novel therapeutic with practice-changing potentials. We hope that by leveraging the two companies’ expertise in clinical development, we will be able to quickly expand the indications of HQP1351. Another one of our assets, APG-2575, is the world’s second, and China’s first Bcl-2 inhibitor that has demonstrated compelling clinical activity with best-in-class potential. As a small-molecule drug, APG-2575’s potential utility in combination with Innovent’s anti-CD20 monoclonal antibody and anti-CD47 monoclonal antibody is very promising. The equity investment in Ascentage Pharma is a major strategic investment signifying Innovent’s strong recognition of our R&D capabilities and our growth potential, and generates powerful tailwind to our global clinical development programs. Moreover, this collaboration between two companies with shared company cultures and mission is groundbreaking for China’s biopharmaceutical industry. We hope this partnership between the two companies will accelerate the development of innovative therapeutics in China and benefit more patients around the world."

About Olverembatinib (HQP1351)

Being developed by Ascentage Pharma, HQP1351 is a novel, orally active, potent third-generation BCR-ABL tyrosine kinase inhibitor (TKI) designed to effectively target a spectrum of BCR-ABL mutants, including T315I, and the first China-developed third-generation BCR-ABL TKI targeting drug-resistant chronic myeloid leukemia (CML). Since 2018, the clinical results of HQP1351 have been selected for oral presentations at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting for three years in a row. At present, a New Drug Application (NDA) for HQP1351 has been submitted in China, and the application was subsequently granted the Priority Review status. Moreover, HQP1351 was cleared by the US Food and Drug Administration (FDA) to enter a Phase Ib clinical study, and was subsequently granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA.

About Lisaftoclax (APG-2575)

APG-2575 is a novel, orally administered small-molecule Bcl-2‒selective inhibitor being developed by Ascentage Pharma. APG-2575 is designed to treat hematologic malignancies and solid tumors by selectively blocking antiapoptotic protein Bcl-2 to restore the normal apoptosis process in cancer cells. APG-2575 is the first China-developed Bcl-2 inhibitor entering clinical development in China.

At present, APG-2575 has been cleared and approved to enter multiple Phase Ib/II studies in the US, China, Europe, and Australia, and is being developed globally for the treatment of multiple hematologic malignancies including chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), and breast cancer. To date, APG-2575 has been granted five ODDs by the US FDA for the treatment of Waldenström macroglobulinemia (WM), CLL, multiple myeloma (MM), AML, and follicular lymphoma (FL).

About HALPRYZA (rituximab biosimilar injection)

HALPRYZA,a rituximab biosimilar injection, is a recombinant human/murine chimeric monoclonal antibody drug co-developed and co-commercialized by Innovent and Eli Lilly and Company. Rituximab binds to the CD20 antigen on the surface of B lymphocytes and mediates complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC). Normal and malignant B cells are targeted for destruction by the antibody, thereby achieving anti-tumor and immunosuppressive therapeutic effects. In China, HALPRYZA is approved by National Medical Products Administration (NMPA) for diffuse large b cell lymphoma (DLBCL), follicular lymphoma (FL), and CLL.

About letaplimab (IBI188)

IBI188 (letaplimab), developed by Innovent Biologics, is a recombinant fully humanized IgG4 monoclonal antibody targeting CD47. CD47 is a transmembrane protein that blocks phagocytosis of macrophage by binding to the signaling regulatory protein (SIRP) on the surface of macrophage, to send a "don’t eat me" signal. After blocking this myeloid checkpoint, IBI188 (letaplimab) enhanced phagocytosis of tumor cells and cross-activated T cells. Preclinical data showed that IBI188 (letaplimab) had clear target, clear mechanism of action and significant efficacy. Phase 1a clinical data showed that the escalation of all the preset doses has completed, with the highest exploratory dose of 30mg/kg QW. No dose-limiting toxicity occurred in each dose group, and IBI188 (letaplimab) was well tolerated generally.