On October 26, 2022 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will report its 2022 third quarter financial results on Wednesday, November 9, 2022, after the close of the U.S. financial markets (Press release, Jazz Pharmaceuticals, OCT 26, 2022, View Source [SID1234622436]). Company management will host a live audio webcast at 4:30 p.m. ET / 9:30 p.m. IST to discuss 2022 third quarter financial results and provide a business and financial update.

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Interested parties may register for the call in advance here or via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast.

A replay of the webcast will be available via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.

On October 26, 2022 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported that it will release results for the third quarter 2022 on Wednesday, November 2, 2022, after the market closes (Press release, Vanda Pharmaceuticals, OCT 26, 2022, View Source [SID1234622435]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Vanda will host a conference call at 4:30 PM ET on Wednesday, November 2, 2022, during which management will discuss the third quarter 2022 financial results and other corporate activities. To participate in the conference call, please dial 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode 5456289.

The conference call will be broadcast simultaneously and archived on Vanda’s website, www.vandapharma.com. Investors should go to the website at least 15 minutes early to register, download, and install any necessary audio software.

A replay of the call will be available on Wednesday, November 2, 2022, beginning at 8:30 PM ET and will be accessible until Wednesday, November 9, 2022, at 8:30 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 5456289.

On October 26, 2022 Samsung Biologics (KRX: 207940.KS), a leading contract development and manufacturing organization, reported its fiscal year 2022 third-quarter financial results, reported that the company’s cumulative revenue in fiscal year 2022 surpassed KRW 2 trillion (Press release, Samsung BioLogics, OCT 26, 2022, View Source [SID1234622434]).

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John Rim, CEO of Samsung Biologics, said: "This past quarter saw strong performance and growth due to a consistent momentum in signing new contracts, helping us meet client demand for integrated offerings and deliver long-term value. Not only have we delivered on our commitments by commencing GMP operations of Plant 4 within just 23 months from the start of its construction, we have also developed and launched our next-generation bio-technologies – S-DUAL and DEVELOPICK – which will help streamline and accelerate the antibody development process to save time and cost for our clients."

THIRD QUARTER 2022 RESULTS

Samsung Biologics in the third fiscal quarter recorded a consolidated revenue of KRW 873 billion, operating profit of KRW 324.7 billion, and net profit of KRW 129.2 billion.

FOURTH QUARTER & FISCAL YEAR 2022 OUTLOOK

As previously announced, Samsung Biologics commenced GMP operations of Plant 4, the world’s largest single bio-manufacturing plant, within just 23 months since its groundbreaking. The construction of the 240,000-liter CDMO plant is expected to be completed in 2023, designating Samsung Biologics as the top global manufacturing hub with a total capacity of 604,000 liters, a volume equivalent to over one-fourth of worldwide CMO capacity.

Samsung Biologics launched its new proprietary development technology platforms – S-DUAL and DEVELOPICK – a high-yield bispecific antibody platform and a rapid developability assessment platform.

Samsung Biologics also achieved several business milestones, including the signing of a land-purchasing agreement for Bio Campus II with 30% greater land area for additional capacity and platform growth. Then in August, a $15 million investment through the Samsung Life Science Fund, a joint venture with Samsung C&T, was granted to Senda Biosciences, a U.S.-based biotechnology company committed to fostering core technologies needed to develop next-generation biopharmaceuticals.

In September, Samsung Biologics received EcoVadis’ Gold Sustainability Rating in recognition of its ongoing sustainable management efforts, placing the company within the top 5 percentile.

For more details on performance and financials, please refer to the Earnings Release.

On October 26, 2022 AI Metrics, an early stage AI-enabled, cancer-imaging radiology software company, reported that it has raised $1.26MM in a bridge financing round (Press release, Metrics, OCT 26, 2022, View Source [SID1234622433]). The round was led by an angel fund and several individual investors, many of them leading radiologists.

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AI Metrics was launched in 2019 by Bob Jacobus, Paige Severino, and radiologist and researcher Dr. Andrew Smith. The company has been developing software to more accurately assess cancer treatment effectiveness — leveraging augmented intelligence to improve radiology workflows and deliver detailed updates of therapy progress to oncologists and patients.

"We are excited to have a mix of existing and new investors support AI Metrics, including several radiologists who are attracted to our promising and innovative technology," said Bob Jacobus, CEO. "AI Metrics expanded its investor base with field experts eager to capitalize on what they see as a breakthrough technology coming to market."

AI Metrics plans to invest in R&D resources to continue its quest to help radiologists deliver improved speed, accuracy, consistency, and clarity of patient condition.

On October 26, 2022 Flare Therapeutics, a biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, reported that new preclinical data in a poster presentation titled, "Novel inhibitors of the luminal lineage transcription factor peroxisome proliferator-activated receptor gamma (PPARG) durably eradicate tumors in urothelial cancer (UC) animal models" at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium in Barcelona, Spain (Press release, Flare Therapeutics, OCT 26, 2022, View Source [SID1234622432]). The data presented by Robert Sims, Ph.D., Chief Scientific Officer and Co-founder of Flare, show that FTX-6746, a potent, selective, small molecule PPARG inhibitor (inverse agonist), drives robust PPARG target gene silencing in UC cell lines and drives tumor regression in PPARG-amplified and RXRA-mutant UC xenograft models.

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"Targeting cell lineage-defined transcription factors with small molecules is a proven and effective therapeutic strategy, as demonstrated by estrogen and androgen receptor therapies for breast and prostate cancers. Our goal is to add PPARG to that list, to potentially enable treatment of urothelial cancers. Leveraging our deep expertise in transcription factor biochemistry, we engineered compounds capable of driving a powerful repressive conformation of PPARG with high specificity, thereby inducing significant pharmacological effects," said Dr. Sims. "In preclinical models, FTX-6746 demonstrated a favorable therapeutic profile, suppressing PPARG target genes with durable tumor regression at well-tolerated doses. We are currently advancing a novel PPARG inhibitor through IND-enabling studies and plan to advance that therapeutic candidate into the clinic in 2023 in locally advanced or metastatic UC."

Data highlights:

FTX-6746 drives an enhanced repressive conformation to overcome UC mutations
FTX-6746 counteracts the activating effects of recurrent PPARG and RXRA missense mutations in preclinical models of UC
FTX-6746 treatment results in robust PPARG target gene silencing in cells (average 50% maximal inhibitor concentration (IC50) ~5 nM); in vitro growth inhibition is preferentially observed in cell lines with activated PPARG signaling
Tumor growth inhibition or regression was observed in PPARG-amplified and RXRA-mutant UC xenograft models, with no tumor regrowth upon cessation of treatment
"Today’s data presentation demonstrates the strength and depth of Flare’s research platform and our teams’ ability to rapidly advance a first in class molecule in precision oncology," said Amit Rakhit, M.D., Chief Executive Officer of Flare Therapeutics. "Flare is poised to transition to a clinical-stage company early next year with our lead molecule in the PPARG program. Given the high unmet medical need with poor survival in advanced stages of disease, novel approaches that provide alternative therapeutic options are needed for people living with bladder cancer."

About Urothelial Cancer

Muscle-invasive UC is a common type of bladder cancer, with about 20,000 individuals diagnosed each year in the United States alone, and significantly higher incidence rates in other regions of the world. This disease has high rates of recurrence and the five-year survival rate is approximately 5% in metastatic cases. The transcription factor peroxisome proliferator-activated receptor gamma (PPARG) is associated with the luminal lineage subtype reflecting approximately 65% of all advanced UC patients. Recurrent genetic alterations in PPARG, including focal amplification, missense mutations, and fusions, as well as hotspot mutations in its binding partner, retinoid X receptor alpha (RXRA) are characteristic of this molecular subtype.