On November 15, 2021 Scandion Oncology A/S reported that it will publish its Q3 interim report on Thursday, November 18, 2021 before 09:00 CET (Press release, Scandion Oncology, NOV 15, 2021, View Source;2021,c3454064 [SID1234595589]).

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Scandion Oncology’s executive management will host a webcast and conference call the same day at 10:00 CET presenting the results and a company update.

At the end of the presentation there will be a Q&A session.

On November 15, 2021 Palatin Technologies, Inc., (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor systems, reported results for its first fiscal quarter ended September 30, 2021 (Press release, Palatin Technologies, NOV 15, 2021, View Source [SID1234595588]).

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"I am excited with the significant advancement of our melanocortin agonist programs and their differentiating product profiles, which include the expected initiation of a Phase 3 pivotal study of PL9643 in patients with dry eye disease next month, and a Phase 2 clinical trial of PL8177 for ulcerative colitis in the first half of calendar year 2022," stated Carl Spana, Ph.D., President and CEO of Palatin.

"Regarding Vyleesi, our measured plan is showing positive trends for our targeted value metrics with net revenue up 98% and net revenue per prescription up 45% over the prior quarter ended June 30, 2021," concluded Dr. Spana.

Recent Highlights and Upcoming Events

Anti-Inflammatory / Autoimmune Programs
PL9643 melanocortin agonist for the treatment of dry eye disease (DED):
Palatin remains on track to initiate its pivotal Phase 3 clinical program in DED patients in December 2021, with data readout expected in the second half of calendar year 2022.
Presented Phase 2 clinical trial results for PL9643 in DED at the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting.
Presented Phase 2 clinical trial results for PL9643 in DED and preclinical data in retinal disease, at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting.
PL8177 melanocortin agonist for the treatment of ulcerative colitis:
A Phase 2 oral formulation study of PL8177 in ulcerative colitis is currently scheduled to start in the first half of calendar year 2022, with data readout expected in the second half of calendar year 2022.
Conducted a Featured Speaker presentation on Vyleesi and two poster presentations of PL9643 and PL8177 at the TIDES USA hybrid conference.
Hosted a Key Opinion Leader webinar on melanocortin agonists for treating ocular indications, with a primary focus on PL9643 and data from the Company’s recently completed Phase 2 clinical trial for dry eye disease. Introduced the Company’s growing portfolio of melanocortin agonists to treat the harmful effects of inflammation in the eye.
Presented the protective effects of PL8331 and PL9654 in mouse models of retinopathy, at the 2021 Annual Meeting of the American Society of Retina Specialists (ASRS). Awarded "Top Ten Poster" Designation.
Research and Development Infrastructure: Strengthened R&D department with key appointments who have demonstrated a high-level of expertise in their fields to support the advancement of our development programs.
Vyleesi (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD): Goal of the Vyleesi program is to demonstrate product value in the marketplace with an objective of re-licensing the U.S. rights to a committed women’s healthcare company.
For the quarter ended September 30, 2021:
Gross product sales increased 18%, net revenue increased 98%, net revenue per prescription dispensed increased 45%, despite a 13% decrease in total prescriptions dispensed, over the prior quarter ended June 30, 2021.
Market access, reimbursement coverage, and refill rates increased over the prior quarter ended June 30, 2021.
Patients and healthcare providers can learn more about HSDD and Vyleesi at www.vyleesi.com and www.vyleesipro.com
First Quarter Ended Fiscal Year 2022 Financial Results

Revenue

Total net revenues consist of gross product sales of Vyleesi, net of allowances and accruals.

Vyleesi gross product sales for the quarter ended September 30, 2021, amounted to $1.4 million, with net product revenue of $159,482, compared to gross product sales for the period July 25 (the date Palatin regained North American rights to Vyleesi) to September 30, 2020, of $809,100, with negative net product revenue of $(288,560).

Operating Expenses

Total operating expenses for the quarter ended September 30, 2021, were $7.4 million, compared to $3.7 million for the comparable quarter of 2020.

The increase in operating expenses was primarily due to the gain of $1.6 million (which reduced expenses) recorded during the quarter ended September 30, 2020, as a result of the Vyleesi Termination Agreement with AMAG Pharmaceuticals, and secondarily to increased commercial expenses related to Vyleesi.

Cash Flows

Palatin’s net cash used in operations for the quarter ended September 30, 2021, was $6.4 million, compared to net cash provided by operations of $3.8 million for the same period in 2020. The difference is due to the cash received in excess of the gain on termination of the Vyleesi agreement with AMAG.

Net Loss

Palatin’s net loss for the quarter ended September 30, 2021, was $7.1 million, or $0.03 per basic and diluted common share compared to a net loss of $3.9 million or $0.02 per basic and diluted common share for the same period in 2020.

The difference between the quarter ended September 30, 2021, and the quarter ended September 30, 2020, was primarily due to the gain of $1.6 million recorded during the quarter ended September 30, 2020, as a result of the Vyleesi Termination Agreement with AMAG Pharmaceuticals and secondarily to increased commercial expenses related to Vyleesi.

Cash Position

As of September 30, 2021, Palatin’s cash and cash equivalents were $53.4 million with $0.9 million of accounts receivable, compared to cash and cash equivalents of $60.1 million with $1.6 million of accounts receivable, as of June 30, 2021.

Based on its current operating plan, Palatin believes that existing cash and cash equivalents will be sufficient to fund currently anticipated operating expenses through calendar year 2022.

Conference Call / Webcast

Palatin will host a conference call and audio webcast on November 15, 2021, at 9:30 a.m. Eastern Time to discuss the quarter ended September 30, 2021, results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-877-614-0009 (US/Canada) or 1-856-344-9283 (international), conference ID 3594800. The audio webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and audio webcast replay will be available one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (US/Canada) or 1-719-457-0820 (international), passcode 3594800. The webcast and telephone replay will be available through November 22, 2021.

About Melanocortin Receptor Agonists and Inflammation

The melanocortin receptor ("MCr") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1r through MC5r. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects.

Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation.

On November 15, 2021 Kintara a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported financial results for its fiscal first quarter ended September 30, 2021 and provided a corporate update (Press release, Kintara Therapeutics, NOV 15, 2021, View Source [SID1234595587]).

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CORPORATE HIGHLIGHTS AND RECENT DEVELOPMENTS

Positioned our management team for our next stage of development by announcing that Robert E. Hoffman, our current Chairman, succeeded Saiid Zarrabian as our President and Chief Executive Officer. Mr. Hoffman will continue in his capacity as our Chairman and Mr. Zarrabian has transitioned to heading up our strategic partnerships initiative and will remain a member of our Board of Directors (November).
Activated additional clinical trial sites for glioblastoma (GBM) patients for the VAL-083 arm of the GBM AGILE registrational study sponsored by the Global Coalition for Adaptive Research (GCAR). There are over 26 activated clinical sites (August).
Reported topline results from the Phase 2 study conducted at the MD Anderson Cancer Center that affirm the safety and efficacy of VAL-083 in two different GBM patient subtypes and support continued evaluation of VAL-083 in the GBM AGILE registrational study.
Topline Phase 2 clinical study results for VAL-083 as adjuvant therapy for newly-diagnosed GBM patients were reported demonstrating progression free survival and overall survival of 10.0 months and 16.5 months, respectively, in efficacy evaluable patients (September).
Topline Phase 2 clinical study results for VAL-083 for recurrent GBM were reported demonstrating median overall survival of 8.0 months for the 48 efficacy evaluable patients initially receiving the GBM AGILE treatment dose of 30 mg/m2/day (July).
Entered into securities purchase agreements with healthcare-focused institutional investors to raise approximately $15.0 million in gross proceeds. Funding from this registered direct offering provides cash for ongoing clinical studies and corporate working capital needs (September).
Continued to advance development of REM-001 for the treatment of Cutaneous Metastatic Breast Cancer (CMBC), including taking critical steps toward manufacturing sufficient quantity of drug to allow for initiation and completion of the 15-patient confirmatory study. Enrollment of first patient is expected in the second quarter of calendar 2022.
"Our focus this past quarter was purely on executing the clinical strategy for VAL-083, our first-in-class, potentially transformational therapy for multiple oncology indications, and REM-001, our late-stage photodynamic therapeutic platform," commented Robert E. Hoffman, Kintara’s President and Chief Executive Officer. "I’m particularly pleased to report that we have exceeded our expectations regarding the pace of enrollment for the GBM AGILE study and as such, remain confident that we’ll meet the goal of advancing to the final registration stage of the study in the third quarter of calendar 2022."

SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2022 FIRST QUARTER ENDED SEPTEMBER 30, 2021

At September 30, 2021, the Company had cash and cash equivalents of approximately $19.3 million. For the three months ended September 30, 2021, the Company reported a net loss of approximately $6.0 million, or $0.25 per share, compared to a net loss of approximately $19.5 million, or $1.33 per share, for the three months ended September 30, 2020. The decrease in the net loss for the three months ended September 30, 2021 compared to the three months ended September 30, 2020 was largely due to the recognition of $16.1 million of non-cash expenses related to the acquisition of in-process research and development costs associated with the merger with Adgero Biopharmaceuticals Holdings, Inc. in August 2020.

On November 15, 2021 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) reported that the United States Food and Drug Administration ("FDA") has granted Orphan Drug Designation (ODD) for toripalimab for the treatment of esophageal cancer. Orphan drug designation is granted to drugs and biologics intended to treat rare diseases with a patient population less than 200,000 in the U.S (Press release, Coherus Biosciences, NOV 15, 2021, View Source [SID1234595586]). The designation provides incentives to advance development and commercialization of rare disease drugs.

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Esophageal cancer ("EC") is a malignant tumor originating in the inner lining of the esophagus. Esophageal squamous cell carcinoma ("ESCC") and adenocarcinoma are the two main subtypes of esophageal cancer. EC is rare in the United States, with approximately 19,000 newly diagnosed cases and 15,000 deaths annually, according to estimates from the American Cancer Society. The prognosis of patients with advanced EC is poor, with five-year survival rates of less than 20%.

"Esophageal squamous cell carcinoma is an aggressive cancer, and patients need new and better treatment options. We plan to work closely with our partner, Junshi Biosciences, to submit a BLA supplement for toripalimab for this indication in 2022," said Denny Lanfear, CEO of Coherus.

In September, Coherus and Junshi Biosciences announced results of the Phase 3 clinical trial, JUPITER-06, a randomized, double blind, placebo-controlled study evaluating toripalimab in combination with chemotherapy as a first-line therapy for patients with advanced or metastatic ESCC. The study met the co-primary endpoints with statistically significant and clinically meaningful improvements in progression free survival (PFS) and overall survival (OS) for patients treated with the toripalimab and chemotherapy combination, compared to chemotherapy alone. In 2022, Coherus and Junshi Biosciences are planning to submit a biologics license application ("BLA") supplement to the FDA for toripalimab in combination with platinum-based chemotherapy for the first-line treatment of advanced or metastatic ESCC. A BLA for toripalimab for advanced recurrent or metastatic nasopharyngeal carcinoma is currently under priority review by the FDA with a target action date of April 2022.

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system’s ability to attack and kill tumor cells. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). On December 17, 2018, toripalimab was granted a conditional approval by the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma ("NPC") after failure of at least two lines of prior systemic therapy. In April, the NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In addition, two supplemental NDAs, one for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic NPC, and the other for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma, were accepted by the NMPA for review in February and July 2021, respectively.

In the United States, the FDA has granted priority review for the toripalimab BLA for the treatment of recurrent or metastatic NPC, an aggressive head and neck tumor which currently has no FDA-approved immuno-oncology treatment options. Earlier, the FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designation for esophageal cancer, NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple other cancer types.

On November 15, 2021 Thermo Fisher Scientific Inc., the world leader in serving science, reported innovative proteomics solutions and a series of co-marketing agreements with industry experts, advancing the throughput, comprehensiveness and quality of proteomics workflows for applications such as single-cell studies and translational research (Press release, Lifescience Newswire, NOV 15, 2021, https://news.lifesciencenewswire.com/newsroom/thermo-fisher-scientific-advances-proteomics-through-select-collaborations-and-new-analytical-instrument-solutions [SID1234595585]).

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The company will showcase these relationships, as well as new additions to its industry-leading offering of mass spectrometry (MS) and chromatography instruments, during the Human Proteome Organization (HUPO) Reconnect event, being held virtually November 15-19.

"Proteomics research has the potential to expand our scientific understanding and uncover new biomarkers to meet unmet medical needs," said Andreas Huhmer, senior director, life sciences research omics marketing, Thermo Fisher Scientific. "While there has been significant progress in our ability to perform advanced analyses such as single-cell and translational proteomics, there are still improvements needed in the efficiency and reproducibility of workflows. The agreements we’re announcing today, will enable us to continue to deliver innovative proteomics solutions to customers with a goal to make these workflows accessible to everyone."

New co-marketing agreements accelerate proteomics workflows

Enhanced quantitation capabilities for high-throughput proteomics

Thermo Fisher is extending their co-marketing agreement with Biognosys, a leading developer of next-generation proteomics solutions, to provide laboratories performing high-throughput plasma analysis with innovative and streamlined instruments, kits and software to enable efficient and accurate workflows at scale. The PQ500 Reference Peptide Kit from Biognosys is able to quantify more than 500 proteins in human plasma/serum samples as part of the SureQuant IS-PRM workflow, enabled only with the Thermo Scientific Orbitrap Exploris 480 mass spectrometer, delivering sensitive and accurate quantitation to drive scientific progress or clinical decision making. Biognosys’ SpectroDive software extends research applications to targeted proteomics enabling automated MS method set-up, signal processing and analysis of targeted experiments, such as the SureQuant IS-PRM workflow.

New liquid chromatography (LC) solution and acquisition strengthen separations for proteomics

The Thermo Scientific Vanquish Neo Ultra-High Performance Liquid Chromatography (UHPLC) System complements high-resolution Thermo Scientific Orbitrap mass spectrometry for proteomics analyses, minimizing sample loss and delivering the highest quality of data. The new system is designed for high-sensitivity LC-MS applications, with excellent analytical performance at flow rates from 1 nL/min to 100 µL/min up to 1500 bar. The separation capabilities and reproducibility of this all-in-one nano-, capillary- and micro-flow LC system will help users to overcome limitations of existing low-flow LC instruments.

Thermo Fisher has also extended its chromatography portfolio through the acquisition of Belgium-based PharmaFluidics, the developer of the μPAC range of micro-chip-based chromatography columns. The µPAC portfolio of columns enhance LC performance in biomarker, proteomics and drug research and development applications, helping biotechnology and pharmaceutical companies uncover new insights and advance scientific discovery.

Expanding single-cell proteomics workflow with sample preparation

One of Thermo Fisher’s goals is to provide customers with a platform to effectively and efficiently analyze thousands of single cells. A co-marketing agreement between Thermo Fisher and Cellenion, experts in single-cell sample preparation solutions, will deliver a full workflow, from sample to results, for scientists performing single-cell proteomics analysis. Laborious sample preparation has typically held back single-cell MS methods. To overcome this, Cellenion’s sample preparation solution, cellenONE, combines single-cell isolation and nanoliter dispensing to perform every step of the sample preparation using a single device. With single-cell proteomics providing vital information on the state of individual cells within heterogeneous environments, the combination of this sample preparation technology with Thermo Fisher’s TMT multiplexing technologies and Orbitrap mass spectrometers will open new doors for researchers.