On November 15, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported a clinical update on omburtamab for Desmoplastic Small Round Cell Tumor ("DSRCT"). Data was presented at the 2019 Connective Tissue Oncology Society ("CTOS") Annual Meeting in Tokyo, Japan on November 15, 2019, by Dr. Shakeel Modak from Memorial Sloan Kettering Cancer Center ("MSK") in New York (Press release, Y-mAbs Therapeutics, NOV 15, 2019, View Source [SID1234551395]).

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DSRCT is an aggressive malignancy that typically presents as intraabdominal sarcomatosis in young males. Less than 100 patients are diagnosed each year in the US, and given this incidence, optimal treatment has not yet been defined. Patients with DSRCT have a very poor prognosis with limited five year survival. Even for those patients where Gross Total Resection ("GTR") is possible, five year Overall Survival ("OS") appears to be approximately 20%. Based on observations from MSK, Whole Abdominalpelvic Intensity-Modulated RadioTherapy ("WA-IMRT") may be advisable for all patients whose tumor can be resected.

Data reported by Dr. Modak was based on evaluation of 33 GTR patients treated at MSK from 2009 to 2017. A total of 24 patients from a Phase I study at MSK received WA-IMRT in combination with omburtamab Interperitoneal Radio Immunotherapy ("IP-RIT") and nine patients received WA-IMRT without omburtamab IP-RIT. The study showed a median OS of 41 months for the DSRCT patients who did not receive omburtamab IP-RIT and 59 months for those receiving omburtamab IP-RIT. The data presented at CTOS indicates that adding IP-RIT with iodinated omburtamab to the standard WA-IMRT treatment appears to be well tolerated. Furthermore, adding omburtamab IP-RIT to GTR improved the five year Kapplan Meier estimated OS from a historical rate of approximately 20% to approximately 40%. While this approach may not help patients who do not achieve GTR of DSRCT, we believe that it may help patients with microscopic disease and help prevent relapse. Lack of evaluable disease means that survival is the only relevant endpoint for these patients.

"We are excited to announce this update for omburtamab in DSRCT, and have recently started a Phase II trial at MSK. DSRCT represent a clear unmet medical need. We plan to advance omburtamab for the benefit of these patients. It is very encouraging to continue to witness omburtamab produce significant data in additional difficult indications, providing further evidence of omburtamab’s potential across B7-H3 positive solid tumors," said Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Moller, Chief Executive Officer further notes, "We are very pleased to see these survival data. This is good news for the DSRCT patients who typically are male teenagers and young adults. We believe that the data illustrates the width of compartmental use of radiolabeled omburtamab, which potentially could be applied to other peritoneal malignancies."

On November 15, 2019 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that Paul Chaplin, President & CEO will provide a corporate presentation at the Jefferies 2019 London Healthcare Conference on Thursday, November 21, 2019 at 3:20 pm GMT (4:20 pm CET) (Press release, Bavarian Nordic, NOV 15, 2019, View Source [SID1234551394]).

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A live and archived webcast of the presentation will be available at http://bit.ly/33G7FsV.

Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations & Communications. Phone +45 61 77 47 43
U.S.: Graham Morrell, Paddock Circle Advisors (US), Tel: +1 781 686 9600

On November 15, 2019 AIM ImmunoTech (NYSE American:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers and immune-deficiency diseases – such as severe chronic fatigue syndrome (CFS) – reported for the third quarter ended September 30, 2019, and has filed its form 10-Q with the U.S. Securities and Exchange Commission, which is available on the Company’s website (Press release, AIM ImmunoTech, NOV 15, 2019, View Source [SID1234551393]).

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Recent Highlights

Reported positive safety data in Phase 1 stage 4 ovarian cancer clinical study using Ampligen
Announced the U.S. Department of Defense’s (DOD) $6.42M "Breakthrough Award" to Roswell Park Comprehensive Cancer Center to fund a clinical trial to study Ampligen as a potential synergistic agent in combination with several other immunotherapies, such as pembrolizumab, in the treatment of brain-metastatic breast cancer.
Announced a second DOD "Breakthrough Award" of $8.3 million to fund a similar Phase 2 clinical trial to study Ampligen as part of a new treatment for brain-metastatic breast cancer at the Moffitt Cancer Center
Received clearance from the FDA for exportation of Ampligen to Argentina for the treatment of severe chronic fatigue syndrome
AIM ImmunoTech CEO Thomas K. Equels commented: "We continue to rapidly progress our clinical activities, as illustrated by a number of major upcoming expected milestones. These include:

In as early as the end of the first quarter of 2020, publication of data from a Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer at University of Pittsburgh Medical Center.
In as early as 11 months, interim data from a follow-up Phase 2 study of advanced recurrent ovarian cancer using cisplatin, pembrolizumab, plus Ampligen at University of Pittsburgh Medical Center.
In as early as five months, interim data from a Phase 2 study of metastatic triple-negative breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab, at Roswell Park Comprehensive Cancer Center.
In as early as one month, first enrollment in a Phase 1 study evaluating the safety and tolerability of a combination of Ampligen and celecoxib, with or without Intron A, when given along with chemotherapy in the treatment of patients with early-stage triple negative breast cancer.
In as early as three months, submission to the U.S. Food and Drug Administration of the protocol for two separate but parallel Phase 2 clinical trials to study Ampligen as a potential synergistic agent in combination with several other immunotherapies – including pembrolizumab and Intron A – in the treatment of brain-metastatic breast cancer (See details above in Recent Highlights).
Balance Sheet Highlights

As of September 30, 2019, AIM ImmunoTech had cash, cash equivalents and marketable securities of $11,730,000 compared with $1,825,000 as of December 31, 2019. The increase is primarily due to capital raises totaling approximately $10 million.

"The $10 million that we raised over the past few months provides us a substantial runway to support our activities while we await reportable data in the six ongoing immuno-oncology clinical trials studying Ampligen. Our role in these trials is solely to supply the Ampligen, as the trials are funded by grants from prestigious third parties directly to the clinical sites. We believe this third-party funding provides substantial validation of our platform and we look forward to providing further updates in the near-term. Meanwhile, we continue to carefully manage expenses in a way we believe will allow us to concentrate on near-term clinical goals, and as our short-term clinical trial manufacturing objectives are reached we expect to further reduce our burn rate."

Third Quarter Financial Highlights

Research and development-related expenses for the third quarter of 2019 were $1,190,000, compared with $1,595,000 million for the third quarter of 2018. Costs decreased primarily due to a general reduction in the level of Ampligen manufacturing and a decrease in clinical research costs.

General and administrative expenses for the third quarter of 2019 were $1,846,000, compared with $1,273,000 for the third quarter of 2018. The increase in G&A expenses during the current period was mainly due to an increase in stock-based compensation, an increase in public relations expenses, an increase in investment banking fees and an increase in legal fees.

The net loss from continuing operations for the third quarter of 2019 was $2,948,000, compared with $3,078,000 for the third quarter of 2018.

On November 15, 2019 Gracell Biotechnologies Co., Ltd. ("Gracell"), a clinical-stage immune cell therapy company, reported five presentations to be delivered at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida, held from December 7-10 (Press release, Gracell Biotechnologies, NOV 15, 2019, View Source [SID1234551391]).

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The presentations centre on Gracell’s breakthrough FasTCAR technology, and other two platform technology in four product categories used in the treatment of hematological malignancies, each with well-defined objectives, including:

FasT CAR-19 (GC007F)
Dual CAR-19-22 (GC022)
Dual CAR-BCMA-19 (GC012)
Donor CAR-19 (GC007G)
The four product candidates are currently being studied in ongoing phase I clinical trials conducted by Gracell, Hebei Yanda Lu Daopei Hospital, and Xinqiao Hospital of AMU, and six other hospitals nationwide in China.

"These clinical studies demonstrated Gracell’s product development strategy and strong capabilities to bring multiple novel therapies through clinical investigations," said Dr. William CAO, CEO of Gracell. "These invaluable data provides guidance for and enhance our confidence in pipeline selection."

Oral presentations:

A Feasibility and Safety Study of a New CD19-Directed Fast CAR-T Therapy for Refractory and Relapsed B cell Acute Lymphoblastic Leukemia
Abstract #825
Session Name: 612. Acute Lymphoblastic Leukemia: Clinical Studies: Therapeutics Strategies
Presenter: Peihua Lu, M.D., Hebei Yanda Lu Daopei Hospital
Location: Orange County Convention Center, Tangerine 1 (WF1), Level 2
Time: 5:00 pm, Monday, December 9, 2019
View Source

Anti-CD19/CD22 Dual CAR-T Therapy for Refractory and Relapsed B-Cell Acute Lymphoblastic Leukemia
Abstract #284
Session Name: 612. Acute Lymphoblastic Leukemia: Clinical Studies: Novel Therapies
Presenter: Peihua Lu, M.D., Hebei Yanda Lu Daopei Hospital
Location: Orange County Convention Center, W224, Level 2
Time: 4:15pm, Saturday, December 7, 2019
View Source

Poster presentations:

CD19-Directed Fast CART Therapy for Relapsed/Refractory Acute Lymphoblastic Leukemia: From Bench to Bedside
Abstract #1340
Session Name: 614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation: Poster I
Presenter: Cheng Zhang, M.D., Xinqiao Hospital of AMU
Location: Orange County Convention Center, Hall B, Level 2
5:30-7:30 pm, Saturday, December 7, 2019
View Source

A Bcma and CD19 Bispecific CAR-T for Relapsed and Refractory Multiple Myeloma
Abstract # 3147
Session Name: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Presenter: Hua Zhang, PhD., Gracell Biotechnology Ltd., Shanghai, China, Shanghai, China
Location: Orange County Convention Center, Hall B, Level 2
6:00 PM-8:00 pm, Sunday, December 8, 2019
View Source

Role of Donor-Derived CD19.CAR-T Cells in Treating Patients That Relapsed after Allogeneic Hematopoietic Stem Cell Transplantation
Abstract #4561
Session Name: 723. Clinical Allogeneic and Autologous Transplantation: Late Complications and Approaches to Disease Recurrence: Poster III
Presenter: Cheng Zhang, M.D., Xinqiao Hospital of AMU
Location: Orange County Convention Center, Hall B, Level 2
6:00-8:00 pm, Monday, December 9, 2019
View Source

About FasT CAR-19

FasT CAR-19, or GC007F, is an investigational CD19-targeted CAR-T cell therapy for adolescent and adult patients with refractory or relapsed B-ALL, as well as aggressive non-Hodgkin lymphoma. Thanks to Gracell’s patented FasTCAR technology, the bioprocessing time for GC007F has been significantly reduced from two weeks to 24 hours with substantially lower cost. The improved CAR-T cell fitness resulted in superior proliferation capabilities, potency, and extensive bone marrow migration making GC007F a potential best-in-class therapy for refractory or relapsed B-ALL.

About Dual CAR-19-22

Dual CAR-19-22, or GC022, is an investigational CAR-T cell therapy redirected to target CD19 and CD22, in treating patients with CD19+, or/and CD22+ relapsed/refractory B-ALL. A low toxicity with dose-dependent high CR rate including patients who previously treated with CD19 CAR-T cells were observed.

About Dual CAR-BCMA-19

Dual CAR-BCMA-19, or GC012, is an investigational CAR-T cell therapy redirected to target BCMA and CD19, in treating patients with BCMA+, or/and CD19+ relapsed/refractory multiple myeloma. Previous research shows CD19 could express on the myeloma progenitor cells, while BCMA is a well validated target for MM.

About Donor CAR-19

Donor CAR-19, or GC007G, is an investigational CD19 targeted CAR-T cell therapy manufactured in use of donor’s lymphocytes. The objective of this study is to further investigate and better understand the safety and efficacy of donor derived CAR-T cells in treatment of relapsed and refractory B-ALL patients.

About B-ALL

B-ALL is a sub-type of acute lymphoblastic leukemia, although rare, is one of the most common forms of cancer in children between the ages of two and five and adults over the age of 50[1]. In 2015, ALL affected around 876,000 people globally and resulted in 110,000 deaths worldwide[2]. It is also the most common cause of cancer and death from cancer among children. ALL is typically treated initially with chemotherapy aimed at bringing about remission. This is then followed by further chemotherapy carried out over several years.

About MM

Myeloma begins when a plasma cell becomes abnormal. The abnormal cell divides to make copies of itself. These abnormal plasma cells are called myeloma cells. In time, myeloma cells collect in the bone marrow. They may damage the solid part of the bone. When myeloma cells collect in several of your bones, the disease is called "multiple myeloma." This disease may also harm other tissues and organs, such as the kidneys. Myeloma cells make antibodies called M proteins and other proteins. These proteins can collect in the blood, urine, and organs[3].

On November 15, 2019 China Pharma Holdings, Inc. (NYSE American: CPHI) ("China Pharma," the "Company" or "We"), an NYSE American-listed corporation with a fully-integrated specialty pharmaceuticals subsidiary based in China, reported financial results for the quarter ended September 30, 2019 (Press release, North China Pharmaceutical, NOV 15, 2019, View Source [SID1234551390]).

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Third Quarter Highlights

Revenue increased by 3.4% to $2.4 million in the third quarter 2019 from $2.3 million in the same period of 2018;
Gross margin was 15.7% in the third quarter 2019, compared to 22.3% in the same period of 2018;
Loss from operations was $0.6 million in the third quarter 2019 compared to $1.9 million in the same period of 2018, an improvement of $1.3 million;
Net loss was $0.7 million in the third quarter 2019 compared to $1.9 million in the same period of 2018. Loss per common share was $0.02 per basic and diluted share in the third quarter 2019, compared to $0.04 per basic and diluted share in the same period of 2018.
Ms. Zhilin Li, China Pharma’s Chairman and CEO, commented, "We experienced negative effects on our sales from the strict implementation of the government policy of controlling the proportion of the spending on drugs to the patients’ total expenditures in hospitals in recent quarters. Management endeavors to vigorously promote sales through active participation in recent provincial market openings to solicit new drug tender offers and allow China Pharma to expand its presence in these markets." Ms. Li continued, "In addition, we are experiencing sustained pressure from the more stringent requirements of drug registration standards, consistency evaluations, which has created a challenging environment in our industry during this period. We will continue actively adapting to the state policy guidance and further evaluate market conditions for our current existing products, pipeline products, and competition in the market, in order to optimize our development strategy. We will simultaneously actively implement the launch of our nutrition product."

Third Quarter Results

Revenue increased by 3.4% to $2.4 million for the three months ended September 30, 2019, as compared to $2.3 million for the three months ended September 30, 2018.

Gross profit for the three months ended September 30, 2019 was $0.4 million, as compared to $0.5 million during the same period in 2018. Our gross profit margin in the three months ended September 30, 2019 was 15.7% as compared to 22.3% during the same period in 2018. The decrease in our gross profit margin was mainly due to the increased ratio of fixed cost to revenue.

Our selling expenses for the three months ended September 30, 2019 and 2018 were $0.6 million and $0.9 million, respectively. Selling expenses accounted for 25.8% of the total revenue in the three months ended September 30, 2019, as compared to 40.3% during the same period in 2018.

Our general and administrative expenses were $0.3 million for each of the three months ended September 30, 2019 and 2018. General and administrative expenses accounted for 14.0% and 14.2% of our total revenues in the three months ended September 30, 2019 and 2018, respectively.

Our research and development expenses for the three months ended September 30, 2019 were $0.04 million, as compared to $0.06 million in the same period in 2018. Research and development expenses accounted for 1.7% and 2.7% of our total revenues in the three months ended September 30, 2019 and 2018, respectively. The consistency evaluations discussed under the "Business Overview & Recent Developments" section hereof is expected to have a significant impact on all generic products not only in our pipeline products, but also throughout the existing Chinese market for similar generic products. Because of the continuous introduction of detailed implementation rules under this policy, our pipeline products did not experience any further development in the third quarter of 2019.

Our bad debt expenses for the three months ended September 30, 2019 was $0.03 million, as compared to $1.13 million for the same period in 2018. The decrease of bad debt expenses in this period was mainly due to the decrease in the amount of accounts receivable that is turning to over 2 years old in this period. Our bad debt allowance estimate requires 70% of accounts receivable that are between 365 days and 720 days old, and 100% of accounts receivable that are greater than 720 days old.

Net loss for the three months ended September 30, 2019 was $0.7 million, or $0.02 per basic and diluted common share, as compared to a net loss of $1.9 million, or $0.04 per basic and diluted common share, for the same period a year ago. The decrease in net loss was mainly the result of controls on expenditures outweighed the impact of decrease in gross profit margin.

Nine Months Results

For the nine months ended September 30, 2019, our sales revenue was $7.9 million, which represented a decrease of $1.2 million, or 13.3%, from the $9.1 million in the corresponding period of 2018.

Gross profit for the nine months ended September 30, 2019 was $1.2 million, compared to $2.1 million in the same period of 2018. Gross profit margins for the nine months ended September 30, 2019 and 2018 were 15% and 24%, respectively.

Our net losses for the nine months ended September 30, 2019 and 2018 were $2.0 million and $3.2 million, respectively, which represented an improvement of $1.2 million for the period in 2019. This improvement was mainly due to the decrease of bad debt expenses in this period.

Financial Condition

As of September 30, 2019, the Company had cash and cash equivalents of $0.8 million compared to $1.2 million as of December 31, 2018.

As of September 30, 2019, our net accounts receivable was $0.7 million, compared to $0.9 million as of December 31, 2018.

For the nine months ended September 30, 2019, cash flow from operating activities was $1.4 million, as compared to $1.0 million for the same period in 2018.