On November 26, 2021 AnPac Bio-Medical Science Co., Ltd. ("AnPac Bio," the "Company" or "we") (NASDAQ: ANPC), a biotechnology company with operations in China and the United States, reported its unaudited financial results for the nine months ended September 30, 2021 (Press release, Anpac Bio, NOV 26, 2021, View Source [SID1234596104]). The Company’s financial statements and related financial information for the quarter ended September 30, 2021 are unaudited and have not been reviewed by the Company’s independent registered accountant. These financial results could differ materially if they were reviewed by the Company’s independent registered accountant.

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Financial highlights:

Total revenue was approximately RMB13.7 million (US$2.1 million) for the nine months ended September 30, 2021, an increase of 55.3% from RMB8.8 million for the same period of 2020.
Gross profit margin was 59.3% for the nine months ended September 30, 2021, representing an increase of 8.8% from 50.5% for the same period of 2020, primarily due to higher selling prices charged for cancer differentiation analysis ("CDA")-based tests and improved operational efficiency during the nine months ended September 30, 2021.
The average selling price ("ASP") of CDA-based tests was RMB463(US$71.6) for the nine months ended September 30, 2021, an increase of RMB194, or 72.3% from RMB269 in the same period of 2020, primarily due to a broader product offering of more comprehensive multi-cancer detection tests at higher price points.
Net loss was approximately RMB89.0 million (US$13.8 million) for the nine months ended September 30, 2021, representing an increase of approximately RMB19.5 million from RMB69.5 million for the same period of 2020, primarily due to the Company recognized an aggregated unrealized loss of approximately RMB9.3 million (US$1.4 million) in related to changes in fair value of convertible debt for the nine months ended September 30, 2021, while in the same period of 2020 it was an unrealized gain of approximately RMB7.3 million.
Non-GAAP net loss1 was approximately RMB55.0 million (US$8.5 million) for the nine months ended September 30, 2021, reduced from a non-GAAP net loss of approximately RMB59.1 million for the nine months ended September 30, 2020. Non-GAAP net loss was reduced by 6.8% compared with the nine months ended September 30, 2020.
Short-term debt was approximately RMB30.0 million (US$4.6 million) as of September 30, 2021, an increase of 264.5% from RMB8.2 million at the end of last fiscal year (December 31, 2020). The increase in short-term debt was mainly due to issuance of additional convertible debentures.
As of September 30, 2021, the Company had cash and cash equivalents of approximately RMB5.5 million (US$0.8 million), compared to RMB3.0 million as of December 31, 2020.
(1) Non-GAAP net loss is defined as net loss excluding change in fair value of convertible debts and stock-based compensation. For more information, refer to "Use of Non-GAAP Financial Measures" and "Reconciliations of Non-GAAP Results" at the end of this press release.

Business Highlights for the Nine Months Ended September 30, 2021

On August 18, 2021, the Company completed an acquisition of 60% equity interest in Anpai (Shanghai) Health Management Consulting Co., Ltd ("Anpai Shanghai"), consisting of an acquisition of 40% equity interest of Anpai Shanghai from Dr. Chris Chang Yu for a consideration of RMB 8.5 million approved by the Board of Directors, and an investment of 20% equity interest in Anpai Shanghai which the Company has already held prior to August 18, 2021. Anpai Shanghai is engaged in providing medical screen and detection service in the PRC.
The Company continued to receive validation on the efficacy of CDA testing through clinical study follow-ups. As of September 30, 2021, AnPac Bio had contacted 24,823 individuals tested using CDA packages in China and received substantive feedback regarding health conditions and disease development from 14,806 individuals.
Completed development and evaluation of a second-generation cancer detection sensor with improvements in multiple areas including reduced device cost, improved signal stability, cancer detection sensitivity and specificity.
Launched a joint venture to focus on a novel cancer treatment technology and medical device development which leverages AnPac Bio’s deep and extensive knowledge and experience in biophysics and its correlations with cancer occurrence and cancer detection.
As of September 30, 2021, the Company filed 261 patent applications globally, among which 150 patents had been granted, including 20 patents granted in the United States, 66 in greater China (including eight in Taiwan), and 64 in other countries and regions.
The Company continued to build a cancer risk assessment database, which totaled approximately 244,310 samples as of September 30, 2021, including approximately 200,330 samples from commercial CDA-based tests and approximately 43,980 samples from research studies.
Dr. Chris Yu, AnPac Bio’s Chairman and CEO commented: "We are very pleased with our progress in research and development, commercialization, and operational performance for the first 9 months in 2021. We grew revenue by 55.3% and gross margin by 8.8 percentage points. At the same time, we reduced non-GAAP loss by 6.0%. Our number of issued patents, and clinical and commercial sample sizes all reached record high in Q3, 2021. We are making solid progress in obtaining regulatory approval for our class III medical device for lung cancer assisting in diagnosis and have also submitted application for registration testing of our multi-cancer detection medical device for 11 types of cancer. We are also working very hard to obtain Laboratory Developed Test (LDT) status for our CDA cancer test in the US. Based on our current status and progress, we now expect to obtain registration approval for our class III medical device (for lung cancer assisting in diagnosis) in late 2022."

Key Items of Financial Results for the Nine Months Ended September 30, 2021

Revenue

Total revenues increased by 55.3% to approximately RMB13.7 million (US$2.1million) for the nine months ended September 30, 2021 from approximately RMB8.8 million for the same period of 2020, primarily due to a significant increase in our revenue from cancer screening and detection tests.

Cost of Revenues

Cost of revenues increased by 27.8% to approximately RMB5.6 million (US$862,000) for the nine months ended September 30, 2021 from approximately RMB4.4 million for the same period of 2020, primarily due to the increased staff costs.

Gross Profit and Gross Margin

Gross margin was 59.3% for the nine months ended September 30, 2021, representing a significant increase from 50.5% for the same period of 2020, primarily due to higher selling prices we charged for CDA-based tests.

Selling and Marketing Expenses

Selling and marketing expenses increased by 66.4% to approximately RMB17.3 million (US$2.7 million) for the nine months ended September 30, 2021 from approximately RMB10.4 million in the same period of 2020, primarily due to higher marketing expenses as a result of our enhanced marketing efforts.

Research and Development Expenses

Research and development expenses increased by 5.7% to approximately RMB11.9 million (US$1.8 million) for the nine months ended September 30, 2021 from approximately RMB11.2 million for the same period of 2020, primarily due to the increased share-based compensation for our research and development personnel.

General and Administrative Expenses

General and administrative expenses decreased by 3.1% to approximately RMB58.9 million (US$9.1 million) for the nine months ended September 30, 2021 from approximately RMB60.8 million for the same period of 2020, primarily due to the decreased listing-related professional fees.

Change in fair value of convertible debt

The Company recognized the convertible debt at fair value. For the nine months ended September 30, 2021 and 2020, the Company recognized an aggregated unrealized loss of approximately RMB9.3 million (US$1.4 million) and unrealized gain of approximately RMB7.3 million, respectively, due to changes in fair value of convertible debt.

Gain from fair value change in equity investment

For the nine months ended September 30, 2020, the Company recorded a gain from fair value change in equity investment of approximately RMB3.2 million (US$489,000) due to the acquisition of Anpai Shanghai.

Net Loss

Net loss increased to approximately RMB89.0 million (US$13.8 million) for the nine months ended September 30, 2021, compared to approximately RMB69.5 million for the same period of 2020. Basic and diluted loss per share was RMB6.52 (US$1.01) for the nine months ended September 30, 2021, compared to that of RMB6.22 for the same period of 2020.

Balance Sheet

As of September 30, 2021, the Company had cash and cash equivalents of approximately RMB5.5 million (US$0.8 million), compared to approximately RMB3.0 million as of December 31, 2020.

On November 26, 2021 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or the "Company"), an Australian-based clinical stage radiopharmaceutical company developing next-generation products to address the growing need in oncology, reported that the patent application covering formulations of Clarity’s optimised Prostate Specific Membrane Antigen (PSMA) targeting agent, SAR-bisPSMA, has entered the national phase in multiple jurisdictions, including the USA, Europe and China (Press release, Clarity Pharmaceuticals, NOV 26, 2021, View Source [SID1234596096]). SAR-bisPSMA is a Targeted Copper Theranostic (TCT) for diagnosis and treatment of prostate cancer. A patent including claims covering the SAR-bisPSMA compound was recently granted in the USA, with an expiry date of 5 June 2038.

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SAR-bisPSMA has entered two clinical trials in July 2021:

SECuRE trial in the US: A Phase I/IIa Theranostic Study of 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (NCT04868604)1
PROPELLER trial in Australia: Positron Emission Tomography Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA: A Multi-Centre, Blinded Review, Dose Ranging Phase I Study (NCT04839367)2
The prostate cancer market is a key focus for Clarity and the company is rapidly hitting key milestones in the development of SAR-bisPSMA with the recent completion of patient recruitment into the dosimetry phase of the SECuRE trial and ongoing recruitment in the PROPELLER trial.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are very pleased with the evolving patent protection of one of our core products, SAR-bisPSMA, with the entry of the international application into the National Phase around the world. This further strengthens our position in the radiopharmaceutical field as we progress the clinical development of this asset in the US and Australia. This milestone is testament to Clarity’s strong emphasis on Intellectual Property (IP) protection since the inception of the company with a patent strategy designed to cover the SAR Technology platform as well as radiopharmaceutical products and the "Discovery Program" focused on developing new products and new IP for a range of cancer indications. This aggressive patent strategy allows us to gain strong protection with any targeting agent and expand our product pipeline, gaining a sustainable competitive advantage in this field."

This broad and deep patent strategy has resulted in the allowance and grant of a number of Clarity’s patent applications for key compounds in major jurisdictions, including patents for SARTATE and SAR-Bombesin. Clarity continues to extend its patent position with the recent filing of new provisional applications.

Dr Alan Taylor said, "Clarity’s patenting strategy enables us to successfully leverage our IP to develop a pipeline of next-generation radiopharmaceuticals and we are determined to fully exploit the broad coverage of the platform to continue pursuing our ultimate goal of developing better treatments for children and adults with cancer."

This announcement has been authorised for release by the Executive Chairman.

On November 25, 2021 APIM Therapeutics (APIM), a clinical stage biotech company, focusing on the development of novel peptide therapeutics targeting PCNA (Proliferating Cell Nuclear Antigen), reported that the first patient has been treated in a clinical Phase 1b/2a study in ovarian cancer (Press release, APIM Therapeutics, NOV 25, 2021, View Source,c3460072 [SID1234605478]).

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The clinical study (ClinicalTrials.gov Identifier: NCT04814875) investigates ATX-101, the lead compound of APIM’s development program, in combination with platinum-based chemotherapy in patients suffering from recurrent, platinum sensitive ovarian, fallopian tube and primary peritoneal cancer. The study consists of 2 parts; Part 1 is a safety part with dose limiting toxicity as primary endpoint, Part 2 is an efficacy part with progression free survival as primary endpoint. Approximately 72-78 patients will be treated.

The study started recruitment in Australia; further APAC sites will be opened soon. Prof Tarek Meniawy is the Coordinating Investigator of this study. "Although a lot of progress has been made in the treatment of ovarian cancer over the last years, it remains a life-threatening disease and new treatment approaches are needed." Dr. Meniawy said. "ATX-101 is a first-in-class compound with the potential to boost the effect of standard of care chemotherapy."

"This proof-of-concept study is an important step for APIM Therapeutics. Preclinical data have shown that ATX-101 can potentiate the effect of a wide range of anticancer therapies." said Dr. Kostas Alevizopoulos, CEO of APIM. "In particular, the combination of ATX-101 with platinum-based therapies has shown very promising data. This clinical study is the logical next step in our development program."

ATX-101 has been investigated as single agent in a Phase 1 study which has been finished recently. "Data have shown that ATX-101 infusions are well tolerated and indicate clinical activity in late-stage solid tumors." Dr. Jens-Peter Marschner, CMO of APIM Therapeutics, said. "Ovarian cancer is an appropriate indication to investigate the combination of ATX-101 with platinum-based chemotherapy. We have discussed this development step with experts and authorities, including the FDA. A proof-of-concept for this combination could open the doors for further cancer indications with high medical need."

About ATX-101

ATX-101 is a first-in-class, cell penetrating peptide featuring a novel PCNA-interacting motif (AlkB homolog 2 PCNA Interacting Motif or APIM). In preclinical experiments, it was shown that APIM-containing proteins bind to PCNA and mediate processes of escape mechanisms and survival of cancer cells. ATX-101 competitively inhibits interaction of PCNA with APIM-containing protein complexes resulting in cancer cell death and altered cellular signaling. These properties translate in anticancer effects of ATX-101 as demonstrated in several preclinical models in vitro and in vivo.

About ovarian cancer

The term "ovarian cancer" also covers cancer of the fallopian tubes and primary peritoneal cancer. Epithelial ovarian cancer (90% of all ovarian cancers) is the gynecological cancer with the highest death rate. 75% of patients treated with initial standard platinum-based chemotherapy are platinum sensitive, i.e., they show a relatively long stabilization of disease. But almost all patients experience tumor progression after some time. New drugs have been approved over the last years which extend the disease stabilization, but ovarian cancer remains a life-threatening disease with a high unmet medical need.

On November 25, 2021 Elekta (EKTA-B.ST) reported that its latest African order for Elekta Unity MR-Linac comes less than six months after the company introduced its ACCESS 2025 strategy, which includes giving more than 300 million people access to radiation therapy with the addition of 800 to 1,000 additional Elekta linacs in underserved markets (Press release, Elekta, NOV 25, 2021, View Source [SID1234596093]).

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In addition to the Unity system, the Eugene Gasana Jr. Foundation signed an agreement on behalf of the International Children’s Cancer Research Centre (ICCRC) to also acquire two Elekta Versa HD linear accelerators as well as Elekta Studio* including the ImagingRing, a brand-new mobile imaging device for brachytherapy treatments, and a Flexitron afterloader.

As a member of the Elekta MR-Linac Consortium, ICCRC will actively investigate the potential benefits of magnetic resonance-guided radiation therapy (MRgRT) in pediatric oncology. In addition, ICCRC will join hospitals around the world in providing high precision radiation therapy to treat cancer in children.

"We are very excited that Ghanaians will have access to the same cancer care as the best hospitals in the U.S., Europe or Asia," said Habib Nehme, Executive Vice President Turkey, India, Middle East, Africa, APAC & Japan. "And while a focus on children’s’ health is especially appreciated; I know that having the tools to treat advanced-stage cervical cancer is welcome as rates for the indication are particularly high in Africa. We are also proud to collaborate with partners of the Eugene Gasana Jr. Foundation in providing comprehensive training for the hospital staff."

Of the more than 24,000 new cancer cases recorded in Ghana each year1, approximately 1,200 are estimated to be children under the age of 152. Cervical and prostate cancers are the most common among women and men respectively and are regularly treated with brachytherapy. Versa HD is a system designed to treat a spectrum of tumors throughout the body using both conventional and highly sophisticated techniques. And Elekta Unity uses dynamic real-time adaptation to tailor treatment based on changes in the shape, size and position of the tumor and surrounding anatomy.

Construction of the new hospital will begin in the first quarter of 2022 calendar year, with deliveries at the end of 2023. The equipment is scheduled to be clinical during 2024.

*Elekta Studio is comprised of multiple medical devices, some of which may not yet be available in all markets. Confirm availability with your local Elekta representative.

On November 25, 2021 Priothera Ltd, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound, mocravimod, reported the appointment of Elisabeth Kueenburg, M.D., as Chief Medical Officer (Press release, Priothera, NOV 25, 2021, View Source [SID1234596092]). Dr. Kueenburg will lead the advancement of mocravimod into Phase 2b/3 clinical trials as a potential treatment for patients with Acute Myeloid Leukemia (AML) receiving hematopoietic stem cell transplantation (HSCT), and expansion of Priothera’s pipeline.

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"The breadth of knowledge Elisabeth has gained working at Celgene, alongside her extensive clinical experience, makes her a crucial addition to our team," said Florent Gros, Co-Founder and CEO of Priothera. "We are delighted to welcome Elisabeth during this exciting time as we look to progress mocravimod, into a Phase 2b/3 study as a potential treatment for patients with Acute Myeloid Leukemia receiving hematopoietic stem cell transplantation. The study is expected to begin in 2022."

"I am pleased to join Priothera at such an important stage of its development," said Dr. Kueenburg. "Mocravimod has the potential to address the significant unmet need of AML patients undergoing HSCT. I look forward to guiding mocravimod and future programs into the clinic and making an important contribution to Priothera’s future success."

Dr. Kueenburg brings significant drug development and medical affairs experience from her years at Celgene where she most recently served as Clinical Development Lead. At Celgene she developed deep clinical development and medical affairs expertise, providing strategic insight and overseeing the coordination of multiple clinical trials, in the area of hematology and specifically in multiple myeloma. Furthermore, Dr. Kueenburg has supported the successful global launch of Celgene’s Revlimid.

Prior to her numerous roles at Celgene, Dr. Kueenburg spent more than 15 years in clinical practice and academic research specializing in oncology and hematology.

Dr. Kueenburg gained her Doctor of Medicine from the University of Vienna in Austria.