On April 30, 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 annual financial results for the year ended December 31, 2020 (Press release, Anpac Bio, APR 30, 2021, View Source [SID1234578939]).

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Financial Highlights for Fiscal Year 2020

Total revenues were RMB20.5 million (US$3.1 million) in fiscal year 2020, an increase of 89.1% from RMB10.8 million (US$1.6 million) in fiscal year 2019.
Gross margin was 62.8% in fiscal year 2020, an increase of 18.6% from 44.2% in fiscal year 2019.
The average selling price ("ASP") of CDA-based tests was RMB446 (US$68.4) in fiscal year 2020, increased by RMB248, or 125.3% from RMB198 in fiscal year 2019, primarily due to a broader product offering of more comprehensive multi-cancer detection tests at higher price points.
Net loss decreased to RMB80.6 million (US$12.3 million) in fiscal year 2020 from RMB101.6 million in fiscal year 2019. The net loss in fiscal year 2020 was mainly attributable to RMB 19.7 million (US$ 3.0 million) selling and marketing expenses and RMB 74.8 million (US$ 11.5 million) general and administrative expenses.
Short-term debt decreased significantly (a decrease of approximately 78.7%) compared to the end of last fiscal year (December 31, 2019).
Business Highlights for Fiscal Year 2020

The Company successfully listed on the NASDAQ stock exchange on January 30, 2020.
Two new products were launched, including a proprietary immunology test named AnPac Defense Medical Examination ("ADME") and a new cancer test package named AnPac Pan Cancer Screening ("APCS") combining CDA technology with ct-DNA methods.
The Company continued to receive validation on the efficacy of CDA testing through clinical study follow-ups. As of December 31, 2020, AnPac Bio had contacted 22,979 individuals tested using CDA packages in China and received substantive feedback regarding health conditions and disease development from 13,859 individuals.
As of December 31, 2020, the Company filed 237 patent applications globally; among these, 141 patents have been granted.
The Company continued to build a cancer risk assessment database, which totaled approximately 216,560 samples as of December 31, 2020, including approximately 172,860 samples from commercial CDA-based tests and approximately 43,700 samples from research studies.
The San Jose, California US lab received the College of American Pathologists ("CAP") certification. The lab also has completed the validation of a COVID-19 antibody test using a major supplier’s FDA emergency use authorized equipment, and is capable of commercializing the test.
The Philadelphia, Pennsylvania US lab completed renovations and in August 2020, the lab received CLIA certification.
Dr. Chris Yu, CEO and Chairman of AnPac Bio commented: "We are very pleased with our excellent financial performance in 2020. Although the COVID-19 pandemic adversely impacted businesses around the world over the last year, AnPac Bio still achieved significant growth in its revenues and gross margin while reducing its net loss by approximately 20.7%. This illustrated the capabilities of Anpac Bio’s management team and also demonstrated that our technology and products are getting increased acceptance in the marketplace.

AnPac Bio developed two new products in 2020 which continue to gain traction with our customers. Our issued patents reached 141 at the end of 2020. We are proud of what AnPac Bio has achieved in 2020. We will continue to focus on research and development, obtaining the Class III medical device registration certificate in China, marketing our test as a laboratory developed test, or LDT, in the U.S., launching new products, and controlling costs and expenses.

As we enter 2021, we are capitalizing on an expanding market and customer acceptance of AnPac’s products and services and are driven by our vision to be a market leader around the globe in early-stage cancer screening and detection. As we announced recently, we have achieved a record Q1 for paid CDA-based cancer test volume in 2021."

Financial Results for Fiscal Year 2020

Revenue

Total revenues increased by 89.1% to RMB20.5 million (US$3.1 million) in fiscal year 2020 from RMB10.8 million (US$1.6 million) in fiscal year 2019, primarily due to a significant increase in our revenue from cancer screening and detection tests.

Cost of Revenues

Cost of revenues increased by 26.1% to RMB7.6 million (US$1.2 million) in fiscal year 2020 from RMB6.0 million in fiscal year 2019. The increase was primarily attributable to an increase in depreciation expense, as we put more CDA devices into use to carry out our CDA-based tests.

Gross Profit and Gross Margin

Gross profit increased by 168.5% to RMB12.9 million (US$2.0 million) in fiscal year 2020 from RMB4.8 million in fiscal year 2019. Gross margin was 62.8% in fiscal year 2020, an increase of 18.6 percentage points from 44.2% in fiscal year 2019.

Selling and Marketing Expenses

Selling and marketing expenses increased by 44.3% to RMB19.7 million (US$3.0 million) in fiscal year 2020 from RMB13.6 million in fiscal year 2019, primarily due to higher marketing expenses as a result of our enhanced marketing efforts.

Research and Development Expenses

Research and development expenses increased by 17.7% to RMB11.6 million (US$1.8 million) in fiscal year 2020 from RMB9.8 million in fiscal year 2019, primarily due to the increased research and development activities we conducted in 2020.

General and Administrative Expenses

General and administrative expenses increased by 8.2% to RMB74.8 million (US$11.5 million) in fiscal year 2020 from RMB69.1 million in fiscal year 2019, primarily due to increased listing-related professional fees as well as increased staff compensation incurred in 2020.

Net Loss

Net loss was decreased to RMB80.6 million (US$12.3 million) in fiscal year 2020, compared to RMB101.6 million in fiscal year 2019. Basic and diluted loss per share was RMB7.19 (US$1.10) in fiscal year 2020, compared to that of RMB11.31 in fiscal year 2019.

Balance Sheet

As of December 31, 2020, the Company had cash and cash equivalents of RMB3.0 million (US$462,000), compared to RMB6.1 million as of December 31, 2019.

Cash Flow

Net cash used in operating activities was RMB59.0 million (US$9.0 million) in fiscal year 2020, compared to RMB48.6 million in fiscal year 2019.

Net cash used in investing activities was RMB2.5 million (US$380,000) in fiscal year 2020, compared to RMB3.5 million in fiscal year 2019.

Net cash provided by financing activities was RMB60.9 million (US$9.3 million) in fiscal year 2020, compared to RMB46.1 million in fiscal year 2019.

Conference Call

The Company’s management will host an earnings conference call at 8:30 am US Eastern Time on April 30, 2021 (5:30 am US Pacific Time/8:30 pm Beijing Time) to discuss the financial results for the year ended December 31, 2020. To attend this earnings conference call, please use the information below for either dial-in access or webcast access. When prompted, please reference "AnPac Bio/ANPC".

Please dial in at least 15 minutes before the commencement of the call to ensure timely participation. For those unable to participate, an audio replay of the conference call will be available from approximately one hour after the end of the live call until May 7, 2021. The dial-in for the replay is +1 877-344-7529 within the United States or +1 412-317-0088 internationally. The replay access code is 10153699.

A live webcast of the call will also be available at View Source

On April 30, 2021 Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, reported enrollment of 12 patient Pilot cohort of its Phase 2 trial (NCT04268706) in relapsed / refractory Classical Hodgkin Lymphoma (R/R cHL) (Press release, Tessa Therapeutics, APR 30, 2021, https://www.prnewswire.com/news-releases/tessa-therapeutics-announces-enrollment-of-12-patient-pilot-cohort-in-its-relapsed-or-refractory-hodgkin-lymphoma-phase-2-study-301281049.html [SID1234578907]). The next step in the two-part study is enrollment of the 82 patient Pivotal cohort to assess the safety and antitumor efficacy of Tessa’s autologous CD30 CAR-T in R/R cHL, which is planned to commence in 2H 2021.

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"Tessa’s CD30 CAR-Ts previously demonstrated excellent safety and efficacy in heavily pre-treated R/R cHL patients across two independent Phase 1/2 studies. It is exciting to see the rapid enrollment of the Pilot cohort, and we look forward to working with Tessa in the pivotal cohort of this trial. There is a high unmet need for effective treatments in R/R cHL and we are pleased to be able to advance this novel CD30 directed CAR-T cell therapy for our patients," said Sairah Ahmed, M.D., Associate Professor, The University of Texas MD Anderson, Cancer Center.

CD30 is a well validated lymphoma target with homogeneous expression in 98% of classical Hodgkin Lymphoma (cHL) and a significant proportion of subsets of non-Hodgkin Lymphomas. Tessa’s technology modifies the patient’s T-cells by introducing a CD30 directed Chimeric Antigen Receptor, or CAR, to target and kill cHL. Tessa’s CD30 CAR-T therapy, previously induced a Complete Response in 59% of heavily pretreated R/R cHL patients, with no instance of neurotoxicity or grade 3 Cytokine release syndrome (CRS) (and published in Journal of Clinical Oncology[1]). Tessa’s therapy was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration and PRIority MEdicines (PRIME) designation by European Medicines Agency.

"The speed of enrollment of our 12 patient Pilot cohort, in less than 3 months, is testament to the strong physician and patient interest in our CD30 CAR-T therapy, and further endorses the clinical data generated under the dual Phase 1/2 studies. This marks a critical milestone as Tessa gears up to commence our Pivotal cohort in second half of the year," said Jeffrey H. Buchalter, President and CEO of Tessa Therapeutics. "We believe that Tessa’s CD30 CAR-T therapy, with its promising efficacy and excellent safety profile, addresses current gaps in the treatment of cHL, and has the potential to rapidly move to earlier lines of therapy."

On April 30, 2021 Immunicom, Inc., a clinical-stage biotechnology company pioneering "subtractive" advanced cancer therapies, reported that promising preliminary data from trials investigating ImmunopheresisTM therapy for metastatic, refractory, solid tumor cancer patients who previously failed multiple lines of therapy (Press release, Immunicom, APR 30, 2021, View Source [SID1234578906]). The results presented by Immunicom’s Chief Medical Officer, Dr. Robert Segal, at the 2021 ISFA/E-ISFA virtual joint conference established that Immunopheresis administered to end-stage cancer patients was generally well-tolerated and has the potential for treating refractory malignancies.

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Immunicom’s ongoing clinical trials are in the most difficult to treat, late-stage cancer patients. Immunicom’s novel Immunopheresis therapy uses its proprietary subtractive LW-02 column to selectively remove immune-suppressive cytokines produced by cancer tumors.

"Standard drug treatments are additive therapies that introduce substances into the body to treat cancers. We are developing high-affinity subtractive therapies specifically for these difficult metastatic cancers," said Immunicom’s CEO, Amir Jafri. "Our mission is to define a new era of cancer treatment that is safe and effective."

Dr. Segal’s presentation focused on results from over 600 Immunopheresis procedures conducted in 34 end-stage cancer patients from ongoing clinical trials, demonstrating the viability of this technology as a new treatment strategy. The clinical trials are evaluating the LW-02 column for treating multiple cancers, including triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), metastatic melanoma, and renal cell carcinoma. The LW-02 column is being investigated both as a monotherapy and in combination with low-dose metronomic chemotherapy and the well-known immunotherapy checkpoint inhibitors Opdivo (Bristol-Myers Squibb) and Tecentriq (Roche). These trials are being conducted in collaboration with world-renowned research organizations and thought leaders including:

Poland – at Jagiellonian University of Krakow Hospital, under the direction of Principal Investigator, Professor Piotr Wysocki, MD, PhD;

Israel – at Sheba Medical Center’s Ella Lemelbaum Institute for Immuno-Oncology (Tel Aviv), under the direction of Dr. Ronnie Shapira, MD and Prof. Gal Markel, MD, PhD; and

Turkey – at Acıbadem Altunizade Hospital (Istanbul), a member of the Acıbadem/IHH Healthcare Group, under the direction of Principal Investigator, Prof. Dr. Gokhan Demir, MD, PhD.

Subtractive Therapy – ImmunopheresisTM and the LW-02 Column

Immunicom’s innovative Immunopheresis approach uses the LW-02 column to extract specific immune-suppressive cytokines produced by cancer tumors. Selective removal of these targeted cytokines is intended to neutralize cancer’s ability to block a patient’s natural immune defense mechanisms which are significantly compromised in late-stage, metastatic disease and thereby "re-energizes the immune system to aggressively fight cancer." Immunopheresis is a "subtractive therapy," in contrast to drugs that are "additive." Subtractive therapy is meant to avoid the side effects, toxicity and negative impact on a patient’s quality of life typical of other cancer treatments.

Immunicom believes that the LW-02 column could be used either in combination with other therapies or as a stand-alone treatment. The LW-02 Immunopheresis column has already received Breakthrough Device Designation for stage IV metastatic cancers from the U.S. Food and Drug Administration (FDA). Immunicom has obtained ISO 13485 certification for its manufacturing and related quality systems.

For an overview of how Immunopheresis breakthrough technology works, watch Immunicom’s How it Works video.

Immunopheresis and the LW-02 column is considered an investigational therapy by the U.S. FDA and other regulatory authorities. The clinical efficacy of the LW-02 column has not yet been demonstrated. Clinical investigations evaluating the clinical efficacy of the LW-02 column for TNBC are ongoing.

On April 30, 2021 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that it has received exercise notices from Kreos Capital along with other historical investors who have converted warrants to shares (Press release, Noxxon, APR 30, 2021, View Source [SID1234578905]).

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A total of 3,768,449 new shares in NOXXON shall be issued consequently to the transaction, and NOXXON shall receive €1.2 million. This brings the total number of outstanding shares in NOXXON to 65,223,981. Following this warrant exercise, Kreos Capital holds 7.38% of outstanding shares in NOXXON.

The warrants were issued in connection with NOXXON’s €1 million private placement, Kreos Capital’s partial conversion of debt into equity and €10 million convertible notes with warrants on May 2, 2017. Details of the transaction can be found in the associated press release.

"We are pleased to exercise these warrants and increase our investment in NOXXON. We have been involved in NOXXON since 2014 and are confident the company has exciting long-term prospects, based on its differentiated technology, strong oncology-focused pipeline and the development strategy being implemented by management," said Aris Constantinides, General Partner at Kreos Capital.

"I would like to thank Kreos Capital for their ongoing long-term support of NOXXON. We look forward to working closely together as we continue to focus on improving cancer treatments by targeting the tumor microenvironment, including our lead candidate NOX-A12, which is progressing well in a Phase 1/2 brain cancer trial, with data read-outs expected in May and November 2021," said Aram Mangasarian, CEO of NOXXON.

On April 30, 2021 KIYATEC, Inc reported that it secured a $2.5 million investment from Boston-based healthcare service and technology venture capital fund Seae Ventures (Press release, KIYATEC, APR 30, 2021, View Source [SID1234578904]). The fund’s focus in disruptive healthcare technologies aligns with KIYATEC’s goal to fundamentally change the way cancer drugs are selected by providing oncologists with patient-specific evidence of response, prior to treatment initiation.

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Although significant strides toward personalized medicine have been achieved in the past two decades, oncologists remain largely unable to predict treatment response for individual patients. As a result, many patients receive ineffective drug therapies, while unnecessarily experiencing toxic side effects and shouldering high cost of treatment. KIYATEC’s 3D-Predict platform and associated tests increase the patient-centric value of cancer drugs by informing oncologists’ pre-treatment cancer drug selection. Importantly, the platform also aids pharmaceutical companies by improving decision-making across drug lifecycles.

"We are grateful for Seae Venture’s ’yes’ to KIYATEC and welcome the addition of their managing partner, Jason Robart, to our board of directors. The fund’s healthcare industry relationships coupled with Jason’s personal experience with health insurance innovation will be beneficial as we implement our strategy to impact those who need it most – cancer patients and their providers," said Matthew Gevaert, CEO and co-founder of KIYATEC.

The investment comes on the heels of other recent announcements of success for KIYATEC. The first release of the 3D-PREDICT clinical study data in late 2020, combined with the more recent March 2021 publication demonstrating platform expansion into immuno-oncology, highlight the rapid and disruptive nature of KIYATEC’s progress. The company’s platform has been shown to be clinically predictive for patient-specific response to chemotherapy and targeted agents, and it has been analytically validated in both ovarian cancer and high-grade gliomas.

Robart said, "KIYATEC has the potential to significantly improve outcomes for patients and their providers, not just for one cancer type, but across many solid tumors. We’re excited about the science, the team and the potential. We welcome KIYATEC into our portfolio of companies and I’m thrilled to join its board of directors."