Yiling Pharmaceutical Reports Revenue of $1.53B in 2021

On April 30, 2022 Yiling Pharmaceutical reported its 2021 Annual Report Friday and disclosed the main development statistics (Press release, Yiling Pharmaceutical, APR 30, 2022, View Source;301536781.html [SID1234613262]). According to the report, its annual revenue reached USD 1.53 billion, an increase of 15.19% from last year, besides, net profit attributable to equity holders reached USD 203.75 million, achieving a 10.27% growth YoY.

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The annual revenue of Tongxinluo Capsules, Shensong Yangxin Capsules, and Qili Qiangxin Capsules, Yiling’s 3 main products for cardio-cerebrovascular diseases, reached USD 687.4 million, accounting for 44.82% of the overall revenue, achieving a 31.56% YoY growth despite the Covid-19 hit. Notably, in 2021, the annual revenue of Lianhua Qingwen Capsules reached USD 622.8 billion. It also ranked No.1 in the sales of patented traditional Chinese medicine for cold in China’s public medical market in 2021H1, according to statistics.

Public information indicates that Lianhua Qingwen Capsules was developed in the SARS period, it is the only herbal medicine for cold and flu that has won the Second Prize of China’s National Progress Award in Science and Technology.

In 2020, a clinical study Efficacy and safety of Lianhuaqingwen capsules, a repurposed Chinese herb, in patients with coronavirus disease 2019: A multicenter, prospective, randomized controlled trial published in Phytomedicine, shows that along with routine treatment, oral administration of Lianhua Qingwen Capsules for 14 days, COVID-19’s clinical symptoms such as fever, fatigue, and cough can be alleviated significantly, and the pulmonary imaging lesions can be improved dramatically, the duration of symptoms was obviously shortened and the clinical cure rate was obviously elevated.

Lianhua Qingwen has been granted for sale in nearly 30 countries and regions. Furthermore, it has been approved for COVID-19 indications in Kuwait and Mongolia, and selected to be listed on the whitelist of anti-epidemic drugs issued by the Ministry of Health of Uzbekistan. In July 2021, it has been adopted as a treatment in the COVID-19 patients’ self-care protocol at home by the Cambodian Ministry of Health.

Genome Insight Draws $23 Million in Series B Funding to Open the Whole Genome Era for Transforming Precision Medicine

On April 30, 2022 Genome Insight, a global leader in Whole Genome Sequence analysis and interpretation, reported $23 million in Series B funding (Press release, Genome Insight, APR 30, 2022, View Source [SID1234613261]).

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Dunamu & Partners led the financing with participation from InterVest, Signite Partners, KC, and VNTG Corporation, as well as existing investors DSC Investment, Paratus Investment, and Schmidt. The funding will be allocated towards advancing Genome Insight’s data production and curation pipelines that enable scalable investigation of whole-genome sequences (WGS), the most comprehensive technique for understanding the molecular origin of human diseases. These efforts will bring WGS in real-world clinics for clinicians and patients for next-generation medical practice, in particular, for cancer and rare diseases.

Genome Insight is a start-up company with expertise in the biomedical curation of WGS data. WGS examines the entire genomic sequence of diseased tissues, providing the most comprehensive characterization of tens of thousands of genomic mutations carried on it as a whole. While historically confined as a research tool, due to its massive data size and high cost for data curation, WGS is a leading driver for opening up an ultimate era of personalized medicine with entire genomic information. Making biomedical sense of the vast amount of WGS data at an affordable cost, predictable timeline, and standardized procedure has been the main barrier to the widespread use of WGS.

"With the falling cost of genome data production, we are at the tipping point of a whole-genome based transformation in treating genetically driven illnesses such as cancer and rare diseases. We plan to bring the analysis and interpretation technologies to make whole-genome sequences meaningful," said Young Seok Ju, founder of Genome Insight. "We are excited to have as our new investors, not only those in bio-tech but also those in digital-tech. This investment is a clear signal that the field is at the forefront of bio-tech and digital-tech convergence."

Genome Insight was founded in 2020 in South Korea by co-founders Young Seok Ju and Jeong Seok Lee, who are both physician-scientists and professors at KAIST (Korea Advanced Institute of Science and Technology). Earlier this year, the Company announced its incorporation as a US company and is now headquartered in San Diego, at the heart of the genomics hotbed of the west coast.

Theralase Release FY2021 Audited Financial Statements

On April 29, 2022 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated PhotoDynamic Compounds ("PDC") and their associated drug formulations intended to safely and effectively destroy various cancers reported its audited annual consolidated 2021 financial statements (Press release, Theralase, APR 29, 2022, View Source [SID1234613460]).

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Financial Highlights:

For the years ended December 31st:

Total revenue decreased 16%, year over year, and is primarily attributed to the slower than anticipated Canadian and US economic recovery from the COVID-19 pandemic in 2021.

Cost of sales for the year ended December 31, 2021 was $470,698 or 60% of revenue resulting in a gross margin of $309,943 or 40% of revenue. In comparison, the cost of sales in 2020 was $659,442 or 71% of revenue resulting in a gross margin of $269,680 or 29% of revenue. The gross margin increase, as a percentage of sales, year over year, is primarily attributed to a decrease in labour and material costs.

Selling expenses for the year ended December 31, 2021, decreased to $363,886, from $447,882 in 2020, a 19% decrease. The decrease in selling expenses is primarily attributed to the COVID-19 pandemic, resulting in reduced advertising (43%), commissions (17%) and salaries (8%).

Administrative expenses for the year ended December 31, 2021, decreased to $1,562,867 from $2,070,261 in 2020, a 25% decrease. The decrease in administrative expenses is primarily attributed to decreased spending on director and advisory fees (37%) and general and administrative expenses (21%). Stock based compensation expense decreased 63% in 2021 due to a reduction in stock options granted.

Net research and development expenses for the year ended December 31, 2021, decreased to $2,924,733 from $3,448,243 in 2020, a 15% decrease. The decrease in research and development expenses for the year ended December 31, 2021, is primarily attributed to the significant delay in patient enrollment and treatment in the Phase II NMIBC clinical study ("Study II") due to the COVID-19 pandemic. Research and development expenses represented 62% of the Company’s operating expenses and represents investment primarily into the research and development of the Company’s ACT technology.

The net loss for the year ended December 31, 2021 was $4,411,061 which included $618,586 of net non-cash expenses (i.e.: amortization, stock-based compensation expense and foreign exchange gain/loss).

This compared to a net loss in 2020 of $5,598,540 which included $1,202,017 of net non-cash expenses. The ACT division represented $3,426,488 of this loss (78%) for the year ended December 31, 2021.

The decrease in net loss is primarily attributed to the following:

Significant delay in patient enrollment and treatment due to the COVID-19 pandemic, resulting in decreased research and development expenses in Study II.
Decreased salaries due to the COVID-19 pandemic, resulting in the resignation or termination of certain non-essential administrative, research and production personnel.
Operational Highlights:

1. Break Through Designation Update. In 2020, the FDA granted Theralase Fast Track Designation ("FTD") for Study II. As a Fast Track designee, Theralase has access to early and frequent communications with the FDA to discuss Theralase’s development plans and ensure the timely collection of clinical data to support the approval process. FTD can also lead to Break Through Designation ("BTD"), Accelerated Approval ("AA") and/or Priority Review, if certain criteria are met, which the FDA has previously defined to the Company for BTD to represent a complete clinical dataset on approximately 20 to 25 patients enrolled, treated and followed-up, who demonstrate significant safety and efficacy clinical outcomes.

In 2021, Theralase completed its first significant milestone of Study II by enrolling and treating 25 patients. The Company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after completion of the 450 day assessment for 25 patients, expected in 4Q2022, subject to the Clinical Study Sites ("CSS") availability to complete all required assessments.

2. COVID-19 Pandemic Update. In the ACT division, the Company continues to experience delays in patient enrollment and treatment rates in Study II due to the ongoing COVID-19 pandemic; however, these rates have improved as Canada and the US commence their recovery from the business and economic impacts of the COVID-19 pandemic.

In the CLT division, the Company continues to experience variations in sales and the timing of these sales due to the ongoing COVID-19 pandemic and has taken actions to minimize expenses by eliminating non-essential personnel and imposing a temporary hiring freeze commencing in March 2020. The Company lifted the temporary hiring freeze in 4Q2021, now that the Canadian and United States ("US") economies have started to demonstrate a sustainable business and economic recovery from COVID-19.

3. Clinical study site status and update. The Company has successfully launched five CSS in Canada and seven CSSs in the US that are open for patient enrollment and treatment for a total of 12 CSSs.

To date, the phase II NMIBC clinical study has enrolled and provided the primary study treatment for 35 patients (including three patients from Phase Ib study treated at the Therapeutic Dose) for a total of 38 patients.

The interim analysis of the Study II Evaluable Patient clinical data (with 3 patients from Study Ib) supports the following provisional conclusions:

Note: Evaluable Patients are defined as patients who have evaluable data; hence, have been evaluated by the principal investigator and thus excludes patients who have clinical data pending.

For evaluable patients, who completed Study II, who achieved a CR at 90 days, 78% continue to demonstrate that CR at 180 and 270 days, while 56% continue to demonstrate that CR at 360 and 450 days.

Note: The current interim analysis presented above, should be read with caution, as the reported clinical data is extremely interim in its presentation, as Study II is still ongoing and new clinical data collected may or may not continue to support the current trends.

Note: The data analysis is only a representation of the data accrued to date with and does not intend to represent a tendency or portray any conclusion as to the effectiveness, duration or safety of the investigational treatment. A significant number of treated patients are still pending assessments.

For a more comprehensive analysis of the interim data please refer to Managements Discussion and Analysis ("MD&A") for the year ended December 31, 2021.

4. Additional cancer indications. The Company has demonstrated significant anti-cancer efficacy of Rutherrin, when activated by laser light or radiation treatment across numerous preclinical models; including: Glio Blastoma Multiforme ("GBM") and Non-Small Cell Lung Cancer ("NSCLC"). The Company has commenced Non – Good Laboratory Practices ("GLP") toxicology studies with Rutherrin in animals to help determine the maximum recommended human dose of the drug, when administered systemically into the human body, via intravenous injections. Theralase plans to commence GLP toxicology studies in animals in 4Q2022.

5. COVID-19 Research Update. In April 2021, Theralase executed a Collaborative Research Agreement ("CRA") with the National Microbiology Laboratory, Public Health Agency of Canada ("PHAC") for the research and development of a Canadian-based SARS-CoV-2 ("COVID-19") vaccine. Under the terms of the agreement, Theralase and PHAC are collaborating on the development and optimization of a COVID-19 vaccine by treating the SARS-CoV-2 virus grown on cell lines with Theralase’s patented PDC and then light activating it with Theralase’s proprietary TLC-3000A light technology to inactivate the virus and create the fundamental building blocks of a COVID-19 vaccine. This inactivated virus would then be purified and used to inoculate naive animals followed by challenge with the SARS-CoV-2 virus, to ascertain the efficacy of the vaccine. The project is entitled, "Photo Dynamic Compound Inactivation of SARS-CoV-2 Vaccine" and commenced in mid-April 2021.

In February, 2022 Theralase reported that PHAC had demonstrated that light-activated TLD-1433, was effective in rapidly inactivating the SARS-CoV-2 virus by up to 99.99%, compared to control in an in vitro study. Further research is required to confirm these findings.

These results have now laid the groundwork for the next phase of the CRA, which is evaluating the Theralase COVID-19 vaccine in the ability to prevent animals from contracting COVID-19, when exposed to the virus, which is expected to commence in 2Q2022 and be completed by 4Q2022.

Note: The Company does not claim or profess that they have the ability to treat, cure or prevent the contraction of the COVID-19 coronavirus.

About Study II

Study II utilizes the therapeutic dose of TLD-1433 (0.70 mg/cm2) activated by the proprietary TLC-3200 medical laser system. Study II is focused on enrolling and treating approximately 100 to 125 BCG-Unresponsive NMIBC Carcinoma In-Situ ("CIS") patients in up to 15 Clinical Study Sites ("CSS") located in Canada and the United States.

About TLD-1433

TLD-1433 is a patented PDC with over 10 years of published peer reviewed preclinical research and is currently under investigation in Study II.

ASKB589 Achieved Partial Response in Phase I/II Clinical Trial

On April 29, 2022 AskGene reported that its lead program ASKB589 has recently achieved single agent efficacy in its on-going Phase I/II clinical trial (Press release, AskGene Pharmaceuticals, APR 29, 2022, View Source [SID1234613278]). Two gastric cancer patients have achieved partial response (PR) after receiving ASKB589 monotherapy for 6 weeks.

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ASKB589 is an innovative biological drug discovered and developed by AskGene. It is a recombinant humanized monoclonal antibody targeting claudin18.2. The drug mediates antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) through high-affinity binding to cancer cells. ASKB589 is intended for use in gastric and gastroesophageal junction cancers and pancreatic cancer. The multi-center Phase I/II clinical trial in China is led by Professor Shen Lin from Peking University Cancer Hospital.

In the on-going Phase I/II single-agent dose escalation and expansion study, two patients with advanced gastric cancer have achieved PR according to RECIST 1.1 after 6 weeks of treatment with ASKG589 monotherapy. The target lesions were significantly reduced, some non-target lesions disappeared, and tumor markers were significantly reduced. The two patients were among the 10 mg/kg and 20 mg/kg group, respectively, and were relapsed/refractory after multiple lines of chemotherapy and anti-PD-1 antibody therapy. In addition, in the dose escalation study of ASKB589 in combination with CAPOX chemotherapy for the first-line treatment of gastric cancer, three patients in the 3 mg/kg and 6 mg/kg dose groups achieved PR according to RECIST 1.1, after 6 weeks or 12 weeks of treatment.

Professor Shen Lin, Vice President of Peking University Cancer Hospital and Director of the Division of Gastrointestinal Oncology, said: "Claudin18.2 has become an exciting target in the field of gastric cancer treatment. Currently, many companies are developing drugs targeting CLDN18.2. ASKB589 is the third (among the first wave) in China to obtain a CDE clinical trial license. The clinical trial is progressing smoothly, and patients in both high-dose single-agent and combination therapy have shown good tolerance. In terms of efficacy, ASKB589 has also shown efficacy in the single-agent group. The dose-escalation study of combination therapy is also progressing smoothly."

Dr. Jianfeng (Jeff) Lu, Chief Executive Officer of AskGene, said: "Gastric cancer is one of the malignant tumors with high morbidity and mortality in China. The development of innovative drugs for gastric cancer has not been the focus of international companies. We hope to bring safe and efficacious innovative drugs to gastric cancer patients. Claudin18.2 is a very promising target for gastric cancer treatment. The significant anti-tumor activity observed in single-agent therapy is a very gratifying start. The company will accelerate clinical development, hoping to benefit more patients as soon as possible."

10-Q – Quarterly report [Sections 13 or 15(d)]

Bristol-Myers Squibb has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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