On March 28, 2022 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, reported recent business highlights and financial results for its fourth quarter and full year ended December 31, 2021 (Press release, HCW Biologics, MAR 28, 2022, View Source [SID1234611058]).

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Dr. Hing C. Wong, the Founder and CEO of HCW Biologics, stated, "We accomplished a number of significant achievements in the past year. We fortified our balance sheet through an initial public offering. We advanced our clinical development programs, overcoming headwinds from the COVID-19 pandemic, supply chain disruptions, and critical supply shortages. We begin 2022 poised to initiate multiple clinical trials to evaluate HCW9218 in cancer indications. We are hopeful later this year we begin to see human data that demonstrate the potential for our immunotherapeutics in the treatment of chemotherapy-resistant cancer, and validate our focus on the elimination of cellular senescence, which is the etiology for many age-related diseases."

Year in Review – Business Highlights:

In the year ended December 31, 2021, the Company achieved several milestones:

IPO. On July 22, 2021, the Company closed its IPO resulting in net proceeds of approximately $49.2 million, after deducting underwriting discounts and commissions and offering expenses paid by the Company.

HCWB added to Total Market Index. The Company was added to the S&P Total Market Index ("TMI") on September 20, 2021.

FDA clearance for Company-sponsored Phase 1b clinical trial in cancer. On October 28, 2021, the Company announced that it was cleared by the FDA to proceed to evaluate its lead drug candidate, HCW9218, in a first-in-human Phase 1b clinical trial in patients with advanced pancreatic cancer.

FDA clearance for Investigator-sponsored Phase 1 clinical trial in cancer. On January 24, 2022, the Company announced that the Masonic Cancer Center at the University of Minnesota, a National Cancer Institute designated Comprehensive Cancer Center, was cleared by the FDA to proceed to evaluate the Company’s lead drug candidate, HCW9218, in a Phase 1 clinical trial in patients with advanced solid tumors with progressive disease after prior chemotherapies.

Two new independent board members. The Company increased the skill set of its Board of Directors with the addition of two new board members: Lisa M. Giles and Gary M. Winer. Ms. Giles has extensive experience in pharmaceutical, diagnostic, device, and other healthcare industries. Mr. Winer has led and built successful, multinational businesses in the biopharma and diagnostic healthcare sectors as a Chief Executive Officer or President, and has held senior leadership positions with AbbVie and Abbott.

Dr. Hing C. Wong, Company’s Founder and CEO, Weaver H. Gaines Entrepreneur of the Year. Hing C. Wong, Ph.D., the Company’s CEO and Founder, was named the 2021 Weaver H. Gaines Entrepreneur of the Year by BioFlorida. Presented annually at the BioFlorida Conference, the award recognizes an individual who has made extraordinary contributions to the growth of life sciences in the leadership of a company or institution. This marks the second time Dr. Wong was recognized for his outstanding contributions with this award.

Expanding IP Portfolio. The Company continues to expand its intellectual property portfolio through filing provisional and utility U.S. applications based upon new research, filing non-U.S. national stage phase patent applications, and filing U.S. trademark applications. The Company’s earlier filed applications are progressing through the prosecution phase.

Three publications in peer-reviewed journals. Publications in peer-reviewed journals, which are based on inventions and discoveries made by the Company, are a pillar in the Company’s strategy to establish leadership in oncology and other age-related diseases especially with the scientific and clinical communities. As of today, the Company has published three papers:

An article in Cancer Immunology Research describing its platform: Becker-Hapak MK, et al. A Fusion Protein Complex Combines IL-12, IL-15, and IL-18 Signaling to Induce Memory-like NK Cells for Cancer Immunotherapy. September 9, 2021.

An article in Molecular Therapy on the characterization of its lead molecules, HCW9218: Liu B et al., Bifunctional TGF-ß Trap/IL-15 Protein Complex Elicits Potent NK Cell and CD8 + T Cell Immunity Against Solid Tumors. October 6, 2021.

An article in Molecular Therapy which discusses HCW9218 and its ability to augment anti-tumor activity and reduce side effects of chemotherapy regimens: Chaturvedi, P et al., Immunotherapeutic HCW9218 Augments Anti-tumor Activity of Chemotherapy via NK Cell Mediated Reduction of Therapy Induced Senescent Cells, January 17, 2022.

Fourth Quarter and Year-End Financial Results:

Cash and cash equivalents: On December 31, 2021, the Company’s cash balance was $11.7 million, short-term investments were $25.0 million and long-term investments were $9.9 million. The net proceeds from the IPO were $49.2 million. The Company estimates that it has sufficient cash to fund operation expenses to the end of 2023. This estimated cash runway does not include potential sources of non-dilutive financing, which may be obtained from new or existing out-licensing agreements.

Revenues: Revenues for the fourth quarter and year ended December 31, 2020 and 2021 were $4.1 million and none, respectively. On December 24, 2020, the Company entered an exclusive worldwide licensing agreement granting Wugen, Inc. limited rights to two of our molecules. Revenues were generated from the sale of cGMP clinical materials, R&D knowledge transfer, and an in-kind payment consisting of shares of Wugen common stock. In the year ended December 31, 2021, the Company recognized $1.8 million in deferred revenue to the extent cash was received for sales of clinical and research-grade materials to Wugen prior to the finalization of contractual terms of purchase.

Research and development (R&D) expenses: R&D expenses for the fourth quarter ended December 31, 2020 and 2021 were $1.4 million and $1.5 million, respectively. R&D expenses for the year ended December 31, 2020 and 2021 were $7.3 million and $8.2 million, respectively. The annual increase of 13% was primarily attributable to an increase in expenses associated with IND-enabling activities, offset by a reimbursement for certain R&D expenses as provided for in the Wugen license.

General and administrative expenses (G&A): G&A expenses for the fourth quarter ended December 31, 2020 and 2021 were $1.0 million and $1.6 million, respectively. G&A expenses for the year ended December 31, 2020 and 2021 were $2.7 million and $5.2 million, respectively. The annual increase of 93% was primarily due to an increase in costs related to operating as a public company, including legal fees for corporate work, intellectual property protection, other professional services, and insurance.

Net income (loss): Net income for the fourth quarter ended December 31, 2020 was $2.1 million. Net loss for the fourth quarter ended December 31, 2021 was $3.2 million. Net loss for the year ended December 31, 2020 and 2021 was $5.8 million and $12.9 million, respectively.

On March 28, 2022 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported financial results for the year ended December 31, 2021, and provided an update on key highlights for 2022 (Press release, CASI Pharmaceuticals, MAR 28, 2022, View Source [SID1234611073]).

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Wei-Wu He, Ph.D., CASI’s Chairman, and Chief Executive Officer, commented, "We are pleased to report $9.12 million in EVOMELA revenues for the fourth quarter of 2021. We have achieved our goal for full-year 2021 revenue growth to reach 100% growth. Through the efforts of the global CASI team and our commercial group of more than 100 hematology sales and medical marketing specialists in China, we have built a strong foundation for our commercial franchise. We plan to continue building our commercial franchise throughout 2022 and beyond."

Dr. He continued, "As we assemble a world-class pipeline of assets and drive existing development forward, we continue to execute on several key milestones across our broad portfolio. In 2021, our team prepared for the anticipated China NDA filing of the CD19 CAR-T program, which we currently expect to be in the second half of 2022. We anticipate that EVOMELA will continue to be the core of our commercial operations in the quarters ahead. During 2022, we also expect the start of the BI-1206 Phase I trial in China, receipt of CTA approval from NMPA for CB-5339, and the continued progression of the Phase I study of CID-103."

Key Highlights for 2022

EVOMELA (melphalan for injection)

Prior to EVOMELA’s entry into the Chinese market, an average of 800 stem cell transplants per year were conducted in the multiple myeloma treatment setting. Following EVOMELA’s launch in August 2019, CASI worked closely with key opinion leaders to drive market awareness and expedite EVOMELA adoption in the Chinese market. In 2021, EVOMELA was used in the treatment of nearly 6,000 patients in China. CASI continues to pursue a similar strategy with respect to marketing efforts and physician visits to further the adoption of stem cell transplantation as a standard of care in the multiple myeloma treatment setting and will continue working to address the persistent high unmet need in this patient population.

CNCT19 (CD19 CAR-T)

Our partner, Juventas Cell Therapy Ltd (Juventas), continues the development of CNCT19, an autologous CD19 CAR-T investigative product for which CASI has co-commercial and profit-sharing rights. CNCT19 is being developed as a potential treatment for patients with hematological malignancies which express CD19 including, B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL). The Phase 2 B-ALL and B-NHL registration studies are both currently enrolling. In December 2020, CNCT19 received Breakthrough Therapy Designation based on initial data from the ongoing single-arm, open-label, non-randomized, dose-escalation, Phase 1 study designed to determine the safety and efficacy of CNCT19 in B-ALL. Earlier this year, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to Juventas, for CNCT19, for the treatment of patients with Acute Lymphoblastic Leukemia (ALL). Currently, there are no CD-19 CAR-T therapies marketed in China based on domestically developed CAR-T technology. CASI intends for CNCT19 to be locally developed and manufactured to be more affordable and widely accessible to patients.

BI-1206 (Anti-FcyRIIB antibody)

Along with our partner, BioInvent, we continue to progress the development and regulatory framework for BI-1206 in China. The National Medical Products Administration (NMPA) granted BI-1206 Clinical Trial Application (CTA) approval in December 2021. Ethics committee approval from a leading investigational site was granted in January 2022. BI-1206 is currently being investigated outside of China in two Phase 1/2 trials. One is evaluating the BI-1206 combination with rituximab for the treatment of non-Hodgkin lymphoma (NHL), which includes patients with follicular lymphoma (FL), mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL) who have relapsed or are refractory to rituximab. A second Phase 1/2 trial is investigating BI-1206 in combination with anti-PD1 therapy Keytruda (pembrolizumab) in solid tumors. Earlier this year, the U.S. FDA granted Orphan Drug Designation, for BI-1206, for the treatment of follicular lymphoma, the most common form of slow-growing non-Hodgkin lymphoma.

CB-5339 (VCP/p97 inhibitor)

CB-5339 CTA application for the multiple myeloma indication is in preparation after receiving an acceptance letter for the CB-5339 IND package from the China Center of Drug Evaluation. Cleave Therapeutics is responsible for the ex-China development of CB-5339, an oral second-generation, small molecule VCP/p97 inhibitor, and is evaluating the molecule in a Phase 1 clinical trial in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

CID-103 (Anti-CD38 Mab)

CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies. CASI maintains exclusive global rights and is developing CID-103 for the treatment of patients with multiple myeloma. The Phase 1 dose escalation and expansion study of CID-103 in patients with previously treated relapsed or refractory multiple myeloma is ongoing in France and the UK.

Full-Year 2021 Financial Highlights

Revenues consist primarily of product sales of EVOMELA. Revenue was $30.0 million for the year ended December 31, 2021, compared to $15.0 million for the year ended December 31, 2020.
Costs of revenues were $12.6 million for the year ended December 31, 2021, compared to $9.5 million for the year ended December 31, 2020, which includes royalty payment of $5.9 million and $3.0 million for the same period. Costs of revenues excluding royalty were approximately $6.6 million and $6.6 million for the year ended December 31, 2021, and December 31, 2020 respectively. Costs of revenues, excluding royalty as a percentage of revenues, decreased significantly for the year ended December 31, 2021, compared to 2020; and, secondarily, such decrease in costs of revenues, excluding royalty as a percentage of revenues, resulted from a decrease in the unit cost of inventories of EVOMELA.
Research and development expenses for the year ended December 31, 2021, were $14.4 million, compared with $11.5 million for the year ended December 31, 2020.
General and administrative expenses for the year ended December 31, 2021, were $23.8 million, compared with $19.7 million for the year ended December 31, 2020.
Selling and marketing expenses for the year ended December 31, 2021, were $14.7 million, compared with $7.8 million for the year ended December 31, 2020. The increase in selling and marketing expenses primarily was due to the expansion of the sales team in China in 2021.
Net loss for the year ended December 31, 2021, was $35.8 million compared to $47.5 million for the year ended December 31, 2020, primarily due to the increase in revenues.
As of December 31, 2021, CASI had cash and cash equivalents of $38.7 million compared to $57.1 million as of December 31, 2020.
Further information regarding the Company, including its Annual Report on Form 10-K for the year ended December 31, 2021, can be found at www.casipharmaceuticals.com.

Conference Call

The conference call can be accessed by dialing 1-877-870-4263 (U.S.) or 1-412-317-0790 (international) and ask to be joined into the CASI Pharmaceuticals call to listen to the live conference call.

This call will be recorded and available for replay by dialing 1-877-344-7529 (U.S.) or 1-412-317-0088 (international) and enter 4990100 to access the replay.

On March 28, 2022 ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (hereinafter referred to as "ImmuneOnco") reported that data from 2 different new projects in two posters will be presented at the 2022 annual meeting of American Association for Cancer Research (AACR) (Free AACR Whitepaper) hold in New Orleans from April 8 to 13 (Press release, ImmuneOnco Biopharma, MAR 28, 2022, View Source [SID1234655644]). Two abstracts from ImmuneOnco were selected for poster presentation at the AACR (Free AACR Whitepaper) 2022. These posters will summarize the progress of the company’s early clinical and preclinical pipelines like IMM2902.

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Dr. Wenzhi Tian, founder, chairman and CEO of ImmuneOnco, said: "The data we present at AACR (Free AACR Whitepaper) 2022 will provide insight into the targets related to our 3 pipelines and promising data to support further clinical development. These study data have played a critical role in guiding our clinical development program. We are excited to have the opportunity to share these data with our colleagues in the oncology field.

On March 28, 2022 Abbott (NYSE: ABT) reported that it will announce its first-quarter 2022 financial results on Wednesday, April 20, 2022, before the market opens (Press release, Abbott, MAR 28, 2022, View Source [SID1234611043]).

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The announcement will be followed by a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern), and will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.

On March 28, 2022 AIM ImmunoTech Inc. (NYSE: American AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, reported that study data evaluating the direct effects of Ampligen (rintatolimod) on human pancreatic ductal adenocarcinoma (PDAC) cells was accepted for presentation at the 15th Annual International Hepato-Pancreato-Biliary Association (IHPBA) World Congress being held March 30 – April 2, 2022 in New York, NY (Press release, AIM ImmunoTech, MAR 28, 2022, View Source [SID1234611059]).

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Details of the presentation are as follows:

Title: Rintatolimod: a potential therapeutic molecule for human pancreatic cancer cells expressing Toll-Like Receptor 3
Presenting Author: Hassana El Haddaoui, Ph.D., Erasmus University Medical Center
Poster Number: EP02C-111
Presentation Type: E-Poster Presentation
Session: 2C- Pancreas Tumours
Date: Saturday, April 2, 2022

"We are encouraged by the data demonstrated by Ampligen and its potential to offer beneficial anti-tumor effects in pancreatic cancer patients. Importantly, the direct effect of Ampligen on tumor cells and its ability to boost the anti-tumor immune response via TLR-3 present in immune cells provides the validation needed to further evaluate its potential to offer therapeutic effect to pancreatic cancer patients," commented Thomas Equels, Chief Executive Officer of AIM.

For the study, three PDAC cell lines (CFPAC-1, MIAPaCa-2, and PANC-1) were treated with various concentrations of Ampligen and their corresponding vehicle control. The proliferation and migration effects were examined using in-vitro assays and the molecular effect was examined by targeted gene expression profiling. Additionally human PDAC samples were used to validate the expression of toll-like receptor 3 (TLR3) by immunohistochemistry.

Dr. El Haddaoui added, "TLR-3 signaling has been linked to cancer cell survival and migration. Based on these results, treating pancreatic cancer with Ampligen may have a direct anti-tumor effect in pancreatic cancer cells expressing TLR-3. We look forward to further evaluating Ampligen for the treatment of pancreatic cancer."

Results from the study demonstrated Ampligen decreased the proliferation and migration ability of CFPAC-1 cells. In addition, it decreased the proliferation of MIAPaCa-2 cells and the migration of PANC-1 cells. However, it did not have a dual effect in MIAPaCa-2 and PANC-1 cells. Interestingly, TLR3 was highly expressed in CFPAC-1 cells, low expressed in MIAPaCa-2 and not expressed in PANC-1. Gene expression analysis revealed the upregulation of interferon-related genes, chemokines, interleukins and cell cycle regulatory genes. The heterogeneity of TLR3 expression was confirmed in human PDAC samples.