On August 13, 2021 HCW Biologics Inc. (the "Company") (NASDAQ: HCWB), an innovative, 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 financial results and recent business highlights for its second quarter ended June 30, 2021 (Press release, HCW Biologics, AUG 13, 2021, View Source [SID1234586547]).

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"HCW Biologics delivered on a milestone as we achieved our goal of closing our initial public offering on July 22 to raise capital to advance the clinical development of our lead molecules," stated Hing C. Wong, Ph.D., founder and CEO of HCW Biologics Inc. "We started HCW Biologics three years ago with an idea to develop immunotherapeutic treatments for age-related diseases. Since that time, we applied our expertise in advanced protein engineering to internally develop our TOBITM (Tissue factOr-Based fusIon) discovery platform and successfully developed immunotherapeutic molecules based on TOBITM technology that can be administered by subcutaneous injection as well as used in adoptive cell therapy approaches. After extensive studies to assess the molecules we created, we selected two lead molecules, HCW9218 and HCW9302 for clinical development."

"HCW Biologics’ clinical development strategy is to prove the safety and efficacy of both lead molecules individually in future clinical trials, and eventually combine them as an immunotherapeutic for some of the most difficult to treat age-related diseases. Our gateway indication for our lead molecule, HCW9218, is cancer. Several scientific studies have revealed that increased normal tissue cellular senescence can promote tumor progression, creating a link between aging and cancer. In preclinical studies, HCW9218 has shown it can reduce chemotherapy-induced tumor and normal tissue senescence and decrease senescence associated secretory phenotype (i.e., proinflammatory) factors that senescent cells secrete, in particular TGF-ß. We are wrapping up IND-enabling activities and expect to submit an Investigational New Drug (IND) application for a Phase 1b/2 clinical trial to assess HCW9218 in the treatment of pancreatic cancer by the end of 2021."

Business Highlights:

Initial Public Offering: On July 22, 2021, the Company closed on its IPO with the sale of 7,000,000 shares of common stock at a public offering price of $8.00 per share, resulting in net proceeds of approximately $49.0 million, after deducting underwriting discounts and commissions and estimated offering-associated expenses.

As part of the preparations of becoming a public company, HCW Biologics shareholders elected two new independent board members in May 2021. Mr. Scott Garrett serves as the Chairman of the Board and Chairman of the Compensation Committee. His experience as a Chief Executive Officer and in other senior leadership positions with biomedical and diagnostics companies enables him to bring to the Board of Directors an operational perspective as well as valuable insights and experience. Mr. Rick Greene serves as the Chairman of the Audit Committee. His experience as a Chief Financial Officer and in other financial management and reporting, operations and business development positions in the healthcare industry enables him to bring financial expertise to the Board of Directors. The Company is committed to expanding the size of its Board of Directors to bring additional diversity and operational expertise.

As of June 30, 2021, the Company completed good laboratory practice (GLP) toxicology studies on nonhuman primates and mice to understand the onset, degree of severity, and time length up to which a particular dose of a drug demonstrates any toxic effects. The Company will continue to complete IND-enabling activities for HCW9218 and prepare for the IND filing in the second half of 2021.

The Company launched the execution of its strategy to use pivotal publications to establish its leadership in oncology and age-related diseases in scientific and clinical communities. The Company currently has two articles published online:

An article published online by Cancer Immunology Research describing the TOBITM discovery 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. July 9, 2021.
An article published online by Molecular Therapy on the characterization of the Company’s lead molecules, HCW9218: Liu B et al. Bifunctional TGF-β Trap/IL-15 Protein Complex Elicits Potent NK Cell and CD8+ T Cell Immunity Against Solid Tumors. June 3, 2021.
Second Quarter Financial Results:

Cash and cash equivalents: On June 30, 2021, the Company’s cash balance was $5.1 million. Together with net proceeds of $49.0 million from the IPO, the Company estimates that it has sufficient cash to fund operations and capital expenditures for at least the next 24 months. This does not include potential sources of non-dilutive financing, which may be obtained as a result of entering out-licenses, such as upfront cash payment and shares of Wugen common stock that were received as a result of entering a license agreement with Wugen for limited rights to two of the Company’s molecules.
Research and development expenses: Research and development expenses were $1.7 million in the second quarter of 2021, as compared to $2.1 million for the second quarter of 2020. Higher costs in the second quarter of 2020 were a result of the ramp up costs required for initiation of cGMP manufacturing for five of the Company’s internally developed molecules.
General and administrative expenses: General and administrative expenses were $1.1 million in the second quarter of 2021, as compared to $0.7 million for the second quarter of 2020. The difference reflects additional general and administrative costs arising primarily from additional patent filings to broaden the protection of the Company’s intellectual property and performance-based bonuses.
Net loss: Net loss was $2.8 million in the second quarter of 2021, as compared to $2.8 million for the second quarter of 2020.

On August 13, 2021 Compass Therapeutics, Inc. (OTC:CMPX), a clinical-stage biotechnology company developing proprietary antibody therapeutics reported that Thomas Schuetz, MD, PhD, Co-Founder and Chief Executive Officer will participate in a fireside chat at the Citi 16th Annual Biopharma Conference (Press release, Compass Therapeutics, AUG 13, 2021, View Source [SID1234586565]).

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Fireside Chat with Compass Therapeutics, CEO, Thomas Schuetz: Wednesday, September 8, 2021, at 3:15pm ET.
A replay of the Fireside chat will be available at the "Investors – Events and Presentations" tab on the Compass website www.compasstherapeutics.com.

On August 13, 2021 Kiromic BioPharma (NASDAQ: KRBP), a pre-clinical stage biotechnology company using its proprietary DIAMOND artificial intelligence ("A.I.") platform to improve drug discovery and development with a therapeutic focus on immune-oncology, reported its quarterly results for the three and six months ended June 30, 2021, and provided an update on its corporate developments (Press release, Kiromic, AUG 13, 2021, View Source [SID1234586548]).

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"Kiromic achieved important scientific and operational milestones during the first half of the year that we believe have us well positioned for preparing our staff and our facilities for the first in-human dosing during the first quarter of 2022," said Dr. Maurizio Chiriva-Internati, PhD, CEO and President of Kiromic BioPharma.

"We are thankful to our employees and collaborators who have maintained this high level of execution this year. From their efforts, we submitted two investigational new drug applications to the United States Food and Drug Administration in May 2021."

Our approach and goal are to defeat cancer by developing immunotherapies by improving target discovery and validation. With better targets, we believe our therapies will be more effective than the current array of immunotherapies using older targets.

Corporate and Scientific Highlights

Events that occurred during the three months ended June 30, 2021

Re-Submission of Two IND Applications – On May 17, 2021 and May 24, 2021, we announced re-submission of two investigational new drug ("IND") applications to the United States Food and Drug Administration. These INDs were for our ALEXIS-PRO-1 and ALEXIS-ISO-1 product candidates, respectively. ALEXIS-PRO-1 is our allogeneic gamma delta chimeric T cell therapy product candidate targeting PD-L1. ALEXIS-ISO-1 is our allogenic gamma delta CAR-T cell therapy product candidate targeting Isomesothelin (the isoform of Mesothelin).

Since re-submitting the INDs, the FDA returned with comments on our allogeneic CAR-T products with respect to:
Tracing of all reagents used in manufacturing
Flow chart of manufacturing processes
Certificate of Analysis (COA) for the Company’s CAR-T products (allogeneic CAR-T)

We have an FDA response taskforce, staffed with sufficient and appropriate personnel to prepare the response to the FDA. The company’s plans to submit the prepared response by the first half of September 2021. The commencement of the dosing of its first in human clinical trial is expected to be delivered in the first quarter of 2022.

Appointment of Chief Operating and Manufacturing Officer – On June 7, 2021, we entered into an Executive Agreement with Mr. Ignacio Nunez to be our Chief Operating and Manufacturing Officer ("COMO"). The COMO will lead and manage the Company’s functions/departments assigned by the CEO. The COMO will be responsible for the manufacturing function and will provide vision, leadership, and management to ensure we effectively and efficiently deliver research, clinical and commercial cell therapies. This position involves direct oversight and management of the manufacturing function to ensure the successful establishment of a new GMP facility and the commencement of manufacturing operations.
Membership Purchase Agreement with InSilico Solutions, LLC – On June 14, 2021, we entered into a Membership Interest Purchase Agreement (the "Purchase Agreement") with InSilico Solutions, LLC ("InSilico") and Michael Ryan (the "Seller") pursuant to which the Company acquired all of the outstanding membership interests of In Silico from the Seller for an aggregate purchase price of $540,000 (the "Purchase Price"). The Purchase Price is payable in full through (i) the delivery to the Seller of a number of shares of the Company’s stock that is equal to $400,000 and (i) the delivery to the employees of In Silico of the Company’s restricted stock units under the Company’s 2021 Omnibus Equity Incentive Plan that is equal to $140,000.

InSilico is a bioinformatics services company that performs data analysis and software tool development for genome-wide research projects. Their headquarters is located in Fairfax, VA. InSilico performs contract research and collaborate on grant funded research with academic, government, and commercial organizations located throughout the United States.

With this acquisition, Kiromic will bring in-house a team of experts in bioinformatics and AI in order to lengthen its lead in the race for an AI technology with the capability to select the optimal bio-markers needed for cutting edge immunotherapeutics such as CAR-T cell therapy.
Events occurring after June 30, 2021 until August 13, 2021

Closing of Public Offering – On July 2, 2021, we received net proceeds of $37,121,200 from a public offering, after deducting underwriting discounts and commissions of $2,399,900 and other offering expenses of $478,900 incurred. The Company issued and sold 8,000,000 shares of common stock in the public offering at a price of $5.00 per share. In connection with the public offering, 400,000 representative warrants were issued with a price of $6.25 per share.

This public offering significantly strengthens the Company’s balance sheet to support clinical trials for our ALEXIS-ISO-1 and ALEXIS-PRO-1 product candidates, GMP facility expansion, intellectual property protection and reinforcement, IND applications and IND enabling trials and working capital and general corporate purposes.
Completion of InSilico Acquisition – On July 26, 2021, we announced the completion of the InSilico acquisition.
Communications with the FDA – Supported by IQVIA, instead of simply addressing the FDA’s questions with a written response only (WRO), we took the decision to apply for a Type A meeting with the FDA. The Type A meeting will address the clinical hold issues and will allow us to discuss path toward our first-in-human dosing.
Q2 2021 Financial Highlights

Cash Position: Cash and cash equivalents were $3,070,400 as of June 30, 2021, compared to $10,150,500 as of December 31, 2020. The difference is attributable to cash outflows of $6,344,100, $590,600, and $145,400 for operating activities, investing activities, and financing activities respectively.

R&D Expenses: Our research and development expenses increased by $1,385,800, or 108.92%, to $2,658,100 for the three months ended June 30, 2021, from $1,272,300 for the three months ended June 30, 2020. Our research and development expenses increased by $2,243,300, or 97.52%, to $4,543,700 for the six months ended June 30, 2021, from $2,300,400 for the six months ended June 30, 2020. The increase was attributable to increased headcount, manufacturing, and experimentation costs for our ALEXIS-ISO-1 product candidate.

G&A Expenses: Our general and administrative expenses decreased by $7,780,500, or 77.08%, to $2,314,100 for the three months ended June 30, 2021 from $10,094,600 for the three months ended June 30, 2020. Our general and administrative expenses decreased by $6,534,100, or 59.54%, to $4,385,100 for the six months ended June 30, 2021 from $10,919,200 for the six months ended June 30, 2020. This decrease was primarily due to reduced stock compensation expenses.

Net Loss: Our net loss decreased to $8,928,800 during the six months ended June 30, 2021 compared to $13,219,600 during the six months ended June 30, 2020.

On August 13, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Vicineum (oportuzumab monatox-qqrs) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) (Press release, Sesen Bio, AUG 13, 2021, View Source [SID1234586566]).

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The FDA has determined that it cannot approve the BLA for Vicineum in its present form and has provided recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls (CMC) issues pertaining to a recent pre-approval inspection and product quality.

"We are deeply disappointed by this unexpected result, and it is an unfortunate day for patients suffering from BCG-unresponsive NMIBC," said Dr. Thomas Cannell, president, and chief executive officer of Sesen Bio. "We remain dedicated to our mission to save and improve the lives of patients by bringing new treatment options to patients, and we intend to work closely with the FDA to understand next steps."

The Company plans to request a Type A meeting as soon as possible with the FDA to discuss the next steps that are needed before the application may be approved.

As of June 30, 2021, the Company had $151.1 million in cash, cash equivalents and restricted cash.

Conference Call and Webcast Information

Members of the Sesen Bio management team will host a conference call Monday, August 16, 2021, at 8:00 AM ET. To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 2772032. The teleconference details can be accessed in the Investor Relations section of the Company’s website at www.sesenbio.com. A replay of the teleconference will be available in the investor section of the Company’s website at www.sesenbio.com for 60 days following the call.

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company’s BLA file for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On August 13, 2021 ArcticZymes Technologies reported for the second quarter 2021 on Thursday, 19. August 2021 at 08.30 a.m (Press release, Biotec Pharmacon, AUG 13, 2021, View Source [SID1234586518]).

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Due to the ongoing situation with spread of coronavirus, a number of measures are being implemented to prevent the spread of infection. These measures are being taken to safeguard the health and security of the Company’s shareholders, employees and other stakeholders, and to ensure compliance with applicable national and local restrictions and guidelines. The Company will therefore conduct the presentation only as a webcast over Teams and as a telephone conference.

CEO, Jethro Holter and CFO, Børge Sørvoll will hold the presentation.

Participants who want to participate in the live webcast are asked to send an email to [email protected] for a separate invitation, which will be distributed 1 day prior to the meeting. Participants who want to participate by telephone should dial in on +47 21 40 24 87 with conference id: 235 027 209#. It will be possible to post questions through the webcast and over the phone after the presentation is finished. The report for the second quarter 2021 will be available on www.newsweb.no and on the company’s homepage www.arcticzymes.com from 07.00 a.m. on 19. August 2021.