On November 12, 2021 HCW Biologics Inc. (the "Company" or "HCW Biologics") (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 recent business highlights and financial results for its third quarter ended September 30, 2021 (Press release, HCW Biologics, NOV 12, 2021, View Source [SID1234595516]).

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"The third quarter of 2021 and recent weeks were an important period for HCW Biologics and our strategy to build a pipeline of first-in-class immunotherapeutic treatments for age-related diseases," stated Hing C. Wong, Ph.D., founder and CEO of HCW Biologics Inc. "The third quarter provided bookends to what has been a busy time for the Company. In July, we closed our initial public offering and subsequently listed our common stock on Nasdaq. The Company has never been on stronger financial footing, and we believe we now have capital resources sufficient to fund our operations into 2023. During the third quarter, we filed our first IND to evaluate our lead bifunctional molecule, HCW9218, in a pancreatic cancer trial. We completed the regulatory review shortly after the end of the third quarter, and we announced FDA clearance for the Phase 1b clinical trial on October 28, 2021."

Business Highlights:

On July 22, 2021, HCW Biologics closed on its IPO, raising $56 million in gross proceeds. The net proceeds of the offering and the Company’s existing cash and cash equivalents are sufficient to fund operating expenses and capital expenditure requirements into 2023.

HCW Biologics was added to S&P Total Market Index (TMI) on September 20, 2021.

The Company expanded its Board of Directors with the addition of two new independent directors in October 2021, Lisa M. Giles and Gary M. Winer. Ms. Giles has extensive experience in pharmaceutical, diagnostic, device, and other healthcare industries. She held senior leadership positions in strategic planning, operations, and commercial planning. In addition, she brings a wealth of corporate governance experience, having served as a board member for several public companies. Mr. Winer has led and built successful, multinational businesses in the biopharma and diagnostic healthcare sectors as a Chief Executive Officer or President, including senior leadership positions with AbbVie and Abbott. He brings valuable insights and experience for operations as well as support and advice for strategic transactions.

On October 28, 2021, HCW Biologics announced that it received clearance from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application for a Phase 1b first-in-human clinical trial to evaluate HCW9218 in patients with advanced pancreatic cancer. The Company is in discussions with several leading National Cancer Institute-designated cancer centers as potential clinical trial sites. Discussions are simultaneously underway with a research facility to sponsor an IND for a second, investigator-initiated trial to evaluate HCW9218 in patients with solid tumors (breast, ovarian, prostate, and colorectal cancers).

HCW Biologics continues IND-enabling studies involving HCW9302, its second lead investigational drug candidate. The Company expects to complete FDA-required preclinical studies in mice by the end of 2021 and non-clinical toxicology studies in non-human primates in the second half of 2022. HCW9302 is an IL-2-based immunotherapeutic designed to stimulate regulatory T (Treg) cells to suppress the activity of inflammasome-bearing cells and inflammatory factors. HCW Biologics intends to evaluate HCW9302 in autoimmune diseases.

The HCW Biologics’ founder and CEO, Dr. Hing C. Wong, has accepted invitations to present at two noted industry events. Dr. Wong will present at the BioFlorida Annual Conference taking place on December 8-10, 2021, in Orlando, Florida, where he will participate in the featured session, "New Strategies in the Fight Against Cancer." Dr. Wong will also lead a presentation during the Cambridge Healthtech Institute’s 24th Annual PepTalk taking place on January 17-19, 2022, in San Diego, California. His presentation, entitled "A Novel Platform to Create Multi-functional Immunotherapies for Cancer," will focus on the TOBI discovery platform and HCW9218.

The Company continues to expand its intellectual property portfolio through filing provisional U.S. applications based upon new research, filing non-U.S. national stage phase patent applications, and filing U.S. trademark applications. As of September 30, 2021, HCW Biologics is the owner of record of 60 pending patent applications worldwide, including 11 pending U.S. utility patent applications, two pending provisional U.S. patent applications, seven pending PCT applications, 36 pending non-U.S. national phase patent applications, and four pending Hong Kong patent applications. The Company also owns five U.S. trademark applications related to its corporate name and logo, and the TOBITM platform.
Third Quarter Financial Results:

Cash and cash equivalents: On September 30, 2021, the Company’s cash balance was $15.1 million, short-term investments were $25.0 million and long-term investments were $10.0 million. The net proceeds from the IPO were $49.0 million. The Company estimates that it has sufficient cash to fund operations and capital expenditures into 2023. This estimated cash runway does not include potential sources of non-dilutive financing, which may be obtained from existing or new out-licensing agreements.

Research and development (R&D) expenses: R&D expenses were $2.7 million for the three-month period ended September 30, 2021, as compared to $2.1 million for the three-month period ended September 30, 2020. Higher costs in the third quarter of 2021 were primarily the result of higher manufacturing and IND-enabling activity costs. During the nine-month period ended September 30, 2021, R&D expenses were $6.7 million versus $5.8 million during the nine-month period ended September 30, 2020. The 14% increase in expense was driven primarily by an increase in IND-enabling and preclinical activities.

General and administrative expenses (G&A): G&A expenses were $1.4 million for the three-month period ended September 30, 2021, as compared to $0.6 million for the three-month period ended September 30, 2020. This reflects an increase in compensation expense including salaries, performance-based bonuses and board compensation, and an increase in certain operating expenses including higher insurance costs, professional fees, and legal services expenses. For the nine-month period ended September 30, 2021, G&A expenses were $3.6 million versus $2.0 million for the same period ended September 30, 2020. The 75% increase was primarily driven by an increase in expenses for salaries, performance-based bonuses, employee benefits, professional fees, and other expenses.

Net loss: Net loss was $4.1 million for the three-months ended September 30, 2021, compared to $2.7 million for the three-months ended September 30, 2020. For the nine-months ended September 30, 2021, net loss was $9.7 million, compared to $7.9 million for the same period in the prior year.
About the TOBI platform:
HCW Biologics has combined deep understanding of disease-related immunology with its expertise in advanced protein engineering to develop the TOBI discovery platform. The TOBI platform is a proprietary immunotherapeutic drug design and discovery platform. The Company has utilized this modular, tunable technology to generate a novel pipeline of immunotherapeutic candidates capable of activating and targeting desired immune responses while blocking unwanted immunosuppressive activities. The balancing of these two activities is believed to be the key to developing immunotherapeutic agents that will be safe, well tolerated and efficacious.

On November 12, 2021 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a clinical-stage oncology company pioneering the discovery and development of small molecule therapies designed to activate p53 function, reported financial results for the third quarter ended September 30, 2021 and provided corporate highlights (Press release, PMV Pharma, NOV 12, 2021, View Source [SID1234595515]).

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"We made important progress in the third quarter of 2021 as we advanced the clinical development of our lead candidate, PC14586, an investigational small molecule p53 Y220C reactivator, and strengthened our corporate foundation to ensure that we have the talent and resources in place to support our future success," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "Our ongoing Phase 1/2 trial of PC14586 is progressing well, with twelve sites at leading oncology centers, and we expect to present data from the study in the first half of next year."

Corporate Highlights and Guidance

Data from the Phase 1 portion of the ongoing Phase 1/2 clinical trial of PC14586, the Company’s first-in-class, tumor-agnostic, investigational small molecule p53 Y220C reactivator, in patients with advanced solid tumors that harbor a p53 Y220C mutation (NCT04585750) are expected in the first half of 2022
Appointed Tim Smith as Senior Vice President, Head of Corporate Development. Prior to joining PMV Pharma, Mr. Smith was Chief Business Officer of Verseau Therapeutics. He has held senior business development leadership roles at IDEAYA Biosciences, Cleave Biosciences, and Celgene Corporation. He spent his early career in equity research covering the biotechnology sector at RBC Capital Markets, Lazard Capital Markets, and Citi Research. Mr. Smith holds a B.S. in biology from the University of Texas at Arlington, an MBA in finance from Fordham University and an M.A. in biotechnology from Columbia University.
Strong cash, cash equivalents and marketable securities position of $326.3 million as of September 30, 2021 sufficient to support execution of clinical, research and operational goals through the end of 2023.
Third Quarter 2021 Financial Results

PMV Pharma ended the third quarter with $326.3 million in cash, cash equivalents, and marketable securities, compared to $361.4 million as of December 31, 2020. Net cash used in operations was $34.5 million for the nine months ended September 30, 2021, compared to $22.4 million for the nine months ended September 30, 2020.
Net loss for the nine months ended September 30, 2021 was $39.5 million compared to $24.0 million for the nine months ended September 30, 2020.
Research and development (R&D) expenses were $24.3 million for the nine months ended September 30, 2021 compared to $17.8 million for the nine months ended September 30, 2020. The increase in R&D expenses was primarily due to increased headcount and clinical expenses related to development of PC14586, the Company’s lead drug candidate.
General and administrative (G&A) expenses were $15.5 million for the nine months ended September 30, 2021 compared to $6.7 million for the nine months ended September 30, 2020. The increase in G&A expenses was primarily due to costs relating to building the infrastructure necessary to operate as a public company.
About p53

p53 plays a pivotal role in preventing abnormal cells from becoming a tumor by inducing programmed cell death. Mutant p53 takes on oncogenic properties that endow cancer cells with a growth advantage and resistance to anti-cancer therapy. The p53 Y220C mutation is associated with many cancers, including but not limited to breast, non-small cell lung cancer, colorectal, pancreatic, and ovarian cancers.

About PC14586

PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have the p53 Y220C mutation and has been granted Fast Track designation by the U.S. FDA.

On November 12, 2021, NantHealth, Inc. (the "Company") reported that it entered into an Open Market Sale Agreement (the "Sale Agreement") with Jefferies LLC (the "Sales Agent") under which it may offer and sell up to $30,000,000 of shares of its common stock, par value $0.0001 per share (the "Shares"), from time to time through the Sales Agent (Filing, 8-K, NantHealth, NOV 12, 2021, View Source [SID1234595514]). The sales and issuances of the Shares under the Sale Agreement will be made pursuant to the Company’s effective shelf registration statement on Form S-3 (the "Registration Statement") that was declared effective on May 6, 2021. The offering is described in the Company’s Prospectus, as supplemented by a Prospectus Supplement dated November 12, 2021, as filed with the U.S. Securities and Exchange Commission (the "SEC") on November 12, 2021 (together, the "Prospectus").

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Pursuant to the Sale Agreement, sales, if any, of the Shares, will be made under the Prospectus, by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended (the "Securities Act"), including block transactions, sales made directly on the Nasdaq Global Select Market or sales made into any other existing trading market for the registrant’s common stock. The Sales Agent is not required to sell any specific amount of securities, but will act as our sales agent using commercially reasonable efforts to sell the Shares from time to time, consistent with their normal trading and sales practices, applicable state and federal laws, rules and regulations and the rules of The Nasdaq Global Select Market, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company has agreed to pay the Sales Agent a commission of 3.0% of the aggregate gross proceeds from each sale of Shares pursuant to the Sale Agreement and to provide the Sales Agent with customary indemnification and contribution rights, including for liabilities under the Securities Act. The Sales Agent’s obligations to sell the Shares under the Sale Agreement are subject to satisfaction of certain conditions, including customary closing conditions.

The Company is not obligated to sell any Shares under the Sale Agreement and may at any time suspend solicitation and offers under the Sale Agreement. The Sale Agreement may be terminated by either party as set forth in the Sale Agreement.

The foregoing description of the Sale Agreement is not complete and is qualified in its entirety by reference to the full text of the Sale Agreement, a copy of which is filed herewith as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Wilson Sonsini Goodrich & Rosati, Professional Corporation, counsel to the Company, has issued a legal opinion relating to the validity of the Shares being offered pursuant to the Sale Agreement. A copy of such legal opinion, including the consent included therein, is filed as Exhibit 5.1 to this Current Report on Form 8-K and is incorporated herein by reference.

On November 12, 2021 xCures reported their poster presentation at the 26th Annual Meeting of the Society for Neuro-Oncology, held from the 18th to the 21st of November (Press release, xCures, NOV 12, 2021, View Source [SID1234595513]). The Society for Neuro-Oncology (SNO) is a multidisciplinary society of healthcare professionals dedicated to promoting advances in neuro-oncology through research and education. Their annual meeting features research and educational sessions on brain tumors, including the latest on diagnosis and treatments.

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xCures poster presentation, entitled XCELSIOR: A real-time, real-world learning platform for patients with advanced cancer, will show clinical outcomes of real-world datasets from over 400 CNS cancer patients and approximately 250 glioblastoma patients. XCELSIOR is a direct-to-patient evidence-based platform leveraging a nationwide observational research protocol. The platform allows for continuous learning towards informing treatment decisions by aggregating, normalizing, and analyzing N-of-1 clinical outcomes from anywhere in the country.

At the conference, xCures will discuss their real-time learning infrastructure and present results of clinical case studies for pharma and non-profit groups, including more than 100 reported virtual tumor boards. Outcomes shown will be from real-world evidence generated from hundreds of patients with CNS cancers that xCures have helped in partnership with Cancer Commons and the Musella Foundation.

"I look forward to connecting with colleagues and presenting our first analysis of real-world clinical outcomes of CNS cancer patients from our observational registry, including a preliminary analysis of patients that received immune checkpoint inhibitors," stated Tim Stuhlmiller, VP of Scientific and Medical Affairs at xCures. "It is inspiring to see our approach to gather and analyze real-world data in real-time via patient participation in a nationwide observational research protocol yield evidence-based insights."

Al Musella, President of the Musella Foundation said, "With the launch of their provider portal xDECIDE, the xCures platform offers a major opportunity for oncologists all over the country to collaborate on observational research without the burden of data entry. The CNS dataset presented at the conference provides a foundation for ongoing clinical research to identify the most promising new combinations of therapies in glioblastoma."

"Cancer Commons’ close partnership with xCures, the Musella Foundation, and the expert physician advisers that serve on our virtual tumor boards has helped inform brain cancer patients across the U.S. about treatment options specific to their case. The data presented here demonstrates our first steps towards building a ‘learning health system’ that we hope will change the care for brain cancer patients, tightly integrate clinical care and research, and help us learn from each individual’s experience." said Matt Warner, Scientist at Cancer Commons.

For more information, visit the poster session on Friday, November 19th from 7:30-9:30 pm EST in Exhibit Hall D, or attend the live presentation of the xCures platform and preliminary RWD on CNS cancers on Saturday, November 20th at 1 pm EST in Room 309 in the Hynes convention center.

On November 12, 2021 Upsher-Smith Laboratories reported that (Press release, Upsher-Smith Laboratories, NOV 12, 2021, View Source [SID1234595512])

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1. Financial Highlights for the First Quarter of FY2021 (for the six-month period ended September 30, 2021)

(1） Consolidated Operating Results
(2) Consolidated Financial Position

2. Cash Dividends