On October 29, 2021, CASI Pharmaceuticals, Inc. ("CASI" or "Company"), reported that it entered into a Common Stock Sales Agreement (the "Sales Agreement") with H.C. Wainwright & Co., LLC ("HCW") (Filing, 8-K, CASI Pharmaceuticals, OCT 29, 2021, View Source [SID1234593965]). Pursuant to the terms of the Sales Agreement, the Company may sell from time to time, at its option, shares of the Company’s common stock, par value $0.01 per share, through HCW, as sales agent, with an aggregate sales price of up to $20 million (the "Shares"). The Company does not currently intend to make any sales under the Sales Agreement at the present time and will use discretion in initiating sales, taking into account among other factors, market conditions, the trading price of the Company’s common stock, alternative financing opportunities, and need for capital. The Company believes that it is in the best interests of its stockholders to have the flexibility to raise additional capital under favorable market conditions to support its efforts to build long-term stockholder value.

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Any sales of Shares pursuant to the Sales Agreement will be made under the Company’s effective "shelf" registration statement (the "Registration Statement") on Form S-3 (File No. 333-250801) which became effective on December 2, 2020 and the related prospectus supplement and the accompanying prospectus, as filed with the Securities and Exchange Commission (the "SEC") on October 29, 2021.

Under the terms of the Sales Agreement, the Company may sell shares of its common stock through HCW by any method permitted that is deemed an "at the market offering" as defined in Rule 415 under the Securities Act of 1933, as amended (the "Securities Act"). HCW will use its commercially reasonable efforts consistent with its normal trading and sales practices to sell the Company’s common stock from time to time, based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose). Actual sales will depend on a variety of factors to be determined by the Company from time to time, including (among others) market conditions, the trading price of the Company’s common stock, capital needs and determinations by the Company of the appropriate sources of funding for the Company. The Company is not obligated to make any sales of common stock under the Sales Agreement and the Company cannot provide any assurances that it will issue any Shares pursuant to the Sales Agreement. The Company will pay a commission rate of 3.0% of the gross sales price per share sold and agreed to reimburse HCW for certain specified expenses, including the fees and disbursements of its legal counsel in an amount not to exceed $50,000 and have agreed to reimburse HCW an amount not to exceed $2,500 per quarter during the term of the Sales Agreement for legal fees to be incurred by HCW. The Company has also agreed pursuant to the Sales Agreement to provide HCW with customary indemnification and contribution rights.

The Company or HCW upon notice to the other, may suspend the offering of the Shares under the Sales Agreement at any time. The offering of the Shares pursuant to the Sales Agreement will terminate upon the sale of Shares in an aggregate offering amount equal to $20 million, or sooner if either the Company or HCW terminate the Sales Agreement pursuant to its terms.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. The Sales Agreement is also incorporated by reference into the Registration Statement.

A copy of the opinion of Arnold & Porter Kaye Scholer LLP relating to the legality of the Shares issuable under the Sales Agreement, is filed as Exhibit 5.1 to this Current Report on Form 8-K and is also incorporated by reference into the Registration Statement.

The above disclosure 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 in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

The representations, warranties and covenants contained in the Sales Agreement were made solely for the benefit of the parties to the Sales Agreement. In addition, such representations, warranties and covenants (i) are intended as a way of allocating the risk between the parties to the Sales Agreement and not as statements of fact, and (ii) may apply standards of materiality in a way that is different from what may be viewed as material by stockholders of, or other investors in, the Company. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Sales Agreement, which subsequent information may or may not be fully reflected in public disclosures.

On October 29, 2021 Apollo Intelligence reported that Despite the FDA’s recent hold on select chimeric antigen receptor (CAR) T-cell clinical trials for cancer treatments using allogeneic products, new data show US oncologists, hematologists, and hematology-oncologists remain highly enthusiastic about the potential for CAR T-cell therapies for their patients (Press release, Apollo Intelligence, OCT 29, 2021, View Source [SID1234592208]).

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Data were sourced on October 20-21, 2021, by InCrowd, real-time market insights company and a brand of Apollo Intelligence (Apollo), global insights innovator for the life sciences industry, as part of InCrowd’s Instant Insights series on timely topics.

Allogenic CAR T-cell therapies—using cells from sources other than the patient — are promising because they potentially enable access to off-the-shelf treatments, versus autologous CAR T-cell therapies which use cells taken from the patient. On October 8, the FDA placed a select hold on allogenic CAR T-cell clinical trials conducted by one manufacturer following reports of a chromosomal abnormality in one patient of the manufacturer’s allogenic CAR T-cell trial.

Despite the FDA’s action, InCrowd found that 72% of cancer specialist respondents are excited about the future of CAR T-cell therapy in general.

Sixty-two percent believe other allogenic CAR T-cell clinical trials will emerge and succeed.
Forty-two percent said these allogenic CAR T-cell trials will reconvene as soon as soon as more data is released.
Only 12% of US cancer specialists said the FDA’s hold causes them concern with all gene therapy technologies.
Just 13% said allogenic CAR T-cell therapy is not a viable therapy to research further.
Two-thirds (67%) of respondents agree that the FDA’s hold on the select allogenic CAR T-cell therapy clinical trials had no impact on their perception of allogenic CAR T-cell therapy in general.

"The InCrowd Instant Insights data show that the FDA’s actions had very little impact on oncologists’ perceptions of allogeneic or autologous CAR T-cell therapy and gene therapy in general," said Daniel S. Fitzgerald, CEO of Apollo Intelligence, parent company to InCrowd. "It’s encouraging to see that cancer specialists in the US remain optimistic about the promise of CAR T-cell therapies for helping their patients."

The one-minute InCrowd survey included n=76 US oncologists, hematologists, and hematology-oncologists responding on October 20-21, 2021. Respondents reported that they were at least somewhat knowledgeable about new and emerging cancer treatments such as CAR T-cells, bispecific T cell engager (BiTE) antibodies, and antibody-drug conjugates (ADC.) For more visit InCrowd.

On October 29, 2021 Signet Therapeutics, a biopharmaceutical startup focusing on developing innovative targeted cancer drugs using novel disease models, reported it has completed seed-2 round of approximately 10 million US dollars (Press release, Signet Therapeutics, OCT 29, 2021, View Source [SID1234592207]).

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The new round was led by 5Y Capital (Morningside Venture), with participation from Yael Capital, Blue Ocean Capital, and existing investors Tiantu Capital and Sky9 Capital. The new funding will advance Signet’s two first-in-class oncology programs toward clinical trials. In addition, Signet plans to expand its platform of disease models to other cancer areas and empower target discovery and pharmacodynamics studies at other pharmaceutical companies on a greater scale. Founded in 2020, Signet has raised a seed round of ￥60 million in CNY (equivalent to approximately $10 million), totaling two rounds of around $20 million within its first year.

Dr. Haisheng Zhang, CEO of Signet Therapeutics, and his core team members were from Dana-Farber Cancer Institute, Harvard Medical School, one of the world’s leading cancer research institutions. Traditional in vitro studies use cell lines that cannot accurately model patient’s drug performance, often returning misleading bioactivity results that misguide the screening and optimization of lead compounds, which could result in clinical failure. Leveraging years of oncology and functional biology and genomic research expertise, Signet developed a unique platform of novel disease models based on real-world cancer genomics data to simulate drug effects in 3D organ tissues that bear a closer resemblance to human biology and produce pharmacodynamics data with higher relevance to clinical performance.

Gastric cancer is the third leading cause of cancer death in the world. Close to one-third of the cases are of the diffusive gastric cancer (DGC) subtype, which is associated with poor prognosis and a low response rate to existing cancer therapies and medicines. Using its novel disease models platform, Signet made the groundbreaking discovery of a promising new target for DGC. It launched a drug discovery program with the leading AI drug R&D company XtalPi and, in March 2021, announced the identification of a pre-clinical candidate in over six months.

As Signet quickly advance its first-in-class DGC pipeline toward clinical trials, it has recently expanded its drug discovery program with XtalPi to another novel cancer target discovered by Signet. The two companies hope to build upon their existing success in combining XtalPi’s AI drug discovery capabilities with Signet’s customized novel disease models to quickly discover and validate candidates with potent bioactivity and a desirable drug property profile that can translate to enhanced clinical performance.

On October 29, 2021 IMPACT Therapeutics reported that its ATR inhibitor IMP9064 has received the IND clearance from the U.S. Food and Drug Administration (FDA) for the Phase I/II clinical study, which will begin soon in the U.S (Press release, Impact Therapeutics, OCT 29, 2021, View Source [SID1234592206]). This will be the first in human study for the ATR inhibitor of IMPACT Therapeutics, representing a major leap of the company’s global development strategy for its synthetic lethality pipelines.

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This study is designed as a Phase I/II, dose escalation and expansion study, including individual arms to evaluate the safety, pharmacokinetics, and anti-tumor activities of IMP9064 as monotherapy and in combination with PARP inhibitor Senaparib in patients with advanced solid tumors.

IMP9064 is an ATR inhibitor discovered and developed by IMPACT Therapeutics, with worldwide intellectual property rights. In preclinical studies, IMP9064 was found to be a highly potent ATR inhibitor and is selective against other kinases. Additionally, IMP9064 has demonstrated high activities in several ATM-deficient cell lines and more active than reference compound in xenograft in vivo models, which could potentially lead to a wider therapeutic window, better tolerability in long-term administration as a single agent, and providing more flexibility in combination therapy. Senaparib, a PARP inhibitor developed by IMPACT Therapeutics, has been explored in several clinical studies worldwide. IMP9064 in combination with Senaparib will be evaluated in this clinical study to explore the combination therapy of an ATR inhibitor and a PARP inhibitor, which is highly anticipated in the DNA Damage Response (DDR) research field.

ATR is a synthetic lethality target of ATM mutations, which are commonly found in hematologic malignancies as well as a variety of solid tumors. ATR inhibitors have demonstrated proof-of-concept (POC) efficacy data in tumors harbored ATM mutations in previous clinical studies, and ATR is considered as one of the most promising synthetic lethality targets after PARP. Data from an ongoing ATR inhibitor clinical study presented at TRIPLE Conference 2021 showed that ATR inhibitor exhibits good efficacy as a monotherapy, but there is still significant room for improvement. This raised stronger interest to investigate combination of ATR inhibitor with other drugs. Among them, the combination of ATR inhibitor with PARP inhibitor is especially promising. In addition, the combination of ATR inhibitor with PARP inhibitor might overcome PARP inhibitor monotherapy resistance. As a company with both ATR inhibitor and PARP inhibitor in development, IMPACT Therapeutics is better positioned to study the combination therapy of ATR inhibitor with PARP inhibitor.

Combination therapy approach has been widely recognized as a major trend in the development of synthetic lethality-based therapeutics and targeted anticancer therapeutics to expand indications as well as to enhance anti-tumor activity. As a biopharmaceutical company dedicated to the discovery and development of novel therapeutics based on synthetic lethality, IMPACT Therapeutics has built extensive DNA Damage Response (DDR) pipelines including PARP, Wee1, ATR, and ATM inhibitors. IMPACT’s compounds were uniquely designed to have high activity and selectivity, which enables the company to target broader cancer indications and provide more opportunities for its in-house combination therapies.

Dr. Chih-Yi Hsieh, Senior Vice President and Chief Medical Officer said, "The pre-clinical data of IMP9064 has demonstrated its superiority among the same-class compounds. The clearance of this clinical program in the U.S. will enable us to validate the high potency, high selectivity, and robust anti-tumor activity of IMP9064 in the clinical study. IMPACT has formulated a differentiated clinical strategy for our ATR inhibitor which could advance the clinical development as efficient as possible, expand our synthetic lethality pipelines, and benefit more patients worldwide."

On October 29, 2021 Yiling Pharmaceutical reported the three-quarter report on the evening of October 28 (Press release, Yiling Pharmaceutical, OCT 29, 2021, View Source [SID1234592205]). In the first three quarters, the operating income of the company reached CNY 8.112 billion, up 25.81% year on year; the net profit attributable to shareholders of the listed company hit CNY 1.224 billion, up 20.43% from the previous year, surpassing that of last year as a whole; the weighted average return on equity was 13.40%, up 1.22 percentage points over the same period last year.

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In terms of marketing, the company has always adhered to academic promotion, relied on existing product lines, continuously integrated internal and external resources, optimized the sales management model, strengthened the professional construction of the sales team, and continuously advanced the optimization and upgrading of the marketing system. Benefiting from the "Construction of TCM Collateral Theory and Its Guidance for Prevention and Treatment of Microangiopathy" which won the First Prize of the National Science and Technology Progress Award in 2019, the company’s cardiovascular and cerebrovascular products achieved accelerated growth and its market share continued to rise. In addition, the company’s second-tier products were continuously promoted by the company’s academic and social brands, and the marketing system was optimized and upgraded, realizing rapid growth.

In terms of R&D, in the first three quarters of this year, the R&D expenditure amounted to CNY 538 million, with a year-on-year increase of 37.86%, which was higher than the growth rate of the operating income, showing that the company continued to increase R&D investment and the efficiency of R&D output also continued to improve. In terms of TCM, the company strengthened the establishment of the evidence system for registration and evaluation of TCM, which integrates TCM theory, human experience and clinical trials, continued the core theoretical advantages and systematic R&D advantages of TCM, and continuously enriched the R&D array of TCM varieties. The company’s patented new drug Tablet for Tonifying Kidney, Nourishing Heart and Tranquilizing Mind used for the treatment of insomnia was approved for marketing in September. Besides, Suxia Capsule for Dispel Melancholy and Relieving Restlessness used for the treatment of mild and moderate depression was filed for production in March. The company is expected to achieve a breakthrough in the nervous system field. Moreover, Lianhua Qinggan Granule for Children was approved to enter the clinical study stage. The company also introduced Rujietai products, enriching the product lines and filling in a gap in the field of gynecological products. In terms of chemical drugs, Felbinac Trometamol, a new drug in Category I, passed the CDE publicity and entered the third clinical stage. It is expected to become the company’s first approved new drug in Category I of chemical drugs.

According to the latest research report released by Ping An Securities, Yiling Pharmaceutical’s Lianhua Qingwen boasts a solid customer base in the antivirus field, and its market share continues to increase; its second-tier products are at the market expansion stage, with steady sales growth. Dongxing Securities believes that, based on the exclusive theory of collateral disease, the company has built core product lines of major varieties of Chinese patent medicines such as cardio-cerebrovascular series of products and Lianhua Qingwen series of products; the second- and third-tier products are also rich in varieties; the channel sales and promotion capabilities in the end-use market are also the company’s unique advantages; at present, the structural adjustment of the company’s sales staff have been completed in line with the product lines, and the number of sales staff has greatly increased; the refined coverage in the end-use market and the expansion of the grass-roots market are expected to enhance the continuous improvement of the market penetration rate of all products.