On August 23, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) reported that HUTCHMED has been selected as a constituent stock of several indexes administered by Hang Seng Indexes Company Limited ("Hang Seng"), including the Hang Seng Composite Index, in accordance with the latest index series release by Hang Seng, with effect from Monday, September 6, 2021 (Press release, Hutchison China MediTech, AUG 23, 2021, View Source [SID1234586919]).

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The Hang Seng Composite Index offers a comprehensive Hong Kong market benchmark that covers about the top 95th percentile of the total market capitalization of companies listed on the Main Board of The Stock Exchange of Hong Kong Limited. HUTCHMED has also been selected for six other indexes of Hong Kong-listed stocks, including the Hang Seng Healthcare Index and the Hang Seng Hong Kong-Listed Biotech Index.

In addition to the above indexes of stocks listed in Hong Kong, Hang Seng has also selected HUTCHMED for inclusion in six cross-market indexes, including the Hang Seng Stock Connect China 500 Index, which aims to measure the overall performance of the 500 largest Chinese companies in terms of market capitalization listed in Hong Kong and/or mainland China that are eligible for Northbound or Southbound trading under the Stock Connect schemes.

On August 23, 2021 Agilent Technologies Inc. (NYSE: A) reported that the company’s PD-L1 IHC 22C3 pharmDx assay has expanded its use in Europe (Press release, Agilent, AUG 23, 2021, View Source [SID1234586818]). The assay is now CE-IVD marked for use as an aid in identifying esophageal cancer patients for treatment with KEYTRUDA using Combined Positive Score (CPS) ≥ 10.1 In Europe, KEYTRUDA is approved in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with locally advanced unresectable or metastatic esophageal carcinoma or HER2 negative gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥ 10].2

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"Pathologists’ confidence in their PD-L1 test is critical, as a growing number of patients are becoming eligible for treatment with these therapies. With expanded use of our PD-L1 IHC 22C3 pharmDx assay, Agilent can provide pathologists with the quality, reliability, and accuracy they need to ensure diagnostic confidence."

"PD-L1 has been established as an essential biomarker for anti-PD-1 therapies like KEYTRUDA," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "Pathologists’ confidence in their PD-L1 test is critical, as a growing number of patients are becoming eligible for treatment with these therapies. With expanded use of our PD-L1 IHC 22C3 pharmDx assay, Agilent can provide pathologists with the quality, reliability, and accuracy they need to ensure diagnostic confidence."

In Europe, almost 53,000 people were diagnosed with esophageal cancer in 2020, and this type of cancer caused more than 45,000 deaths the same year.3

KEYTRUDA is a humanized monoclonal antibody that enhances the ability of the immune system to detect and fight tumor cells. KEYTRUDA blocks the PD-1 pathway, thereby activating T lymphocytes that may affect both tumor cells and healthy cells.2 KEYTRUDA and other targeted immunotherapies are changing cancer treatment, and their therapeutic value is being realized across a growing list of cancer types. PD-L1 IHC 22C3 pharmDx was developed by Agilent as a companion diagnostic for KEYTRUDA in partnership with Merck (known as MSD outside the United States and Canada).

On August 23, 2021 Emergent BioSolutions Inc. (NYSE: EBS) repored that members of the company’s senior management team will participate in the following investor conferences (Press release, Emergent BioSolutions, AUG 23, 2021, View Source [SID1234586836]):

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Three Part Advisors IDEAS Midwest Conference
August 25-26, 2021
Pre-recorded presentation available on August 26; 1-on-1 meetings on August 26
Wells Fargo 2021 Virtual Healthcare Conference
September 9-10, 2021
Fireside chat on September 9 at 9:20 am ET; 1-on-1 meetings all day
Morgan Stanley 19th Annual Global Healthcare Conference
September 9-10 & 13-15, 2021
Fireside chat on September 9 at 3:30 pm ET; 1-on-1 meetings all day
Baird’s 2021 Global Healthcare Conference
September 14-15, 2021
Fireside chat on September 14 at 4:55 pm ET; 1-on-1 meetings all day
Singular Research Compelling Values Webinar
September 16, 2021
Company presentation schedule will be posted on website
Cantor 2021 Virtual Global Healthcare Conference
September 27-30, 2021
Fireside chat on September 27 at 4:00 pm ET; 1-on-1 meetings all day
For conferences where a presentation is planned, the company’s webcast presentation may include a discussion of the company’s recent business developments as well as its financial results and guidance. The webcast will be available both live, if possible, and by replay, and will be accessible from the Emergent website.

On August 23, 2021 TransCode Therapeutics, Inc. (Nasdaq: RNAZ), an emerging RNA oncology company, created on the belief that cancer can be defeated through the intelligent design and effective delivery of RNA therapeutics, reported recent business progress and second quarter 2021 financial results (Press release, TransCode Therapeutics, AUG 23, 2021, View Source [SID1234586819]).

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"2021 has so far been foundational for TransCode, highlighted by our recent initial public offering and listing on Nasdaq. With resources from the IPO and additional support from the NIH, we are driving progress across our organization, including key staff additions who bring valued expertise to our team and advancement of our preclinical work," said Michael Dudley, co-founder, president and CEO of TransCode Therapeutics. "Looking forward, we are positioning to move our pipeline into clinical development, as we seek to demonstrate the power and versatility of our TTX platform in solving the challenges of RNA delivery in oncology. We remain on track to submit an exploratory Investigational New Drug Application (eIND) in the first quarter of 2022 to test our lead therapeutic candidate, TTX-MC138, in a Phase 0 study in metastatic solid tumors. We believe this study has the potential to establish proof-of-mechanism for our platform, upon which we hope to build a broad and diverse pipeline of therapeutics and diagnostics with the potential to reach previously undruggable genetic targets."

Second Quarter 2021 and Recent Highlights

Completed an initial public offering of 7,187,500 shares of common stock, including full exercise of the underwriters’ option to purchase additional shares, resulting in aggregate gross proceeds of $28.8 million, before deducting underwriting discounts and commissions and other offering expenses.
Awarded a Fast-Track Small Business Innovation Research (SBIR) grant from National Institutes of Health (NIH), totaling $2.3 million expected over three years to support the clinical evaluation of TTX-MC138. The Company expects to use these funds for translational experiments to identify and optimize a method for measuring miR-10b expression in breast cancer clinical samples, as well as IND-enabling activities and measurement of delivery and target engagement of TTX-MC138.
Strengthened the Company’s leadership team with several key appointments, including:
Judy Carmody, Ph.D., as SVP of Operations, Susan Duggan as VP of Clinical Operations, Dustan Bonnin as VP of Corporate Strategy and Subrata Ghosh, Ph.D., as Principal Scientist; and
Dejan Juric, M.D., appointed to its Scientific Advisory Board. Dr. Juric, a renowned expert in personalized cancer medicine and breast cancer specialist, is currently serving as director of the Henri and Belinda Termeer Center for Targeted Therapies and Investigational Cancer Therapeutics Program at Massachusetts General Hospital.
Advanced preclinical work for TTX-MC138, the Company’s lead program, targeting miR-10b for treatment of metastatic solid tumors. The Company has completed development of a diagnostic assay validating a method for measuring miR-10b expression in patient blood and tissue samples. This new assay should support future TTX-MC138 clinical trials including the initial Phase 0 study.
Initiated IND-enabling activities to support its planned eIND filing for TTX-MC138.
Planned Upcoming Milestones

TransCode continues to advance its portfolio and has set the following goals:

TTX-MC138
Submission to FDA of an eIND application in the first quarter of 2022.
Initiation of Phase 0 clinical study evaluating TTX-MC138 for treatment of metastatic solid tumors later in 2022.
Concurrent completion of IND-enabling studies to support second half of 2022 filing an IND application for a Phase I clinical trial of TTX-MC138.
Publication of preclinical results supporting its TTX delivery platform in the second half of 2021.
Second Quarter Financial Highlights

Cash and Cash Equivalents: As of June 30, 2021, cash and cash equivalents totaled approximately $80 thousand, excluding approximately $25.4 million in net proceeds from the Company’s July IPO.
R&D Expenses: Research and development expenses were approximately $212 thousand in the second quarter of 2021, compared to approximately $75 thousand in the second quarter of 2020. The increase was primarily due to purchases of materials, license fees, lab facility expenses, costs related to development of intellectual property, and share-based compensation expenses.
G&A Expenses: General and administrative expenses were approximately $144 thousand in the second quarter of 2021, compared to approximately $177 thousand in the second quarter of 2020. The increase was primarily due to increased legal, accounting, insurance, and investor relations costs associated with the Company’s IPO and to share-based compensation expenses.
Operating Income (Loss): Operating loss was approximately $356 thousand in the second quarter of 2021, compared to approximately $92 thousand in the second quarter of 2020. Net income was approximately $2.8 million, or $0.60 per basic share and $0.51 per diluted share, for the second quarter of 2021, compared to a net loss of approximately $127 thousand, or $0.03 per basic and diluted share, for the second quarter of 2020. The results in the second quarter of 2021 primarily reflect a change in fair value of derivative liabilities related to convertible promissory notes. The convertible promissory notes automatically converted into common stock upon completion of the IPO. In the foreseeable future, the Company expects that operating losses will increase substantially and does not expect net profits.
Financial Guidance

TransCode expects that its cash and cash equivalents as of June 30, 2021, together with net proceeds from its initial public offering and the SBIR award, are sufficient to fund planned operations through year-end 2022.

On August 23, 2021 PharmaCyte Biotech, Inc. (NASDAQ: PMCB) (PharmaCyte or Company), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported the closing of its previously announced registered direct offering priced at-the-marked under Nasdaq rules, of 14,000,000 shares of the Company’s common stock (or pre-funded warrants to purchase common stock in lieu of common stock) at an effective purchase price of $5.00 per share for gross proceeds of approximately $70 million, before deducting the placement agent’s fees and other offering expenses payable by the Company (Press release, PharmaCyte Biotech, AUG 23, 2021, View Source [SID1234586820]). In a concurrent private placement, PharmaCyte also issued to the investors in the offering unregistered warrants to purchase up to an aggregate 7,000,000 shares of common stock.

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Immediately following the closing of the registered direct offering and the concurrent private placement, the number of outstanding shares of common stock of the Company will be 18,979,465 and the Company will have approximately $90 million in cash in its bank account.

H.C. Wainwright acted as the exclusive placement agent for the offering.

The warrants have an exercise price equal to $5.00 per share, are exercisable immediately upon issuance and will expire five years from the issuance date.

The Company intends to use the net proceeds of this offering (i) to complete activities requested by the U.S. Food and Drug Administration (FDA) to address the FDA’s clinical hold on its Investigational New Drug application (IND) with respect to the Company’s planned Phase 2b clinical trial in locally advanced, inoperable, pancreatic cancer (LAPC), including conducting several additional preclinical studies and assays and providing the FDA with the additional information it requested, (ii) to fully fund and conduct the Phase 2b clinical trial in LAPC, if and when the clinical hold on the IND is lifted, (iii) to continue clinical development of the Company’s cancer program, (iv) to continue development of the Company’s diabetes program, (v) to continue development of the Company’s malignant ascites program and (iv) for general corporate purposes.

The shares of common stock (and common stock equivalents) described above (but not the warrants or the shares of common stock underlying the warrants) were offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333-255044) that was previously filed with and subsequently declared effective by the U.S. Securities and Exchange Commission (SEC) on April 14, 2021, and an additional registration statement on Form S-3 filed on August 19, 2021, pursuant to Rule 462(b), which became effective automatically upon filing. The offering of the shares of common stock (or common stock equivalents) was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The final prospectus supplement and the accompanying base prospectus relating to the shares of common stock (or common stock equivalents) being offered in the registered direct offering have been filed with the SEC and are available on the SEC’s website at View Source Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or by email at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended ("Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.