On June 18, 2021 Guardant Health reported that STUDY SHOWS GUARDANT REVEAL BLOOD-ONLY LIQUID BIOPSY TEST PREDICTS RISK FOR COLORECTAL CANCER RECURRENCE WITH INDUSTRY-LEADING SENSITIVITY (Press release, Guardant Health, JUN 18, 2021, View Source [SID1234584169]).

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For patients with early-stage colorectal cancer (CRC), the presence of circulating tumor DNA (ctDNA) or minimal residual disease (MRD) after curative intent treatment is becoming an important prognostic biomarker for cancer recurrence, and can also be used to evaluate the potential need for adjuvant treatment in post-surgical patients. Until recently, tests developed to detect MRD required tumor tissue to gain the necessary genomic information needed to accurately identify high-risk patients. A new study led by Massachusetts General Hospital Cancer Center and published in Clinical Cancer Research demonstrates that Guardant Reveal, the first blood-only liquid biopsy to identify MRD, identifies those patients most likely to recur, with industry-leading sensitivity, without the need for tumor tissue. 1,2

The single-center, prospective study evaluated the effectiveness of the Guardant Reveal liquid biopsy test to detect MRD in patients with stage I-IV colorectal cancer after curative intent therapy. Blood draws were taken one month after completion of definitive treatment, either surgery or adjuvant therapy, and at various surveillance or monitoring timepoints. Blood samples were analyzed using the Guardant Reveal test, which integrates both cancer-specific epigenomic signatures and genomic alterations, unlike standard MRD tests which analyze only genomic alterations.

In the primary landmark analysis (n=84), blood samples were taken from the curative intent patient population one month (median 31.5 days) after completion of definitive treatment. In the subset of patients with at least one year of clinical follow-up, all patients with detectable ctDNA recurred (100% PPV). Guardant Reveal test sensitivity and specificity were 55.6% and 100% respectively for this single timepoint. By incorporating longitudinal surveillance samples, sensitivity improved to 91%. Integrating epigenomic signatures increased test sensitivity by 36% versus using genomic alterations alone. Additionally, CEA tests, the traditional biomarker for colorectal cancer, did not predict recurrence in this patient cohort.

"The integration of cancer-specific epigenomic and genomic signatures allows Guardant Reveal to detect minimal residual disease in early-stage colorectal cancers with industry-leading performance and without the need for tumor tissue," said AmirAli Talasaz, Guardant Health president. "We believe that Guardant Reveal can be a powerful decision-making tool for oncologists managing patients with early-stage colorectal cancer. In addition, our blood-only approach offers a more streamlined workflow and faster turnaround time for clinical decision making."

"By detecting minimal residual disease after curative intent treatment, we can have a better understanding of which patients are at high-risk for recurrence and perhaps tailor additional therapy," said Aparna Parikh, MD, MPH, Gastrointestinal Oncologist at Massachusetts General Hospital and Assistant Professor of Medicine, Harvard Medical School. "This study demonstrates that the incorporation of epigenomic signatures with genomic alterations allows for Guardant Reveal to have high sensitivity and specificity, but without the need for tumor tissue."

Tissue-dependent MRD tests have previously reported sensitivities of 40%-50% with a single post-surgical blood draw. 1,3 When looking only at the subset of patients with stage II or III CRC in this study, Guardant Reveal had a sensitivity of 63% and a specificity of 100% for recurrence. These data show that Guardant Reveal can detect minimal residual disease from a simple blood draw. In addition, the sensitivity of the test increases with additional longitudinal blood draws, allowing for earlier detection of recurrence in the patient surveillance setting compared with standard imaging methods.

The Guardant Reveal test achieves industry-leading sensitivity (91%) 2 for detecting ctDNA by simultaneously interrogating genomic and epigenomic alterations. The test accurately identifies genomic alterations down to allele frequencies of 0.01% and effectively filters out biological noise sources such as mutations caused by clonal hematopoiesis. The incorporation of biologically relevant epigenomic signatures is essential to increasing test sensitivity in the post curative intent and surveillance patient populations.

The publication titled, "Minimal Residual Disease Detection using a Plasma-Only Circulating Tumor DNA Assay in Colorectal Cancer Patients" can be found here

On June 18, 2021 Privo Technologies, Inc. reported attends the BIO International Convention online from June 14-18, 2021 (Press release, Privo Technologies, JUN 18, 2021, View Source;utm_medium=rss&utm_campaign=bio-international-convention-2021 [SID1234586911]).

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Despite the conference being held online this year due to COVID-19, Bio International 2021 was
informative and enjoyable. The company connected with potential investors and industry partners in
discussing their PRV111 and PRV211 technology. In addition, the company discussed technology
collaborations with pipeline products.

On June 18, 2021 HUTCHMED (China) Limited ("HUTCHMED" or the "Company") (Nasdaq/AIM: HCM) reported the launch of its Hong Kong public offering (the "Hong Kong Public Offering"), which forms part of the global offering (the "Global Offering") of 104,000,000 new ordinary shares (the "Offer Shares") and the proposed primary listing of its ordinary shares (the "Shares") on the Main Board of The Stock Exchange of Hong Kong Limited (the "SEHK") under the stock code "13" (Press release, Hutchison China MediTech, JUN 18, 2021, View Source [SID1234584174]). The Company will receive all of the net proceeds from the Global Offering.

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The Global Offering initially comprises 13,000,000 new Shares under the Hong Kong Public Offering and 91,000,000 new Shares under the international offering (the "International Offering"), representing approximately 12.5% and 87.5% of the total number of Offer Shares in the Offering, respectively, subject to re-allocation between the Hong Kong Public Offering and the International Offering for any over-subscriptions in the Hong Kong Public Offering and over-allotment. In addition, the Company expects to grant the international underwriters an over-allotment option ("Over-allotment Option") to purchase up to an additional 15,600,000 new Shares in the International Offering, representing not more than 15% of the Offer Shares initially available under the Global Offering.

The offer price for the Global Offering (the "Offer Price") will be not more than HK$45.00 per Share (the "Maximum Offer Price"), which is equivalent to approximately US$29 per American depositary share ("ADS") or £4.15 per Share. The Company is expected to set the Offer Price on or about June 23, 2021 Hong Kong time by making reference to, among other factors, the closing price of the ADSs on the Nasdaq Global Select Market ("Nasdaq") and the Shares on the AIM market of the London Stock Exchange ("AIM") on the last trading day on or before the price determination date and investor demand during the marketing process. Shares will be traded on the SEHK in board lots of 500 Shares. The Company expects to announce the Offer Price so determined on June 23, 2021.

The Company has entered into cornerstone investment agreements with entities affiliated with The Carlyle Group Inc., Canada Pension Plan Investment Board, General Atlantic, HBM Healthcare Investments and CICC Grandeur Fund. Under such agreements, they have agreed to, subject to certain conditions, subscribe for such number of Offer Shares that may be purchased with an aggregate amount of HK$2,535 million (approximately US$325 million) at the Offer Price, representing approximately 54% of the Offer Shares initially being offered under the Global Offering assuming such Offer Shares are sold at the Maximum Offer Price, which percentage is subject to the Over-allotment Option. Such Offer Shares are being sold in reliance on Regulation S ("Regulation S") or another exemption from the registration requirements of the U.S. Securities Act of 1933 ("Securities Act"), and this cornerstone placing will form part of the International Offering.

The Company’s ADSs, each representing five ordinary shares of the Company, will continue to be listed and traded on the Nasdaq, and the Shares will remain admitted to trading on AIM. Investors in the Global Offering will only be able to purchase Shares and will not be able to take delivery of ADSs. Upon listing, the Hong Kong-listed Shares will be fully fungible with the Shares represented by ADSs listed on Nasdaq and the Shares admitted to trading on AIM.

The Company plans to use the net proceeds from the Global Offering primarily to advance its late-stage clinical programs as well as its pipeline of clinical-stage and preclinical drug candidates, further strengthen its commercialization, clinical, regulatory and manufacturing capabilities, fund potential global business development and strategic acquisition opportunities and for general corporate purposes.

Morgan Stanley Asia Limited, Jefferies Hong Kong Limited and China International Capital Corporation Hong Kong Securities Limited are the joint sponsors for the proposed Global Offering.

*****

Fully Electronic Application Process for the Hong Kong Public Offering
HUTCHMED has decided to adopt a fully electronic application process for the Hong Kong Public Offering, with no printed copies of the prospectus or application forms. As a company which has been highly committed to environmental, social and corporate responsibility matters since its founding, HUTCHMED believes such method will help mitigate the environmental impact of printing and minimize the exploitation of natural resources, among others. The prospectus is available at the website of the SEHK at www.hkexnews.hk and the Company’s website at www.hutch-med.com.

The Company encourages applicants for the Hong Kong Public Offering to view its prospectus and apply online through the White Form eIPO service at www.eipo.com.hk, or apply through the CCASS EIPO service. The Hong Kong Public Offering will commence at 9:00 a.m. on Friday, June 18, 2021 Hong Kong time and will close at 12:00 noon on Wednesday, June 23, 2021 Hong Kong time.

Potential applicants may call the enquiry hotline of Computershare Hong Kong Investor Services Limited if they have any question about making applications for the Hong Kong Offer Shares. The hotline number is +852 2862 8646, and will be open from 9:00 a.m. to 9:00 p.m. on Friday, June 18, 2021, Monday, June 21, 2021 and Tuesday, June 22, 2021; from 9:00 a.m. to 6:00 p.m. on Saturday, June 19, 2021 and Sunday, June 20, 2021; and from 9:00 a.m. to 12:00 noon on Wednesday, June 23, 2021, Hong Kong time.

Information about the Global Offering
The International Offering will include Shares to be offered and sold (i) pursuant to the shelf registration statement on Form F-3ASR that was filed with the SEC and became effective on April 6, 2020, and the preliminary prospectus supplement to be filed with the SEC and the final prospectus supplement to be filed with the SEC on or about June 24, 2021 (the "Registered Offering") and (ii) in respect of shares sold to cornerstone investors, in reliance on Rule 901 of Regulation S or pursuant to another exemption from the registration requirements of the Securities Act (the "Exempt Offering"). For investors in the Registered Offering, the registration statement on Form F-3 and the preliminary prospectus supplement will be available at the SEC website at: www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus for the Registered Offering, as well as the international offering circular for the Exempt Offering, may also be obtained from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attention: Prospectus Department, or E-mail: [email protected]; Jefferies Hong Kong Limited, Email: [email protected]; and China International Capital Corporation Hong Kong Securities Limited, Email: [email protected].

The proposed Global Offering is subject to market and other conditions, and there can be no assurance as to whether or when the Global Offering may be completed, or as to the actual size or terms of the Global Offering. This announcement shall not constitute an offer to sell or the solicitation of an offer or an invitation to buy any securities of the Company, nor shall there be any offer or 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. This announcement does not constitute a prospectus (including as defined under the laws of Hong Kong) and potential investors should read the prospectus of the Company for detailed information about the Company and the proposed offering, before deciding whether or not to invest in the Company. This announcement has not been reviewed or approved by the SEHK or the Securities and Futures Commission of Hong Kong.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018) ("MAR").

On June 18, 2021 KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, reported it has entered into agreements with certain of its holders of its existing warrants exercisable for 6,117,509 shares of its common stock, in the aggregate, pursuant to which such holders agreed to exercise their warrants for cash in exchange for the Company’s agreement to issue in a private placement new warrants to purchase up to 1,529,379 shares of its common stock (Press release, KemPharm, JUN 18, 2021, View Source [SID1234584138]). The new warrants are immediately exercisable and have substantially the same terms as the existing warrants, except that the new warrants have an exercise price of $16.50 per share and expire on December 31, 2026. The aggregate gross proceeds from the exercise of the existing warrants and the issuance of the new warrants are expected to total approximately $39.1 million, before deducting the financial advisory fees.

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Roth Capital Partners is acting as a financial advisor in connection with the private placement.

The securities offered in the private placement have not been registered under the Securities Act of 1933, as amended, or applicable under state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. As part of the transaction, the Company has agreed to file a resale registration statement on Form S-3 with the Securities and Exchange Commission within 10 days of the closing to register the resale of the shares of common stock underlying the warrants issued in the private placement.

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

On June 18, 2021 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders inside and outside of the brain, reported the closing of its previously announced underwritten public offering of 15 million shares of its common stock at a price to the public of $3.00 per share (Press release, Inhibikase Therapeutics, JUN 18, 2021, View Source [SID1234584139]). The gross proceeds to Inhibikase from the public offering, before deducting underwriting discounts and commissions and offering expenses payable by Inhibikase, were $45 million. Inhibikase has granted the underwriters a 45-day option to purchase up to an additional 2,250,000 shares of common stock, at the public offering price less discounts and commissions.

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Inhibikase intends to use the net proceeds from the public offering, together with existing funds, to fund the costs of a Phase 1b extension study for IkT-148009 in Parkinson’s patients and to validate target engagement markers in the central and peripheral nervous system; to fund production of IkT-148009 for Phase 1b and Phase 2 clinical studies and to fund a Phase 2 efficacy trial of IkT-148009 in Parkinson’s patients. This funding will further support the clinical dose calibration study(ies) of IkT-001Pro in healthy subjects to support approval under the Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act and to fund drug product production for IkT-001Pro. The balance will support general research and development activities, medicinal chemistry for additional molecules and IND-enabling studies, team building, and other general corporate activities.

ThinkEquity, a division of Fordham Financial Management, Inc., acted as sole book-running manager for the offering. JonesTrading Institutional Services LLC acted as the co-manager for the offering.

The offering was made pursuant to a registration statement on Form S-1 (File No. 333-257032) that was declared effective by the Securities and Exchange Commission (the "SEC") on June 15, 2021. A final prospectus related to the offering has been filed with the SEC and is available on the SEC’s website, located at www.sec.gov. Copies of the final prospectus relating to this offering may be obtained from the offices of ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these 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. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.