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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

On June 17, 2021 BioNTech SE (NASDAQ: BNTX, "BioNTech" or "the Company"), reported that the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899)(Press release, BioNTech, JUN 18, 2021, View Source [SID1234584122]). The study is evaluating the Company’s therapeutic cancer vaccine candidate BNT111 in combination with Libtayo (cemiplimab) in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma. BNT111 is the lead product candidate from BioNTech’s FixVac platform that targets a fixed combination of mRNA-encoded, tumor-associated antigens with the objective of triggering a strong and precise immune response against cancer and is fully owned by BioNTech.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The BNT111-01 trial which is being conducted in collaboration with Regeneron, was reviewed and approved by the regulatory authorities in Spain, Germany, Italy and Poland as well as in the United Kingdom, the United States and Australia. The open-label randomized trial evaluates the efficacy, tolerability, and safety of BNT111 in combination with Libtayo, an anti-PD-1 monoclonal antibody, being co-developed by Regeneron and Sanofi. The trial is enrolling a total of 120 patients and will evaluate the effects of the combination as well as single agents alone. The primary endpoint is the overall response rate of BNT111 in combination with Libtayo. Secondary endpoints include overall response rate in the single agent arms, duration of response, and safety. The first patient has been dosed in the EU. BioNTech retains global commercial rights to BNT111.

"Our vision is to harness the power of the immune system against cancer and infectious diseases. We were able to demonstrate the potential of mRNA vaccines in addressing COVID-19. We must not forget, that cancer is also a global health threat, even worse than the current pandemic," said Özlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech. "BNT111 has already shown a favorable safety profile and encouraging preliminary results in early clinical evaluation. With the start of patient treatment in our Phase 2 trial, we are encouraged to continue on our initial path to realize the potential of mRNA vaccines for cancer patients."

BNT111 is an intravenous therapeutic cancer vaccine candidate encoding for a fixed set of four cancer-specific antigens optimized for immunogenicity and delivered as RNA-lipoplex formulation. More than 90% of melanomas in patients express at least one of the four tumor-associated antigens encoded in BNT111 (NY-ESO-1, MAGE-A3, tyrosinase, and TPTE). BNT111 is one of the most advanced of five clinical-stage FixVac product candidates within BioNTech’s development pipeline.

This Phase 2 clinical trial is based on previous results from the Phase 1 Lipo-MERIT dose escalation trial (NCT02410733) that demonstrated a favorable safety profile in 89 patients with advanced melanoma. In addition, efficacy analysis of the Lipo-MERIT study in a subset of 42 metastatic melanoma patients previously treated with a checkpoint-inhibitor (CPI) showed that BNT111 mediated durable responses both as a single agent and in combination with anti-PD-1 antibodies and that durable objective responses by BNT111 were associated with activation and strong expansion of tumor-antigen-specific CD4+ and CD8+ T cells. These results were published in Nature in July 2020.

The Company also plans to start randomized Phase 2 trials with mRNA vaccine product candidates in two additional programs in 2021 (FixVac: BNT113 and iNeST: BNT122). As part of its development strategy, BioNTech aims to rapidly advance its broad oncology pipeline and expects to bring additional candidates into late-stage clinical development and towards market entry within the next five years.

About FixVac
BioNTech’s FixVac platform candidates consist of a fixed combination of mRNA-encoded non-mutated antigens shared within specific cancer types. They feature the Company’s proprietary RNA-lipoplex delivery formulation which is designed to enhance stability and translation of the mRNA cargo as well as specifically target dendritic cells. Thus, the vaccine candidate aims to trigger a strong and precise innate and adaptive immune response against cancer cells overexpressing the respective antigen.