Chi-Med Announces US$100 Million Equity Investment by General Atlantic

On June 25, 2020 Hutchison China MediTech Limited ("Chi-Med" or the "Company") (Nasdaq/AIM: HCM) reported that it has entered into a definitive agreement for the sale of US$100 million of shares at a price equivalent to US$25.00 per American Depositary Share ("ADS") via a private placement to General Atlantic, a leading global growth equity firm (Press release, Hutchison China MediTech, JUN 25, 2020, https://www.chi-med.com/us100-million-equity-investment-by-general-atlantic/ [SID1234561459]). This fundraise could increase to US$200 million, through a warrant granted with a term of 18 months for a further US$100 million in Chi-Med shares exercisable at a price per share equivalent to US$30.00 per ADS, a 32.5% premium to the 30-day VWAP.

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Chi-Med is delivering on its strategic intention to become a global oncology business. In 2020, there has been significant progress in building an innovative, global, science-focused biopharmaceutical company including three U.S. Food and Drug Administration (FDA) Fast Track Designations for fruquintinib in metastatic colorectal cancer and surufatinib for two forms of advanced neuroendocrine tumors. The submission of a New Drug Application (NDA) for surufatinib in the United States is also planned for later this year.

Chi-Med will receive all proceeds from this private placement, which will fund ongoing research and clinical development and support the further growth of its commercialization capabilities both in China and globally.

This financing also highlights the strong commitment General Atlantic is making to Chi-Med. General Atlantic has 40 years’ experience in investing in global growth equity companies, with a demonstrated history in the biopharma sector, and has approximately US$34 billion of assets under management. It has a broad portfolio of life science company investments with whom they constructively partner to support further growth.

Mr. Christian Hogg, Chief Executive Officer of Chi-Med, said, "Over the last few months, we have made significant development, regulatory and commercial progress in several oncology programs intended for the global market. We are delighted therefore to welcome General Atlantic to our existing shareholder base and to further strengthen our balance sheet. We are confident that in this phase of material progress for Chi-Med we can deliver innovative cancer therapies to patients internationally."

Mr. David Hodgson, Vice Chairman of General Atlantic, said, "General Atlantic is committed to supporting innovation in the global life sciences industry. Chi-Med has built a deep pipeline of assets powered by its robust research and development engine. We endorse Chi-Med’s strategy to become a leading biopharma innovator and will leverage our global organization in support of Chi-Med’s mission to deliver safe and effective therapeutics to cancer patients in need around the world."

Mr. Lefei Sun, Managing Director and Head of Healthcare for China at General Atlantic, continued, "We believe Chi-Med is a pioneer of the Chinese biotech market in bringing advanced oncology therapies to the world. We are delighted to partner with Chi-Med to help unlock future value."

Chi-Med has agreed to issue the equivalent of 4,000,000 ADSs in a private placement to General Atlantic at a price equivalent to US$25.00 per ADS, resulting in aggregate gross proceeds of US$100 million to Chi-Med. The purchase price represents a 10.4% premium to the 30-day VWAP. The Company has also granted a warrant to General Atlantic to purchase up to an additional equivalent of 3,333,334 ADSs, at an exercise price equivalent to US$30.00 per ADS, and a term of 18 months.

Description of Share Capital and Securities Regulation
Each ADS represents five ordinary shares, par value US$0.10 each (the "Shares"). The new Shares to be issued by Chi-Med including shares issuable upon exercise of the warrant, pursuant to the private placement will, when issued, be credited as fully paid and will rank pari passu in all respects with the existing ordinary shares of Chi-Med.

The securities to be sold in the private placement will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Subject to certain conditions, the Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the Shares sold in the private placement and the Shares issuable upon exercise of the warrant to facilitate future resales by General Atlantic. Any offering of the securities under the resale registration statement will only be made by means of a prospectus. General Atlantic has the right to appoint an observer or a representative director to the board of directors of the Company upon achieving certain ownership thresholds in the future.

This announcement, including any information included or incorporated by reference in this announcement, is for information purposes only and shall not constitute nor form part of, and should not be construed as, an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. No public offering of the securities referred to in this announcement is being made in the United States or elsewhere.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.

Admission to the London Stock Exchange AIM market and Shares Outstanding After Completion
The private placement of 20,000,000 Shares (equivalent to 4,000,000 ADSs) to General Atlantic will comprise the issuance of 18,700,000 Shares ("First Tranche Shares") and the issuance of 1,300,000 Shares ("Second Tranche Shares"). Application will be made to the London Stock Exchange for the First Tranche Shares and the Second Tranche Shares to be admitted to the AIM market operated by the London Stock Exchange ("Admission"). It is expected that admission of the First Tranche Shares will become effective at 8:00 a.m. British Summer Time on July 3, 2020 and admission of the Second Tranche Shares will become effective at 8:00 a.m. British Summer Time on July 6, 2020.

Following admission of the First Tranche Shares to trading on AIM, the issued share capital of Chi-Med will consist of 709,274,765 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury. Following admission of the Second Tranche Shares to trading on AIM, the issued share capital of Chi-Med will consist of 710,574,765 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury. The figure of 709,274,765 (following admission of the First Tranche Shares but prior to admission of the Second Tranche Shares) and the figure of 710,574,765 may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, Chi-Med under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.

For illustrative purposes only, if the 710,574,765 ordinary shares were converted in their entirety, they would be equivalent to 142,114,953 Nasdaq-traded ADSs (each equating to five ordinary shares).

In addition, the Company will apply for the block listing of up to 16,666,670 new ordinary shares in accordance with the block listing process under Rule 29 of the AIM Rules for Companies to cover the potential exercise of the warrant. The new ordinary shares subject to the block admission will not be allotted immediately, but rather will be issued and allotted on exercise of the warrant from time to time. The Company will make six-monthly announcements of the utilization of the block listing, in line with its obligations under Rule 29 of the AIM Rules for Companies. The expected effective date of admission of these securities to AIM is on July 6, 2020.

About General Atlantic
General Atlantic is a leading global growth equity firm providing capital and strategic support for growth companies. Established in 1980, General Atlantic combines a collaborative global approach, sector specific expertise, a long-term investment horizon and a deep understanding of growth drivers to partner with great entrepreneurs and management teams to build exceptional businesses worldwide. The firm’s global Life Sciences portfolio includes Adagene, CANbridge, Ginkgo Bioworks, Immunocore, Motif FoodWorks, Ocumension, PathAI, and Royalty Pharma. General Atlantic has more than 150 investment professionals based in New York, Amsterdam, Beijing, Greenwich, Hong Kong, Jakarta, London, Mexico City, Mumbai, Munich, Palo Alto, São Paulo, Shanghai, and Singapore. For more information on General Atlantic, please visit the website: www.generalatlantic.com.

Evive Biotech unveiled as the new corporate brand for Generon Biomed

On June 24, 2020 Generon BioMed Inc, an innovative biotech company developing novel biological therapeutics, announced on 24 June 2020 that it has rebranded to Evive Biotech – effective immediately Generon BioMed Inc, an innovative biotech company developing novel biological therapeutics, announced on 24 June 2020 that it has rebranded to Evive Biotech – effective immediately. The name change reinforces the company’s commitment to addressing unmet medical needs for patients worldwide.

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"We are very excited and proud to announce our new corporate identity," said Dr. Jacky Liu, CEO of Evive Biotech. "Evive Biotech is a contemporary, international brand that we feel better reflects and articulates who we are as a business and the ambitions that we hold as an Asian-rooted firm with a global outlook. As we transition to the next phase of our development, we believe that the new brand will unite us all still further as we strive to bring breakthrough therapies to patients."

Since its inception in 2004, the company has been focused on addressing unmet medical needs in oncology and inflammatory disorders that are difficult to treat and present a challenging prognosis. In that time, the company has established state-of-the-art cGMP facilities and global operations in the United States, Singapore, and China and today employ over 200 people worldwide. The company combines strong research and clinical development capabilities with exceptional regulatory expertise to bring innovative therapies to market faster.

The rebrand also marks an exciting time for Evive Biotech as it seeks to advance a portfolio of novel drug candidates through its proprietary technology platforms, and ensure broad access to treatment options for patients. These candidates include F-627 for the treatment of chemotherapy-induced neutropenia (CIN), and F-652 that is under development to treat alcoholic hepatitis (AH) and acute graft-versus-host disease (GVHD). F-652 was granted orphan drug status by the U.S. FDA in 2019.

. The name change reinforces the company’s commitment to addressing unmet medical needs for patients worldwide.

"We are very excited and proud to announce our new corporate identity," said Dr. Jacky Liu, CEO of Evive Biotech. "Evive Biotech is a contemporary, international brand that we feel better reflects and articulates who we are as a business and the ambitions that we hold as an Asian-rooted firm with a global outlook. As we transition to the next phase of our development, we believe that the new brand will unite us all still further as we strive to bring breakthrough therapies to patients."

Since its inception in 2004, the company has been focused on addressing unmet medical needs in oncology and inflammatory disorders that are difficult to treat and present a challenging prognosis. In that time, the company has established state-of-the-art cGMP facilities and global operations in the United States, Singapore, and China and today employ over 200 people worldwide. The company combines strong research and clinical development capabilities with exceptional regulatory expertise to bring innovative therapies to market faster.

The rebrand also marks an exciting time for Evive Biotech as it seeks to advance a portfolio of novel drug candidates through its proprietary technology platforms, and ensure broad access to treatment options for patients. These candidates include F-627 for the treatment of chemotherapy-induced neutropenia (CIN), and F-652 that is under development to treat alcoholic hepatitis (AH) and acute graft-versus-host disease (GVHD). F-652 was granted orphan drug status by the U.S. FDA in 2019.

Targovax announces presentation of pre-clinical data from Next Generation ONCOS at AACR Virtual Annual Conference

On June 24, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, reported that data from a pre-clinical study with next-generation ONCOS-200 series viruses with novel anti-cancer double-transgenes was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting (Press release, Targovax, JUN 24, 2020, View Source [SID1234564005]).

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The pre-clinical in vitro and in vivo findings demonstrated that both ONCOS-210 & ONCOS-212 have anti-cancer properties and that the double transgenes act synergistically. The encouraging preclinical findings will be further investigated to elucidate transgene functionality and mode of action.

See poster here: Next generation ONCOS oncolytic adenovirus with novel anti-cancer double-transgenes shows synergistic anti-cancer effect in a melanoma mouse model.

Media CoverageU.S. Patent for Bolt Biotherapeutics’ Boltbody™ ISAC Platform Technology is a Major Milestone in the Development of BDC-1001

On June 24, 2020 Bolt Biotherapeutics reported that the U.S. Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,675,358 entitled "Antibody Adjuvant Conjugates (Press release, Bolt Biotherapeutics, JUN 24, 2020, View Source [SID1234562557])." Bolt Biotherapeutics a private clinical-stage biotechnology company developing a new category of immunotherapies called Immune-Stimulating Antibody Conjugate (ISAC).

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The platform technology is designed to harness the power of the innate immune system to treat cancer.

The patent provides protection for immunoconjugates of a piperazinyl imidazoquinoline adjuvant bound to an antibody, including Bolt’s BDC-1001 ISAC.

HER2-expressing solid tumors
BDC-1001 is being developed as a monotherapy for patients with HER2-expressing solid tumors. BDC-1001 is an ISAC comprised of trastuzumab conjugated to a Bolt proprietary TLR7/8 agonist payload.

In preclinical models, systemic administration of HER2-ISACs demonstrated localized immune activation that results in robust single-agent activity, generation of host immunological memory against cancer, and epitope spreading.

Furthermore, preclinical data, presented at SITC (Free SITC Whitepaper) 2019, showed complete, durable regression of established tumors resistant to trastuzumab (Herceptin; Genentech/Roche) and immunological memory providing protection against tumor cells that no longer express the HER2 antigen in syngeneic mouse cancer models. This offers the potential for durable and meaningful responses for HER2-expressing cancers. The promise of Immunological memory. Bolt Biotherapeutics’ ImmuneStimulating Antibody Conjugate (ISAC) selectively target tumors for U.S. Patent for Bolt Biotherapeutics’ Boltbody ISAC Platform Technology is a Major Milestone in the Development of BDC-1001 By ADC Review | Editorial Team-July 9, 2020  destruction by the immune system. Tumor-associated myeloid cells engulf ISAC-bound tumors, become armed with tumor neoantigens, and migrate to the lymph nodes where they mediate the activation and expansion of tumor-reactive T-cells. In preclinical tumor models, ISAC therapy leads to the regression of established tumors and generation of immunological memory, which guards against the recurrence of tumors that express tumor neoantigens even if they no longer express the ISAC target antigen. Image courtesy: © 2020 Bolt Biotherapeutics.

Translating scientific discovers in therapeutic agents
"The development of Boltbody ISACs is motivated by the insatiable need to translate scientific discoveries into products that will help cancer patients become survivors," noted Michael N. Alonso, Ph.D., scientific co-founder and vice president of immunology and pharmacology of Bolt Biotherapeutics.

"This patent issuance is an important milestone that provides protection for our BDC-1001 clinical asset and our Boltbody ISAC technology platform. Our dedicated and talented teams will continue to aggressively build a robust patent portfolio to protect our pipeline, our platform, and our commitment to patients," Alonso added.

In March Bolt Biotherapeutics confirmed that it had started a clinical trial for BDC-1001 involving patients with HER2-expressed solid tumors. This phase I, open-label, dose-escalation, and doseexpansion study will evaluate the safety, pharmacokinetics, pharmacodynamics, and proof of mechanism of BDC-1001.

"Bolt is eager to explore the potential of BDC-1001 for treating HER2-expressing cancers, which includes patients with breast and gastric cancers that are refractory to trastuzumab and adotrastuzumab emtansine (Kadcyla; Genentech/Roche), as well as cancers for which no HER2-targeting therapies have yet been approved," Schatzman said at the time of the announcement.

"We’re looking forward to working with the medical community to bring the promise of this exciting new approach to patients and anticipate initial data will drive our future development plans."

Technology platform

The Boltbody platform consists of Immune-Stimulating Antibody Conjugates (ISAC) that harness the ability of innate immune agonists to convert cold tumors into immunologically hot tumors thereby illuminating tumors to the immune system and allowing them to be invaded by tumor-killing cells.

Boltbody ISACs have demonstrated the ability to eliminate tumors following systemic administration in preclinical models and have also led to the development of immunological memory, which is predicted to translate into more durable clinical responses for patients.

Funding Earlier this month Bolt Biotherapeutics completed a U.S. $ 93.5 million Series C round of financing. the funding round was led by Sofinnova Investments and included additional investors RA Capital Management, Rock Springs Capital, and Samsara BioCapital.

In conjunction with the financing, Jason Pitts Ph.D., principal at Sofinnova Investments, will join Bolt Biotherapeutics’ board of directors.

"We believe Bolt is well-positioned to execute on its vision of developing immuno-oncology therapies with the potential to generate systemic immunological memory and provide durable clinical benefit. I look forward to helping the company realize its goal of developing the ISAC platform across a range of solid tumor targets," Pitts said. Since its founding in 2015, the company has raised more than U.S. $ 170 million. This latest funding round will be used to support the clinical development of its lead Immune-Stimulating Antibody Conjugate (ISAC), BDC-1001.

Clinical trial

A First-in-human Study Using BDC-1001 in Advanced and HER2-Expressing Solid Tumors – NCT04278144

Reference
Gingrich J. How the Next Generation Antibody Drug Conjugates Expands Beyond Cytotoxic Payloads for Cancer Therapy. ADC Review; April 7, 2020 [Article]

Evelo Biosciences Announces Proposed Public Offering of Common Stock

On June 24, 2020 Evelo Biosciences, Inc. (Nasdaq: EVLO) ("Evelo"), a clinical stage biotechnology company developing a new modality of orally delivered, systemically acting biologic therapies, reported that it intends to offer and sell, subject to market and other conditions, $40 million of its common stock in an underwritten public offering (Press release, Evelo Biosciences, JUN 24, 2020, View Source [SID1234561616]). Evelo expects to grant the underwriters a 30-day option, solely to cover over-allotments, if any, to purchase up to an additional $6 million of its common stock. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares in the proposed offering are to be sold by Evelo.

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Morgan Stanley, Cowen and BMO Capital Markets are acting as joint book-running managers for the offering.

Evelo intends to use the net proceeds from the offering, in addition to its existing cash resources, for the following purposes: (i) advance EDP1815 into two Phase 2 clinical trials and a Phase 2/3 clinical trial for the treatment of inflammatory diseases and hyperinflammation caused by viral infections including SARs-CoV-2; (ii) advance EDP1815 in a Phase 1b trial in atopic dermatitis with an enteric capsule formulation; (iii) continue the clinical development of EDP1503, a monoclonal microbial candidate for oncology; (iv) other research and development activities for additional product candidates, including EDP1867 and EDP2939, for the treatment of inflammatory diseases, and advancing additional oral biologics through preclinical development in other disease areas; and (v) the remainder, if any, for working capital and other general corporate purposes.

A registration statement relating to the securities being sold in the offering has been declared effective by the Securities and Exchange Commission. The securities will be offered only by means of a prospectus supplement and accompanying prospectus forming a part of the effective registration statement. A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained, when available, from: Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attn: Prospectus Department or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (631) 274-2806.