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Transgene announces the success of its Capital Increase via a Private Placement

On June 22, 2021 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, ("Transgene" or the "Company") reported the successful completion of its capital increase through the issuance of ordinary shares through a private placement with waiver of preferential subscription rights, via an accelerated bookbuilding pursuant to Articles L. 225-136 of the French Commercial Code and L. 411-2 1° of the French Monetary and Financial Code for an amount of approximately 34,1 million euros (the "Capital Increase") (Press release, Transgene, JUN 22, 2021, View Source [SID1234621817]).

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Hedi Ben Brahim, Chairman and CEO of Transgene, said: "We are very pleased to have concluded this successful fund raising, which has been supported by both historical shareholders and specialized healthcare investors, such as Invus. We are now well placed to execute on our ambitious corporate strategy of progressing our world leading myvac and Invir.IO technology platforms through first clinical validations of our personalized cancer vaccine TG4050 and our novel oncolytic virus BT-001 while advancing our randomized Phase II of TG4001. Transgene’s future has never looked brighter, and I am looking forward to the multiple key value-driving corporate milestones, we expect to announce over the next 18 months."

The capital increase results in the issuance of 13,930,000 new ordinary shares at a subscription price of 2.45 euros (including issue premium), representing 16,6 % of the current share capital of the Company for a total amount of approximately 34,1 million euros. The subscription price represents a discount of 6.5% compared to the closing price of Transgene on June 21, 2021 (€2.62).

Institut Mérieux, which currently holds 99.5% through its subsidiary TSGH, 60% of the company’s share capital, and SITAM Belgium, which holds 4.9% of the company’s share capital, subscribed for new ordinary shares in the capital increase for a total amount of 25 million euros and 1,67 million euros, respectively. Several specialized healthcare investors, including Invus, also participated in the Offering.

As a result of the Capital Increase, the company’s share capital will be made up of 97,771,334 shares, each having a nominal value of €0.50, for a total share capital of 48,885,667 euros.

The funds raised in the Capital Increase will be used to strengthen the Company’s financial structure until the fourth quarter of 2023, in order to be able to conduct its clinical development plan, in particular on its new innovative product platforms myvac and Invir.IO, with the finalization of clinical studies, and to be able to serenely negotiate partnership and codevelopment agreements based on the results obtained from the end of 2021.

Funds will be directly used by descending order of strategic priority:
• circa €25m for the finalization of clinical studies and the obtention of data with TG4001, TG4050, BT-001 and TG6002;
• circa €4m to launch the clinical development of new oncolytic viruses based on the Invir.IO platform and currently undergoing preclinical evaluation;
• for the remainder, to finance, together with operational products of the Company, R&D and operational costs, as well as current cash consumption.

The transaction will be carried out under the 22nd resolution of the Combined General Shareholders’ Meeting of May 27, 2020. The Capital increase was the subject of a placement agreement entered into by the Company and the Global Coordinators on June 21, 2021. The placement agreement may be terminated by the Global Coordinators at any time up to (and including) the settlement date of the Capital Increase which is expected to take place on June 24, 2021, subject to certain customary conditions. Not for release, publication or distribution, directly or indirectly, in or into the United States of America, Canada, Australia or Japan

To the Company’s knowledge, the breakdown of its share capital after the Capital Increase is as follows

(1): (1) On a non-diluted basis: before the potential exercise of the 41,352 stock-options outstanding as of the date of this press release and representing 0,0004% of both share capital and voting rights of Transgene.

SHAREHOLDERS’ SUBSCRIPTION AND LOCK-UP AGREEMENTS TGSH and SITAM Belgique have agreed with the Global Coordinators for the contemplated transaction that they will not sell or transfer its shares of Transgene for a period ending 90 days after the settlement and delivery of the Capital Increase, subject to the customary exceptions. In connection with the Capital Increase, the Company will enter into a lock-up agreement with the Global Coordinators for a period ending 90 days after the settlement and delivery of the Capital Increase, subject to the customary exceptions.

RISKS FACTORS Transgene draws the attention of the public to:
• The risk factors presented in the Universal Registration Document; the materialization of any or all of these risks is likely to have a detrimental effect on the activity, financial situation, or the results of Transgene or on its ability to achieve its objectives.
• The main risks associated with the Capital Increase are the following: o the market price of the Company shares may fluctuate and fall below the subscription price of the new shares; o due to stock market fluctuations, the volatility and liquidity of the Company shares may vary significantly; o the sale of Company shares may occur on the secondary market, after the capital increase, and have a negative impact on the Company share price; o regarding the use of the expected proceeds of the issuance within the context of the Capital Increase, the Company has room for maneuver as to the use of the funds raised and could use them in a way that the shareholders may not adhere to or that would not increase the value of their investment in the short term; and o a new market-based call by the Company, after the Capital Increase, could result in further dilution for the investors.

HUTCHMED announces savolitinib approved in China for patients with lung cancer with MET exon 14 skipping alterations

On June 22, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM) reported that AstraZeneca PLC ("AstraZeneca") and HUTCHMED’s savolitinib has been granted conditional approval in China for the treatment of patients with non-small cell lung cancer ("NSCLC") with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy (Press release, Hutchison China MediTech, JUN 22, 2021, View Source [SID1234586912]). This approval follows a priority review designation by China’s National Medical Products Administration ("NMPA") and marks the first regulatory approval globally for this oral, potent and selective MET tyrosine kinase inhibitor ("TKI").

Approximately 2-3% of newly diagnosed NSCLC patients have MET exon 14 skipping alterations, a specific genetic mutation.

The approval by the NMPA was based on positive results from a Phase II trial conducted in China in patients with NSCLC with this mutation, including patients with the more aggressive pulmonary sarcomatoid carcinoma subtype. Savolitinib demonstrated effective anti-tumor activity based on an independent review of objective response rate ("ORR") and disease control rate ("DCR"). The approval is conditional upon successful completion of a confirmatory study in this patient population.

Christian Hogg, Chief Executive Officer of HUTCHMED, said: "It is with great pleasure that today we announce the first regulatory approval of savolitinib globally, HUTCHMED’s third self-discovered oncology drug to be commercialized. Our collaboration with AstraZeneca in 2011 has been an important driver in the development of this novel targeted oncology drug, involving both a China-based biotech and a global pharma company. This approval is a testament to the perseverance and scientific ingenuity of this long-standing alliance, and we are hopeful that this is only the beginning of the progress we can achieve for patients with MET-altered tumors."

Dave Fredrickson, Executive Vice President, Oncology Business Unit of AstraZeneca, said: "This approval makes savolitinib the only targeted medicine approved for these biomarker-selected patients in China, and it adds another novel medicine to our already diverse lung cancer portfolio. We are proud that this first-ever regulatory approval of savolitinib is in China, where we have a long-standing commitment to improving patient outcomes and working with the right partners to achieve that goal. Alongside HUTCHMED, we look forward to the continued development of this medicine across a range of cancers where MET alterations and amplification are drivers of tumor growth and treatment resistance."

About savolitinib
Savolitinib is an oral, potent and selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations).

Savolitinib is currently under development for multiple tumor types, including lung, kidney and gastric cancers, as a single treatment and in combination with other medicines.

HUTCHMED and AstraZeneca collaboration
In 2011, HUTCHMED and AstraZeneca entered a global licensing agreement with respect to the development and commercialization of savolitinib. HUTCHMED is responsible for the manufacturing and supply of savolitinib, and AstraZeneca is responsible for its commercialization in China and worldwide.

Tempest and Millendo Announce Stockholder Approval of Merger

On June 22, 2021 Tempest Therapeutics, Inc. ("Tempest"), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, and Millendo Therapeutics, Inc. (Nasdaq: MLND) ("Millendo"), reported the results for the proposals voted upon by Millendo stockholders at a Special Meeting on June 22, 2021 (Press release, Tempest Therapeutics, JUN 22, 2021, View Source [SID1234585165]). The stockholders voted in favor of all proposals at the Special Meeting, including to approve the proposed merger between the companies.

The closing of the merger is anticipated to take place on or around Friday, June 25, 2021. Following the closing of the merger, the combined company will be renamed Tempest Therapeutics and shares will begin trading with the open of the market on Monday, June 28, 2021 under the ticker "TPST."

Entry into a Material Definitive Agreement

On June 22, 2021, BioXcel Therapeutics, Inc. (the "Company") reported that entered into an underwriting agreement (the "Underwriting Agreement") with BofA Securities, Inc., as representative of the several underwriters named therein (collectively, the "Underwriters") and the selling stockholder named therein (the "Selling Stockholder"), in connection with the issuance and sale by the Company in a public offering of 3,155,000 shares of the Company’s common stock at a public offering price of $31.70 per share, less underwriting discounts and commissions, pursuant to an effective shelf registration statement on Form S-3ASR (Registration No. 333-240118) and a related prospectus supplement filed with the Securities and Exchange Commission (the "SEC") (Filing, 8-K, BioXcel Therapeutics, JUN 22, 2021, View Source [SID1234584368]). Under the terms of the Underwriting Agreement, the Selling Stockholder has also granted the Underwriters an option exercisable for 30 days to purchase up to an additional 473,250 shares of common stock at the public offering price, less underwriting discounts and commissions. The Company will not receive any of the proceeds from any sale of shares in the offering by the Selling Stockholder.

The Company received net proceeds from the offering of approximately $96.8 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The Company intends to use the net proceeds of the offering to fund ongoing clinical trials, commercialization preparation and for general corporate purposes.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company and the Selling Stockholder, customary conditions to closing, indemnification obligations of the Company, the Selling Stockholder and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions.

The foregoing description of the Underwriting Agreement is not complete and is qualified in its entirety by reference to the full text of the Underwriting Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated by reference herein. An opinion of Latham & Watkins LLP regarding the validity of the shares to be issued and sold in the offering by the Company is filed as Exhibits 5.1 and an opinion of the Company’s Chief Legal Officer regarding the validity of the shares to be sold in the offering by the Selling Stockholder is filed as Exhibit 5.2.

Based on the planned use of proceeds from the offering, the Company believes that the net proceeds from the offering and its existing cash and cash equivalents will be sufficient to enable it to fund operating expenses and capital expenditure requirements into the first half of 2023. The Company has based this estimate on assumptions that may prove to be incorrect, and could utilize available capital resources sooner than currently expected. The amounts and timing of the Company’s actual expenditures will depend on numerous factors, including the progress of the Company’s clinical trials and other development efforts and other factors, as well as the amount of cash used in the Company’s operations.

AI-driven biotech firm Insilico Medicine raises $255 mln in new financing

On June 22, 2021 Hong Kong-based company Insilico Medicine, which uses artificial intelligence (AI) for drug discovery and development, reported that it has raised $255 million in a new funding round by U.S. private equity firm Warburg Pincus , it said on Tuesday (Press release, Insilico Medicine, JUN 22, 2021, View Source [SID1234584360]).

The fundraising attracted nearly 20 investors according to the company’s announcement, including CPE, Sequoia Capital China and Mirae Asset Capital.

Existing investors including Qiming Venture Partners, Sinovation Ventures and Baidu Ventures also joined in the funding round.

Insilico did not disclose its valuation in the release.

Founded in 2014 by Scientist Alex Zhavoronkov, Insilico develops AI systems that utilize deep generative models, reinforcement learning (RL), transformers, and other modern machine learning techniques for the generation of new molecular structures with specific properties.

It also develops software for the generation of synthetic biological data, target identification, and the prediction of clinical trials outcomes.

The new funds raised will be used to progress Insilico’s current therapeutic programs into human clinical trials, initiate multiple new programs for novel and difficult targets, and further develop its AI and drug discovery capabilities, the company said.

The company is known for its 2019 research about its development of an AI system that was able to design a drug in 21 days and was named a 2020 breakthrough technology by MIT Technology Review.

It now operates in six locations worldwide with over 160 scientists, according to its website.

The company has raised over $310 million from expert pharmaceutical, and technology investors since its inception, it said. (Reporting by Kane Wu)