BERGENBIO ASA – PRIVATE PLACEMENT SUCCESSFULLY PLACED

On May 4, 2020 BerGenBio ASA (OSE:BGBIO) ("BerGenBio" or the "Company") reported that contemplated private placement of new shares in the Company (the "Private Placement") (Press release, BerGenBio, MAY 4, 2020, View Source [SID1234556994]).

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The Company is pleased to announce that the Private Placement has been successfully placed, raising gross proceeds of NOK 500 million through the allocation of 13,325,000 shares at a subscription price of NOK 37.50 per share (the "Subscription Price"). The Private Placement, that was oversubscribed, took place through an accelerated book building process after close of market on 4 May 2020. Arctic Securities AS, Carnegie AS and DNB Markets, a part of DNB Bank ASA acted as Joint Bookrunners (together the "Managers") in connection with the Private Placement.

The Company intends to use the net proceeds from the Private Placement to take full advantage of clinical development opportunities stemming from the Company’s technology and to progress readiness for early commercialisation possibilities, as well as for general corporate purposes.

In connection with the Private Placement, a group of employees in the Company realized a small portion of their existing shares or shares acquired through exercise of options, in total 302,500 shares in the Company, at the same price as the subscription price in the Private Placement (the "Secondary Sale", and together with the Private Placement the "Transaction"). The following primary insiders either subscribed for shares or sold shares or options in the Transaction:

Meteva AS, represented on the board of directors by Sveinung Hole, was allocated 1,706,667 shares in the Transaction. Following the Transaction, Meteva will own 21,956,142 shares in the Company, equal to 25.32% of the share capital.

Altitude Capital AS, represented on the board of directors by Grunde Eriksen, was allocated 65,000 shares in the Transaction. Following the Transaction, Altitude Capital AS, will own 780,000 shares in the Company, equal to 0.90% of the share capital.

Richard Godfrey (Chief Executive Officer and primary insider) has through Gnist Holding AS sold 200,000 existing shares in the Company as part of the Transaction. Following the Transaction, Richard Godfrey will own 21,005 shares (equal to 0.02% of the share capital) and 1,542,617 options in the Company.

Endre Kjærland (Associate Director of IP and Contracts and primary insider) will as part of the Transaction exercise options and sell 20,000 shares. Following the Transaction, Endre Kjærland will own 3,262 shares (equal to 0.004% of the share capital) and 130,525 options in the Company.

Gro Gausdal (Director of Research & Bergen Site Leader and primary insider) will as part of the Transaction exercise options and sell 15,000 shares. Following the Transaction, Gro Gausdal will own 143,376 options in the Company.

In addition, non-primary insiders among the Company’s employees will exercise options and sell 67,500 shares as part of the Transaction. The selling employees will enter into a customary 6 months lock-up undertaking on their remaining holdings with the Joint Bookrunners.

The shares allocated in the Transaction will be settled through a delivery versus payment transaction on a regular T+2 basis by delivery of existing and unencumbered shares in the Company that are already listed on the Oslo Stock Exchange pursuant to a share lending agreement between Arctic Securities (on behalf of the Managers), the Company, the sellers in the Secondary Sale and Meteva AS. The shares delivered to the applicants will thus be tradable from allocation. The Managers will settle the share loan with new shares in the Company to be issued by the board of directors of the Company (the "Board") pursuant to an authorization granted at the Company’s annual general meeting held on 16 March 2020. Notification of allocation of shares and payment instructions is expected to be sent to the applicants through a notification from the Managers on 5 May 2020.

Following registration of the new share capital in the Company and issuance of the new shares in the Transaction (including options exercised by employees) with the Norwegian Register of Business Enterprises, which is expected to take place on or about 7 May 2020, the Company will have an issued share capital of NOK 8,672,580.50 divided into 86,725,805 shares, each with a par value of NOK 0.10.

Completion of the Private Placement implies a deviation from the existing shareholders’ pre-emptive rights to subscribe for and be allocated new shares. The Board has considered the Private Placement in light of the equal treatment obligations under under the Norwegian Securities Trading Act and Oslo Børs’ Circular no. 2/2014, and is of the opinion that the proposed Private Placement is in compliance with these requirements. Following careful considerations, the Board is of the view that it will be in the common interest of the Company and its shareholders to raise equity through a Private Placement setting aside the pre-emptive rights of the existing shareholders to subscribe for shares. By structuring the transaction as a Private Placement, the Company will be in a position to raise capital in an efficient manner, with a lower discount to the current trading price and with significantly lower completion risks compared to a rights issue. In addition, the Private Placement was marketed through a publicly announced bookbuilding process.

Subject to inter alia (i) completion of the Private Placement, (ii) relevant corporate resolutions including approval by the Board and the EGM, (iii) prevailing market price of the Company’s shares being noticeably higher than the subscription price, and (iv) approval by the Financial Supervisory Authority of Norway of a prospectus (the "Prospectus"), the Company will carry out a subsequent offering (the "Subsequent Offering") of up to 1,500,000 new shares in the Company. A Subsequent Offering will, if made, and on the basis of the Prospectus, be directed towards eligible shareholders in the Company who (i) are shareholders in the Company as of 4 May 2020, as registered as shareholders in the Company’s register of shareholders with the Norwegian Central Securities Depositary (Nw. Verdipapirsentralen) (the "VPS") as of 6 May 2020, (ii) are not allocated shares in the Private Placement, (iii) are not resident in a jurisdiction where such offering would be unlawful or, for jurisdictions other than Norway, would require any prospectus, filing, registration or similar action, and (iv) have an existing shareholding below a threshold of 150,000 shares in the Company (the "Eligible Shareholders"). The Eligible Shareholders are expected to be granted non-tradable allocation rights. The subscription period in the Subsequent Offering is expected to commence shortly after publication of the Prospectus, and the subscription price in the Subsequent Offering will be the same as in the Private Placement. When deciding the need for and size of a potential subsequent offering, the Board will factor in the amount of upcoming short-term news flow in connection with the Company’s participation in the ACCORD study related to Covid-19 (including the need to avoid that a subsequent offering will provide the Eligible Shareholders with an unreasonable option value). The Board will also consider the trading volume and market price of the shares in the Company in the intermediate period. The Company will issue a separate stock exchange notice with further details on the Subsequent Offering if and when finally resolved.

TargetRx of Shenzhen Raises $21 Million for Novel Small Molecule Cancer Drugs

On May 4, 2020 TargetRx, a Shenzhen company developing small molecules therapeutics for cancer, reported that it has completed a $21.2 million Series A financing, led by CCB Principal Capital Management (Press release, Shenzhen TargetRx, MAY 4, 2020, View Source [SID1234556985]). Founded in 2014, the company is developing novel third/fourth generation candidates with the goal of avoiding acquired drug resistance. Proceeds from the funding will be used for clinical studies of the company’s chronic myeloid leukemia and non-small cell lung cancer treatments and other R&D. The founder of TargetRx, Dr. Yihan Wang, has previously discovered several first-in-class novel drugs.

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Ascentage Pharma’s Core Drug Candidate HQP1351 Granted Orphan Drug Designation by the US FDA for the Treatment of Patients with Chronic Myeloid Leukemia

On May 4, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the US Food and Drug Administration (US FDA) has granted HQP1351, the Company’s core drug candidate, an Orphan Drug Designation (ODD) for the treatment of chronic myeloid leukemia (CML) (Press release, Ascentage Pharma, MAY 4, 2020, View Source [SID1234556982]). This is the first ODD obtained by Ascentage Pharma.

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The term "orphan drugs" refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions. In the United States, an orphan disease is defined as a disease or condition with a prevalence of less than 200,000 patients in the country. Since the Orphan Drug Act was passed in 1983, the US government has provided incentives and policy support to encourage development of orphan drugs. This ODD from FDA qualifies HQP1351 for various development incentives, including a tax credit of 50% of expenditures incurred in clinical studies, a waiver of the New Drug Application (NDA) fee, research grant awarded by FDA, and, most importantly, 7 years of US market exclusivity upon approval.

CML is a rare hematologic malignancy with an annual incidence rate of approximately 1.9 cases/100,000. BCR-ABL tyrosine kinase inhibitors (TKIs) have significantly improved clinical management of CML. However, despite clinical benefits offered by the first-generation BCR-ABL TKI imatinib (Gleevec), and several second-generation TKIs, many patients develop drug resistance. Such acquired resistance to TKIs is a major challenge in the treatment of CML. BCR-ABL kinase mutations represent a key mechanism of acquired drug resistance; T315I, which is the most common drug-resistant mutation, occurs in about 25% of patients with drug-resistant CML. Patients with the T315I mutation are resistant to both first- and second-generation BCR-ABL inhibitors, hence presenting an urgent unmet medical need for next-generation BCR-ABL inhibitors to more effectively target the T315I mutation.

HQP1351 is a novel, orally active, potent third-generation BCR-ABL inhibitor designed to effectively target BCR-ABL mutants, including T315I, and it is being developed for the treatment of patients with CML resistant to first- and second-generation TKIs. In July 2019, HQP1351 was cleared by FDA to enter a Phase Ib study. HQP1351 is the first China-developed third-generation BCR-ABL inhibitor targeting drug-resistant CML. The drug candidate is currently being evaluated in a pivotal Phase II study in China, and Ascentage Pharma plans to submit an NDA for HQP1351 this year. Data from the Phase I clinical study of HQP1351 were selected for oral presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meetings two years in a row and was a finalist of "Best of ASH (Free ASH Whitepaper)" research in 2019.

"There is significant unmet clinical need in the treatment of CML globally. This ODD from FDA marks a major milestone for HQP1351 which will bring about the incentives and support that will enable us to further accelerate the global development and commercialization of this drug candidate," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "Given the favorable safety and efficacy data obtained thus far, we will expedite the development and are hopeful that HQP1351 will soon benefit patients worldwide."

Medicenna Announces Upcoming Presentations at the ASCO Annual Meeting

On May 4, 2020 Medicenna Therapeutics Corp. ("Medicenna" or "the Company") (TSX: MDNA,OTCQB: MDNAF), a clinical stage immuno-oncology company, reported that it will be presenting two abstracts at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Virtual Scientific Program to be held from May 29 to May 31, 2020 (Press release, Medicenna Therapeutics, MAY 4, 2020, View Source [SID1234556981]).

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The first abstract has been selected for a poster discussion and will provide new data on tumor response as well as survival outcomes compared to a matched Synthetic Control Arm ("SCA"). Details of the poster discussion presentation are below:

Presenter:

Dr. John Sampson, MD, PhD, MHSc, MBA, Robert H. and Gloria Wilkins
Distinguished Professor and Chair of Neurosurgery, Duke University School of
Medicine

Title:

"MDNA55 survival in recurrent glioblastoma ("rGBM") patients expressing the
interleukin-4 receptor ("IL4R") as compared to a matched synthetic control"

Abstract #:

2513

Session Title:

CNS Tumors

Discussant:

Dr. Ian Parney, MD, PhD

The second abstract will present pre-clinical data including non-human primate data for MDNA11, one of Medicenna’s IL2 Superkine candidates. Details of the poster presentation are below:

Presenter:

Dr. Moutih Rafei, PhD, Associate Professor, Department of Pharmacology and
Physiology, Université de Montreal

Title:

"In vitro and in vivo characteristics of MDNA11: A long-acting ‘Beta-only’
IL-2 Superkine in syngeneic mice tumor models and non-human primates"

Abstract #:

3036

Session Title:

Developmental Therapeutics Immunotherapy

Presentations and posters will be available for on-demand viewing online at View Source beginning on May 29, 2020 at 8:00 a.m. ET.

Protagonist Therapeutics to Announce First Quarter 2020 Financial Results and Provide Corporate and R&D Update

On May 4, 2020 Protagonist Therapeutics, Inc. (Nasdaq:PTGX) reported that it will announce first quarter financial results after the NASDAQ market closes on Thursday, May 7, 2020 (Press release, Protagonist, MAY 4, 2020, View Source [SID1234556980]). Protagonist management will host a conference call to provide a corporate and R&D update at 5:00 p.m. EDT/2:00 p.m. PDT the same day.

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Conference Call and Webcast Information

Protagonist executives will host a conference call at 5:00 p.m. EDT/2:00 p.m. PDT on Thursday, May 7, 2020. To access the live call, dial 1-844-515-9178 (U.S./Canada) or 1-614-999-9313 (international) and refer to conference ID number 4597494. A live and archived webcast of the call will also be accessible in the Investors section of the Company’s website at www.protagonist-inc.com. A replay will be available on the company’s website approximately two hours after the call and will remain available for 60 days.