On January 7, 2021 Scorpion Therapeutics, Inc., a next-generation precision oncology company, reported the closing of an oversubscribed Series B financing, which raised $162 million (Press release, Scorpion Therapeutics, JAN 7, 2021, View Source;utm_medium=rss&utm_campaign=scorpion-therapeutics-announces-oversubscribed-162-million-series-b-financing [SID1234573610]). The financing was led by Boxer Capital of Tavistock Group, EcoR1 Capital, LLC, Omega Funds and Vida Ventures, with participation from new investors Surveyor Capital (a Citadel company), Invus, Wellington Management Company, Nextech Invest, OrbiMed, Casdin Capital, LLC, Woodline Partners LP, Logos Capital, Janus Henderson Investors and other undisclosed institutional investors, as well as existing investors Atlas Venture and Abingworth. With this financing, Scorpion has raised approximately $270 million since the company was founded in the first quarter of 2020.

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"We are grateful to our new and existing investors for their commitment to our bold vision of advancing precision medicine as an option for many more people diagnosed with cancer," said Gary D. Glick, Ph.D., President and Chief Executive Officer of Scorpion Therapeutics. "This financing will enable us to increase our investment in our platform technologies and programs, as we execute with equal parts urgency and rigor to transform the standard-of-care in cancer. We aim to advance new therapies that provide deeper and more durable responses, are less toxic to healthy tissues and have the potential to overcome key mechanisms of resistance. We look forward to naming our first development candidate in 2021, initiating clinical trials in 2022 and, ultimately, to delivering a pipeline of next-generation targeted cancer therapies to patients who need them."

Proceeds from the financing will be used to support the continued development of Scorpion’s drug hunting engine, which integrates state-of-the-art capabilities across multiple fields of translational medicine, chemical biology, medicinal chemistry, and data science, as well as the advancement of Scorpion’s growing portfolio, which includes several therapeutic candidates across a range of biological approaches for tumor targeting. Scorpion Therapeutics is building its pipeline in three distinct tracks: the first is focused on designing best- or first-in-class therapeutic candidates against known, high-impact oncogenes that leverage optimal therapeutic design to more exquisitely target tumor tissue across all metastatic sites; the second track moves beyond oncogenes and is aimed at developing therapeutic candidates against a set of non-enzymatic targets that have historically been classified as "undruggable;" and the third is focused on a new wave of protein targets, discovered by Scorpion Therapeutics, which have the potential to transform cancer treatment paradigms for large patient populations.

"In less than a year since its founding, Scorpion Therapeutics has grown with remarkable speed and efficiency, articulating a clear strategy for transforming standards of care in oncology, attracting an experienced and accomplished team of scientists and biotech executives and building a robust research-stage portfolio," said Otello Stampacchia, Founder and Managing Director, Omega Funds.

"Scorpion’s novel therapeutic approach represents an important advance with the potential to shift the treatment paradigm for some of the most elusive cancers and make a meaningful impact for patients. With this financing, the company is well-positioned to accelerate its platform technologies and programs into the next stage of development," said Arjun Goyal, M.D., MPhil, Co-Founder and Managing Director of Vida Ventures.

"We believe Scorpion Therapeutics’ multidimensional platform and thoughtful, data-driven approach to clinical development will enable the company to move rapidly and efficiently to deliver Precision Oncology 2.0 and we are proud to support the team in their efforts," added Oleg Nodelman, Founder and Portfolio Manager of EcoR1 Capital LLC.

"Scorpion is at a pivotal stage of its development, as it prepares to name its first development candidate and advance into clinical trials. We look forward to partnering with the management team to build out a robust pipeline, with the goal of addressing current limitations of precision oncology and transforming cancer care for patients," commented Aaron Davis, Co-Founder and Chief Executive Officer of Boxer Capital.

Presentation at the 39th Annual J.P. Morgan Healthcare Conference

Gary Glick, Ph.D., Scorpion’s President and Chief Executive Officer, will provide an overview of the company at the 39th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13 at 10:25 a.m. ET.

The live webcast can be accessed under "News" on the Scorpion website at www.scorpiontx.com. Please connect to the company’s website at least 15 minutes prior to the start of the presentation to ensure adequate time for any software download that may be required to listen to the webcast. The replay will be available for 30 days following the presentation.

On January 7, 2021 Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology company, reported that the GBM AGILE pivotal study (NCT03970447) has commenced recruitment to the paxalisib arm (Press release, Kazia Therapeutics, JAN 7, 2021, View Source [SID1234573609]).

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Key Points

GBM AGILE is an international adaptive, multi-drug study, designed to expedite the development of new therapies for glioblastoma

Kazia executed a definitive agreement with the Global Coalition for Adaptive Research (GCAR) in October 2020 to bring paxalisib into GBM AGILE

Lead investigators for the paxalisib arm are Professor Ingo Mellinghoff (Memorial Sloan Kettering Cancer Center) and Dr Eudocia Q Lee (Dana-Farber Cancer Institute)

Positive data from GBM AGILE is expected to support registration of paxalisib in the US and other key markets

Kazia CEO, Dr James Garner, commented, "we are delighted to have recruitment underway, and this marks an important milestone for Kazia as we begin the new year. The GBM AGILE study has secured the support of leading clinicians in the glioblastoma field, and has increasingly won the confidence of regulators and industry participants, so we are excited to be a part of it. If the data from GBM AGILE is positive, we expect it to provide a basis for registration in glioblastoma, and it therefore represents an important step towards commercialisation of the drug.

Clinical Trial Design

The paxalisib arm of GBM AGILE will recruit newly diagnosed patients with the unmethylated MGMT promotor, a genetic marker that denotes near-total resistance to temozolomide, the existing FDA-approved standard of care. In addition, the study will recruit recurrent patients who have progressed despite treatment with temozolomide. The adaptive design allows GBM AGILE to balance between these two patient groups according to emerging data, so it is possible for paxalisib to emerge successful in one or both populations. The primary endpoint of GBM AGILE is overall survival, which is considered the gold standard for the evaluation of new cancer therapies, and which is the preferred approval endpoint for regulators such as the US FDA.

The study will recruit up to 200 patients on paxalisib in total, and these will be compared against a roughly similar number of patients in a control group, with patients being randomly allocated between the groups. The total data set for paxalisib will therefore include up to approximately 450 patients from GBM AGILE. The duration of paxalisib’s enrolment is initially estimated to be approximately 30-36 months. However, the adaptive design of GBM AGILE means that if a definitive conclusion is evident at an earlier stage, the study will conclude at that point, with a commensurate reduction in timelines and cost.

Further information was provided in Kazia’s announcement to the ASX on 16 October 2020.

Operational Update on GBM AGILE

GBM AGILE commenced operation in July 2019. The first drug to join the study was regorafenib (Bayer), which is an approved therapy for other solid tumours. Kazia Therapeutics’ paxalisib and Kintara Therapeutics’ VAL-083 commenced recruitment in January 2021.

At present, GBM AGILE is operational in over 30 centres across the United States and has screened over 370 patients to date. The study is expected to open sites in Canada, Europe, and China during CY2021.

The first site to open to the paxalisib arm is the Henry Ford Cancer Institute in Detroit, MI, under the oversight of Dr Tom Mikkelsen. It is expected that other sites will rapidly open to the paxalisib arm as they receive approval from their Institutional Review Boards.

Paxalisib Clinical Program

GBM AGILE is one of eight ongoing clinical trials of paxalisib in brain cancer.

On January 7, 2021, Iovance Biotherapeutics, Inc. Presented its corporate presentation (Press release, Iovance Biotherapeutics, JAN 7, 2021, View Source [SID1234573608]).

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On January 7, 2021 Addex Therapeutics Ltd (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported the pricing of an underwritten global offering of 6,000,000 registered shares (the New Shares) (including shares in the form of American Depositary Shares, or ADSs) at a public offering price of approximately CHF1.47 per share or $10.00 per ADS (Press release, Addex Therapeutics, JAN 7, 2021, View Source [SID1234573607]). Each ADS represents the right to receive six shares of Addex. The aggregate gross proceeds from the offering are expected to be $10.0 million, before deducting the underwriting discounts and commissions and offering expenses payable by Addex. The offering is expected to close on or about January 11, 2021, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as sole book-running manager for the offering.

In connection with the offering, Addex has granted the underwriter a 30-day option to purchase up to additional 900,000 shares (or ADSs) at the public offering price, less the underwriting discounts and commissions.

The New Shares will be issued from existing authorized share capital of Addex under exclusion of the existing shareholders’ pre-emptive rights.

The New Shares, if issued, are expected to be listed and admitted to trading on SIX Swiss Exchange. The New Shares will rank pari passu with Addex’s existing shares.

The shares, including those to be settled in the form of ADSs, are being offered and sold pursuant to the Company’s previously filed registration statement on Form F-1 (File No. 333-251322), as amended, with the U.S. Securities and Exchange Commission (SEC) and declared effective by the SEC on January 6, 2021. The offering is being made by means of a prospectus. When available, an electronic copy of the final prospectus relating to, and describing the terms of, the offering may be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996 or e-mail at [email protected] or on the SEC’s website at SEC.gov.

This press release shall 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 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. There is no intention or permission to publicly offer, solicit, sell or advertise, directly or indirectly, any securities of Addex Therapeutics Ltd in or into Switzerland within the meaning of the Swiss Financial Services Act ("FinSA"). Neither this document nor any other offering or marketing material relating to these securities, such as the shares, constitutes or will constitute a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the shares constitutes a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the shares may be publicly distributed or otherwise made publicly available in Switzerland.

On January 7, 2021 The Executive Board of Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported that with the consent of the Supervisory Board, to issue a subordinated mandatory convertible bond in an aggregate principal amount of up to EUR 5,500,000.00 (Press release, Epigenomics, JAN 7, 2021, View Source [SID1234573606]). It may be converted into up to a total of 5,000,000 registered no-par value shares of the Company with a share in the Company’s share capital of up to a total of EUR 5,000,000.00.

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The mandatory convertible bond consists of up to 500,000 notes with a nominal amount of EUR 11.00 each, which will be offered for subscription at an issue price of EUR 11.00 each by means of a rights offering initially to the existing shareholders of Epigenomics AG. Shareholders will be given the option of over-subscription. The rights offering is scheduled for publication on the Company’s website (www.epigenomics.com) and in the German Federal Gazette on January 11, 2021. The subscription period for the Company’s shareholders is scheduled to start on January 13, 2021 and to end on January 27, 2021 (including each of these two days). Epigenomics AG has signed a back-stop agreement with its shareholder Deutsche Balaton Aktiengesellschaft, under which Deutsche Balaton Aktiengesellschaft has undertaken to acquire notes in an aggregate principal amount of up to EUR 4,000,000.00 by exercising its subscription rights and by the acquisition of notes not subscribed for via subscription rights and oversubscription rights. An application has been made for the subscription rights to be traded on the open market of the Hamburg Stock Exchange.

The notes are non-interest-bearing (zero coupon) and have a term until February 29, 2024. In addition to the conversion rights of the holders or creditors of the bonds, the terms and conditions of the bonds also include a conversion obligation for all outstanding notes not yet converted on February 29, 2024.

Subject to any anti-dilution adjustments, the conversion price per share is EUR 1.10 and the conversion ratio is 1:10. This means that each note is convertible into ten no-par value shares with a share in the Company’s share capital of EUR 1.00 per share.

Epigenomics AG plans to use the proceeds from the issue of the mandatory convertible bond to finance its business operations. The proceeds primarily serve to mitigate the financial pressure to act following the pending announcement of the final decision by the U.S. Centers for Medicare & Medicaid Services (CMS) in connection with the ongoing reimbursement process for the Epi proColon colorectal cancer screening test in the U.S.A. (National Coverage Determination, NCD) and not to be dependent on the capital market environment in the short term. Furthermore, the funds will help to financially secure any delay in the announcement of the CMS decision.

M.M. Warburg & CO (AG & Co.) Kommanditgesellschaft auf Aktien is acting as sole underwriter of the transaction.