Diamyd Medical AB reported its intention to carry out a directed share issue corresponding to approximately SEK 125-150 million through a so-called accelerated bookbuilding process (Press release, Diamyd Medical, SEP 9, 2021, View Source;ClipID=4062338 [SID1234587489]). The objective of the directed share issue is to support the Company’s ongoing establishment of its own manufacturing facility in Umeå and a precision medicine phase III trial with the diabetes vaccine Diamyd in individuals recently diagnosed with type 1 diabetes and who carry the genetic HLA type where efficacy has been shown in previous trials.
Diamyd Medical announces its intention to carry out a directed new share issue corresponding to a value of approximately SEK 125-150 million, directed at qualified investors, with deviation from existing shareholders’ preferential rights, based on the authorisation granted by the Annual General Meeting held on 26 November 2020 (the "Directed Share Issue"). Diamyd Medical has engaged G&W Fondkommission to investigate the possibilities to conduct the Directed Share Issue.

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The subscription price for the new shares in the Directed Share Issue is to be determined through an accelerated bookbuilding procedure, which will begin immediately after the announcement of this press release. The Directed Share Issue is contingent on a resolution by the Board of directors, which, alongside pricing and allocation of shares, is expected to occur prior the commencement of trading on Nasdaq First North Growth Market on 10 September 2021. The Board of directors may at any time choose to cancel the bookbuilding procedure, close earlier or later and refrain from executing the Directed Share Issue, in part of in full.

The proceeds from the Directed Share Issue will be used to achieve important milestones with a focus on initiating a precision medicine pivotal phase III trial with the diabetes vaccine Diamyd in all countries that will be included in the trial and for the ongoing establishment of Diamyd Medical’s manufacturing facility in Umeå, Sweden, for the production of the recombinant human protein GAD65, the active component of the therapeutic diabetes vaccine Diamyd. The phase III trial is designed to confirm the efficacy and safety of Diamyd in individuals recently diagnosed with type 1 diabetes and who carry the genetic HLA haplotype where efficacy is likely (approximately half of this target group). Approximately 330 patients will be recruited for the trial and the trial will be conducted at approximately 50 clinics in Europe and the US. The future CGMP-certified production process at the facility in Umeå is a central part of Diamyd Medical’s regulatory strategy for potential future conditional and accelerated market approvals for the diabetes vaccine Diamyd.

The Board has investigated the conditions for alternative financing solutions, including the main alternative, a rights issue, and in their analysis come to the conclusion that a directed issue is the best alternative for the Company, taking into account time and cost efficiency. The Board has taken into account the potential outcomes of various issue alternatives, including dilution for shareholders and the importance of strengthening the Company’s cash position prior to the planned start and operation of the phase III trial and the ongoing establishment of the manufacturing facility. Furthermore, the Board has considered the importance of seeking to diversify the shareholder base with additional insititutional/professional investors, and to further strengthen the financial position as a factor of strength in connection with partner discussions.

Adviser
G&W Fondkommission has been appointed financial adviser in connection with the Directed Share Issue. Aktieinvest FK AB is the issuing agent.

On September 9, 2021 Corcept Therapeutics Incorporated, a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported that results from its 178-patient, randomized, controlled, Phase II trial of relacorilant plus nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer will be featured in a proffered paper oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 (Press release, Corcept Therapeutics, SEP 9, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-announces-presentation-positive-results-randomized [SID1234587482]). The congress will take place from September 16 – 21, 2021.

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"We are extremely excited by the potential of relacorilant to treat women with recurrent platinum-resistant ovarian cancer," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "As we announced when we released our preliminary results, delaying disease progression without increasing side effect burden was a tremendous benefit to the women in this trial. In the first quarter of next year, we plan to initiate a pivotal Phase 3 trial to confirm these positive results."

Presentation Title: Relacorilant, a selective glucocorticoid receptor modulator, in combination with nab-paclitaxel improves progression-free survival in patients with recurrent platinum-resistant ovarian cancer: A 3-arm, randomized, open-label, phase II study

Speaker: Dr. Domenica Lorusso, Gynecologic Oncology Unit Fondazione Policlinico Universitario Gemelli IRCCS

Presentation Number: 721O

Session: Gynecological Cancers Proffered Paper Session

Presentation Date/Time: Friday, September 17, 2021 at 13:40 – 13:50 CEST | Channel 3

About Relacorilant
Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian, adrenal and castration-resistant prostate cancer and Cushing’s syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. It has received orphan drug designation in the United States for the treatment of Cushing’s syndrome and pancreatic cancer.

On September 9, 2021 Bristol Myers Squibb reported that its Board of Directors has declared a quarterly dividend of forty-nine cents ($0.49) per share on the $.10 par value common stock of the company (Press release, Bristol-Myers Squibb, SEP 9, 2021, View Source [SID1234587477]). The dividend is payable on November 1, 2021 to stockholders of record at the close of business on October 1, 2021.

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In addition, the Board of Directors has declared a quarterly dividend of fifty cents ($0.50) per share on the company’s $2.00 convertible preferred stock, payable December 1, 2021 to stockholders of record at the close of business on November 9, 2021.

September 9, 2021 Boston Scientific Corporation reported that it will host a meeting with the investor community to review its financial goals and long-term growth strategies on Wednesday, September 22, 2021, from 8:30 a.m. – 12:30 p.m. EDT (Press release, Boston Scientific, SEP 9, 2021, View Source [SID1234587476]). Company leaders will also provide business unit market overviews, pipeline updates and spotlight key products from the company’s Cardiovascular, MedSurg and Rhythm and Neuro segments.

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The meeting will be held in hybrid format, live in Boston as well as a simultaneous webcast. Investors and other interested parties may register for the live meeting or webcast by visiting the events and presentations section on the company’s investor website at View Source A replay and summary materials from the presentations will also be available online for approximately one year following the event.

On September 9, 2021 Twist Bioscience Corporation, a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported a broad-based research collaboration with Boehringer Ingelheim International GmbH to use Twist’s proprietary antibody libraries to discover therapeutic antibodies against multiple targets provided by Boehringer Ingelheim (Press release, Boehringer Ingelheim, SEP 9, 2021, View Source [SID1234587473]).

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"Boehringer Ingelheim believes Twist’s ability to generate potent, diverse therapeutic antibodies by mining its comprehensive libraries, combined with our extensive capabilities and experience in drug discovery and development, will enable us to deliver breakthrough opportunities to patients," said Clive R. Wood, Ph.D., Senior Corporate Vice President and Global Head of Discovery Research at Boehringer Ingelheim. "We look forward to working with Twist on molecular targets in a broad range of disease areas," added Wood.

Under the terms of the agreement, Twist Biopharma, a division of Twist, will utilize its "Library of Libraries," a panel of synthetic antibody phage display libraries derived only from sequences that exist in the human body, to identify potential therapeutic antibody candidates. Twist and Boehringer Ingelheim will work together to validate and optimize any resulting new antibody candidates, which could be researched against a range of therapeutic areas. Boehringer Ingelheim retains exclusive worldwide rights to develop and commercialize any therapeutic antibodies discovered as part of the collaboration.

Twist will receive an upfront payment for each program entry. In addition, Twist has the potential to earn up to a total of $710 million in success-based clinical, regulatory and commercial milestone payments for the multiple target discovery programs.

"This discovery collaboration with Boehringer Ingelheim covering numerous targets truly illustrates the power of our antibody libraries. We have the ability to generate precise antibodies to a diverse range of targets, which together with Boehringer Ingelheim’s strength in drug development capabilities, could mean multiple new, more personalized treatments in the future for patients," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist.