BioInvent International AB brings forward publication of Year-end report 2020

On February 23, 2021 BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV) reported that the company changes the date for publication of the year-end report 2020, and the interim report for the fourth quarter 2020, to Tuesday February 23, 2021 (Press release, BioInvent, FEB 23, 2021, View Source,c3293702 [SID1234575414]). Earlier communicated publication date was February 25, 2021.

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BioInvent successfully carries out a directed share issue of approximately SEK 962 million (approximately USD 116 million)

On February 23, 2021 The Board of Directors of BioInvent International AB ("BioInvent" or the "Company") (OMXS: BINV) reported that it has resolved to issue 19,095,000 shares (the "New Shares") in a directed share issue to international and Swedish institutional investors, where 2,834,399 New Shares are issued based on the authorization granted by the Extraordinary General Meeting on 27 November 2020, and 16,260,601 New Shares are issued subject to the approval of an upcoming Extraordinary General Meeting to be held on 23 March 2021 (together the "Directed Share Issue") (Press release, BioInvent, FEB 23, 2021, View Source;approxim,c3293708 [SID1234575413]).

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The price for the New Shares is SEK 50.36 per share and corresponds to the 5-day volume weighted share price of BioInvent’s share, as traded on Nasdaq Stockholm.
Investors in the Directed Share Issue are a range of international and Swedish institutional investors.
Through the Directed Share Issue, BioInvent will receive proceeds amounting to approximately SEK 962 million (approximately USD 116 million) before transaction costs.
BioInvent changes the date for publication of the year-end report 2020 and the interim report for the fourth quarter of 2020 to Tuesday, February 23, 2021. The previously announced date for publication was February 25, 2021.
Comments from the CEO

"We are very pleased to carry out this successful share issue, proceeds from which will fund the continued transformation of BioInvent and expansion of our clinical programs. BioInvent has a strong clinical oncology pipeline thanks to our F.I.R.S.T technology platform, with four ongoing clinical trials of first-in-class antibodies with unique mechanisms of action. This capital injection enables us to accelerate and broaden our clinical development." said Martin Welschof, CEO of BioInvent.

"Assuming continued generation of positive data, we plan to in particular use the funds to prepare a pivotal clinical trial of our first-in-class anti-FcγRIIB antibody BI-1206 for the treatment of Non-Hodgkin’s Lymphoma, with the aim of receiving an accelerated regulatory pathway. We also expect to expand the clinical programs of BI-1206 in combination with Keytruda and the anti-TNFR2 antibody BI-1808 as monotherapy and in combination with Keytruda.

Investors in the Directed Share Issue are a range of international and Swedish institutional investors, including Redmile Group, LLC., Invus, HBM Healthcare Investments, The Fourth National Swedish Pension Fund, Swedbank Robur Fonder and Van Herk Investments. Upon completion, Redmile will become the largest shareholder in BioInvent representing approximately 16.8 per cent of the shares and votes in the company.

I would like to thank our existing investors for their continued support and am delighted to welcome new investors in BioInvent. I look forward to continuing to work with all our investors as we continue to advance our innovative treatments to improve patients’ lives."

The Directed Share Issue

The price for the New Shares is SEK 50.36 per share and corresponds to the 5-day volume weighted share price of BioInvent share, as traded on Nasdaq Stockholm. The price per share in the Directed Share Issue has been resolved by the Board of Directors in consultation with the Joint Global Coordinators, based on negotiations with the largest new investor. Through the Directed Share Issue, BioInvent will receive proceeds amounting to approximately SEK 962 million before transaction costs.

The Directed Share Issue consists of two separate tranches: the first tranche amounting to 2,834,399 New Shares based on the authorization granted by the Extraordinary General Meeting held on 27 November 2020 ("Tranche 1") and the second tranche of 16,260,601 New Shares which will be subject to the approval of the Extraordinary General Meeting to be held on 23 March 2021 ("Tranche 2"). Completion of Tranche 1 is not conditional upon completion of Tranche 2.

The first day of trading for the New Shares in Tranche 1 will be on or about 26 February 2021 Subject to the approval of the Extraordinary General Meeting, the first day of trading for the New Shares in Tranche 2 is expected to be on or about 30 March 2021.

Tranche 2 of the Directed Share Issue will be subject to a listing prospectus prior to shares being admitted to trading on Nasdaq Stockholm. The listing prospectus is expected to be approved by the Swedish Financial Supervisory Authority on or about 24 March 2021, i.e. before the shares in Tranche 2 are subject to trading.

The reasons for deviating from the shareholders’ preferential rights are to diversify the shareholder base in the Company amongst international and Swedish institutional investors and at the same time take advantage of the opportunity to raise capital in a time and cost-efficient manner. The Board of Directors’ assessment is that the price per share in the Directed Share Issue is in accordance with market conditions.

The Directed Share Issue will entail a dilution of approximately 32.7 per cent of the number of outstanding shares and votes in the Company after the Directed Share Issue. Through the Directed Share Issue, the number of outstanding shares and votes in the Company will increase from 39,376,096 to 42,210,495 through Tranche 1 and from 42,210,495 to 58,471,096 through Tranche 2. The share capital will increase from SEK 7,875,219.20 to SEK 8,442,099 through Tranche 1 and from SEK 8,442,099 to SEK 11,694,219.20 through Tranche 2.

The Directed Share Issue is subject to certain customary conditions of the placing agreement entered into by the Company with the Joint Global Coordinators in connection with the Directed Share Issue, mainly entailing that the placing agreement is not terminated prior to the delivery of the respective Tranches.

Background and reasons

The net proceeds from the Directed Issue are mainly intended for: (i) preparations towards a pivotal clinical trial with the aim of receiving an accelerated regulatory pathway for BI-1206 for the treatment of Non-Hodgkin’s Lymphoma assuming continued generation of positive data; (ii) progressing the clinical development of BI-1206 in its Phase I/II trial for the treatment of advanced solid tumors in combination with Keytruda (pembrolizumab). Assuming positive clinical data, the net proceeds may be used to broaden the clinical studies; (iii) progressing the clinical development of BI-1808, as monotherapy and in combination with Keytruda (pembrolizumab), for the treatment of solid tumors and cutaneous T-cell lymphoma (CTCL). Assuming positive clinical data, the net proceeds may be used to broaden the clinical studies; (iv) developing BT-001, in partnership with Transgene, for the treatment of solid cancers. Assuming positive clinical data, the net proceeds may be used to broaden clinical studies; (v) advancing BI-1607 into clinical development for the treatment of solid cancers; and (vi) continued development of the Company’s prioritized preclinical projects with the aim to generate additional clinical programs.

Moreover, a strengthened financial position enables increased strategic flexibility and improved ability to negotiate with potential partners.

Lock-up undertakings and voting commitments

In connection with the Directed Share Issue, the Company has undertaken, subject to customary exceptions and the completion of the Directed Share Issue, to not issue additional shares for a period of 180 days as from launch of the Directed Share Issue. In addition, shareholding members of the Board of Directors and management of BioInvent have undertaken to not sell shares in the Company for a period of 90 days as from launch of the Directed Share Issue, subject to customary exceptions.

Shareholders together currently representing approximately 43 per cent of the shares and votes in the Company, have undertaken, or indicated an intention, to vote in favor of the EGM approval of Tranche 2.

Advisors

Van Lanschot Kempen Wealth Management N.V. (Kempen & Co) and Pareto Securities AB have been appointed as Joint Global Coordinators in connection with the Directed Share Issue. Mannheimer Swartling Advokatbyrå acts as legal counsel to the Company and Baker McKenzie acts as legal counsel to the Joint Global Coordinators.

Cue Biopharma to Present at the 7th Annual Immuno-Oncology 360° Conference

On February 22, 2021 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells within the patient’s body, reported that Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma, will deliver an oral presentation and participate in a panel discussion at the 7th Annual Immuno-Oncology 360° Conference on February 25, 2021 (Press release, Cue Biopharma, FEB 22, 2021, View Source [SID1234608292]).

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Presentation Details
Title: Next Generation Synthetic Vaccines
Immuno-STATs: Drugging the Tumor-specific T-cell Repertoire
Date and Time: Thursday, February 25, 2021 at 10:45 a.m. EST

Dr. Suri will present an overview of the Immuno-STAT (Selective Targeting and Alteration of T cells) platform and its next generation derivative, Neo-STAT. He will also highlight the IL-2 based CUE-100 series Immuno-STATs exemplified by CUE-101, the Company’s lead clinical candidate for HPV+ R/M HNSCC and CUE-102, our second drug program designed to target Wilms’ tumor 1 (WT1) specific T cells for the treatment of patients with solid and hematological cancers. The overview will include data supporting mechanistic advantages of the Immuno-STAT and Neo-STAT approach to targeting and activating disease-relevant T cells directly in the patient’s body.

Panel Details
Title: Vaccine Expert Discussion
Date and Time: Thursday, February 25, 2021 at 11:30 a.m. EST

About Immuno-STAT
The company’s Immuno-STAT (Selective Targeting and Alteration of T cells) biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a pMHC to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in highly targeted T cell modulation. Because our drug candidates are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo), and reinfused.

Micronoma Closes $3.5M Convertible Debt Financing Round

On February 22, 2021 Micronoma, a San Diego, Calif.-based cancer detection biotech company reported that utilizes signals from the tumor-related microbiome to diagnose cancer at an early stage with liquid biopsy technology, closed a $3.5m convertible debt financing round (Press release, Micronoma, FEB 22, 2021, View Source [SID1234578332]).

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Backers included SymBiosis, LLC, and The Seerave Foundation. The investments bring the company’s total amount of funding to $6.5m since the first seed round six months ago.

Led by Sandrine Miller-Montgomery, CEO, Micronoma decrypts signals from some of the most ancient matter in the world, the microbiome, to detect cancer early, from all genomes.

The company intends to use the funds to complete its validation study on lung cancer prediction, set up CLIA (Clinical Laboratory Improvement Amendments) operations, establish its go-to-market strategy utilizing its Oncobiota platform, and initiate work on a second cancer target.

Wugen Announces Exclusive License Agreement for their Memory Natural Killer (NK) Cell-based Therapy Program with Washington University in St. Louis

On February 22, 2021 Wugen Inc., a biotechnology company developing novel, universal allogeneic cellular therapies, reported that it has entered into an exclusive license agreement with Washington University in St. Louis, one of the world’s leading research institutions, for the development of Wugen’s Memory Natural Killer (NK) Cell program (Press release, Wugen, FEB 22, 2021, View Source [SID1234576287]).

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While currently approved autologous cellular therapies have been shown to effectively treat B cell cancers, there remains significant unmet need for treating other cancers, including solid tumors. Memory NK cells have been demonstrated in the clinic to be safe and effective, with several significant advantages over existing therapies. By dovetailing its extensive experience in developing "off-the-shelf" CAR-T with Memory NK cells, Wugen will be able to rapidly deliver its off-the-shelf Memory NK platform to patients.

Todd Fehniger, M.D., Ph.D., Professor of Medicine, Oncology Division, at Washington University and a cellular therapy and transplantation specialist, will be leading these efforts. "Wugen’s Memory Natural Killer (NK) Cell-based therapy program will open up new avenues to explore treatment options for incurable and intractable diseases such as Acute Myeloid Leukemia and Multiple Myeloma, for which current treatment options have limited or no benefit," said Dr. Fehniger. "I look forward to partnering with Wugen to advance these NK cell programs and deliver these much-needed solutions to patients worldwide, and to also expand the impact of memory NK cells to solid tumor immunotherapy."

"This agreement expands our ongoing collaboration with one of the leading research institutions to develop cutting edge cell therapies to treat solid and hematological cancers," said John McKearn, Ph.D., CEO of Wugen. "Our innovative approach is aimed to treat patients who currently lack therapeutic options."