On January 19, 2022 Duality Biologics reported a strategic cooperation agreement with Harbour BioMed (Press release, DualityBio, JAN 19, 2022, View Source [SID1234649926]). According to the agreement, Harbour BioMed will grant the self-developed preferred monoclonal antibody for specific tumor targets to Duality Biologics for the exclusive development of ADC medicines in the world. Based on the DITAC (Duality Immune Toxin Antibody Conjugate) technology platform with its independent intellectual property rights, Duality Biologics will rapidly develop the world’s first-in-class ADC medicines to benefit patients all over the world. And Harbour BioMed will receive the down payment, milestone payments and sales-based royalties paid by Duality Biologics.

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Harbour BioMed and Duality Biologics always maintain a strategic win-win cooperative relationship. After signing the agreement, both parties will continue to uphold the common goal of rapid research and development of high-quality ADC: Duality Biologics will be responsible for the preclinical research, clinical development, clinical registration, production and commercialization of the ADC candidate molecule; Harbour BioMed will continue to pay close attention to the relevant follow-up research of this molecule and provide necessary support.

"Previously, fully human antibodies developed from Harbour Mice have been used in multiple company’s ADCs development projects, demonstrating the advantages of our fully human antibodies in ADC development. With Duality Biologics’ strong R&D advantages in ADC development, this strategic collaboration will further strengthen our overall strategy in the field of ADC, maximize the value of Harbour Mice, develop more high-quality and differentiated new ADC drugs to meet global patients’ needs." said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed.

"I’m very pleased to achieve strategic collaboration with Harbour BioMed, and we are both very excited and confident about this new target of ADC drug. The combination of our proprietary ADC platform in next-generation and tumor-specific antibody will optimize the value of our DITAC platform, a leading 3rd generation toxin ADC platform with significantly improved therapeutic window, and rapidly enrich our pipeline to generate original innovative products. The signing of this agreement is the beginning of our platform-based strategic win-win cooperation. In the future, Duality Biologics hopes to maintain the close cooperation with Harbour BioMed and continue to propel more product development, jointly bringing better therapeutics to patients." said Dr. John Zhu, founder and CEO of Duality Biologics.

On January 19, 2022 Oasmia’s Board of Directors reported that subject to approval from the Extraordinary General Meeting on 21 February 2022, to carry out the Rights Issue of approximately SEK 151 million before deduction of issue costs (Press release, Oasmia, JAN 19, 2022, View Source [SID1234605557]).

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Those who are registered as shareholders on the record date of 4 March 2022 have the preferential right to subscribe for new shares in proportion to their existing shareholdings. Subscription of shares may also take place without subscription rights.

The Board of Directors’ resolution on the Rights Issue is subject to approval by the Extraordinary General Meeting on 21 February 2022. For further information, please see separate press release with notice of the Extraordinary General Meeting.

Terms of the Rights Issue

Those who are registered shareholders in Oasmia on the record date 4 March 2022, receive one (1) subscription right for each (1) share. The subscription rights grant the holder preferential right to subscribe for new shares, whereby five (5) subscription rights entitle the shareholder to subscribe for one (1) new share. In addition, investors are offered the possibility to subscribe for shares without subscription rights.

In the event that not all shares are subscribed for under subscription rights, the Board of Directors shall, within the maximum amount of the Rights Issue, resolve on allotment of shares without subscription rights. Allotment will then take place in the following order of priority: primarily, allotment shall be made to those who subscribed for shares under subscription rights, regardless of whether the subscriber was a shareholder on the record date or not, pro rata in relation to the number of subscription rights exercised for subscription and, to the extent that this cannot be done, by drawing lots; secondarily, allotment shall be made to others who have signed up for subscription without subscription rights. In the event that they cannot receive full allotment, allotment shall be made pro rata in proportion to the number of shares subscribed for by each and, to the extent that this cannot be done, by drawing lots; and in the third and final stage, any remaining shares shall be allotted to the parties who have guaranteed the Rights Issue, in relation to the guarantee undertakings made.

The subscription price is SEK 1.68 per new share. Assuming that the Rights Issue is fully subscribed, the share capital will be increased by a maximum of SEK 8,967,390.9 from SEK 44,836,954.6 to SEK 53,804,345.5, by new issue of a maximum of 89,673,909 new shares, resulting in the total number of shares increasing from 448,369,546 shares to 538,043,455 shares. Assuming full subscription, Oasmia will receive total proceeds of approximately SEK 151 million, before deduction of issue costs.

The subscription period runs from 8 March 2022 through 22 March 2022. The Board of Directors of Oasmia is entitled to extend the subscription period and the time for payment which, if applicable, will be announced by the Company in a press release no later than 22 March 2022. Trading in subscription rights will take place on Nasdaq Stockholm during the period from 8 March 2022 through 17 March 2022 and the trading in paid-up subscribed shares (Sw: betalda tecknade aktier) during the period from 8 March 2022 through 4 April 2022.

Shareholders who choose not to participate in the Rights Issue will, assuming that the Rights Issue is fully subscribed, have their shareholdings diluted by approximately 16.7 percent, but are able to financially compensate for this dilution by selling their subscription rights.

Subscription commitments and guarantee undertakings

The Company’s largest shareholder, Per Arwidsson through Arwidsro Investment AB and Fastighets AB Arwidsro, representing approximately 24.8 percent of the total number of shares and votes in Oasmia, has undertaken to subscribe for its pro-rata share of the shares in the Rights Issue.

Additionally, a consortium of external investors have given guarantee commitments to Oasmia of SEK 113 million, corresponding to approximately 75.2 percent of the Rights Issue. Thus, the Rights Issue is fully secured. For the guarantee undertakings, a cash compensation of 6.5 percent is paid on the guaranteed amount.

Prospectus

Complete terms and conditions for the Rights Issue and other information about the Company as well as information about subscription commitments and guarantee undertakings will be available in the prospectus that the Company is expected to publish on 3 March 2022.

Preliminary timetable

The below timetable for the Rights Issue is preliminary and may be adjusted.

2 March 2022 Last day of trading in shares including right to participate in the Rights Issue
3 March 2022 First day of trading in shares excluding right to participate in the Rights Issue
3 March 2022 Estimated date for publication of the prospectus
4 March 2022 Record date for participation in the Rights Issue, i.e. holders of shares who are registered in the share register on this date will receive subscription rights for participation in the Rights Issue
8 March – 17 March 2022 Trading in subscription rights
8 March – 22 March 2022 Subscription period
8 March – 4 April 2022 Trading in paid-up subscribed shares (Sw: betalda tecknade aktier)
24 March 2022 Estimated date for publication of preliminary results of the Rights Issue
25 March 2022 Estimated date for publication of final results of the Rights Issue
Online presentation today at 14:00 CET

The company will hold an online presentation today at 14:00 CET. The presentation will be given by CEO Francois Martelet and CFO Fredrik Järrsten in English. The presentation will be broadcast live via the link: View Source

Questions can be sent in advance to [email protected] or by phone to +46 72-376 90 10.

Advisers

In connection with the Rights Issue, Oasmia has appointed Danske Bank A/S, Danmark, Sverige Filial as financial adviser and Sole Bookrunner. Törngren Magnell & Partners Advokatfirma KB acts as legal adviser to the Company and Schjødt acts as legal adviser to Danske Bank.

On January 19, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx) targeting oncology and immuno-dysregulated diseases, reported positive interim clinical trial safety data demonstrating 100% completion of IMX-110 planned treatment cycles in its ongoing Phase 1b/2a clinical trial (Press release, Immix Biopharma, JAN 19, 2022, View Source [SID1234605579]). Historically, 43-67% of patients have completed planned treatment cycles with approved drugs used to treat soft tissue sarcoma (STS) according to Demetri et al., 2016, and Schöffski et al., 2016. Completion of planned treatment cycles refers to lack of drug-related interruptions (cycle delays, dose reductions, or dose interruptions due to drug toxicity).

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"With standard treatments widely used today, cancer patients face a long list of drug-related debilitating side-effects that cause treatment delays, dose reductions, or dose interruptions due to toxicity, interfering with the ability to treat them effectively," said Ilya Rachman, MD PhD, CEO of ImmixBio. "In this interim clinical trial update, we are thrilled to report that IMX-110 has been well tolerated. We believe that IMX-110 could become a potentially attractive option to improve the patient experience in oncology in the future."

The U.S. Food and Drug Administration ("FDA") has approved orphan drug designation ("ODD") for IMX-110 for the treatment of soft tissue sarcoma. The FDA has already approved rare pediatric disease ("RPD") designation to IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma.

On January 19, 2022 Oasmia Pharmaceutical AB, an oncology-focused specialty pharmaceutical company, reported plans to change its name to Vivesto AB (Press release, Oasmia, JAN 19, 2022, View Source [SID1234605558]). The proposed name change is subject to approval at a company Extraordinary General Meeting (EGM) to be held on 21 February 2022. The new name will, after approval by the EGM, be formally registered with the Companies Registration Office following completion of the recently announced Rights Issue.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Francois Martelet, CEO, said: "Since I became CEO in March 2020, the new management team and Board has set out a focused strategy to transform the business and build an oncology-focused specialty pharmaceutical company with a diversified portfolio. We’ve strengthened our finances by reducing unnecessary operational expenditure and resolved a number of inherited legal issues, at the same time as driving the value of our existing portfolio and expanding our R&D capabilities to make us an attractive partner for promising oncology assets. As we continue to develop Cantrixil, the first in-licensed therapy in our string of pearls strategy and focus on additional in-licensing and M&A opportunities, we believe this is the right time to mark the transformed prospects of our business with a new identity. Vivesto reflects our optimism for the future and our commitment to improving survival and quality of life for patients with hard-to-treat and late-stage cancers through R&D and innovation."

Oasmia has worked closely with the respected Brand Institute London UK to develop its new identity. Vivesto was ranked highly for brand recognition and relevance by patients, medical professionals and investors surveyed in Europe, the US and Sweden.

Online presentation today at 14:00 CET
The company will hold an online presentation today at 14:00 CET. The presentation will be given by CEO Francois Martelet and CFO Fredrik Järrsten in English. The presentation will be broadcast live via the link: View Source

Questions can be sent in advance to [email protected] or by phone to +46 72-376 90 10.

On January 19, 2022 PierianDx, the global leader in clinical genomics knowledge, reported that it has partnered with Biodesix to provide its interpretation technology platform for use with the Biodesix newly launched GeneStrat NGS genomic test, a blood-based tumor profiling test to detect actionable mutations in patients with non-small cell lung cancer (NSCLC) (Press release, PierianDx, JAN 19, 2022, View Source [SID1234605580]). Biodesix (Nasdaq: BDSX) will use the PierianDx platform to provide clear, up-to-date clinical interpretations for mutations detected by the GeneStrat NGS test as part of patient test results used by physicians to help inform a personalized treatment strategy and facilitate monitoring in lung cancer.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The GeneStrat NGS test is a key part of the IQLung testing strategy, designed to measure tumor-specific mutations and patient immune profiles with results in an unprecedented 72 hours so that physicians can assess overall prognosis and personalize treatment plans. The IQLung strategy uses genomic profiling to detect actionable mutations in lung cancer, such as EGFR, ALK, KRAS, MET, NTRK, ERBB2, and others, and delivers them in an expedited timeframe so patient treatment can begin sooner.

The GeneStrat NGS test data will be analyzed and interpreted using the most current therapy approvals and oncology guideline recommendations and delivered in a physician-ready report. The technology is backed by a comprehensive clinical knowledgebase and adaptive learning algorithms that take disparate inputs and translate them into concise interpretations with supporting evidence. As a result, characteristics of patient variants, even though rare or novel, are leveraged to present the most optimal treatment possibilities.

"We are helping to meet an unmet need in the continuum of care for lung cancer," said Scott Hutton, CEO of Biodesix. "Partnering with PierianDx not only helps to deliver rapid results to physicians, but it also gives them information that can be easily interpreted and actioned, supporting them in providing precision care for their patients."

"We are thrilled to provide our interpretation technology to support the outstanding testing solution from Biodesix to treat patients with lung cancer," states Mark McDonough, CEO of PierianDx. "We are committed to democratizing clinical genomics globally and this partnership with Biodesix supports our vision to broaden access to genomic testing and provide precision care to patients everywhere."