Oasmia Pharmaceutical has announced that Swissmedic and Swissethics approval has been received to initiate a Phase 1b clinical trial with the Swiss Group for Clinical Cancer Research (SAKK) of Oasmia’s Docetaxel micellar in patients with advanced prostate cancer. Trial initiation is expected to commence in the first half of 2021, states the company in a press release. About the trial
The SAKK 67/20 trial is an open-label, multicenter, single-stage Phase 1b trial at major hospitals in Switzerland, recruiting 18 chemotherapy-naïve patients with metastatic castration resistant prostate cancer (mCRPC) with adequate bone marrow, liver and renal function. Using a standard Phase I trial design, the primary objective of this study is to determine the maximum tolerated dose of Docetaxel micellar in patients with mCRPC. The secondary objectives are to evaluate the safety of Docetaxel micellar, to assess the preliminary anti-tumor activity, and to characterize the pharmacokinetics of Docetaxel micellar in this population. The treatment will be a 21-day cycle of one of three dose levels of Docetaxel micellar until progression or occurrence of unacceptable toxicity or withdrawal, for a maximum of 10 cycles. About SAKK
SAKK is a non-profit organization, which has been conducting clinical trials in oncology since 1965. Its primary objective is to research new cancer therapies, to develop existing treatments further and to improve the chances of a cure for patients with cancer. Photo of Francois Martelet, CEO, Oasmia Pharmaceuticals

Green light for Oasmia’s phase 1b Docetaxel trial

Prenumera på våra dagliga nyhetsbrev helt gratis. Genom att skicka in mina uppgifter godkänner jag Realtid ABs allmänna villkor. Jag har även tagit del av Realtids personuppgiftspolicy. Nytt jobb
Karolinska Developments finanschef går till Oasmia 
Karolinska Developments finanschef och vice vd Fredrik Järrsten lämnar bolaget för att börja i en motsvarande roll hos Oasmia Pharmaceuticals. Publicerad 2020-09-08
Karolinska Development har påbörjat en process för att rekrytera en ny finanschef. Det framgår av ett pressmeddelande. På Oasmia kommer Fredrik Järrsten att rapportera direkt till vd Francois R. Martelet. – Vi är mycket glada över att få med Fredrik i koncernledningen som CFO. Hans stora erfarenhet av ledarskap och att utveckla företag inom life science- och sjukvårdssektorn kommer vara ovärderliga för Oasmia när vi fortsätter att driva igenom vår tillväxtstrategi, både organiskt och genom förvärv, säger Oasmia-chefen. DELA DEN HÄR ARTIKELN

Karolinska Developments finanschef går till Oasmia

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Den 8 september 2020 presenterar Oasmia Pharmaceuticals VD Francois Martelet att på Aktiespararnas Aktiedagen Digital. Presentationen börjar kl 10:20 och livesänds på: www.aktiespararna.se/tv/live
Presentationen kommer även i efterhand att finnas tillgänglig på Oasmia Pharmaceuticals hemsida. För ytterligare information:
Telefon: 018-50 54 40
Om Oasmia Pharmaceutical AB
Oasmia Pharmaceutical AB utvecklar, tillverkar och marknadsför en ny generation av läkemedel inom human- och veterinär onkologi. Produktutvecklingen syftar till att framställa nya formuleringar innehållande nanopartiklar av väletablerade cytostatika som i jämförelse med befintliga alternativ har förbättrande egenskaper, förbättrad biverkningsprofil samt bredare användningsområden. Produktutvecklingen bygger på egen forskning inom nanoteknik och egna patent. Oasmia har framgångsrikt tagit sin första produktkandidat, Apealea® (paclitaxel micellar) genom klinisk utveckling och har fått marknadsgodkännande i EU och andra territorier. Oasmia är på väg in i kommersialiseringsfasen med Apealea och gör produkten tillgänglig för patienter via sitt partnerskap med Elevar och sina befintliga verksamheter och partnerskap i kvarvarande territorier. Bolagets aktier handlas på Nasdaq Stockholm (ticker: OASM). Besök www.oasmia.com för ytterligare information. Bifogade filer

Oasmia Pharmaceutical : presenterar på Aktiedagen Digital den 8 september

| Source: Oasmia Pharmaceutical AB
multilang-release
Not for release, publication or distribution, directly or indirectly, in or into Australia, Hong Kong, Japan, Canada, New Zealand, South Africa, Switzerland, Singapore, the United States or any other jurisdiction where such distribution of this press release would be subject to legal restrictions. This press release does not constitute an offer of any securities of Oasmia Pharmaceuticals AB (publ). See the section “IMPORTANT INFORMATION” below. The board of Oasmia Pharmaceutical AB (“Oasmia” or the “Company”) announced on 11 November 2019 to carry out a new issue of shares with preferential rights for Oasmia’s shareholders of approximately SEK 399 million (the “Rights Issue”). As a result of the Rights Issue, the Company has prepared a prospectus, which has been approved and registered by the Swedish Financial Supervisory Authority today. Publication of the prospectus
For complete information on the Rights Issue, refer to the prospectus that has been prepared by Oasmia as well as approved and registered by the Swedish Financial Supervisory Authority as of today. The prospectus is available on Oasmia’s website, www.oasmia.com, as well as on ABG Sundal Collier’s website, www.abgsc.com, and SEB’s website for prospectuses, www.sebgroup.com/prospectuses and will be available on the Swedish Financial Supervisory Authority’s website shortly https://fi.se/sv/vara-register/prospektregistret/. Application forms for subscription without subscription rights are available on Oasmia’s website and on each of ABG Sundal Collier’s and SEB’s websites. Updated information
The prospectus contains updated information in several sections. The updated information does not constitute insider information. For example, in the “Capital structure and other financial information”, the Company's capital structure is presented, due to regulatory requirements, as of September 30, 2019. The section “Risk factors” has been updated compared to Oasmia's annual report for the 2018/2019 financial year, partly as a result of new prospectus rules. The section “Risk factors” and the “Legal information and supplementary information” section also include updated information of disputes and legal proceedings, including the class action filed against Oasmia and others before court in New York, USA. Advisors
ABG Sundal Collier is the financial advisor to Oasmia and Hannes Snellman is the legal advisor to Oasmia in connection with the rights issue. Baker McKenzie is the legal advisor to ABG Sundal Collier in connection with the rights issue. For more information:
E-mail: IR@oasmia.com
About Oasmia Pharmaceutical AB
Oasmia Pharmaceutical AB develops, manufactures and markets new generations of drugs in the field of human and veterinary oncology. The company’s product development aims to create and manufacture novel nanoparticle formulations and drug-delivery systems based on well-established cytostatics which, in comparison with current alternatives, show improved properties, reduced side-effects, and expanded applications. The company’s product development is based on its proprietary in-house research and company patents. Oasmia is listed on Nasdaq Stockholm (OASM) and Frankfurt Stock Exchange (OMAX.GR). IMPORTANT INFORMATION
The release, announcement or distribution of this press release may, in certain jurisdictions, be subject to restrictions and the recipients of this press release in jurisdictions in which this press release has been released, announced or distributed shall inform themselves of and follow such legal restrictions. The recipient of this press release is responsible for using this press release, and the information contained herein, in accordance with applicable rules in each jurisdiction. This press release does not constitute an offer, or a solicitation of any offer, to buy or subscribe for any securities in Oasmia in any jurisdiction either from Oasmia or from someone else. Any investment decision in connection with the Rights Issue must be made on the basis of all publicly available information relating to the Company and the Company’s shares. Such information has not been independently verified by ABG Sundal Collier. The information contained in this announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed for any purpose on the information contained in this announcement or its accuracy or completeness. This press release does not constitute or form part of an offer or solicitation to purchase or subscribe for securities in the United States. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the US Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold within the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There is no intention to register any securities referred to herein in the United States or to make a public offering of the securities in the United States. The information in this press release may not be announced, published, copied, reproduced or distributed, directly or indirectly, in whole or in part, within or into, to the United States, Australia, Canada, Hong Kong, Israel, Japan, New Zealand, Singapore, South Africa, Switzerland or in any other jurisdiction where the announcement, publication or distribution of the information would not comply with applicable laws and regulations or where such actions are subject to legal restrictions or would require additional registration or other measures than what is required under Swedish law. Actions taken in violation of this instruction may constitute a crime against applicable securities laws and regulations. This press release is not a prospectus for the purposes of the (EU) Regulation 2017/1129 (the “Prospectus Regulation”) and has not been approved by any national competent authority in any jurisdiction. A prospectus in relation to the Rights Issue as described in this press release has been prepared by the Company and the prospectus has been scrutinized and approved by the Swedish Financial Supervisory Authority (Sw. Finansinspektionen) and has been published on, inter alia, Oasmia's web page. In the United Kingdom, this press release and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, “qualified investors” who are (i) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this press release and should not act or rely on it. Information to distributors
Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II”); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements”), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the Offered shares have been subject to a product approval process, which has determined that the Offered shares are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment”). Notwithstanding the Target Market Assessment, distributors should note that: the price of the Offered shares may decline and investors could lose all or part of their investment; the Offered shares offer no guaranteed income and no capital protection; and an investment in the Offered shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Rights Issue. Furthermore, it is noted that, notwithstanding the Target Market Assessment, ABG Sundal Collier will only procure investors who meet the criteria of professional clients and eligible counterparties. For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the Rights Issue. Each distributor is responsible for undertaking its own target market assessment in respect of the Rights Issue and determining appropriate distribution channels. Forward-looking statements
This press release contains forward-looking statements that reflect the Company’s intentions, beliefs, or current expectations about and targets for the Company’s future results of operations, financial condition, liquidity, performance, prospects, anticipated growth, strategies and opportunities and the markets in which the Company operates, including with respect to prospects for pharmaceutical treatments and studies. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intend”, “may”, “plan”, “estimate”, “will”, “should”, “could”, “aim” or “might”, or, in each case, their negative, or similar expressions. The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurances that they will materialize or prove to be correct. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcome could differ materially from those set out in the forward-looking statements as a result of many factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not guarantee that the assumptions underlying the forward-looking statements in this press release are free from errors nor does it accept any responsibility for the future accuracy of the opinions expressed in this press release or any obligation to update or revise the statements in this press release to reflect subsequent events. Undue reliance should not be placed on the forward-looking statements in this press release. The information, opinions and forward-looking statements contained in this press release speak only as at its date and are subject to change without notice. The Company does not undertake any obligation to review, update, confirm or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this press release. Attachment

Oasmia publishes prospectus in connection with the rights issue of approximately SEK 399 million and updated information included in the prospectus

| Source: Oasmia Pharmaceutical AB
multilang-release
Not for release, publication or distribution, directly or indirectly, in or into Australia, Hong Kong, Japan, Canada, New Zealand, South Africa, Switzerland, Singapore, the United States or any other jurisdiction where such distribution of this press release would be subject to legal restrictions. This press release does not constitute an offer of any securities of Oasmia Pharmaceuticals AB (publ). See the section “IMPORTANT INFORMATION” below. The Board of Directors of Oasmia Pharmaceutical AB (publ) (”Oasmia” or the “Company”) has, by virtue of an authorization from the extraordinary general meeting on 6 November 2019, resolved to carry out a new issue of shares with preferential rights for Oasmia’s shareholders of approximately SEK 399 million (the “Rights Issue”). The subscription price in the Rights Issue is set to SEK 2.00. The Company’s major shareholder Per Arwidsson through Arwidsro Investment AB and related parties (“Arwidsro”) has undertaken to subscribe for its pro rata share in the Rights Issue, corresponding to approximately SEK 98 million or 25 percent of the Rights Issue. The Rights Issue in brief
Shareholders in Oasmia have preferential right to subscribe for four (4) new shares per five (5) existing shares. The subscription price is SEK 2.00 per new share, which, provided that the Rights Issue is fully subscribed, amounts to proceeds of approximately SEK 399 million before deduction of costs related to the Rights Issue. The last day of trading in the Oasmia share including the right to obtain subscription rights is 14 November 2019 and the first day of trading in the Oasmia share excluding the right to obtain subscription rights is 15 November 2019. The record date for participation in the Rights Issue is 18 November 2019. Subscription rights will be traded on Nasdaq Stockholm from and including 20 November 2019 up to and including 2 December 2019. Subscription will take place during the subscription period from and including 20 November 2019 up to and including 4 December 2019. The prospectus for the Rights Issue is expected to be published on 19 November 2019. Oasmia’s major shareholder Arwidsro has undertaken to subscribe for its pro rata share of approximately SEK 98 million or 24.7 percent of the Rights Issue. No compensation is paid to Arwidsro for this subscription commitment. “The Rights Issue is the next logical step for Oasmia to commercialize its key assets. It enables Oasmia to launch Apealea, first in Europe and then in the US, as well as to introduce the Company’s technology platform XR17 in the market. It is very important that Oasmia now gets the financial strength needed to be able to invest in market access activities necessary to realize the Company’s true potential,” comments Sven Rohmann CEO of Oasmia. “A lot has been achieved in the last eight months. I am very grateful for all who supported Oasmia in the turnaround and will continue to support Oasmia and be part of the exciting future”, comments Jörgen Olsson, Chairman of the Board. Background and reasons in summary
Oasmia is an integrated pharmaceutical company that develops, manufactures and markets an enhanced generation of drugs within human and veterinary oncology. The Company’s products and product candidates are based on the proprietary technology platform XR17, which allows for the production of water soluble nano-sized particle formulations of otherwise non-soluble active pharmaceutical ingredients (API). Oasmia has been successful in driving its first product candidate, Apealea, through clinical development and achieving market authorization in the EU and other countries. Oasmia has strengthened its management team to accelerate commercialization and initiated a commercialization phase for the product Apealea with the aim of making the product accessible to patients and to create value for the Company and its stakeholders. The US is by far the largest oncology market in terms of value, mainly due to the acceptance of high prices for innovative drugs, followed by the EU and the Asia-Pacific region. In the short term, Oasmia’s ambition is to commercialize Apealea on the European market. Simultaneously, the Company’s goal is to start the discussions with the US Food and Drug Administration (FDA) regarding a market authorization application of Apealea in the US. Further, Oasmia intends to find a strategic partner to ensure market approval and distribution in both the US and China. The Company also intends to continue to invest in medical development aiming for further use and other cancer indications for Apealea in order to gain higher market penetration as well as continue clinical development of the drug candidates in the portfolio. Oasmia's oncology products intend to represent a range of cytostatic drugs adapted to be combined with so-called targeted treatment such as immuno-oncology drugs, which is the leading form of treatment based on the number of cancer treatments performed. The Board of Directors has, by virtue of an authorization from the extraordinary general meeting on 6 November 2019, resolved to carry out a new issue of shares with preferential rights for Oasmia’s shareholders of approximately SEK 399 million before deduction of costs related to the Rights Issue. The Company has used SEK 45 million for repayment of a convertible loan, which was repaid on 31 October 2019 with cash from the advance payment from the Company's major shareholder Arwidsro. The receivable of SEK 45 million that arose through the advance payment from Arwidsro will be set-off in the Rights Issue. The Company primarily intends to use the remaining portion of the net proceeds from the Rights Issue for the following activities:
Finance and accelerate the commercialization of Apealea, which among others include marketing, market access, sales, manufacturing, technology transfer, machinery and equipment. Explore new business opportunities based on the Company's proprietary XR17 platform. Further development of the product portfolio, such as Docecal, and new partnerships. Continued expansion into new markets, which primarily includes initiating discussions with the FDA for market access. Working capital for operations. The remaining part of the issue proceeds intends to be used to improve the Company's financial position, which further enables expansion in new areas as well as a stable flow of new projects. The Board's assessment is that, through the Rights Issue, the Company will be given sufficient working capital for the next twelve months. Terms for the Rights Issue
Shareholders who are registered shareholders of Oasmia on the record date, 18 November 2019, have preferential right to subscribe for new shares in proportion to the number of shares held on the record date. Shareholders will obtain one (1) subscription right for each share held on the record date. Five (5) subscription rights entitle to subscribe for four (4) new shares. Further, investors are offered the opportunity to subscribe for shares without subscription rights. In the event that not all new shares are subscribed for by exercise of subscription rights, the Board of Directors shall, within the limits of the maximum amount of the Rights Issue, resolve on allotment of new shares subscribed for without subscription rights. Allotment of shares subscribed for without exercise of subscription rights shall, primarily, be allotted to those who have subscribed for shares by exercise of subscription rights and, in addition, have applied for subscription without subscription rights, irrespective of whether the subscriber was a shareholder on the record date or not and, in the event of oversubscription, pro rata in relation to the number of subscription rights each subscriber has exercised for subscription of shares. Secondarily, shares subscribed for without subscription rights will be allotted to others who have applied for subscription without subscription rights and, in the event of oversubscription, pro rata in relation to the number of shares stated in each subscription application. To the extent that allotment of shares according to the above cannot be made pro rata, allotment shall be made by drawing of lots. The Company’s share is traded including the right to obtain subscription rights up to and including
14 November 2019. Subscription will take place during the subscription period from and including
20 November 2019 up to and including 4 December 2019. Trading in subscription rights on Nasdaq Stockholm will take place from and including 20 November 2019 up to and including 2 December 2019, and trading in paid subscribed shares (BTA) will take place on Nasdaq Stockholm from and including 20 November 2019 up to and including 16 December 2019. The share capital may be increased by a maximum of SEK 19,927,535.20 and the maximum number of new shares that may be issued is 199,275,352. The subscription price is SEK 2.00 and, provided that the Rights Issue is fully subscribed, the proceeds are expected to amount to SEK 398,550,704 million before deduction of costs related to the Rights Issue. Shareholders who choose not to participate in the Rights Issue will have their shareholding diluted by approximately 44 percent, but have the opportunity to obtain financial compensation for this dilution by selling their subscription rights. Subscription commitments and support from major shareholders
Oasmia’s major shareholder Arwidsro has undertaken to subscribe for its pro rata share of approximately SEK 98 million or 24.7 percent of the Rights Issue. No compensation is paid to Arwidsro for this subscription commitment. Preliminary timetable for the Rights Issue
14 November 2019
Advisors
ABG Sundal Collier is the financial advisor to Oasmia and Hannes Snellman is the legal advisor to Oasmia in connection with the Rights Issue. Baker McKenzie is the legal advisor to ABG Sundal Collier in connection with the Rights Issue. For more information:
E-mail: IR@oasmia.com
About Oasmia Pharmaceutical AB
Oasmia Pharmaceutical AB develops, manufactures and markets new generations of drugs in the field of human and veterinary oncology. The company’s product development aims to create and manufacture novel nanoparticle formulations and drug-delivery systems based on well-established cytostatics which, in comparison with current alternatives, show improved properties, reduced side-effects, and expanded applications. The company’s product development is based on its proprietary in-house research and company patents. Oasmia is listed on Nasdaq Stockholm (OASM) and Frankfurt Stock Exchange (OMAX.GR). This information constitutes inside information in accordance with the EU Market Abuse Regulation 596/2014 that Oasmia Pharmaceutical AB is obliged to make public. The information was submitted for publication through the agency of the contact person set out above, at the time stated by Oasmia Pharmaceutical AB's news distributor GlobeNewswire at publication of this press release. Important information
The information in this press release does not contain or constitute an offer to acquire, subscribe or otherwise trade in shares, subscription rights or other securities in Oasmia. Any invitation to the persons concerned to subscribe for shares in Oasmia will only be made through the prospectus which Oasmia expects to publish on the Company’s website (www.oasmia.com) on or about 19 November 2019. This press release may not be released, published or distributed, directly or indirectly, in or into Australia, Hong Kong, Japan, Canada, New Zealand, Switzerland, Singapore, South Africa and the United States or any other jurisdiction where participation would require additional prospectuses, registration or measures besides those required by Swedish law. Nor may this press release be distributed in or into such countries or any other country or jurisdiction in which distribution requires such measures or otherwise would be in conflict with applicable regulations. Any failure to comply with the restrictions described may result in a violation of applicable securities regulations. The subscription rights, paid subscribed shares and shares in Oasmia have not been and will not be registered under the United States Securities Act of 1933, as amended (the “Securities Act”) or the securities legislation of any state or other jurisdiction in the United States and no subscription rights, paid subscribed shares or shares may be offered, subscribed for, exercised, pledged, sold, resold, granted, delivered or otherwise transferred, directly or indirectly, in or into the United States except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements under the Securities Act and in compliance with the securities legislation in the relevant state or any other jurisdiction of the United States. There will be no public offering of such securities in the United States. The securities referred to herein have not been approved or disapproved by the US Securities and Exchange Commission, any state securities commission or other regulatory authority in the United States, nor have any of the foregoing authorities passed upon or endorsed the merits of the rights issue or the accuracy or adequacy of this announcement. Any representation to the contrary is a criminal offence in the United States. This press release contains certain forward-looking information that reflects Oasmias’s present view of future events as well as financial and operational development. Words such as “intend”, “assess”, “expect”, “may”, “plan”, “believe”, “estimate” and other expressions entailing indications or predictions of future development or trends, not based on historical facts, constitute forward-looking information. Forward-looking information is inherently associated with both known and unknown risks and uncertainties as it depends on future events and circumstances. Forward-looking information is not a guarantee of future results or development and actual outcomes may differ materially from the statements set forth in the forward-looking information. ABG Sundal Collier is financial advisor to Oasmia and not to anyone else, in relation to the rights issue. ABG Sundal Collier is not responsible to anyone else but Oasmia for advising in relation to the Rights Issue. Attachment

Oasmia resolves on a rights issue of approximately SEK 399 million

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Oasmia Pharmaceutical develops a new generation of drugs within human and veterinary oncology. The product development aims to manufacture novel formulations based on well-established cytostatics which, in comparison with current alternatives, show improved properties, a reduced side-effect profile and an expanded therapeutic area. The product development is based on in-house research within nanotechnology and company patents.

Name	Michael af Winklerfelt
Work History	TitanX, Dynapac, and Atlas Copco
Title	Chief Financial Officer
Status	Former

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