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 Global pharma major Lupin Limited (Lupin) reported that it has entered into a partnership with Shenzhen Foncoo Pharmaceutical Co. Ltd (Foncoo) (Press release, Lupin, JAN 19, 2022, View Source [SID1234605542]). This is Lupin’s first partnership arrangement in China and reinforces Lupin’s commitment to bringing high quality generic and complex generic medicines to patients around the world.

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Dr. Fabrice Egros, President – Growth Markets, Lupin said, "Lupin continues to invest in key growth markets. With China’s growing commitment to affordable and accessible healthcare, Lupin is committed to serving the healthcare needs of the Chinese population by providing high quality generic and complex generic products. We are very excited about our partnership with Foncoo. We will continue exploring additional partnership opportunities in China to leverage our global portfolio including complex generics and specialty medicines."

Mr. Peng Yan, General Manager, Foncoo said, "Foncoo’s successful experiences on importing registration and marketing of the generic formulations and Lupin’s strong capability of making high-quality medicines make us perfect match to each other and our collaboration will have a bright future most likely. We expect that the successful launch of our first product in China will come smoothly and soon. We will also continue exploring more opportunities to work with Lupin for providing more and more high-valued and complex medicines to the Chinese physicians and patients."

On January 19, 2022 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) reported that updated analysis of the ongoing international Phase I/Ib trial of fruquintinib will be presented at the upcoming 2022 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, taking place on January 20-22, 2022 (Press release, Hutchison China MediTech, JAN 19, 2022, View Source [SID1234605536]). The meeting will be held virtually and in person at the Moscone Center in San Francisco, California, US.

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Further details of the presentation are as follows:

Title: Phase I/Ib trial of fruquintinib in patients with advanced solid tumors: preliminary results of the dose expansion cohorts in refractory metastatic colorectal cancer
Presenter: Arvind Dasari, MD, MS, MD Anderson Cancer Center
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Abstract No.: 93
Date & Time: Saturday, January 22, 2022
Location: Moscone Center – West, Level 1, West Hall and virtually

About Colorectal Cancer ("CRC")
CRC is a cancer that starts in either the colon or rectum. CRC is the third most common cancer worldwide, estimated to have caused more than 915,000 deaths in 2020.[1] In the U.S., an estimated 150,000 people were diagnosed with CRC and 53,000 people died from CRC in 2021.[2] In Europe, CRC is the second most common cancer, with an estimated 507,000 new cases and 240,000 deaths in 2020.[2] In Japan, CRC is the most common cancer, with an estimated 147,000 new cases and 59,000 deaths in 2020.[2]

About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

About Fruquintinib Approval in China
Metastatic CRC in China: Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in late November 2018 under the brand name ELUNATE. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. ELUNATE is indicated for the treatment of patients with metastatic CRC who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Results of the FRESCO study[3], a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic CRC in China, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).

About Fruquintinib Development Beyond CRC Monotherapy
The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated:

Gastric Cancer ("GC") in China: In October 2017, HUTCHMED initiated the FRUTIGA study, a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for second-line treatment of advanced gastric or esophagogastric junction ("GEJ") adenocarcinoma. The trial is designed to enroll patients who did not respond to first-line standard chemotherapy. Subjects receive either fruquintinib combined with paclitaxel or placebo combined with paclitaxel. Patients are randomized at a 1:1 ratio and stratified according to factors such as stomach vs. GEJ tumor type and performance status. The primary efficacy endpoint is overall survival (OS). Secondary efficacy endpoints include progression-free survival (as defined by RECIST 1.1), objective response rate, disease control rate, duration of response, and quality-of-life score (EORTC QLQ-C30, version 3.0). Biomarkers related to the antitumor activity of fruquintinib will also be explored (clinicaltrials.gov identifier: NCT03223376). In June 2020, HUTCHMED completed a planned interim data review. Based on the preset criteria, the Independent Data Monitoring Committee (IDMC) recommended that the trial continue.

Immunotherapy combinations: HUTCHMED has entered into collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317, developed by BeiGene, Ltd) and sintilimab (IBI308, developed by Innovent Biologics, Inc. and marketed as TYVYT in China).

Metastatic breast and endometrial cancers in the U.S.: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase Ib/II study in the U.S. to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced, refractory triple negative breast cancer ("TNBC") and endometrial cancer ("EMC"). This study is being conducted to investigate if the addition of fruquintinib can potentially induce activity to immune checkpoint inhibitor therapy in TNBC and EMC. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04577963. Safety and preliminary efficacy of fruquintinib were demonstrated in advanced solid tumors, including TNBC, in a Phase I study conducted in China (NCT01645215) and a Phase I/Ib study is ongoing in the United States (NCT03251378).

Gastric, colorectal and non-small cell lung cancers in China & Korea: BeiGene, Ltd. initiated this open-label, multi-center, Phase II study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced or metastatic, unresectable GC, CRC or non-small cell lung cancer ("NSCLC"). Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04716634.

Solid tumors in China: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase II study to assess the safety and efficacy of fruquintinib in combination with sintilimab in patients with advanced EMC, cervical cancer, CRC, GC, hepatocellular carcinoma (HCC), NSCLC or renal cell carcinoma (RCC). Additional details of the study may be found at clinicaltrials.gov, using identifier NCT03903705. Preliminary results of certain cohorts were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) and the Chinese Society of Clinical Oncology Annual Meeting (CSCO).

On January 18, 2022 Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, reported it has received authorization from Health Canada to conduct a Phase 2a study, examining the safety and efficacy of ZetaMet (Zeta-BC-003) for the treatment of metastatic bone lesions (Press release, Zetagen Therapeutics, JAN 18, 2022, View Source [SID1234643707]).

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"The start of this study marks a critical point in the development of ZetaMet (Zeta-BC-003)," said Bryan Margulies, PhD, chief scientific officer of Zetagen Therapeutics. "So far, our combination technology has, in preclinical studies, demonstrated its ability to resolve existing metastatic bone lesions, inhibit pain and stimulate targeted bone regeneration. Now, our goal is to prove this outcome in human application."

ZetaMet (Zeta-BC-003) works through a mechanism of action (MOA) which is a novel and patented molecular pathway. The small molecule, precisely-dosed, delivered to the affected area through a proprietary drug-eluting carrier, stimulates stem cells, activating cells to grow healthy bone known as "osteoblasts", and inhibits cells associated with bone degradation called "osteoclasts".

"We know that bone metastases are common among late-stage cancer patients and the pain associated with them is debilitating," said Joe C. Loy, CEO of Zetagen Therapeutics. "We look forward to this important next step in the development of ZetaMet (Zeta-BC-003) which, if successful, will bring this novel therapy one step closer to a reality for patients who need it most."

Bone metastases occur when cells from the primary cancerous tumor relocate to the bone. When these cancers relocate, they can cause changes to the bone, damaging it in a process called osteolysis. Osteolysis can cause small holes within the bone, weakening it and increasing the risk of breakage. These holes are called "lytic lesions." Among cancers which metastasize to bone, Breast and Prostate are most prevalent, amounting to approximately 70-percent of cases.[1]

The Phase 2a study will be conducted at a single site in partnership with McGill University, Montreal, Quebec. The study will enroll 10, Stage 4 breast cancer patients, pre-radiation, who present with lytic lesions created by metastatic tumors in their spinal column. The year-long study is scheduled to be completed by Q1 2023.

On January 18, 2022 StarkAge Therapeutics, a pioneering discovery-stage biotechnology company focusing on cellular senescence related diseases, reported it received Bpifrance Deeptech label designation for its lead program in Idiopathic Pulmonary Fibrosis (IPF) (Press release, StarkAge Therapeutics, JAN 18, 2022, View Source [SID1234641094]).

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"This exceptional achievement, under the scientific leadership of Dr. Müge Ogrunc, underscores the potential of the technology we are developing." said Dr. Thierry Mathieu founder and President of StarkAge Therapeutics. "We are grateful for the strong and continuous support from Bpifrance since the creation of StarkAge Therapeutics".

With this label, StarkAge Tx was awarded 2€ million in non-dilutive funding, the maximum allowed per project in this program1, across 4 years. This is a major steppingstone to advance and drive their program to success.

A further increase in capital will likely be required to fully fund their pre-clinical IPF program prior to engaging with US and European regulatory agencies.

"This will help us move our research forward significantly" added Dr. Mathieu. "IPF is the first program we are testing with ExoCiseTM, our cellular senescence biomarker platform. If successfully completed, it could lead to helping with many other age-related diseases."

StarkAge Therapeutics also announced that Dr. Pierre-Michel Bringer, has been appointed Chief Executive Officer. Dr. Bringer has over 35 years of Pharmaceutical Industry experience in multiple countries including the US, spanning M&A / licensing, communication, strategic planning, marketing & sales. Most recently he served 13 years as Investor Relations Officer with Novartis. Pierre-Michel holds a Doctorate of Pharmacy from Paris University

"Pierre-Michel broad industry knowledge, including expertise with investors, and his passion for science make him the strong leader we needed" said Dr. Mathieu "We are thrilled to have Pierre-Michel with us as CEO, and I am happy to hand-over the helm of StarkAge Therapeutics".

"I feel honored and humbled to lead the next steps of StarkAge Therapeutics whose science focuses on harnessing immunotherapy against cellular senescence." said Dr. Bringer.

About senescence
Cellular senescence is a stress-induced, durable cell-cycle arrest of previously replication-competent cells. Senescent cells can be beneficial as well as detrimental regarding host physiology and disease. Indeed, while cellular senescence can facilitate physiological processes such as tissue repair and wound healing, the actions of their secreted pro-inflammatory cytokines can promote tissue dysfunctions, especially during aging. In this context, the rate at which senescent cells accumulate within tissues increases with aging leading to age-related disorders causing diseases such as idiopathic pulmonary fibrosis2,3 (IPF) and many others4,5,6,7. Consequently, these detrimental senescent cells are considered a potential therapeutic target in age-related disorders. Nevertheless, the challenge remains to specifically target detrimental senescent cells while avoiding altering the functions of beneficial ones.

About Bpifrance Deeptech program
Bpifrance’s Deeptech program1 aims to help finance well-characterized and disruptive R&D programs.

The DeepTech label is granted to projects based on innovative technology, in particular:

from a research laboratory (public/private) and/or relying on a team/governance in connection with the scientific world
which constitute a strongly differentiating advantage compared to the competition
characterized by a long/complex go-to-market (development, industrialization, marketing) and therefore probably capital-intensive.
About ExoCiseTM
ExoCise is StarkAge Therapeutics’ proprietary platform designed to analyze extracellular vesicles (EVs), particularly exosomes and microvesicles, identifying robust and specific biomarkers for senescent cells in disease-setting by their specific multi-OMICs8 characterization.

EVs are secreted by virtually all cell types in the body and released in body fluids, particularly blood. EVs contain various molecules such as RNA, proteins, enzymes, cytokines etc. Some of these molecules are specific to the tissue they originate from, and even specific to certain cells within that tissue (biomarkers). EVs secreted from diseased or senescent cells to the blood could be used to detect and diagnose such conditions with a simple blood draw.

By applying ExoCise to patients with age-related diseases involving senescent cell accumulation, StarkAge Therapeutics expects to design safe and targeted immunotherapy solutions, setting StarkAge Therapeutics apart from competitors’ approaches with senolytic drugs which lacked safety and selectivity.

About Idiopathic Pulmonary Fibrosis (IPF)
IPF is a severe and debilitating disease with limited-or-no therapeutic options, in which the lungs become fibrotic and scarred9. It is a progressive illness where breathing becomes increasingly difficult over time until patients die from IPF. There is currently no treatment that can stop the evolution of the disease, or even reverse the scarring of the lungs.

IPF prevalence10 is estimated between 14 and 27.9 cases per 100,000 habitants in the US, in Europe 1.25 to 23.4 cases per 100,000 habitants in Europe.

With regard to IPF life expectancy11, the estimated mean survival is 2-5 years from the time of diagnosis. Estimated mortality rates are 64.3 deaths per million in men and 58.4 deaths per million in women.