On February 19, 2021 Oasmia reported Year-end report financial year May 1, 2020 – December 31, 2020
(Press release, Oasmia, FEB 19, 2021, View Source [SID1234575308])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

SIGNIFICANT EVENTS DURING THE THIRD QUARTER
In November Robert Maiorana joined Oasmia as acting CFO, with effect from December 1, 2020 until Fredrik Järrsten commenced in the role. Thereafter, Robert will work as Finance Manager and support Fredrik.
In December Oasmia shared an update from its partner Elevar Therapeutics on the development plan for Apealea (paclitaxel micellar) in ovarian cancer.
In December Oasmia’s partner Elevar Therapeutics entered a licensing agreement with Inceptua Group for the commercialization of Apealea (paclitaxel micellar) in Europe.
In December Oasmia announced it has secured valuable IP rights in Australia and Brazil.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
In February Oasmia appointed Dr. Heidi B. Ramstad as Chief Medical Officer.
THIRD QUARTER[2]: NOVEMBER 1, 2020 – DECEMBER 31, 2020
Consolidated net sales amounted to TSEK 120 (132)
Operating profit/loss was TSEK -28,580 (-34,056)
Net profit/loss after tax amounted to TSEK –33,627 (-35,171)
Earnings per share was SEK -0.07 (-0.15)
FINANCIAL YEAR[2]: MAY 1, 2020 – DECEMBER 31, 2020
Consolidated net sales amounted to TSEK 482 (565)
Operating profit/loss was TSEK -131,493 (-117,256)
Net profit/loss after tax amounted to TSEK –140,270 (-93,263)
Earnings per share was SEK -0.31 (-0.36)
CEO REVIEW – PUSHING FORWARD
Since I joined Oasmia in March last year, after undertaking an in-depth strategic review I implemented a growth plan based on four key pillars and focused on ensuring that the company is able to deliver it successfully:

Execute on Apealea global partnership with Elevar Therapeutics
Enhancement & Partnering of technology platforms
Clinical development of Docetaxel micellar & new API
In & out-licensing, partnering & M&A in oncology
I am pleased to report that we have made good progress on all of these during the year, initiating the transformation of Oasmia, and laying down a strong foundation on which to support our future growth.

As part of the strategic review, we undertook a comprehensive cost control program designed to focus our resources, including a reduction of headcount bringing the total number of staff at Oasmia to under 30 employees at the end of the year, making Oasmia a truly lean, research and development focused biotechnology company. In addition, we have served notice for our current offices in Uppsala and we will move Oasmia’s head quarter to a new more cost-efficient building in Stockholm over coming months, while we will keep our R&D laboratory facility in Uppsala. We are now realizing annualized costs saving of more than SEK 100 million and have reduced cash burn rate to around SEK 12 million per month. These cost savings have enabled us to invest in areas which can deliver the greatest return, including pipeline development which is critical for our success and future growth.

The most significant event in 2020 was the signing of a global strategic partnership with Elevar Therapeutics, Inc. (‘Elevar’) for our lead program Apealea (paclitaxel micellar) for advanced ovarian cancer. This agreement delivered an immediate upfront payment of USD 20 million, with the potential of milestone payments of up to USD 678 million and double-digit royalties in the future.

Our partnership with Elevar continues to go from strength to strength, with several positive developments during the year that underscore the commercial potential of new therapeutic options for ovarian cancer patients. These include Elevar signing a licensing agreement with Inceptua Group for the commercialization of Apealea in Europe, and with Taiba Middle East FZ LLC in the Middle East and North Africa region. In addition, Elevar announced the signing and subsequent launch of a global named patient program with Tanner Pharma, enabling access to Apealea outside the US for eligible patients at the request of a treating physician.

In December, following a series of interactions with the US Food and Drug Administration (FDA), we shared an update from Elevar providing clarity on the US commercialization pathway for Apealea. This includes two additional studies which will be initiated in 2021, before filing a new drug application (NDA) according to Elevar. These two new studies of Apealea may help to secure a successful registration in the U.S. and may provide new data to support a strong product label – critical for commercial success.

As part of our four pillar strategy, we have continued to progress in a number of areas of strategic focus, including exploring additional opportunities to apply our proprietary XR-17 solubility-enhancing technology in oncology and other therapeutic areas, and out-licensing non-core applications. Specialized investment firms are now helping us to identify appropriate partners for our Animal Health division as well as the XR-17 platform. We are also actively exploring a number of potential M&A and in-licensing opportunities that we believe will fit with our strategic goals. We aim to update you shortly as we make progress.

We have also initiated further research into XR-18, a next-generation solubility-enhancing technology platform which we expect to have even greater versatility and potential than XR-17. With combination therapies becoming ever more prominent in modern medicine, we are also in the process of establishing proof of-concept to demonstrate the feasibility of XR-19, a dual encapsulation solubilization platform, which could have the potential to enable combination therapies to be delivered in a single intravenous administration.

Another key part of our growth strategy is to advance and build our pipeline. Following on from Apealea, two other promising development candidates are already in or poised for clinical development. Docetaxel micellar is being prepared to progress into a Phase Ib clinical study for advanced prostate cancer with the Swiss Group for Clinical Cancer Research (SAKK). Like Apealea, Docetaxel micellar uses our proprietary XR-17 platform to enable intravenous administration of docetaxel without solubility enhancers and therefore has the potential to offer similar benefits to advanced prostate cancer patients in terms of side effect profile and removing the need to take additional drugs. Prostate cancer will affect one in every seven men in their lifetime, so if successful Docetaxel micellar could benefit many patients.

We are also aiming to add a new product candidate in pre-clinical development, using our XR-17 technology in partnership with a leading academic research institute in Sweden to evaluate potential candidates for progression. I hope to be able to disclose further details soon.

Securing Oasmia’s long-term success depends on building a senior team and network of trusted advisors with the expertise and capabilities to deliver our strategic growth plans. I am pleased to report that over the last year we have appointed a few high caliber individuals with significant pharma and biotech experience. These include Fredrik Järrsten joining as Chief Financial Officer, Dr. Heidi Ramstad joining as Chief Medical Officer, and Peter Selin joining as Chief Business Officer. We have also appointed two senior scientists to our technical operations team. Investing in this crucial area of the business will enable us to further develop and upgrade our proprietary technology platforms.

With our growing pipeline and a new and experienced leadership team in place, I look forward to 2021 and beyond with renewed confidence, and to updating you on our progress. Thank you for continuing to support the ongoing transformation of Oasmia as we strive to build a sustainable, profitable, high growth pharmaceutical business.

Conference call
The company will hold a conference call and an online presentation on on February 19, 2021 at 10.00 am CET. The call will be hosted by CEO Francois Martelet, CEO and Acting CFO Robert Maiorana. The presentation will be in English.

On February 19, 2021 Acacia Pharma Group plc ("Acacia Pharma" or the "Company") (EURONEXT: ACPH), a commercial stage biopharmaceutical company focused on developing and commercializing novel products to improve the care of patients undergoing serious medical treatments such as surgery, invasive procedures, or chemotherapy, reported the successful completion of the placing announced yesterday (the "Placing") (Press release, Acacia Pharma, FEB 19, 2021, View Source [SID1234575307]).

Capitalized terms not otherwise defined in this announcement have the meanings given to them in the announcement made by the Company at 13:15 CET yesterday afternoon.

Pursuant to the Placing, Placees have agreed to subscribe for 10,000,000 New Ordinary Shares at a price of EUR 2.70 per share (the "Placing Price"), which represents a 6.9 % discount to the last trading share price on 18 February 2021. The Placing will raise gross proceeds of approximately EUR 27,000,000. The New Ordinary Shares issued pursuant to the Placing represent 11.1% of the Company’s issued share capital prior to the Placing.

Trading of Acacia Pharma shares was temporarily suspended as a result of the Bookbuild and shall resume today, as of the start of trading.

Bank Degroof Petercam SA/NV ("Degroof Petercam") is acting as Sole Bookrunner and Listing Agent (the "Sole Bookrunner" or the "Bank") in connection with the Placing.

Following issuance of the New Ordinary Shares, the total number of ordinary shares in issue in the Company will be 99,689,451.

Mike Bolinder, CEO of Acacia Pharma, commented: "We are very pleased with the rapid and successful completion of this Placing, which will provide us with the financial resources to support the continued launch and roll out of BARHEMSYS and BYFAVO in the US. As we reported in yesterday’s announcement, early progress in gaining formulary access for BARHEMSYS has been very promising, exceeding our expectations, and comparing very favorably with recent comparable US hospital product launches. Gaining formulary acceptance is a crucial step to driving sales longer term, and we are delighted with the very positive early market reception to the US launch of BARHEMSYS. We would like to thank our existing and new shareholders for their support and look forward to providing a further update on our progress at the time of our full year results in late March."

Acacia Pharma intends to use the net proceeds of the Placing:

(i) To meet its sales force and marketing costs relating to BARHEMSYS and BYFAVO including brand development and engagement with key opinion leaders, healthcare professionals and medical conference and speaker programs;
(ii) To continue implementing post-approval research and development commitments including pediatric studies for BARHEMSYS and BYFAVO and a renal study for BARHEMSYS;
(iii) To satisfy interest and principal payments under existing loan agreements; and
(iv) For general corporate purposes relating to ongoing commercial activities.

In connection with the Placing, the Company has agreed to a lock-up undertaking, not to issue additional shares for a period of 90 days following settlement of the Placing. In addition, in connection with the Placing, senior managers and directors of the Company as well as Cosmo Technologies Limited ("Cosmo"), a substantial shareholder in the Company, have agreed not to sell any shares in Acacia Pharma for a period of 90 days following the settlement of the Placing, subject to customary exceptions.

Application has been made to Euronext Brussels for admission of the New Ordinary Shares issued pursuant to the Placing to trading on the regulated market of Euronext Brussels ("Admission"). It is expected that Admission will take place on or around 08:00 CET on 23 February 2021 (or such later time or date as the Bank may agree with the Company) and that unconditional dealings in the New Ordinary Shares issued pursuant to the Placing will commence at the same time. The Placing is conditional upon, inter alia, Admission becoming effective and the placing agreement between the Company and the Bank not being terminated in accordance with its terms.

The payment and delivery of the New Ordinary Shares is expected to take place on 23 February 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

On February 18, 2021 PCI Biotech’s (OSE: PCIB) reported that fourth quarter and preliminary full year 2020 interim report will be released on 24 February 2021 at 07.00 CET (Press release, PCI Biotech, FEB 18, 2021, View Source [SID1234585155]). The interim report and presentation will be made available on www.newsweb.no and on the company’s webpage, www.pcibiotech.com.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

A results presentation (in English) will be held through a live webcast at 08.30 CET the same day. The webcast can be accessed through www.pcibiotech.com. There will be a Q&A session at the end of the presentation. It will be possible to post written questions through the webcast console or through a teleconference facilitated for investors intending to ask questions verbally during the Q&A session.

On February 18, 2021 Eli Lilly and Company (NYSE: LLY) and Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel’s R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases (Press release, Rigel, FEB 18, 2021, View Source [SID1234577529]). Pursuant to the collaboration, Lilly will also lead all clinical development of brain penetrating RIPK1 inhibitors in central nervous system (CNS) diseases.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Rigel’s lead RIPK1 inhibitor, R552, has completed Phase 1 clinical trials and will begin Phase 2 clinical trials in 2021 as part of the collaboration. Rigel also has ongoing pre-clinical activities with its lead CNS penetrant RIPK1 inhibitor candidates.

Under the terms of the agreement, Lilly will pay an upfront cash payment to Rigel of $125 million. Rigel may also be eligible to receive up to $835 million in potential development, regulatory, and commercial milestone payments, as well as tiered royalties ranging from the mid-single digit to high-teens that will vary depending upon Rigel’s clinical development investment. Lilly and Rigel will co-develop R552 at specified contribution levels. Lilly will be responsible for all costs of global commercialization for R552, and Rigel will have the right to co-commercialize R552 in the U.S. Lilly will be solely responsible for all clinical development and commercialization of brain penetrating RIPK1 inhibitors in CNS indications.

RIPK1 is a critical signaling protein implicated in a broad range of key inflammatory cellular processes including necroptosis, a type of regulated cell death, and cytokine production. In necroptosis, cells rupture leading to the dispersion of cell contents which can trigger an immune response and enhance inflammation. Inhibiting RIPK1 may be a new approach to treating various autoimmune, inflammatory, and neurodegenerative disorders. In pre-clinical studies, Rigel’s R552 demonstrated prevention of joint and skin inflammation in a RIPK1-mediated murine model of inflammation and tissue damage.

"At Lilly, our immunology strategy is focused on the pursuit of novel targets that have the potential to develop into best-in-class medicines for patients with autoimmune conditions," said Ajay Nirula, M.D., Ph.D., vice president of immunology at Lilly. "RIPK1 inhibitors are a promising approach, and R552 is an exciting addition to our immunology pipeline. We look forward to working with Rigel to advance its clinical development."

"We are very excited to form this strategic partnership with Lilly. This collaboration will provide significant resources and expertise to support a broad investigation in multiple disease indications with our RIPK1 inhibitors," said Raul Rodriguez, Rigel’s president and CEO. "With Lilly’s extensive knowledge in immune and CNS diseases, they are our ideal partner to ensure the clinical and commercial success of our RIPK1 inhibitor program."

This transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976. This transaction will be reflected in Lilly’s reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP). There will be no change to Lilly’s 2021 non-GAAP earnings per share guidance as a result of this transaction.

On February 18, 2021 Eli Lilly and Company (NYSE: LLY) and Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel’s R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases (Press release, Rigel, FEB 18, 2021, View Source [SID1234577481]). Pursuant to the collaboration, Lilly will also lead all clinical development of brain penetrating RIPK1 inhibitors in central nervous system (CNS) diseases.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Rigel’s lead RIPK1 inhibitor, R552, has completed Phase 1 clinical trials and will begin Phase 2 clinical trials in 2021 as part of the collaboration. Rigel also has ongoing pre-clinical activities with its lead CNS penetrant RIPK1 inhibitor candidates.

Under the terms of the agreement, Lilly will pay an upfront cash payment to Rigel of $125 million. Rigel may also be eligible to receive up to $835 million in potential development, regulatory, and commercial milestone payments, as well as tiered royalties ranging from the mid-single digit to high-teens that will vary depending upon Rigel’s clinical development investment. Lilly and Rigel will co-develop R552 at specified contribution levels. Lilly will be responsible for all costs of global commercialization for R552, and Rigel will have the right to co-commercialize R552 in the U.S. Lilly will be solely responsible for all clinical development and commercialization of brain penetrating RIPK1 inhibitors in CNS indications.

RIPK1 is a critical signaling protein implicated in a broad range of key inflammatory cellular processes including necroptosis, a type of regulated cell death, and cytokine production. In necroptosis, cells rupture leading to the dispersion of cell contents which can trigger an immune response and enhance inflammation. Inhibiting RIPK1 may be a new approach to treating various autoimmune, inflammatory, and neurodegenerative disorders. In pre-clinical studies, Rigel’s R552 demonstrated prevention of joint and skin inflammation in a RIPK1-mediated murine model of inflammation and tissue damage.

"At Lilly, our immunology strategy is focused on the pursuit of novel targets that have the potential to develop into best-in-class medicines for patients with autoimmune conditions," said Ajay Nirula, M.D., Ph.D., vice president of immunology at Lilly. "RIPK1 inhibitors are a promising approach, and R552 is an exciting addition to our immunology pipeline. We look forward to working with Rigel to advance its clinical development."

"We are very excited to form this strategic partnership with Lilly. This collaboration will provide significant resources and expertise to support a broad investigation in multiple disease indications with our RIPK1 inhibitors," said Raul Rodriguez, Rigel’s president and CEO. "With Lilly’s extensive knowledge in immune and CNS diseases, they are our ideal partner to ensure the clinical and commercial success of our RIPK1 inhibitor program."

This transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976. This transaction will be reflected in Lilly’s reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP). There will be no change to Lilly’s 2021 non-GAAP earnings per share guidance as a result of this transaction.