A Powerful Investment Alliance of Aztiq and Innobic Acquires Alvogen’s Shares in Lotus and Adalvo in a US$475m Deal

On November 26, 2021 The Iceland based healthcare investor, Aztiq ("Aztiq"), founded by Alvogen’s Chairman and CEO, Róbert Wessman and Innobic Asia ("Innobic"), a wholly-owned Life Science arm of PTT Public Company Limited ("PTT", SET ticker: PTT), Thailand’s largest publicly traded conglomerate, reported that have signed a definitive agreement to acquire a 100% stake in Alvogen Emerging Market Holdings Limited ("AEMH") from Alvogen Lux Holdings Sarl ("Alvogen") (Press release, Lotus Pharmaceutical , NOV 26, 2021, View Source [SID1234596109]). Key shareholders in Alvogen include CVC Capital Partners ("CVC") and Temasek Holdings of Singapore ("Temasek"), as well as Aztiq. The total transaction value is estimated to be approximately US$475 million, and the deal is expected to close during the first quarter 2022.

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!

With this transaction the consortium becomes the leading shareholder in the global oncology pharmaceutical company Lotus Pharmaceuticals ("Lotus", TWSE ticker: 1795), and the owner of 100% shares in Alvogen Malta (Out-Licensing) Holding Ltd., shareholder of the fast-growing global business to business (B2B) pharmaceutical company Adalvo.

Alvogen Lux Holdings Sarl will remain a leading shareholder in the generics pharmaceutical company Alvogen US, including specialty pharma company Almatica, as well as being the second largest shareholder in global biosimilar company Alvotech.

Róbert Wessman, Chairman and CEO of Alvogen and Founder of Aztiq, will continue to serve as Chairman of the board of Lotus and Adalvo.

Róbert Wessman, Chairman and CEO of Alvogen/ Founder of Aztiq, commented: "I am very proud to have witnessed the maturation of both Lotus and Adalvo. I would like to take this opportunity to thank the existing shareholders for their great support in transformation and at the same time I would like to welcome our new partner as we look forward to carrying out the essential work of expanding access to medicines with strong expertise collectively by all parties. With the comprehensive geographic networks and solid market intelligence in ASEAN brought by PTT and Innobic, I believe that Lotus and Adalvo will have a compelling competitive advantage, which enables them to become global leaders in the pharma industry."

Tomas Ekman, Director of the Board, Alvogen Lux Holding Sarl commented: After seven years as the lead shareholder of Lotus and the broader Asian business, Alvogen concluded that now is the right time to monetize our investment and letting Aztiq and Innobic continue the journey Lotus is on. Both Adalvo and Lotus will continue to collaborate closely with the Alvogen group of companies. Today’s announcement is consistent with Alvogen’s strategic focus and we intend to deploy the proceeds from the transaction in line with our capital allocation priorities to maximize shareholder value.

Dr. Buranin Rattanasombat, Senior Executive Vice President, Innovation and New Ventures, PTT and Chairman of Innobic (Asia), commented: "This partnership will accelerate our goal and enable Innobic to leap into being a fully integrated pharmaceutical company. By being the major shareholder in Lotus jointly with Aztiq, Innobic will have access to the capability of operating a full suite of pharmaceutical business, ranging from research, development, and formulation to production and commercialization, with a primary focus on generic drugs covering a wide range of therapeutic areas, in particular, oncology and central nervous system. The strengthened access to high quality medicines, together with the global networks and commercialization capability of Adalvo, and Innobic’s support to further expand the pharmaceutical businesses in the ASEAN and globally, make this investment fully in line with the goals and strategies for realizing life science business in Thailand and the ASEAN."

Alvogen acquired a majority stake in Lotus in 2014 and together with its shareholders, Lotus has evolved into a next generation pharmaceuticals company focused on global oncology with direct market access in more than 10 countries in Asia and global reach of its portfolio to over 130 markets.

Alvogen has further developed Adalvo in 2018 from an in-house B2B platform into a separate business unit focusing on global markets. In a short period of time, Adalvo has achieved a remarkable growth with over 500 transactions and a world class portfolio of 60 differentiated medicines and is currently one of the fastest growing B2B pharmaceutical company globally, serving its partners and patients in over 100 markets around the world.

In April of 2021, Innobic invested approximately US$50 million into Lotus by acquiring newly-issued shares via a private placement. Both parties, Lotus and Innobic, are committed to further collaboration with the aim of expanding access to high quality medicines. Further participation by Innobic, through its investment in AEMH, demonstrates both a strong belief in the Lotus strategy as well as a commitment to drive opportunities in South East Asian pharmaceutical markets including Thailand, Vietnam, Philippines, Malaysia and other ASEAN countries.

Oasmia to present at Stora Aktiedagen Stockholm on December 2

On November 26, 2021 Oasmia Pharmaceutical’s CEO, Dr Francois Martelet reported that it will present at Aktiespararna’s Stora Aktiedagen Stockholm on December 2, 2021 (Press release, Oasmia, NOV 26, 2021, View Source [SID1234596108]). The presentation starts at 9:30 CET and will be broadcast live as a webcast at: www.aktiespararna.se/tv/live.

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!

The presentation will be available online the following day on www.aktiespararna.se/tv/evenemang and on Oasmia Pharmaceutical’s website www.oasmia.com.

Oasmia to present at the Erik Penser Bank Life Science Day on December 2

On November 26, 2021 Oasmia Pharmaceutical’s CEO, Dr Francois Martelet reported that it will present at the Erik Penser BankLife Science Day on December 2, 2021 (Press release, Oasmia, NOV 26, 2021, View Source [SID1234596107]). The presentation starts at 13:45 CET and will be live streamed via View Source

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!

The presentation will be held in English and will also be available afterwards on Oasmia Pharmaceutical’s website www.oasmia.com

Can-Fite Reports Third Quarter 2021 Financial Results & Provides Clinical Update

On November 26, 2021 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported financial results for the quarter ended September 30, 2021 (Press release, Can-Fite BioPharma, NOV 26, 2021, View Source [SID1234596106]).

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!

Corporate and Clinical Development Highlights Include:

Completed Patient Enrollment in Phase III Psoriasis Study – The Phase III Comfort study completed patient enrollment. Topline results are expected in Q1 2022. The study is designed to establish Piclidenoson’s superiority compared to placebo and non-inferiority compared to Apremilast (Otezla) in patients with moderate to severe plaque psoriasis.

Can-Fite Ends Phase II COVID-19 Trial to Focus on Core Indications – In 2020, with the aim of developing a much-needed drug to treat manifestations of COVID-19, mainly the Cytokine Release Syndrome, Can-Fite initiated a Phase II COVID-19 study of its lead drug candidate, Piclidenoson, with patient enrollment in Israel and Europe. With the anticipated launch of Pfizer’s oral COVID-19 antiviral drug candidate, Can-Fite has made a strategic decision to end its COVID-19 program and to focus its resources on its other clinical programs, all in advanced clinical trials.

Patents Granted for NASH in Japan, Hong Kong, and Mexico – Can-Fite continues to build its IP portfolio for NASH which now includes patents granted and allowed in 37 countries. Most recently, patents were issued and allowed in Japan, Hong Kong, and Mexico for the patent titled "An A3 Adenosine Receptor Ligand for Use In Treating Ectopic Fat Accumulation". This patent addresses the use of the A3 Adenosine Receptor (A3AR) ligand, the target receptor for Can-Fite’s drug platform technology, in the treatment of NASH.

Data on A3AR-based Cannabis Compounds in the Treatment of Liver Diseases Presented at AASLD and Published in HEPATOLOGY – Can-Fite delivered a poster presentation titled "Growth Inhibition of Hepatocellular Carcinoma (HCC) by CBD Rich T3/C15 Cannabis Fraction is Mediated via the A3 Adenosine Receptor" at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting during the Hepatobiliary Neoplasia: Experimental Hepatocarcinogenesis; Diagnostics and Liver Imaging session. The findings were also published in an abstract in the October 2021 supplement of HEPATOLOGY, a premier peer-reviewed publication in the field of liver disease published on behalf of the AASLD.

Positive Phase IIa NASH Data Published in Alimentary Pharmacology & Therapeutics – The peer-reviewed scientific journal focused on gastroenterology and hepatology published an article titled "Randomised clinical trial: A phase 2 double-blind study of namodenoson in non-alcoholic fatty liver disease and steatohepatitis". The article includes highlights from Can-Fite’s Phase IIa NASH study of Namodenoson which achieved its study endpoints including significant anti-steatotic, anti-fibrotic, and anti-inflammatory effects.

Fortified Balance Sheet

On September 30, 2021, Can-Fite had approximately $13.3 million in cash, cash equivalents, and short-term deposits.

"Our NASH program has received a high level of interest at scientific conferences based on our positive Phase IIa results, and we continue to fortify our IP around this indication. We expect to commence enrollment in our pivotal Phase III liver cancer and Phase IIb NASH studies, as we look forward to topline results from our Phase III in psoriasis in the first quarter of 2022. Our advanced pipeline with a growing body of safety and efficacy data has significant potential to help patients with unmet needs," stated Can-Fite CEO Dr. Pnina Fishman.

Financial Results

Revenues for the nine months ended September 30, 2021 were $0.65 million compared to revenues of $0.61 million during the nine months ended September 30, 2020. The increase is considered immaterial.

Research and development expenses for the nine months ended September 30, 2021 were $6.75 million compared with $9.06 million for the same period in 2020. Research and development expenses for the nine months period ended September 30, 2021 comprised primarily of expenses associated with two studies for Piclidenoson, a Phase II study in COVID-19 and a Phase III study in the treatment of psoriasis. The decrease is primarily due to costs incurred in the first nine months of 2020 associated with Phase II studies for Namodenoson in the treatment of liver cancer and NASH, and a Phase III study of Piclidenoson for the treatment of rheumatoid arthritis, partially offset by the two ongoing studies of Piclidenoson in the first nine months of 2021. We expect research and development expenses will increase for the remainder of 2021 and beyond.

General and administrative expenses were $2.71 million for the nine months ended September 30, 2021 compared to $2.14 million for the same period in 2020. The increase is primarily due to the increase in salaries and related benefits due to the distribution of bonuses to employees, increase in public relations expenses and insurance expenses. We expect general and administrative expenses will remain at the same level for the remainder of 2021 and beyond.

Financial income, net for the nine months ended September 30, 2021 was $0.31 million compared to financial expense, net of $0.22 million for the same period in 2020. The decrease in financial expense, net was mainly due to finance income recorded from revaluation of our short-term investments.

Can-Fite’s net loss for the nine months ended September 30, 2021 was $8.49 million compared with a net loss of $10.81 million for the same period in 2020. The decrease in net loss was primarily attributable to a decrease in research and development expenses which were partly offset by an increase in general and administrative expenses and a decrease in finance expenses, net.

As of September 30, 2021, Can-Fite had cash, cash equivalents and short-term deposits of $13.3 million as compared to $8.26 million at December 31, 2020. The increase in cash during the nine months ended September 30, 2021 is due to an aggregate of $2.74 million in net proceeds received through warrant exercise transactions during the first quarter of 2021, an advance payment of $2.25 million from a distribution agreement with Ewopharma and from a $10 million registered direct offering in August 2021 which were offset by Company’s operating activity.

The Company’s consolidated financial results for the nine months ended September 30, 2021 are presented in accordance with US GAAP Reporting Standards.

8-K – Current report

On November 26, 2021, Atara Biotherapeutics, Inc. (the "Company") reported that it entered into a sales agreement (the "2021 ATM Facility") with Cowen and Company, LLC ("Cowen") under which the Company may offer and sell, from time to time at the Company’s sole discretion, shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), having an aggregate offering price of up to $100.0 million through Cowen, as sales agent (Filing, 8-K, Atara Biotherapeutics, NOV 26, 2021, View Source [SID1234596105]).

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!

Cowen may sell the Common Stock by any method that is deemed to be an "at the market offering" as defined in Rule 415 of the Securities Act of 1933, as amended, including sales made directly on the Nasdaq Global Select Market or any other trading market for the Company’s common stock. Cowen will use commercially reasonable efforts to sell the Common Stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay Cowen a commission of up to 3.0% of the gross sales proceeds of any Common Stock sold through Cowen under the 2021 ATM Facility and has provided Cowen with customary indemnification rights.

The Company is not obligated to make any sales of Common Stock under the 2021 ATM Facility. The offering of shares of Common Stock pursuant to the 2021 ATM Facility will terminate upon the earlier of (i) the sale of all common stock subject to the 2021 ATM Facility or (ii) termination of the 2021 ATM Facility in accordance with its terms.

The foregoing description of the 2021 ATM Facility is qualified in its entirety by reference to the 2021 ATM Facility, a copy of which is attached hereto as Exhibit 1.1 and incorporated herein by reference.

The shares of Common Stock being offered pursuant to the 2021 ATM Facility will be offered and sold pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-253731). The Company intends to file a prospectus supplement relating to the ATM Offering with the Securities and Exchange Commission.

The legal opinion of Sidley Austin LLP relating to the shares of Common Stock being offered pursuant to the 2021 ATM Facility is filed as Exhibit 5.1 to this Current Report on Form 8-K.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.