On March 14, 2022 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 it has received a Notice of Allowance from the U.S. Patent and Trademark Office (PTO) for its invention titled "Method for Treating Fibrotic Liver Tissue Using CL-IB MECA" (Press release, Can-Fite BioPharma, MAR 14, 2022, View Source [SID1234610051]).

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!

Currently, Namodenoson (CL-IB-MECA) is being developed for two liver indications, liver cancer and NASH. The allowance granted by the US PTO opens the door for much broader market needs which entail all clinical conditions with advanced liver fibrosis including autoimmune hepatitis, primary biliary cirrhosis (PBC), nonalcoholic fatty liver disease (NAFLD), and alcoholic liver disease (ALD) among others. The global liver disease treatment market was valued at approximately $20 billion in 2020 by Allied Market Research.

Can-Fite is currently enrolling patients in a Phase IIb trial of Namodenoson for the treatment of NASH, an advanced non-alcoholic fatty liver disease, for which there is no U.S. FDA approved treatment. Additionally, the Company expects to commence enrollment in a pivotal Phase III study of Namodenoson in the treatment of advanced liver cancer (hepatocellular carcinoma CPB7).

Can-Fite’s robust IP portfolio includes patents that address NASH and liver cancer, issued in approximately 40 countries. Namodenoson has been out-licensed in select countries for the treatment of NASH and liver cancer with agreements that include upfront and milestone payments.

"This U.S. patent is a very important addition to our growing IP portfolio in liver diseases. It is very well timed with our Phase IIb NASH study and Phase III liver cancer trial. Both are high value indications in which our robust patent portfolio and Namodenoson’s safety and efficacy profile position Can-Fite for potential additional strategic distribution deals worldwide," stated Can-Fite CEO Dr. Pnina Fishman.

About NASH

There is currently no U.S. FDA approved treatment for NASH, an addressable pharmaceutical market estimated to reach $35-$40 billion by 2025 driven by increasing incidence. The U.S. National Institutes of Health estimate the prevalence of NASH in the U.S. at 2-5% of the population. NASH is the leading cause for liver transplants among women and second leading cause overall in the U.S. Given the rate of increase, it is expected to become the leading indication for liver transplants in males as well.

About HCC

Hepatocellular carcinoma (HCC) is the most common form of liver cancer. HCC with underlying Child Pugh B7 (CPB7) is one of the most advanced forms of liver cancer. More than 800,000 people are diagnosed with liver cancer annually and approximately 700,000 die of the disease each year, according to the American Cancer Society. The HCC drug market is projected to reach $3.8 billion by 2027.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On March 14, 2022 Catamaran Bio, Inc., a biotechnology company developing off‑the-shelf chimeric antigen receptor (CAR)-NK cell therapies to treat cancer, reported an expansion and extension of its research collaboration with Branden Moriarity, PhD, of the University of Minnesota, to further advance the versatility of transposon engineering for arming CAR-NK cell therapies with functional attributes not found in earlier generations of cell therapies (Press release, Catamaran Bio, MAR 14, 2022, View Source [SID1234610050]).

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!

Catamaran has also secured an exclusive, worldwide license to University of Minnesota patent rights covering next generation cell expansion technologies which do not require the use of feeder cells. These new technologies were invented during the parties’ research collaboration which has been in place since early 2020. Cell expansion technologies which do not rely on the use of feeder cells offer the potential to improve the efficiency and decrease the cost of manufacturing CAR-NK cell therapies.

"This expanded collaboration and license demonstrate our commitment to develop and integrate the most advanced technologies for scalable and robust manufacturing of our allogeneic CAR-NK cell therapies," said Alvin Shih, MD, Chief Executive Officer at Catamaran Bio. "We will continue to innovate in the areas of cell engineering and processing to keep Catamaran on the leading edge of CAR-NK cell therapy manufacturing and to allow us to rapidly advance the most effective cell therapies for cancer patients."

In the new phase of the collaboration, research teams from the University of Minnesota and Catamaran will further optimize the TcBusterTM transposon system, a next generation nonviral genetic modification system which has been integrated into Catamaran’s TAILWINDTM platform. TcBuster was engineered for use in human immune cells by a team led by Dr. Branden Moriarity, Catamaran’s scientific co-founder and Associate Professor in the Department of Pediatrics, Division of Hematology/Oncology, the University of Minnesota. Catamaran licensed the TcBuster transposon system from Bio-Techne Corporation.

"In contrast to viral engineering methods commonly used today to make cell therapies, transposon genetic modification systems offer greater versatility because they can carry larger and more complex genetic payloads and they allow for multiplex gene editing in one step," said Joseph Gold, PhD, Vice President, Technical Operations and Manufacturing at Catamaran Bio. "With our extended collaboration with Dr. Moriarity’s lab, we will further expand the boundaries of what is possible with transposon engineering to ensure that we are able to develop CAR-NK cell therapies with all of the desired functional attributes to optimize effectiveness against solid tumors."

On March 14, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported its financial and operating results for the fourth quarter and year ended December 31, 2021 (fiscal 2021) and provided a corporate update (Press release, Biodesix, MAR 14, 2022, View Source [SID1234610049]).

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!

"Despite the ongoing challenges caused by the global pandemic, the fourth quarter and fiscal 2021 were very productive," said Scott Hutton, CEO of Biodesix. "Most notably, we successfully executed on our revenue growth strategy by doubling our direct, dedicated sales force, which significantly contributed to our core lung diagnostic revenue growth of 48% and 49% for fourth quarter and fiscal 2021, respectively. We further executed on our third quarter 2021 commitment to a commercial launch of our GeneStrat NGS test in January 2022. From the clinical data standpoint, we presented new data during the fourth quarter of 2021 on our NodifyXL2 test from the prospective ORACLE study, and on our VeriStrat test from the prospective INSIGHT study. This new data truly underscores the value of both products in the real-world setting and adds to the body of evidence. We continue to be excited about the trajectory of the business, despite the challenges from the ongoing pandemic, which gives us confidence heading into 2022."

Fourth Quarter and Full Year 2021 Financial Results

Total revenue of $7.2 million and $54.5 million for the fourth quarter and fiscal 2021, respectively;
Continued lung diagnostic year over year growth despite COVID-19 variant surges;
Core lung diagnostic revenue of $5.4 million and $18.7 million for the fourth quarter and fiscal 2021, respectively, an increase of 48% and 49% over the respective prior year comparable periods;
Nodify nodule management tests and sales force expansion continue to drive lung diagnostic growth;
BioPharma Services revenue of $1.4 million and $5.6 million for the fourth quarter and fiscal 2021, respectively, a decrease of 29% and increase 20% over the respective prior year comparable periods;
COVID-19 testing revenue of $0.4 million and $30.2 million for the fourth quarter and fiscal 2021, respectively, a decrease of 98% and increase 7% over the respective comparable periods in 2020;
Decline over the fourth quarter of 2020 commensurate with the shift away from lab-based testing and towards point-of-care and at-home rapid antigen testing during much of the back half of 2021;
Fourth quarter 2021 gross margin of $4.7 million or 65% as a percentage of revenue as compared to 46% in the comparable prior year period primarily driven by the mix shift of sales to higher-margin core lung diagnostics and away from lower-margin COVID-19 testing;
Operating expenses (excluding direct costs and expenses) of $16.4 million and $64.9 million for the fourth quarter and fiscal 2021, an increase of 9% and 40% over the comparable prior year periods;
Doubled the size of lung focused direct and dedicated sales force in 2021;
Includes non-cash stock compensation expense of $1.3 million and $4.9 million during fourth quarter and fiscal 2021, respectively;
Net loss of $13.3 million and $43.2 million for the fourth quarter and fiscal 2021, respectively, an increase of 193% and 38% over the respective comparable periods in 2020;
Cash and cash equivalents of $32.7 million, inclusive of a fourth quarter 2021 equity capital issuance of $15.7 million in net proceeds and the prepayment of $20 million of the 2021 Term Loan;
Announced a Common Stock Purchase Agreement for up to $50 million.
2022 Financial Outlook

The Company anticipates generating between $37.5 million to $39.5 million in total revenue in 2022.

Conference call and webcast information

Management will host an investor conference call and webcast today, March 14, 2022 at 8:30 a.m. Eastern Time.

Investor dial-in (domestic):

An archived replay of the webcast will be available on the Company’s website for a period of 90 days.

For a full list of Biodesix’s press releases and webinars, please visit Biodesix.com.

On March 14, 2022 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported a research and evaluation collaboration with The Laura and Isaac Perlmutter Cancer Center, a National Cancer Institute designated Comprehensive Cancer Center and part of NYU Langone Health (Press release, NexImmune, MAR 14, 2022, View Source [SID1234610048]). The collaboration is centered around NexImmune’s artificial antigen presenting cells’ (aAPCs) ability to expand neoantigen-specific CD8+ T cells in apheresis material provided by melanoma patients. Dr. Jeffrey S. Weber, Deputy Director of the Laura and Isaac Perlmutter Cancer Center will guide the research and evaluation.

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!

"NexImmune is excited to have Dr. Weber and NYU, one of the nation’s leading academic cancer centers, as a partner on this collaboration," said Kristi Jones, Chief Executive Officer of NexImmune. "The AIM technology platform offers a way to explore the expansion of neoantigens not only in melanoma, but a myriad of other cancers. This step will help validate our approach to these novel targets. Collaboration in this field will continue to help us deliver novel and impactful therapies to people suffering with cancer."

"I look forward to working with NexImmune on this important work, with the goal of advancing these technologies and delivering next-generation immunotherapies to patients suffering with cancer," stated Dr. Weber. "NexImmune’s platform has proven it can consistently expand antigen specific T cells for known tumor and viral antigens. This work could help us create T cell products that directly target disease specific neoantigens by utilizing the AIM platform."

Further terms of this evaluation agreement have not been disclosed.

On March 14, 2022 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, MAR 14, 2022, View Source [SID1234610047]). This programme is part of the overall share repurchase programme of up to DKK 22 billion to be executed during a 12-month period beginning 2 February 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!

Under the programme initiated 2 February 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 2 February 2022 to 2 May 2022.

Since the announcement 7 March 2022, the following transactions have been made:

Number of

B shares

Average

purchase price

Transaction

value, DKK

Accumulated, last announcement 2,494,151 1,672,029,156
7 March 2022 110,000 693.55 76,290,472
8 March 2022 110,000 699.04 76,894,538
9 March 2022 105,000 689.72 72,420,439
10 March 2022 110,000 704.36 77,479,852
11 March 2022 100,000 691.13 69,112,536
Accumulated under the programme 3,029,151 2,044,226,993

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 34,815,319 B shares of DKK 0.20 as treasury shares, corresponding to 1.5% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 22 billion during a 12- month period beginning 2 February 2022. As of 11 March 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 3,029,151 B shares at an average share price of DKK 674.85 per B share equal to a transaction value of DKK 2,044,226,993.