GBA Presents: THE GREEN MARKET

DEC 16--> A few hours ago,news came out that the CEO of Beyond Air (XAIR) bought 40,000 shares of common stock at an average price of $8.53 for a total outlay of $341,000, boosting his stake by ~4%.I think this is undoubtedly a bullish sign that needs to be paid close attention to.
 
Feb 10-> XAIR
02:45 We continue to believe in the potential of LungFit PH to revolutionize the treatment of persistent pulmonary hypertension of the newborn or PPHN, in the United States and cardiac surgeries around the world. Today, our commercial team continues to prepare for a U.S. commercial launch of LungFit PH in anticipation of a regulatory decision in the first half of this calendar year. I will have our Chief Commercial Officer, Duncan Fatkin discuss this preparation in much greater detail shortly.

03:14 Beyond Air continues to work collaboratively with the FDA to bring our device to the market as quickly as possible. I won't be able to comment further on our ongoing interactions with the FDA. Except to assure everyone that the dialogue is productive, and we have provided the agency with all information and support we believe they need to grant approval for LungFit PH. Additionally, we remain on track to receive CE Mark in Europe in the first half of this calendar year. We expect to secure an international commercial partnership for LungFit for ex U.S. Markets following CE Mark, and we will provide more information on our global strategy at a later time.
 
06:35 We have always had an interest in investing in other indications with our LungFit GO system and have announced our intention of beginning a pilot study to treat severe COPD exacerbations due to lung infections over the next 12 to 24 months.

06:50 Moving on to our viral lung infection program, which uses the LungFit Pro system at a 150 parts per million nitric oxide to treat community acquired viral pneumonia in adults and bronchiolitis in children under 2 years of age. As many of you may recall, we presented interim data from our adult cohort of hospitalized pneumonia patients last May at the American Thoracic Society international conference. At the time of the cut off period for these data, we analyzed a total of 19 patients on an intend to treat basis. None of the patients in the NO treatment arm and 10 in the control arm, all of which were COVID-19 patients.

07:30 These data show that 150 parts per million NO administered by LungFit Pro was deemed to be safe and well tolerated with no treatment related or possibly related adverse events or serious adverse events. Additionally, 22% of subjects in the NO treated group required oxygen support beyond their hospital stay compared to 40% of control subjects.
 
Private affiliate-- beyond Cancer.... $$$$$$$$$$$ Spin off?

Finally, I would like to provide updates on our private affiliate beyond cancer. Late last year, we successfully raised $30 million in a private placement of common shares to spin out our oncology program, developing ultra-high concentration nitric oxide or UNO therapy for the treatment of solid tumors. We believe UNO therapy may not only partially ablate or shrink the primary tumor, but also can arm the immune system to recognize an attack same tumor cells if they metastasize to other regions in the body.

09:00 Our preclinical data show that treating and tumor with UNO therapy will cause local cell death, exposing the immune system to tumor antigens, thereby by creating a memory immune response. For patients, this could mean preventing recurrence or metastases.

09:16 Under the leadership of CEO, Dr. Selena Chaisson Beyond Cancer has established at 6 member board with the recruitment of Mr. David Dvorak, previously the CEO of Zimmer Biomet and Dr. Gregory Berk, a clinically trained physician who is currently serving as a Chief Medical Officer and Interim CEO of GT Biopharma, a clinical stage immune oncology company.

09:37 Additionally Beyond Cancer will present 2 datasets at the American Association for Cancer Research Annual Meeting, which is being held from April 8 through 13 in Orleans.
 
Slow rollout?

As I highlighted last year, the commercial organization is ready to LungFit PH domestically as soon as we receive FDA approval. Our strategy has not changed. As we aim to focus on a limited release for the first 6 to 9 months post launch and target a select number of hospitals that have level 3 or level 4 NICUs and staff experienced with inhaled nitric oxide.

10:57 We continuously refine our marketing plan and work to optimize our customer service model as we draw closer to a decision date from the FDA. Our launch team is securely in place and consists of highly experienced individuals with decades of nitric oxide experience who will work closely with our target hospitals to ensure that we provide the best possible logistics support, customer service and product performance.

11:24 As I’ve said before, since many of our target hospitals are currently in multi-year contracts with cylinder based nitric oxide suppliers, we will be targeting hospitals with fewer than 12 months left on their existing contracts, and we anticipated taken approximately 4 years to have an opportunity to convert every hospital that uses nitric oxide in the United States.
 
For the fiscal quarter ended December 31, 2021, the company used $6.3 million of cash for operating activities. As of December 31, 2021, the company had cash and cash equivalents of $83.5 million, of which $54.5 million is in Beyond Air and $29 million is in Beyond Cancer. And keep in mind, this does not the additional $4.6 million we brought in in January that I mentioned earlier.

17:29 We believe that our cash on hand is sufficient to fund operations well beyond the next 12 months, including through the commercial launch phase of LungFit PH in the U.S.
 
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