Kalytera Therapeutics Inc (OTCMKTS:KALTF) Signs A Letter Of Intent To Acquire Stero Biotechs

Kalytera Therapeutics Inc (OTCMKTS:KALTF) has today announced that it has made major headway into the acquisition of Stero Biotechs. This was an undertaking that involved the business guru signing a Letter of Intent (“LOI”), and seemingly there is a lot of good that comes with the new move.

The nature of the solutions provided

Stero Biotechs has been operating as a private business whose main area of focus has been the development of Cannabidiol. This company’s product has been playing a critical role in ensuring wellness when combined with steroids.

Experts in the health and wellness segment outline that Stero’s business strategy was well-calculated. According to them, the business targeted cutting down on the dosages of the steroids by a significant margin.

It was about helping needy patients deal with the wide-ranging safety issues associated with the use of steroids by providing a better functioning alternative. There are high chances the deal might be closed anytime soon.

However, that is tied to whether or not the shareholders approve the deal in question. That is not the only thing because there will also be other conditions that Kalytera Therapeutics will need to fulfill.

Why the acquisition deal?

Kalytera Therapeutics has its reasons for moving into the deal. However, one notable point is that both businesses focus on the development of CBD pharmaceutical products. The only difference that exists is the point that Stero’s CBD programs are more objective and elaborate as compared to those of Kalytera. Stero’s programs have always been known to target bigger commercial markets, and the same thing can’t be said for Kalytera’s programs.

A good indicator of this is what each of the businesses has achieved so far. Kalytera hasn’t been holding back when it comes to the issuance of patents targeted at dealing with the graft versus host disease (“GVHD”).On the other hand, Stero has been known for its efforts in the issuance of patents that pay focus on the use of CBD for the steroid. Its activities have helped in staging a strong fight against almost 130 different diseases and disorders. Analysts say that it is representative of almost a multi-billion dollar commercial opportunity.


Kalytera Therapeutics (OTCMKTS:KALTF) Moves Closer To A Fully Vertically Integrated Company Status

This year has seen Kalytera Therapeutics (OTCMKTS:KALTF) engaged in numerous deals aimed at expanding the company’s scope. The company has set clear objectives concerning what it expects to achieve this year. One of these objectives is to be a fully vertically integrated company.

Acquisition of a CBD extraction firm

In late June 2019, Kalytera signed a letter of intent (LOI) to buy into Oregon 01. This is a cannabidiol (CBD) extraction company based in Oregon. Operating under Clean Bi Design as its business name, the firm has the capability to produce around 600 kg of CBD isolate for a single shift every month.

The Clean Bi Design facility is duly certified by the FDA and GMP and has extraction equipment which is sure to optimize the extraction activity. Notably, the equipment can perform extraction, isolation and distillation all at the same time. Kalytera expects to begin operation at the facility by the fourth quarter 2019.

Clean Bi Design will cost Kalytera $3.5 million which will give the company a 51% shareholding. According to the LOI, the deal should be closed by early October.

A step closer to a leadership position

The cannabis industry is just taking off, especially in the US. But companies have to deal with complicated legal procedures just to hit the ground running. This is due to the absence of a clear legal environment regarding cannabis in the US.

Despite the complexities, Kalytera is determined to take pole position in the industry. As per the company’s CEO and President, Robert Farrell, the new acquisition should help Kalytera to cement its dominance of the interface between consumer and medical CBD markets.

Kalytera intends to be a vertically integrated company and Clean Bi Design is the right move toward that goal.

For starters, the company has interests in both medical and consumer markets in the cannabis industry. Just last month, KALTF revealed positive progress in the development of a CBD molecule which expedites pain relief.

As per the company, this molecule, dubbed KAL-1816, can ably shut down the transmission of pain in conditions such as colitis, sciatica and arthritis.


Kalytera Therapeutics Inc (OTCMKTS:KALTF) Announces Change Of Share Issuance And Extension Under Payment Agreements With Salzman Group

Kalytera Therapeutics, Inc. (OTCMKTS:KALTF) has announced that it has elected to issue common shares of the company to the Salzman Group in payment of the invoices issued under a payments agreements with Salzman Group that was announced on Mid-June last year. The deal involves Kalytera paying invoices for services provided by The Salzman Group in common shares.

Terms of Agreement Amended

The June 2018 agreement was that, The Salzman Group together with its affiliates provides general as well as administrative support services, strong set-up work for the planned studies connected with the use of CBD in the treatment of GVHD, development and research work all in connection with Kalytera’s exclusive license of the Cannabidiol-naproxen conjugates meant for pain treatment.

However, the June agreement was amended to change the scope of the services which are provided thereunder. The additional services which will be provided, relate to Phase 1 clinical study proposal in evaluating the effect of food on Pharmacokinetics of CBD. Another is a proposal of phase 1 clinical study in investigating any drug-to-drug interactions with the CBD and studies respect to CBD use in preventing GVHD as well as a proposed pre-clinical study in evaluating the efficacy of CBD to protect against intestinal mucosal injury.

The amendment of the June agreement, as well as share issuance in payment of invoices for the additional services, is subject to any TSXV approval which is required in connection with the amendment.

Extension of Payment

In connection to the issuance of the common shares, the parties also have agreed to extend the term of the June Agreement to March 1 this year whereby there won’t have to be any increase in maximum dollar amount of the services eligible for payment.

The invoiced amounts that are to be paid in common shares to The Salzman Group amount up to US$714,197. The common shares number that is to be issued is based on the deemed issue price of C$0.072% common share which is 90% of the closing price of common shares on TSXV on January 30, 2019, which is a trading day before the election of the company to pay the invoiced amounts in common shares.


Kalytera Therapeutics Inc (OTCMKTS:KALTF) Announces Breakthrough With Cannabinoid-Based Pain Treatment

Kalytera Therapeutics Inc (OTCMKTS:KALTF) has announced that it made a significant breakthrough with a cannabinoid-based developmental treatment for acute and chronic pain.

The announcement revealed that the cannabinoid compound treatment features a mechanism that targets alpha3 glycine receptor activation. The alpha3 glycine receptors block pin signals from reaching the brain when activated. Kalytera teamed up with Beetlebung Pharma Ltd on the treatment development program to determine which cannabinoid novel analogue would block pain signals through the alpha3 glycine receptor mechanism.

The cannabinoid-based acute and chronic pain treatment makes Kalytera Therapeutics the first company to introduce a solution that targets the alpha3 glycine receptors. It therefore marks a big win for the company. Kalytera Therapeutics managed to create a new compound by manipulating the Canabidiol structure.

The new compound is reportedly 40 times more potent than the alpha3 glycine receptor agonist, desoxy-CBD. Its potency is a key determinant for clinical testing to determine whether it is a good opioid substitute for treating chronic pain.

“The objective of our program is to develop a potent, non-psychotropic, oral analgesic for intractable pain that will be safe and well tolerated,” stated Kalytera CEO, Robert Farrell.

Farrell also added that the new compound can block pain without risks such as respiratory suppression as is the case with opioid analgesics and without addiction risks. He also stated that the company also managed to come up with a way to make the CBD compound water soluble. This is great news because treating patients in special cases such as surgical procedures or childbirth will become easier.

Such a major breakthrough also translates to good financial fortunes ahead for the company since the commercial opportunities are huge. A Transparency Market Research report claims that the global pain management market will be worth around $83 billion over the next five years. Patents for the CBD compound already exist in the U.S as well as other markets and Kalytera has already acquired an exclusive BLP global license for the compound. BLP is a cannabinoid-based therapeutics firm that is based in Israel.


Kalytera Therapeutics Inc (OTCMKTS:KALTF) Discloses Details Regarding The Pre-IND Summit Date With FDA

Kalytera Therapeutics Inc (OTCMKTS:KALTF) has disclosed that it will on Tuesday hold a meeting with the Center for Drug Evaluation and Research. This happens to be one of the departments under U.S. Food and Drug Administration.

This meeting will pay a huge deal of focus on Kalytera’s much anticipated registration study. It will be a study looking into the role of cannabidiol towards the treatment of host disease versus acute graft.

Farrell’s perspective

Robert Farrell, current CEO of Kalytera is quite pleased with the latest developments. He termed the meeting with CDER a major step forward for them as they look forward to succeed in offering quality treatment for acute GVHD. It was a short while ago that this company submitted a number of questions to the FDA. One company official outlined that the questions were a part of the pre-IND submission package.

It is expected that in the course of this meeting CDER will provide answers to questions posed. Aside from that, it will move further to provide important details that will be useful in making future plans.

Farrell opined, “We will be in position to address any open issues or requests of CDER before submitting our IND. Once the IND is submitted and found to be acceptable to the FDA, we will initiate our planned registration study in treatment of acute GVHD.”

GVHD and its effects

The bone marrow transplant procedures are quite delicate in nature. If not handled in a proper way, a person ends up suffering from this condition called GVHD. It is a life-threatening condition that has claimed many lives over the years. It starts off by the donor cells staging attacks on the organs of the patient. Such organs could include the eyes, lungs, liver, GI tract and above all the skin.

GVHD could result in reduced quality of life, disability, infections, chronic illness and even at times death. As per this moment, FDA hasn’t yet given approval any therapy towards the treatment of acute GVHD.

FDA has made a statement outlining that it foresees the possibility using CBD products towards treatment of acute GVHD. Kalytera is also seeking to develop a working solution to help with treatment of Menstrual Cramps and Psoriasis. The future is looking bright according to one company official.

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