On July 26, 2021 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the purchase of 4,629,630 shares of its common stock (or common stock equivalents) at a purchase price per share of $2.70, in a private placement priced at-the-market under Nasdaq rules. Additionally, Xenetic has also agreed to issue to the investor warrants to purchase up to 4,629,630 shares of common stock (Press release, Xenetic Biosciences, JUL 26, 2021, View Source [SID1234585186]). The warrants to purchase 4,629,630 shares of common stock have an exercise price of $3.30 per share, will be immediately exercisable and will expire three and one half years from the date the registration statement registering for resale the shares of common stock issuable upon exercise of the warrants is declared effective by the U.S. Securities and Exchange Commission. The closing of the offering is expected to occur on or about July 28, 2021, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as exclusive placement agent for the offering.

The gross proceeds to Xenetic, before deducting placement agent fees and other offering expenses, are expected to be approximately $12.5 million. The potential gross proceeds from the exercise of the warrants, if fully exercised on a cash basis, will be approximately $15.3 million. No assurance can be given that any of the warrants will be exercised. Xenetic intends to use the net proceeds from the offering for general working capital purposes.

The securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and Regulation D promulgated thereunder, and the securities have not been registered under the Act or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. Pursuant to a registration rights agreement with the investor, the Company has agreed to file a resale registration statement covering the shares of common stock, common stock equivalents, and shares of common stock underlying the warrants described above within 30 days.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 26, 2021 Kiromic Biopharma, Inc. (Nasdaq: KRBP), a pioneer in immuno oncology cellular therapy in solid tumors, reported it has completed the acquisition of InSilico Solutions (Press release, Kiromic, JUL 26, 2021, View Source [SID1234585202]).

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InSilico Solutions is a world-class bio-informatics and artificial intelligence innovator with a long standing collaborative relationship with its clients at MD Anderson Cancer Center, Johns Hopkins School of Medicine, and the National Cancer Institute.

With this acquisition, Kiromic will bring in-house a team of experts in bioinformatics and AI in order to lengthen its lead in the race for an AI technology with the capability to select the optimal bio-markers needed for cutting edge immunotherapeutics such as CAR-T cell therapy.

Many CAR-T developers are still developing their CAR-T with biomarkers from decade old target libraries with known poor clinical outcomes.

Chief Executive Officer of Kiromic, Maurizio Chiriva-Internati, DBSc, PhDs, commented

We are pleased to have officially closed this long awaited acquisition of InSilico Solutions.

The InSilico Solutions is another testament to our commitment to developing the very best possible CAR-T. And the very best CAR-T will start with having the best possible bio-markers by employing cutting edge bio-informatics and AI technologies.

Our CAR-T will be outpatient, off-the-shelf allogeneic.

The amount of information that oncologists and scientists gather from cancer patients continues to grow exponentially.

The number of scientists and the time those scientists have to analyze those billions of data point have not grown exponentially.

It makes sense that bioinformatics and artificial intelligence are brought to bear on the tasks of going through the mountains of data to select biomarkers in a few hours which would have required decades of human labor to do.

Best bio-informatics and AI.

Better biomarkers.

Better Manufacturing.

Better CAR-Ts.

Better Clinical Outcomes.

Chief of BioInformatics and Research Computing Officer, Michael Ryan, PhD commented :

Over the past 3 years we have had an amazingly productive collaboration with Kiromic.

Together we produced a highly effective system that allows Kiromic to identify the needles in the haystack of genomic data – small sections of protein that are specific to the surface of cancer cells and that can be targeted by immunotherapy.

The entire InSilico staff is extremely energized by the acquisition by Kiromic.

We believe we can have an immediate, significant impact on accelerating delivery of effective treatment to patients.

Our next focus will be on utilizing AI methods to optimize response to allogeneic T cell therapy.

In particular, we are developing models using WGS, RNASeq, scRNASeq, cytrometry, and cytokine panels to assist in selecting donor T cells with the strongest therapeutic potential.

Similar data from clinical trials will be used refine our understanding of efficacy and toxicity to improve treatment protocol and patient selection.

We will continually evaluate, implement, and improve our industry leading systems that will accelerate therapeutic development, manufacturing, and clinical testing of Kiromic’s off-the-shelf allogeneic CAR-T for solid tumors.

Chief Medical Officer of Kiromic, Scott Dahlbeck, MD commented:

World-wide, patients with advanced cancer conditions are in great need of effective treatment solutions that can be added to the clinical armamentarium of medical providers.

However, in order to achieve significant gains in patient survival, innovative discoveries in biomarker discovery, selection, and validation are critical to facilitate the development of the next generation of immunotherapeutics that can truly make a difference.

The acquisition of InSilico Solutions is a major step forward in this process, and we are looking forward to the breakthroughs that will result from this expansion of Kiromic’s AI capabilities and subsequently its CAR-T.

Chief of Strategy and Innovation Officer, Mr. Gianluca Rotino commented:

The acquisition of InSilico will allow significant advancement in the use of computational technologies throughout the development process, from discovery to manufacturing and in clinical trials.

This places Kiromic among the pioneers in innovative cell therapy and makes the upcoming clinical trial a critical milestone not only for the company, but for all the Cell Therapy Space.

Under the agreement terms, Kiromic acquires InSIlico through a stock-swap operation, hiring the entire staff of InSIlico and their material and immaterial assets.

The deal was followed up by the Strategy and Corporate Development department of Kiromic Biopharma

BEVILACQUA LLP served as Legal Counsel.

ThinkEquity served as financial advisors. ThinkEquity, a division of Fordham Financial Management, Inc.

Chief Financial Officer, Mr. Tony Tontat commented:

InSilico Solutions was a great find for the company 3 years ago when the collaboration started.

It’s an even better find today with the closing of this acquisition.

InSilico in-house will mean that our bio-informatics department will have the continuous attention of developers as new developments evolve.

The InSilico acquisition will not impact the company’s cash runway post the recent follow-on financing which closed on July 2021.

On July 26, 2021 LifeGift, the organ procurement organization (OPO) facilitating organ and tissue donation in Southeast, West, and North Texas, and Ossium Health, a therapeutics company harnessing the power of stem cell science to improve treatment for patients with blood and immune diseases, reported a collaborative partnership (Press release, Ossium Health, JUL 26, 2021, View Source [SID1234585438]). In 2017, LifeGift was the first OPO to work with Ossium and this ongoing partnership resulted in the successful banking of cells from their first clinically transplantable donor at the beginning of 2020. Cell banking systems are set up to assure a uniform population of cells is preserved, their integrity maintained, and a sufficient supply of material is accessible for the life of the product.

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Bone marrow recovered by LifeGift and Ossium Health’s other OPO partners is processed for future use in transplant tolerance for individuals receiving organ and tissue transplants, bone marrow transplant for blood cancer patients, and regenerative medicine cell therapies for patients with a variety of inflammatory, autoimmune, and degenerative conditions.

Roughly 20,000 new U.S. patients seek a bone marrow transplant each year, but only 30 percent have a relative who provides a match. Of the remaining 14,000 patients, fewer than 5,000 receive transplants from unrelated donors. The living donor bone marrow registry, autologous bone marrow transplants, and umbilical cord blood banks have provided lifesaving solutions for thousands of patients with hematologic diseases. However, these methods still experience significant limitations driven by the scarcity of matched bone marrow.

LifeGift’s partnership with Ossium Health enables transformative clinical work such as Ossium’s recently approved clinical trial for intestinal transplants. Intestinal transplantation is rare because of historically high rejection rates. However, by infusing bone marrow cells from the same donor as the transplanted intestines, the immune system could see the donor organ as "self" so that long-term graft acceptance can be achieved without life-long immunosuppression.

"We are thrilled to have been the first collaborating partner with Ossium Health among all organ procurement organizations more than four years ago," says Kevin Myer, president and CEO of LifeGift. "This partnership aligns perfectly with LifeGift’s focus on research and innovation to support our efforts to increase transplantation. We are relentless in our goal to save more lives through donation, and Ossium Health’s initiatives will drive clinical advancements allowing us to help more patients and advance important clinical research."

"Ossium’s first of its kind bone marrow bank combined with bone marrow recovered by LifeGift establishes a powerful new platform for bringing cell therapies to patients across the globe," says Ossium co-founder, president and CEO, Kevin Caldwell. "The future looks bright as the partnership moves forward to improve the health, vitality, and longevity of human beings through bioengineering."

On July 26, 2021 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the Company has entered into licensing agreements and strategic partnerships with Seqirus Pty Ltd ("Seqirus"), a subsidiary of CSL Limited, and AVIR Pharma Inc. ("AVIR") for tirbanibulin (Press release, Athenex, JUL 26, 2021, View Source [SID1234585172]).

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Under the terms of the agreements, Seqirus will have an exclusive license to commercialize tirbanibulin in Australia and New Zealand, and AVIR will have an exclusive license to commercialize tirbanibulin in Canada.

The addition of these territories enhances the global coverage of the marketing and sales of Klisyri (tirbanibulin ointment) for the treatment of actinic keratosis (AK). Athenex currently has strategic partnerships for tirbanibulin in the U.S., Europe, China, Taiwan, Japan and now also Australia, New Zealand and Canada, among several other territories. In addition to upfront payments and milestone payments, the royalty/transfer prices generally range from 15% to 30% of annual sales across different territories.

"These new partnerships with Seqirus and AVIR will expand tirbanibulin access to more patients around the world," said Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. "Tirbanibulin, or Klisyri, is approved and launched in the United States for the treatment of actinic keratosis of the face or scalp, and is a significant step forward because of its short treatment protocol, proven efficacy, and favorable safety profile. Klisyri has recently also received approval for marketing by the European Commission. The expansion of our international partnerships represents an important step in Athenex’s strategy to optimize the potential value of this important drug and create value for our stakeholders."

Tirbanibulin is a novel, topical first-in-class microtubule inhibitor with a selective antiproliferative mechanism of action. Athenex received approval from the U.S. Food and Drug Administration for the commercialization of tirbanibulin, under the brand name Klisyri, for the topical treatment of AK of the face or scalp. Klisyri was launched in the U.S. in February 2021, led by the Company’s partner, Almirall. In July, Almirall received European Commission approval of Klisyri (tirbanibulin) for the topical treatment of AK of the face or scalp, which followed a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in May.

"We are delighted to collaborate with Athenex to commercialize KlisyriTM in Australia and New Zealand," said Dani Dowell, Seqirus Head of Commercial Australia and New Zealand. "This is an exciting opportunity, building on Seqirus’ strong presence as a successful in-license partner in Australia and New Zealand. The addition of Klisyri will broaden our portfolio and is another example of our work to deliver innovative offerings to meet unmet patient need."

Actinic keratosis is one of the most common diagnoses in dermatology practices.[1] Australia has one of the highest prevalence of AK, with an estimated prevalence of 40-50% in the Australian Caucasian population over 40 years of age.[2] Treatment is a critical aspect in the management of the disease as it may progress to invasive skin squamous cell carcinoma.

On July 26, 2021 Nuvo Pharmaceuticals Inc. (TSX:MRV; OTCQX:MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian focused, healthcare company with global reach and a diversified portfolio of commercial products, reported it expects to release its second quarter 2021 financial results before markets open on Monday, August 9, 2021 (Press release, Nuvo Pharmaceuticals, JUL 26, 2021, View Source [SID1234585187]).

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The Company will subsequently hold a conference call the same day, Monday, August 9, 2021 at 11:00 a.m. ET, hosted by Jesse Ledger, Miravo’s President & Chief Executive Officer and other senior management. A question-and-answer session will follow the corporate update.