Xenetic Biosciences, Inc. to Present at the H.C. Wainwright 23rd Annual Global Investment Conference

On September 8, 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 Jeffrey F. Eisenberg, Chief Executive Officer of Xenetic will present at the virtual H.C. Wainwright 23rd Annual Global Investment Conference taking place September 13-15, 2021 (Press release, Xenetic Biosciences, SEP 8, 2021, https://ir.xeneticbio.com/news/detail/115/xenetic-biosciences-inc-to-present-at-the-h-c-wainwright-23rd-annual-global-investment-conference [SID1234587409]).

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In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

A video webcast of the presentation will be available for viewing on-demand beginning Monday, September 13, 2021, at 7:00 AM ET for those registered for the event and will be accessible on the Events page in the Investors section of the Company’s website (xeneticbio.com). The webcast replay will be archived for 90 days following the event.

CytRx to Present at the H.C. Wainwright 23rd Annual Global Investment Conference

On September 8, 2021 CytRx Corporation (OTCQB: CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, reported that Steven A. Kriegsman, the Company’s Chairman and Chief Executive Officer, is scheduled to present at the H.C. Wainwright 23rd Annual Global Investment Conference, which is taking place virtually September 13-15, 2021 (Press release, CytRx, SEP 8, 2021, View Source [SID1234587427]).

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Mr. Kriegsman’s presentation will focus on CytRx’s high-potential pipeline and assets, including its licensing agreements with ImmunityBio, Inc. and Orphazyme A/S. The presentation will also discuss the Company’s assessment of its Centurion BioPharma subsidiary and its LADR Platform, which aims to concentrate ultra-high-potency drugs in solid tumors and minimize systemic toxicity. In addition to the LADR Platform, the technology includes the ACDx diagnostic, which was developed to allow oncologists to determine which patients can benefit from the ultra-high-potency drugs.

The virtual presentation will be available for on-demand access at this link and on CytRx’s website under the News & Events section beginning the week of September 13th.

Shoreline Biosciences to Present at Upcoming Investor Conferences

On September 8, 2021 Shoreline Biosciences, Inc. (Shoreline), a biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized, and targeted induced pluripotent stem cells (iPSC) derived natural killer (NK) and Macrophage cellular immunotherapies, reported that company management will present and be available for one-on-one meetings at the Wells Fargo 2021 Virtual Healthcare Conference, September 9 -10, 2021, and the H.C. Wainwright 23rd Annual Global Investment Conference, September 13 – 15, 2021 (Press release, Shoreline Biosciences, SEP 8, 2021, View Source [SID1234587445]).

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Details on the presentations can be found below.

Wells Fargo 2021 Virtual Healthcare Conference
September 9, 2021 at 12:40 PM ET

H.C. Wainwright 23rd Annual Global Investment Conference
Presentation Date: Corporate presentation will be available on-demand to conference
registrants starting at 7:00 AM ET on September 13, 2021

Sanofi to acquire Kadmon to further strengthen growth of transplant business

On September 8, 2021 Sanofi reported that it has entered into a definitive merger agreement with Kadmon Holdings, Inc. (NASDAQ: KDMN) a biopharmaceutical company that discovers, develops, and markets transformative therapies for disease areas of significant unmet medical needs (Press release, Sanofi, SEP 8, 2021, View Source [SID1234587374]). The acquisition supports Sanofi’s strategy to continue to grow its General Medicines core assets and will immediately add Rezurock(belumosudil) to its transplant portfolio. Rezurock is a recently FDA-approved, first-in-class treatment for chronic graft-versus-host disease (cGVHD) for adult and pediatric patients 12 years and older who have failed at least two prior lines of systemic therapy.

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Shareholders of Kadmon common stock will receive $9.50 per share in cash, which represents a total equity value of approximately $1.9 billion (on a fully diluted basis). The Sanofi and Kadmon Boards of Directors unanimously approved the transaction.

"We are transforming and simplifying our General Medicines business and have shifted our focus on differentiated core assets in key markets," said Olivier Charmeil, Executive Vice President General Medicines. "We are thrilled to add Kadmon’s Rezurock to our well-established transplant portfolio. Our existing scale, expertise, and relationships in transplant create an ideal platform to achieve the full potential of Rezurock, which will address the significant unmet medical needs of patients with chronic graft-versus-host disease around the world."

"We are excited that Sanofi has acknowledged the value of Rezurock and the deep potential of our pipeline," said Harlan Waksal, M.D., President and Chief Executive Officer, Kadmon. "By leveraging Sanofi’s global resources and long-standing expertise in developing and commercializing innovative medicines, Rezurock is now well positioned for global accessibility, faster. I want to thank the entire Kadmon team, including management and the Board of Directors, and the Sanofi organization, for their ongoing commitment to patients and their caregivers."

Sanofi’s transplant business mainly consists of Thymoglobulin (anti-thymocyte globulin), a polyclonal, anti-human thymocyte antibody preparation that acts as a broad immunosuppressive and immunomodulating agent and Mozobil (plerixafor), a hematopoietic stem cell mobilizer. Both products are among General Medicines core assets and are currently registered and marketed in more than 65 countries.

In July 2021, the FDA approved Rezurock for the treatment of adult and pediatric patients 12 years and older with cGVHD after the failure of at least two prior lines of systemic therapy. Rezurock was launched in August in the United States. It is the first and only approved small molecule therapy that inhibits the Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response and fibrotic processes. Sanofi will work closely with regulatory authorities across different geographies to ensure that patients suffering from cGVHD can benefit from belumosudil treatment as early as possible. Kadmon is also developing Rezurock for the treatment of diffuse cutaneous systemic sclerosis, with an open-label Phase 2 clinical trial currently ongoing.

Kadmon’s pipeline includes drug candidates for immune and fibrotic diseases as well as immuno-oncology therapies.

The transaction is expected to be modestly dilutive to Sanofi’s EPS in 2022.

Transaction Terms

Under the terms of the merger agreement, holders of Kadmon’s common stock will receive $9.50 per share in an all-cash transaction, reflecting a total equity value of Kadmon of approximately $1.9 billion. The offer price represents a premium of 79% over the closing price on September 7, 2021 and a premium of approximately 113% over the 60 trading days volume weighted average price.

The consummation of the transaction is subject to customary closing conditions, including the approval of holders of a majority of the outstanding shares of Kadmon voting stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions. Following the successful completion of the merger, a wholly owned subsidiary of Sanofi will merge with Kadmon and the outstanding Kadmon shares will receive $9.50 per share in cash. Sanofi plans to fund the transaction with available cash resources. Subject to the satisfaction or waiver of customary closing conditions, Sanofi expects to complete the acquisition in the fourth quarter of 2021.

Weil, Gotshal & Manges LLP is acting as legal counsel to Sanofi. Cantor Fitzgerald & Co. and Moelis & Company LLC are acting as exclusive financial advisors to Kadmon in the transaction, while DLA Piper LLP (US) is acting as legal counsel.

Scandion Oncology provides a clear path to market for SCO-101 at today’s Capital Markets Day

On September 8, 2021 Scandion Oncology A/S, the Cancer Drug Resistance Company, reported it will provide novel information on its lead candidate drug SCO-101 and a focused clinical strategy with a clear path to registration at today’s Capital Markets Day (Press release, Scandion Oncology, SEP 8, 2021, View Source,c3411474 [SID1234587392]). The company will also communicate about its pipeline, future business opportunities and give an update from part 1 of the CORIST Phase II study.

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Data from the CORIST study have triggered an updated focused clinical strategy. Scandion has documented a unique Mode of Action (MoA) for SCO-101 in the CORIST study, where the company shows a significant potentiation of Irinotecan by combining SCO-101 with FOLFIRI in patients. The combination resulted in a dramatically increased exposure and half-life of SN-38 (the active metabolite of Irinotecan). The molecular mechanism of action driving the increased exposure has been identified. The Company has filed a patent application on this unique mode of action.

Scandion Oncology will become a Phase III company
"Our path forward is built on a unique Mode of Action (MoA) and we have focused our clinical strategy to provide a clear route to registration and return on investments in RAS wild-type metastatic colorectal cancer. The ultimate outcome is to become a Phase III company as early as in 2023. We further see a huge opportunity for building on this platform knowledge, to broaden the clinical opportunities for SCO-101 in combination with Irinotecan and maximize business value," said Bo Rode Hansen, President & CEO.

Refocusing from last line mCRC to 2nd line
This also means, that Scandion will refocus from last line metastatic colorectal cancer (mCRC) to second line of treatment to add significantly more value. To maximize the market potential in second line mCRC, the Company aims to position SCO-101 in combination with VEGF monoclonal antibodies (mAbs) and/ or EGFR monoclonal antibodies (mAbs) which are used as backbone in 1st and 2nd line of treatment of RAS wild-type mCRC.

In preparation for the pivotal study, the company will redesign part 3 of CORIST, which is funded, to include 10 patients as a separate arm that will run in parallel to the 25 patients in CORIST part 2. CORIST part 3 will evaluate safety of combining SCO-101 and FOLFIRI with mAbs (VEGF and/or EGFR), pharmacokinetics and be included in the overall efficacy assessment in CORIST Phase II. The company is further planning to open an Investigational New Drug (IND), to allow for inclusion of patients from US clinical sites.

Focusing our pipeline on value creation and highest probability of success
"We are prioritizing SCO-101 in combination with Irinotecan over other projects in our pipeline, as we see the most value creation potential for this combination. We will therefore cease investing in less documented MoAs including SCO-101 in combination with anti-oestrogens and in indications outside of cancer (antibiotics). The implications are that we de-prioritize two of our preclinical projects: EndoRIST and SOM-001. In terms of pipeline, we will focus on maximum value creation and highest probability of success. We have defined a clear roadmap for our coming years," said Bo Rode Hansen.

The Capital Markets Day will take place between 9am and 11.30am CET today and will be webcasted live and is accessible at: View Source

This information is information that Scandion Oncology A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on September 8, 2021 at 8:30 CET.