On March 22, 2022 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, reported that Company’s Management will provide a corporate update and participate in a panel discussion entitled "Pancreatic Cancer: Turning the Tide for One of the Most Challenging Indications in Oncology," at the Maxim 2022 Virtual Growth Conference, to be held virtually March 28-March 30, 2022 (Press release, Synthetic Biologics, MAR 22, 2022, View Source [SID1234610749]).

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Details on the panel discussion include:

Title: "Pancreatic Cancer: Turning the Tide for One of the Most Challenging Indications in Oncology"

Date: March 28, 2022

Time: 12:00 p.m. – 1:00 p.m. ET

The conference will be available through the M-Vest portal for registered members.

On March 22, 2022 LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT), notes findings by a team of physician-scientists led by principal investigator Dr. Amir Jazaeri, professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center, and reported at the annual meeting of Society of Gynecologic Oncology (SGO) in Phoenix, AZ, that a subset of patients with ovarian clear cell carcinoma (OCCC) treated with immune checkpoint inhibitors lived significantly longer (had increased overall survival) than most patients with the same disease treated with the same regimens (Press release, Lixte Biotechnology, MAR 22, 2022, View Source [SID1234610710]).

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Dr. Emily Hinchcliff (now at Northwestern University Cancer Center), the lead author of the report, noted that based on observations in two exceptional survivors, her team became interested in survival outcomes in patients with inactivating somatic tumor mutations in PPP2R1A, the major scaffold subunit of the protein phosphatase 2A (PP2A) multimeric enzyme. This presentation included preliminary results of 28 recurrent, platinum-resistant OCCC patients enrolled on an ongoing clinical trial testing the efficacy of CTLA4- and PD-L1-targeting immune checkpoint inhibitors (clinicaltrials.gov identifier: NCT03026062). Median overall survival was not reached in seven patients with hotspot inactivation mutations in PPP2R1A versus 6.4 months in the 21 patients without such mutations (p=0.018; HR=0.13 (95% CI: 0.02-0.95). Of note in several patients, response or prolonged disease stabilization leading to longer survival occurred after initial progression. Inactivating mutations in PPP2R1A are known to reduce the enzymatic activity of PP2A.

LIXTE CEO John S. Kovach, MD, commented "the results of Hinchcliff and colleagues strongly support our belief that pharmacologic reduction of PP2A activity by administration of LB-100 will mimic the biological effects of inactivating mutations in the PPP2R1A gene, and therefore may be a general way to enhance immunotherapy for many, if not all, tumor types. Hinchcliff et al. made the striking observation that a few patients with OCCC, a subtype of ovarian cancer, will likely live an exceptionally long time (years as opposed to months) when treated with immunotherapy after failing on standard treatment. Their genetic analysis of tumors from 28 OCCC patients receiving immunotherapy showed that patients living longer on treatment had mutations known to reduce the activity of PP2A, whereas none of the patients progressing on immunotherapy had these mutations."

Dr. Kovach continued: "Additional evidence supporting our hypothesis that LB-100 may be a general way to enhance the benefit of immunotherapy are other recent outside preclinical studies, showing that LB-100 increases immunotherapy effectiveness against several different tumor types (Ho et al 2018, Cui et al 2020, Yen et al 2021). In particular, the studies by Yen and colleagues show that LB-100 converts immunologically unresponsive ("cold") tumors to immunologically responsive ("hot") tumors. Although immunotherapy is a true breakthrough in cancer treatment and is now approved for use in more than 20 different human cancers, most patients unfortunately do not respond. If pharmacologic inhibition of PP2A significantly enhances immunotherapy of even a few human cancers, it will be a game-changer. Fortunately, this hypothesis is readily testable in the clinic, which LIXTE is planning to do."

On March 22, 2022 Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, reported that its venture capital arm, Hikma Ventures has led an $15 million USD round of financing for Activ Surgical, a pioneering digital surgery imaging startup that is developing groundbreaking interoperative surgical intelligence hardware and software (Press release, Hikma, MAR 22, 2022, View Source [SID1234610702]). The investment is an extension of the Series B round that was previously announced by Activ Surgical in September 2021. This most recent financing, which also saw participation from existing investors, brings the total Series B round to $60 million USD.

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Activ Surgical aims to revolutionize access to surgical care, enabling a future of augmented reality (AR)-based and artificial intelligence (AI)-driven surgery that is safe, smart, and accessible to all. The company’s patent-protected surgical intelligence platform – ActivEdge – is being designed to reduce unintended and preventable surgical errors by enhancing a surgeon’s interoperative decision-making through the use of AI. Activ Surgical’s first product — the ActivSight imaging module — seamlessly upgrades existing operating room equipment, serving as the "eyes" of the ActivEdge platform. It allows surgeons to access critical intraoperative visual data as AR overlays. In 2021, the ActivSight imaging module was cleared by the FDA and successfully used in its first-in-human studies. To date, multiple major hospital networks across the U.S. and Europe have been established as pilot sites. The ActivSight imaging module is available now via a limited market release and will be broadly available in 2022.

"Hikma Ventures’ investment in Activ Surgical comes at a critical inflection point in the company’s history as our team is hard at work preparing for the global launch of our ActivSight imaging module later this year," said Todd Usen, CEO, Activ Surgical. "This investment will allow us to scale our business quickly and add resources needed to ensure a successful rollout of the ActivSight imaging module, helping to fulfil our mission to empower surgeons’ intraoperative decision-making and, ultimately, enhance patient safety. Hikma’s position in the global healthcare landscape helps validate our mission to provide better patient outcomes globally."

"We are thrilled to invest in Activ Surgical and support their mission to democratize surgical care and to eliminate unintended surgical complications to improve patient outcomes and empower surgeons across the globe," said Lana Ghanem, Managing Director of Hikma Ventures. "This is the latest example of Hikma Ventures’ commitment to supporting pioneering companies utilizing cutting-edge technologies to meaningfully improve patients’ lives. We look forward to working with the talented Activ Surgical team to help them expand the global reach of their innovative platform to different geographies, especially the Middle East."

On March 22, 2022 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a clinical-stage biopharmaceutical company dedicated to the development of innovative therapies designed to treat or reverse disease, reported that financial results for the three and twelve months ended December 31, 2021 (Press release, Caladrius Biosciences, MAR 22, 2022, View Source [SID1234610662]).

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"Caladrius made significant progress in 2021 that we believe has positioned us well to achieve several important milestones in 2022," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. "Highlights from 2021 include the initiation of our ongoing Phase 2b FREEDOM Trial of XOWNA for the treatment of coronary microvascular dysfunction; the appointment of Kristen K. Buck, M.D., as Executive Vice President of Research & Development and Chief Medical Officer; and the strengthening of our balance sheet with approximately $95 million in capital that will serve as a foundation for our next phase of growth. The Company remains focused on refining and executing its development plans in 2022 and is already off to a strong start with the initiation of our Phase 1 study of CLBS201 in diabetic kidney disease where we anticipate the first patient to be treated early in the second quarter. In parallel, the Company continues to identify and evaluate strategic development opportunities with the aim of consummating transactions that will deliver additional value to our shareholders beyond our current development pipeline."

Product Development and Financing Highlights

HONEDRA (CLBS12) for the treatment of critical limb ischemia ("CLI")

HONEDRA is the Company’s SAKIGAKE-designated product candidate for the treatment of CLI and Buerger’s disease in Japan. As discussed in previous quarters, enrollment in the ongoing registration-eligible trial has been severely impeded by the multiple states of emergency declared by the Japanese government during 2020 and 2021 as a result of the COVID-19 pandemic. This has made even incremental enrollment exceedingly challenging. Since the trial continues to demonstrate positive trends in both safety and efficacy, the key criteria for consideration of conditional approval in Japan under the SAKIGAKE designation, the Company suspended enrollment and turned its focus to securing a Japanese partner either to complete study enrollment of the four remaining patients, if necessary, and/or to explore the possibility of submitting the existing data to the Japanese Regulatory Authorities for registration review. This decision was motivated by the Company’s desire to minimize additional operational and financial burden caused by enrollment delays and the lack of visibility on time to completion of the current study. The Company has had numerous conversations with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan regarding the best path forward and anticipates having clarity on next steps during the second quarter of 2022.

XOWNA (CLBS16) for the treatment of coronary microvascular dysfunction ("CMD")

XOWNA is an experimental regenerative therapy for the treatment of CMD. It was the subject of a positive Phase 2a study (the "ESCaPE-CMD trial") reported in 2020 and is currently being evaluated in the U.S. Phase 2b FREEDOM Trial. The FREEDOM Trial is a double-blind, randomized, placebo-controlled study designed to assess the efficacy and safety of delivering autologous CD34+ cells to subjects with CMD and without obstructive coronary artery disease. As previously communicated, enrollment in the FREEDOM Trial initially proceeded as planned with the first patient treated in January 2021, however, the impact of the COVID-19 pandemic in the U.S. has contributed to a general slowing of enrollment that continues to this day. Caladrius has taken steps to accelerate enrollment by expanding the number of participating investigational sites as well as modifying the study protocol to make study inclusion criteria more flexible. At this time, the Company is unable to give guidance on when enrollment will be

completed but expects the study to run into 2023, if continued as planned. Final data from the study is expected approximately six months after last patient/last visit in the study. Caladrius continues to monitor the progress of the study and will consider additional future protocol and/or execution changes, as appropriate, to accelerate completion.

CLBS201 for the treatment of diabetic kidney disease ("DKD")

Progressive kidney failure is associated with attrition of the microcirculation of the kidney. Pre-clinical studies in kidney disease and injury models have demonstrated that protection or replenishment of the microcirculation results in improved kidney function. Based on these observations, the Company recently initiated a Phase 1, open-label, proof-of-concept trial evaluating CLBS201, a CD34+ regenerative cell therapy investigational product for intra-renal artery administration in patients with DKD. Although still in the pre-dialysis stage of kidney disease, the selected patients will exhibit rapidly progressing stage 3b disease. The protocol provides for a staggered, sequentially dosed cohort of six patients overseen by an independent Data Safety Monitoring Board (DSMB) with the objective of determining the tolerance of intra-renal cell therapy injection in DKD patients as well as the ability of CLBS201 to regenerate kidney function. A key read-out of data will occur at the 6-month follow-up visit for all patients. As previously announced, the Company anticipates the first patient to be treated in this study early in the second quarter of 2022 with top-line data from all subjects expected by the first quarter of 2023.

Fourth Quarter and Full Year 2021 Financial Highlights

Research and development expenses for the fourth quarter of 2021 were $4.2 million, a 43% increase compared with $2.9 million for the fourth quarter of 2020, and $17.7 million for the year ended December 31, 2021 compared to $9.3 million for the year ended December 31, 2020, representing an increase of approximately 91%. Research and development activities in both the current year and prior year periods focused on the advancement of our ischemic repair platform and related to:

•Expenses associated with efforts to continue execution and acceleration of enrollment of the FREEDOM Trial;
•Expenses associated with the planning, preparation and initiation of the Phase 1 proof-of-concept trial for CLBS201 as a treatment for DKD; and
•Ongoing expenses for HONEDRA in CLI and Buerger’s disease in Japan associated with maintenance of manufacturing facility and personnel qualification as well as Contract Research Organization engagement despite no subject treatment execution due to the COVID-19 imposed state of emergency in Japan.
General and administrative expenses, which focus on general corporate related activities, were $2.7 million for the three months ended December 31, 2021, representing an increase of 6% compared to $2.5 million for the three months ended December 31, 2020, and $11.4 million for the year ended December 31, 2021, representing an increase of 15% compared to $9.9 million for the year ended December 31, 2020. This increase was primarily due to an increase in directors and officers liability insurance premiums and strategic consulting expenses.

Overall, net losses were $27.5 million and $8.1 million for the years ended December 31, 2021, and 2020, respectively.

Balance Sheet Highlights

As of December 31, 2021, we had cash, cash equivalents and marketable securities of approximately $95.0 million. Based on existing development programs, the Company projects that its current cash balance will fund operations for the next several years. Based on this favorable cash position, the Company will continue its concerted efforts to identify and acquire additional development assets to diversify its portfolio of product candidates and to enhance the opportunity for shareholder value creation.

Conference Call

Caladrius will hold a live conference call today March 22, 2022, at 4:30 p.m. (ET) to discuss financial results, provide a business update and answer questions. To join the conference call, please refer to the dial-in information provided below. A live webcast of the call will also be available under the Investors & News section of the Caladrius website (View Source) and will be available for replay for 90 days after the conclusion of the call.

Please dial-in 10 minutes before the start of the conference call.

For those unable to participate on the live conference call, an audio replay will be available that day starting at 7:30 p.m. (ET) until March 29, 2022, by dialing 855-859-2056 (U.S. Toll-Free) or 404-537-3406 (International) and by entering the replay passcode: 5066195.

On March 22, 2022 Alkermes plc (Nasdaq: ALKS) reported that its Chief Executive Officer, Richard Pops, will participate in a fireside chat at the Stifel 2022 CNS Days on Tuesday, March 29, 2022 at 8:30 a.m. ET (1:30 p.m. BST) (Press release, Alkermes, MAR 22, 2022, View Source [SID1234610654]). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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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

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