On March 23, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the fourth quarter and year-to-date for the period ended December 31, 2021 (Press release, Navidea Biopharmaceuticals, MAR 23, 2022, View Source [SID1234610753]).

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Alexander L. Cappello, Chair of Navidea’s Board of Directors, said, "We remain focused on our mission of developing precision immunodiagnostic agents and immunotherapeutics to enhance patient care. We are confident that our strong management team, supported by our experienced and active Board of Directors, can continue to execute on our business plan and fulfill the vision we have for Navidea."

Fourth Quarter 2021 Highlights and Subsequent Events

Continued to work on financing for the Company. We have engaged with an investment bank and options are being pursued.
Initiated and enrolled into the Company’s NAV3-33 Phase 3 trial in rheumatoid arthritis ("RA") titled "Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFα Therapy Response in Patients with Moderate to Severe Active Rheumatoid Arthritis."
Continued enrollment into the Company’s NAV3-32 Phase 2b trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active RA. Eleven patients out of an originally estimated maximum of 24 based on subject pathotype are now enrolled with both imaging and biopsy performed.
Completed enrollment in the Company’s NAV3-35 Phase 2b study, "Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging with Tc99m Tilmanocept."
Completed the investigator-initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals. An abstract was presented at the Conference on Retroviruses and Opportunistic Infections in February 2022.
Signed research agreement with the University of Pennsylvania evaluating Tc99m tilmanocept as a prognostic marker for glioblastoma.
Signed a Letter of Intent with the image analysis company MIM Software, Inc., to be the Company’s commercial partner for image quantification of Tc99m tilmanocept imaging in RA.
Filed two new provisional patent applications. The first is related to new methods of attaching chemotherapeutics to the Manocept platform, and the second relates to maximizing target-tissue uptake and off-target competitive blocking. These have important implications for pipeline applications.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The clinical research team continues to work diligently to advance the technology in key disease areas, with an emphasis on our RA program. The NAV3-33 Phase 3 trial is enrolling, we continue to enroll into the NAV3-32 Phase 2b trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients, and we have completed our normative database trial enrollment. Concurrent with all of this, we continue to make progress in our therapeutics pipeline, and we expect to keep advancing these towards the clinic."

Financial Results

Total net revenues for the fourth quarter of 2021 were $50,000, compared to $219,000 for the same period in 2020. Total net revenues for the full year of 2021 were $532,000, compared to $914,000 in 2020. The decrease was primarily due to decreased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development and decreased royalty and license revenue from sales of Tc99m tilmanocept in Europe, offset by the partial recovery of debts previously written off in 2015 and receipt of reimbursement from Cardinal Health 414, LLC of certain R&D costs.
Research and development ("R&D") expenses for the fourth quarter of 2021 were $1.4 million, compared to $1.3 million in the same period in 2020. R&D expenses for the full year of 2021 were $5.1 million, compared to $4.9 million in 2020. The net increase during the year to date was primarily due to increased regulatory consulting, employee compensation, travel, recruiting and general office expenses, coupled with net increases in drug project expenses, including increased Manocept therapeutic and Tc99m tilmanocept development costs, offset by decreased Manocept diagnostic development costs.
Selling, general and administrative ("SG&A") expenses for the fourth quarter of 2021 were $2.3 million, compared to $1.7 million in the same period in 2020. SG&A expenses for the full year of 2021 were $7.5 million, compared to $6.7 million in 2020. The net increase during the year to date was primarily due to termination of our former Chief Executive Officer, coupled with increased consulting services related to European distribution of Tc99m tilmanocept, director compensation related to additional board members and increased board compensation rates, insurance costs, losses on the abandonment of certain intellectual property, recruiting fees, travel and general office expenses, offset by decreases in legal and professional services, employee compensation, investor relations costs, European annual registration fees, facilities costs and franchise taxes.
Navidea’s net loss attributable to common stockholders for the fourth quarter of 2021 was $3.7 million, or $0.12 per share, compared to $3.0 million, or $0.11 per share, for the same period in 2020. Navidea’s net loss attributable to common stockholders for the full year of 2021 was $11.7 million, or $0.40 per share, compared to $11.4 million, or $0.48 per share, in 2020.
Navidea ended the fourth quarter of 2021 with $4.2 million in cash and cash equivalents.
Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

To participate in the call and webcast, please refer to the information below:

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On March 23, 2022 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Dr. Roy D. Baynes, head of Global Clinical Development (GCD) and Chief Medical Officer, Merck Research Laboratories (MRL), will be retiring from Merck in July (Press release, Merck & Co, MAR 23, 2022, View Source [SID1234610752]). Dr. Baynes will be succeeded by Dr. Eliav Barr, effective April 1, 2022. Dr. Baynes will continue to report to Dr. Dean Y. Li, president, Merck Research Laboratories, until his retirement.

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"Roy is one of the world’s pre-eminent oncologists and clinical development experts, and his masterful spearheading of the development of KEYTRUDA leaves an indelible mark on Merck, on oncology and on the lives of patients and their families. As textbooks are updated to reflect the era of immuno-oncology, Roy’s contributions cannot be overstated, and will persist far beyond his eight years with Merck," said Dr. Li. "I know there are many who join me in thanking Roy for his efforts and wishing him well in his next chapter."

Dr. Baynes joined Merck in 2013. Under his leadership, Merck has become a leading oncology company and achieved more than 140 medicine and vaccine approvals globally across numerous therapeutic areas. This includes the development of KEYTRUDA (pembrolizumab), WELIREG (belzutifan), VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine), ZEPATIER (elbasvir and grazoprevir), LAGEVRIO (molnupiravir), ZERBAXA (ceftolozane and tazobactam), RECARBRIO (relebactam), PREVYMIS (letermovir), BRIDION (sugammadex) among others and, in collaboration with AstraZeneca, Eisai and Bayer, the development of Lynparza (olaparib), Lenvima (lenvatinib) and VERQUVO (vericiguat), respectively. He also led the expansion of Merck’s research and development in China and Japan.

"It has been a privilege to have led the global clinical development organization during my tenure at Merck," said Dr. Baynes. "I am immensely proud of the team’s accomplishments and the difference we are making in the lives of patients worldwide. I look forward to continuing to work with Eliav in the coming months to ensure a smooth transition."

Dr. Baynes will be succeeded by Dr. Eliav Barr, senior vice president, Global Clinical Development. During his more than two decades at Merck, Dr. Barr has held positions of increasing responsibility including leadership roles in oncology and infectious diseases clinical development. Dr. Barr oversaw the company’s Vaccines/Infectious Disease area during a period of high productivity, including the development of novel therapies for chronic hepatitis C and HIV-1 infections. Most recently he led MRL’s Global Medical Affairs organization from 2018 to January 2022, significantly expanding Merck’s scientific engagement and implementation efforts in oncology, vaccines and more. In his new role Dr. Barr will lead all late-stage clinical development for Merck’s expansive human health portfolio and pipeline and will report to Dr. Li.

"Eliav’s career at Merck has been marked by roles spanning infectious diseases, oncology and vaccines involving the development of several first-of-their-kind medicines and vaccines that have since been used by millions of people around the world. Most notably, he led the development of Merck’s human papillomavirus (HPV) vaccines, which have become key tools in the global effort to reduce the burden of certain cancers and diseases caused by HPV," said Dr. Li. "Eliav’s expertise in global clinical development combined with his unwavering commitment to patients and Merck’s purpose to save and improve lives make him well qualified to be the next Chief Medical Officer for Merck and the ideal leader for our industry-leading global clinical development team."

Dr. Barr is a cardiologist by training. He received his undergraduate degree from Penn State University and his medical degree from Sidney Kimmel Medical College, Thomas Jefferson University. He completed his Internal Medicine residency and Cardiology Fellowship at Johns Hopkins University, and subsequently pursued post-doctoral training at the University of Michigan. Prior to joining Merck in 1995, he held a faculty position at the University of Chicago. In 2019, he was a proud recipient of a Penn State Alumni Fellow Award for his dedication to the development of medicines and vaccines that treat and prevent infectious diseases.

"I am honored to assume the role as head of Merck’s industry-leading clinical development organization," said Dr. Barr. "I am grateful to Roy for his mentorship and excited by the opportunity to build on Merck’s proud legacy of delivering breakthrough medicines and vaccines for the patients we serve."

On March 23, 2022 Medigene reported that results for fiscal year 2021 and outlook Martinsried/Munich, 23 March 2022. Medigene AG ( View Source) (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology company focusing on the development of T-cell-based cancer therapies, today published its financial results and Annual Report for the 2021 fiscal year and its outlook for 2022 (Press release, MediGene, MAR 23, 2022, View Source [SID1234610751]). The full version of the Annual Report 2021 can be downloaded here: View Source/investors-media/reports-presentations/

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Business review and outlook

The Company has been repositioned with the aim of fully focusing its future development programs on T cell receptor-modified T cell immunotherapy (TCR-T immunotherapy) of solid cancer, based on scientific, clinical and commercial considerations. Medigene believes that this direction optimally leverages its unique technologies and opens the greatest commercial opportunities for the Company now and in the future. It remains Medigene’s mission to offer seriously ill cancer patients new, effective and well-tolerated therapies developed internally or through partnerships.

Validating, comprehensive TCR-T and technology partnership with BioNTech SE (BioNTech)

BioNTech recently acquired Medigene’s TCR-4 from the MDG10XX program and has an exclusive option to acquire additional existing TCRs in Medigene’s discovery pipeline. Medigene will develop a number of new TCRs under a development partnership agreement with BioNTech lasting initially for three years and has granted BioNTech licenses to its PD1-41BB switch receptor and precision pairing library. These are technologies that could make TCR-T therapies more efficient and safer.

Under the agreement, Medigene has received an upfront payment of EUR 26 million and will be reimbursed for research and development costs incurred during the period of the collaboration. Medigene will be eligible for development, regulatory and commercial milestone payments up to a triple-digit million Euro amount per program. In addition, the Company will be eligible for tiered deferred option payments on global net sales for products based on TCRs arising from the collaboration and royalties on products utilizing at least one of the licensed technologies.

MDG1011 – clinically validated TCR-T therapy in blood cancers

In June 2021, the last patient was enrolled in the third dose cohort of the Phase-I part of the Phase I/II trial of MDG1011 in blood cancer. Medigene reported on safety, tolerability and feasibility in December 2021. In February 2022, first efficacy and immune monitoring data were published. MDG1011 was successfully produced for 12 of the 13 heavily pretreated patients (92.3%) and proved to be safe and well tolerated. MDG1011 showed signs of both biological and clinical activity and one patient is currently still under observation, over nine months after treatment. In line with Medigene’s focus on solid cancers, the Company has decided that, contingent on the final results from the Phase I part, the Phase II part of the trial would only be conducted with or by a partner.

Unique tumor-specific antigens – the "dark matter" of our genome

Under the Company’s collaboration with the University of Montréal, Medigene gained access to 47 potential new tumor-specific antigens (TSAs) common to solid tumors of different origin, such as ovarian, breast, and lung cancer. Medigene’s high-throughput screening technology identified ten peptides that were immunogenic and able to induce specific T cell responses. To date, Medigene has isolated more than 20 TCRs of T cell clones that recognize these novel TSAs. Their further functional and safety characterization is ongoing.

Development partnerships

Medigene continues its successful collaborations with 2seventy bio, Inc. (formerly: bluebird bio, Inc.) and Cytovant Sciences HK Limited, a biopharmaceutical company founded by Roivant Sciences (Roivant/Cytovant) and initiates operations within a new partnership with BioNTech. To maximize the Company’s value, Medigene continues to evaluate new partnering opportunities related to its suite of technologies and portfolio of product candidates.

Prof. Dolores Schendel, Chief Executive Officer (CEO) and Chief Scientific Officer (CSO) at Medigene: "Our steadfast focus on TCR-T therapies against solid cancers, has led, most recently, to the comprehensive new partnership with BioNTech and the sound financial basis it provides for the Company.

This partnership validates Medigene’s investment in T-cell-based immunotherapy of cancer. This was clearly appreciated and valued by BioNTech in the lengthy due diligence process leading to the deal. We look forward to executing on this partnership.

Medigene is very well positioned to sustainably increase value through partnerships and our internal projects, discovering novel TCRs and developing and improving new technologies to make TCR-T therapies safer, more efficient and cost effective."

Change in the Executive Management Board

Axel Malkomes, Medigene’s Chief Financial and Business Development Officer, will leave the Company at the end of March 2022 by mutual consent at the expiry of his contract. Prof. Dolores Schendel will remain as CEO and CSO.

Dr. Gerd Zettlmeissl, Chairman of Medigene’s Supervisory Board: "Axel was a valued member of the Executive Management Board, making a significant contribution to the restructuring and improvement of Medigene’s financial outlook. We would like to thank Axel and wish him the best in his future endeavors.

We are very pleased that Dr. Birger Kohlert, Vice President Finance, Controlling, Procurement and IT at Medigene since January 2020, will act as CFO. Birger looks back on years of international experience in finance and was previously CFO at S + P Samson, Kissing, Germany, EvoBus Sweden and EvoBus Denmark. Prior to that, he had several positions in the finance department of the Daimler Group in Germany and the USA and in the audit department of KPMG in Germany. He holds a doctorate in the field of international accounting."

Financial development and guidance

In fiscal 2021, the financial forecast that was initially issued was adjusted to reflect the more favorable revenue and cost situation. Thereby, the expected range for total revenues was increased from previously EUR 7 – 9 million to EUR 10 – 11 million and the forecast for research and development expenses (R&D expenses) was reduced from EUR 14 – 20 million to EUR 11 – 12 million. The reason for this was, among other things, the efficiency measures of the previous year and active cost management, which were ultimately also reflected in the EBITDA loss, the range of which also shifted from EUR 10 – 17 million to EUR 7 – 9 million. The total revenues of EUR 10.5 million (2020: EUR 8.0 million) and EBITDA loss incurred in fiscal year 2021 of EUR -6.6 million (2020: EUR -22.2 million) were therefore within the specified forecast range, while R&D expenses of EUR 12.8 million (2020: EUR 22.3 million) were slightly higher.

The financial forecast for 2022 reflects the Company’s focus on and progress in the core business of immunotherapies and does not include potential future milestone payments from existing or future partnerships or transactions, as the timing and extent of such events depends to a large extent on external parties and therefore cannot be reliably predicted by Medigene. In 2022, Medigene expects to achieve revenues of EUR 23 – 28 million, R&D expenses of EUR 11 – 15 million and a positive EBITDA in the amount of EUR 3 – 5 million.

Cash and cash equivalents amounted to EUR 22.4 million at the end of 2021 (31 December 2020: EUR 30.0 million). Including the upfront payment of EUR 26 million received under the new partnership with BioNTech signed in February 2022, Medigene is financed into Q4 2024 based on current planning.

Conference call

The Management Board will hold a conference call in English today at 3 pm CET (10 am ET). Please register beforehand and latest 2 hours prior to the event through this link in order to get your personal access information (phone number, passcode + individual PIN):

On March 23, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported that management will participate in a panel discussion titled, "Pancreatic Cancer-Turning the Tide for One of the Most Challenging Indications in Oncology," at the Maxim Virtual Growth Conference on March 28, 2022, at 12:00 pm ET (Press release, Panbela Therapeutics, MAR 23, 2022, View Source;utm_medium=rss&utm_campaign=panbela-to-participate-in-a-panel-discussion-at-the-maxim-virtual-growth-conference [SID1234610748]).

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In addition to participating in the panel, the company will also give a presentation during the event available to viewers on-demand for the duration of the conference – March 28-30, 2022.

The growth conference is powered by Maxim Group’s MVEST platform and will stream virtually at: https://m-vest.com/events/2022-virtual-growth-conference.

About: SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 12.53 months which is now final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial.

For more information, please visit View Source

On March 23, 2022 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 its financial results for the full year 2021 and provided a corporate update (Press release, Xenetic Biosciences, MAR 23, 2022, View Source [SID1234610747]).

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"Over the course of the past year, our team has continued to advance the XCART program through pre-clinical studies, which are key to defining the best development pathway for this novel platform technology. Looking ahead, we remain focused on moving XCART toward IND-enabling studies. Though still early in its development, we believe XCART continues to demonstrate its potential as an important program due to its ability to target cancers with a patient- and tumor-specific approach," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic.

XCART Platform Technology Overview: Significantly differentiated, proprietary approach to personalized CAR T lymphoma therapy targeting tumor-specific neoantigens that target independently of CD19 or other surface antigens that are common to both normal and malignant B-cells. Lead program for Non-Hodgkin lymphoma, an area of significant unmet need, with the potential to address an initial global market opportunity of over $7 billion annually.[1]

Program Highlights:

Advancing preclinical efforts through ongoing research and development collaborations including with The Scripps Research Institute and other institutions in the United States ("U.S.") covering design and implementation of the pre-clinical development program, as well as activities supporting process development for clinical manufacturing.
Bolstered intellectual property portfolio with issuance of a U.S. patent covering the co-administration of XCART-derived CAR T cells, together with a personalized vaccine designed to enhance the effectiveness of the CAR T therapy.
PolyXen Platform Technology: Patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug’s circulating half-life and potentially improving other pharmacological properties.

Program Highlight:

Royalty payments of approximately $1.2 million were received in the year ended December 31, 2021, representing an approximate 166% increase over 2020 as Takeda’s sublicensee has launched the relevant product in multiple global markets.
Summary of Financial Results for Fiscal Year 2021

Net loss for the year ended December 31, 2021, was approximately $5.6 million. Research and development expenses for the year ended December 31, 2021 increased to $3.2 million compared to $1.7 million for the year ended December 31, 2020, representing continued investment in our XCART technology. General and administrative expenses for the year ended December 31, 2021 were $3.7 million compared to $3.4 million in the same period in 2020. At December 31, 2021, the Company reported working capital of approximately $17.3 million compared to $11.4 million at December 31, 2020. During the year ended December 31, 2021, the Company’s working capital increased by $5.9 million due to the $12.5 million private placement in July 2021 partially offset by the Company’s net loss for the year ended December 31, 2021.

The Company ended the year with approximately $18.2 million of cash.