On March 17, 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 its financial results for the fourth quarter and full year 2020, and provided a corporate update (Press release, Xenetic Biosciences, MAR 17, 2021, View Source [SID1234576810]).

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"Notwithstanding the challenges presented by the COVID-19 pandemic, 2020 was a year of significant progress for the Company, including the establishment of partnerships and academic collaborations and advancement in our development efforts, in particular with respect to CAR design and model cell line development, as well as the strengthening of our financial position. Our focus remains on advancing the XCART platform, and we look forward to further evaluation of our XCART process in a clinical setting during our upcoming exploratory study in Eastern Europe," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "Our goal remains to complete our preclinical development phase and advance into a Phase 1 study as quickly as possible."

XCART Platform Technology Overview: Significantly differentiated, proprietary approach to personalized CAR T therapy targeting tumor specific antigens that are independent of CD19 or other antigens common to all B-Cells. Lead program for Non-Hodgkin lymphomas, an area of significant unmet need, with the potential to address an initial global market opportunity of over $5 billion annually.[1]

Program Highlights:

Collaboration with Pharmsynthez and multiple academic institutions in Eastern Europe to optimize the overall XCART workflow, including clinical manufacturing processes, and ultimately to conduct a first in-human study in B-cell Non-Hodgkin lymphoma (NHL) patients.
Research and development collaboration with Scripps Research covering design and implementation of the preclinical development program, as well as method development activities supporting process development for clinical manufacturing.
Upcoming Potential Milestones

Initiation of exploratory patient biopsy study in Eastern Europe.
Seeking U.S. FDA INTERACT meeting.
Initiating process development for clinical CAR T manufacturing.
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 Highlights:

Exclusive License Agreement with Takeda Pharmaceuticals Co. Ltd. ("Takeda") in the field of blood coagulation disorders.
Takeda currently has one active development program underway.
Royalty payments of approximately $0.4 million received in 2020 as Takeda’s sublicensee has now launched the relevant product in multiple global markets.
Company’s partner, PJSC Pharmsynthez, announced positive Phase 3 trial results and filed a registration dossier in Russia to obtain approval of Epolong, a polysialylated form of human erythropoietin as a treatment for anemia in patients with chronic kidney disease.
Summary of Financial Results for Fiscal Year 2020

Net loss for the year ended December 31, 2020, was approximately $10.9 million. R&D expenses for the year ended December 31, 2020, were $1.7 million compared to $4.9 million for the year ended December 31, 2019. The decrease was primarily due to IPR&D expense of $3.0 million incurred during the year ended December 31, 2019. General and administrative expenses decreased by approximately $1.3 million, or 28.1% for the year ended December 31, 2020, to $3.4 million from $4.7 million in the comparable period in 2019, primarily due to approximately $1.1 million of transaction costs associated with the XCART acquisition incurred during the year ended December 31, 2019. At December 31, 2020, the Company reported working capital was approximately $11.4 million compared to $9.7 million at December 31, 2019. During the year ended December 31, 2020, working capital increased by $1.8 million due to the Company’s December 2020 registered direct common stock offering resulting in approximately $5.4 million in net proceeds. This increase in working capital was substantially offset by the Company’s net loss for the year ended December 31, 2020. The Company ended the year with approximately $11.5 million of cash.

On March 27, 2021 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported that Brian M. Culley, Chief Executive Officer, will be presenting at the Benzinga Global Biotech Small Cap conference on March 24, 2021 at 11:50am Eastern Time / 8:50am Pacific Time (Press release, Lineage Cell Therapeutics, MAR 17, 2021, View Source [SID1234576809]). Mr. Culley will also be participating in a panel entitled "Coming Together to Address Unmet Medical Needs," on March 24, 2021 at 12:50pm Eastern Time / 9:50am Pacific Time.

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Interested investors are encouraged to register for the event in advance: View Source The live and archived webcasts from the event will be available on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.

On March 17, 2021 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ: IPA) (TSX VENTURE: IPA) a leader in full-service, therapeutic antibody discovery and development, reported financial results for the third quarter of its 2021 fiscal year ended January 31, 2020 (Press release, ImmunoPrecise Antibodies, MAR 17, 2021, View Source [SID1234576808]).

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Q3 Fiscal 2021 Financial Highlights:

• Increased revenue for the nine months ended January 31st, 2021 by 32% to $13,035,522.
• Record adjusted EBITDA for the nine months ended January 31st, 2021 of $2,564,257, a significant increase from the $18,356 for the nine months ended January 31, 2020.
• Closed USD$21.7 million bought deal offering of common shares.
• Closed over-allotment option associated with the previously completed bought deal of USD$3.3 Million.

Dr. Jennifer Bath, CEO of ImmunoPrecise, stated, "We are pleased to enter into a new period of the Company’s corporate development lifecycle. Following our successful uplisting to the Nasdaq stock exchange, we continue to be well capitalized to meet our goals to extend our position as a single source partner of choice, antibody discovery engine to our partners. The recent partnerships that we have established with Genmab and Litevax highlight ImmunoPrecise’s technology stack as a biologics discovery platform. Additionally, through our Talem Therapeutics platform, we are creating deep opportunities to meet our goal to deliver shareholder value by monetizing our platform technology’s discovery engine."

Financial Results

Revenue: The Company continued to emphasize the value of technologically advanced discovery programs utilizing diverse animal repertoires and multiple technologies with unique advantages, while continuing to take on a larger volume of contracts in general. As a result, revenues of $4,516,000 were achieved for the three months ended January 31, 2021 compared to revenues of $4,034,440 in 2020, a 12% increase, and revenues of $13,035,522 were achieved during the nine months ended January 31, 2021 compared to revenues of $9,912,904 in 2020, a 32% increase in revenue for the period. During the three months ended January 31, 2021 the Company sold an internally developed therapeutic antibody asset for $1,188,762.

Gross Profit: The Company’s gross profit for the three months ended January 31, 2021 was $3,562,153 (79% gross profit margin) compared to gross profit of $2,223,669 (55% gross profit margin) in 2020. For the nine months ended January 31, 2021 gross profit was $8,761,148 (67% gross profit margin) compared to gross profit of $6,090,090 (61% gross profit margin) in 2020. The increase in gross profit was, in part, a result of the sale of an internally developed therapeutic antibody asset that was expensed as research and development in prior periods, and the elimination of intercompany cost of sales from the first six months of fiscal 2021. Excluding those one-time transactions, gross profit margins would have been 68% and 55% for the three-month periods ended January 31st, 2021 and 2020. For the nine-month periods, gross profit margins would have been 64% and 61% excluding the one-time transactions, which is in line with management expectations.

Research and Development: The Company has been expanding its commitment to research and development initiatives aimed at introducing new technological capabilities through both internal development as well as through partnerships. The Company has also undertaken research and development projects related to COVID-19 and has been awarded government grants and subsidies to support those efforts. During the nine months ended January 31, 2021, the Company invested $1,358,529 in research and development. The Company recorded $2,276,239 in grant income and subsidies through January 31, 2021.

Non-IFRS Measures. *Adjusted EBITDA for the three months ended January 31, 2021 was $836,382, compared to $717,716 for the three months ended January 31, 2020. This increase is related to the increased gross profit offset by the costs associated with the Company’s uplist to Nasdaq. Adjusted EBITDA for the nine months ending January 31, 2021 was $2,564,257, a significant increase from the $18,356 for the nine months ending January 31, 2020. This improvement is the result of the increase in revenue, higher gross profit and grant and subsidy income compared to the prior period offset by Nasdaq costs.

Cash Position. As of January 31, 2021, the Company had cash on hand of $15,720,057 compared to $2,605,706 as of April 30, 2020, a result of exercised warrants and exercised stock options. The Company’s forecast indicates the cash on hand will sustain its existing operations, support its Nasdaq uplist costs and satisfy its obligations through at least 2022.

About IPA’s PolyTope Platform.
IPA’s SARS-CoV-2 PolyTope monoclonal therapies currently in preclinical development are designed to protect against mutagenic escape with an emphasis on efficacy for every patient, variant, and strain of SARS-CoV-2. They are created with the goal of sustainable efficacy in the face of an evolving virus, combining extensively characterized, potently neutralizing, synergistic antibodies exhibiting richly diverse epitope coverage.

O March 17, 2021 VBL Therapeutics (Nasdaq: VBLT) reported that it will release its fourth quarter and full year results for the period ended December 31, 2020 on Thursday, March 25, 2021 before market open (Press release, VBL Therapeutics, MAR 17, 2021, View Source [SID1234576807]). Professor Dror Harats, M.D, Chief Executive Officer and Amos Ron, Chief Financial Officer, will host a conference call at 8:30am ET the same day to discuss the results and provide a corporate update.

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On March 17, 2021 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ("Diffusion" or the "Company"), an innovative biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, reported financial results for 2020 and provided a business update (Press release, Diffusion Pharmaceuticals, MAR 17, 2021, View Source [SID1234576806]).

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Business and financial highlights during 2020 and 2021 year-to-date include:

Strengthened management team: Appointed Robert Cobuzzi, Jr., Ph.D., President and Chief Executive Officer and Director, Christopher Galloway, M.D., Chief Medical Officer, and William Elder, General Counsel. Also added Jane H. Hollingsworth to the Company’s Board of Directors

Advanced development of trans sodium crocetinate ("TSC"): During 2020, the Company initiated its Phase 1b lead-in trial of 24 hospitalized COVID-19 patients. The trial was designed to evaluate the safety and tolerability of TSC when administered every six hours for up to 15 days, a previously untested dosing regimen. The company completed dosing and reported topline results from the study in February 2021. Results indicated that no dose-limiting toxicities or serious adverse events were observed in the trial
• The Phase 1b represents the first major step towards solidifying a redefined TSC development strategy that the company announced in November 2020
• In 2021, the company will execute three oxygenation studies, described below

Enhanced Financial Stability: As of December 31, 2020, the Company had $18.5 million in cash and cash equivalents. As of March 16, 2021, approximately $36.7 million in additional, aggregate gross proceeds have been received by the Company during the first quarter of 2021 through a common stock offering in February 2021 and the cash exercise of certain previously outstanding warrants

"There is no doubt that 2020 was a challenging year, but it was also a transformational year for Diffusion. We formed a new executive team, initiated and advanced our Phase 1b study of TSC in hospitalized COVID-19 patients, and concurrently redefined the clinical development pathway for TSC in an effort to maximize the probability of clinical and regulatory success," said Robert Cobuzzi, President and Chief Executive Officer of Diffusion. "The momentum we gained exiting 2020 has continued into 2021. We have completed the study of TSC in hospitalized COVID-19 patients, designed a series of three clinical trials to be conducted during 2021 to evaluate the effects of TSC on oxygenation, and secured the company’s financial position by completing our $34.5 million equity raise."

Near Term Strategy

In an effort to support further, robust clinical development of TSC, the Company intends to undertake a prospective exploration of the relationship between the level of TSC exposure (dose) and response (change in oxygenation) by conducting three short-term clinical trials in the United States during 2021, all of which the Company expects to be able to fund with cash-on-hand.

The Company believes positive data from any one or more of these three Oxygenation Trials will provide evidence of a definitive effect of TSC on oxygenation, whether through increased uptake in the lungs, enhanced delivery, increased utilization at the tissue level, or some combination thereof.

TCOM Trial: The first of the three Oxygenation Trials, which we expect to initiate imminently, will evaluate the effects of TSC on peripheral tissue oxygenation using a transcutaneous oxygen monitoring ("TCOM") device. The TCOM device directly measures the release of oxygen from the blood vessels through the skin and is commonly used to predict the likelihood of wound healing, the potential for success with hyperbaric therapy, and to map the appropriate location for limb amputation.

The TCOM Trial is designed to evaluate single, ascending, randomized doses of TSC to establish the exposure-response relationship between TSC and enhanced oxygen delivery. We anticipate this study will be completed in the second quarter of 2021, with top line results available within two months of study completion.

Hypoxia Trial: The second planned trial is the Hypoxia Trial, which we expect to initiate in the third quarter of 2021. This trial will evaluate the effects of TSC on maximal oxygen consumption (VO2), and partial pressure of blood oxygen (PaO2), in normal healthy volunteers exposed to conditions that induce hypoxia.

Trial participants will engage in incremental levels of physical exertion while exposed to hypoxic and hypobaric conditions. The primary endpoints will be change from baseline in VO2 and PaO2 after receiving a single intravenous dose of TSC. We anticipate this study will be completed in the second half of 2021, with topline results available within two months of study completion.

DLCO Trial: The third trial is designed to evaluate the effects of TSC on the diffusion of carbon monoxide through the lungs ("DLCO") in patients with previously diagnosed interstitial lung disease who have a baseline DLCO test result that is abnormal. We expect to initiate the DLCO Trial in the third quarter of 2021. DLCO testing is commonly performed as part of standard pulmonary function testing and aids in the diagnosis of dyspnea, also known as shortness of breath, as well as to track improvement or progression over time on prescribed treatments.

In this trial, DLCO will act as a surrogate measure of oxygen transfer efficiency, or uptake, from the alveoli of the lungs, through the plasma, and onto hemoglobin within red blood cells. The DLCO Trial will test single, ascending doses of TSC in an attempt to establish the exposure-response relationship between TSC and oxygen transfer efficiency. We anticipate this study will be completed in the second half of 2021, with top line results available within two months of study completion.

Outcomes from one or each of these Oxygenation Trials will inform the company’s go-forward TSC clinical development path, focusing on the demonstration of clinical and therapeutic benefits of TSC in relevant patient populations across the hypoxia continuum. Assuming success in one or more of the three Oxygenation Trials, the Company expects to identify and announce the specific, hypoxia-related indication it will target, in the fourth quarter of 2021. The Company then plans to initiate a Phase 2, controlled, clinical outcome study evaluating TSC in one or more appropriate hypoxia-related indications in the first half of 2022.

2020 Financial Results

As of December 31, 2020, Diffusion had cash and cash equivalents of $18.5 million as compared to $14.2 million as of December 31, 2019. Net cash used in operating activities during 2020 was $13.6 million, compared to $9.9 million used during 2019. During 2020, the Company raised $12.0 million in gross proceeds through its May 2020 offering of common stock and an additional $8.0 million in gross proceeds through the exercise of certain previously outstanding warrants.

An additional $36.7 million in aggregate gross proceeds have been received by the company thus far during the first quarter of 2021, through its common stock offering in February 2021 and the exercise of certain previously outstanding warrants. As of March 16, 2021, the Company believes it has adequate cash resources to continue operations through 2023, including expenditures related to the three Oxygenation Trials and its planned Phase 2 trial in a hypoxia-related indication.

Research and development expenses were $9.4 million for 2020, compared to $6.6 million for 2019. The increase was primarily attributable to the company’s clinical trial evaluating TSC in hospitalized COVID-19 patients, which resulted in a $1.1 million uptick in manufacturing costs and a $2.2 million increase in clinical trial and other R&D related expenses.

General and administrative expenses were $6.4 million for 2020, compared to $4.8 million for 2019. The Increase was largely driven by a $0.7 million increase in professional fees and a $0.9 million increase in salaries, wages, and stock-based compensation, including certain non-recurring expenses related to the retirement and separation of Diffusion’s former executives during 2020. Diffusion reported a net loss of $14.2 million in 2020, compared to a net loss of $11.8 million in 2019.

Additional information and financial statements can be found in the 10K filed with the SEC on March 17, 2021, which can be found on the Diffusion website at: View Source,
or on Edgar at: View Source;owner=exclude