On July 12, 2022 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that CEO and Co-Founder Mr. James Nathanielsz, BAS, MEI, believes the Company’s lead asset could unlock value as PRP advances to a Phase I, First-In-Human study in advanced cancer patients (Press release, Propanc, JUL 12, 2022, View Source [SID1234616618]). As a less toxic therapy compared to standard treatments with a unique approach for the treatment and prevention of metastatic cancer, PRP has the potential to be a welcome addition to the treatment process that is complementary to existing therapies. Notwithstanding recent advances in the oncology sector, metastasis from solid tumors remains the unsolved final frontier and is the biggest killer of cancer sufferers.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Consequently, despite the relatively early stage of development of PRP, Mr. Nathanielsz comments that the clinical history of PRP in the treatment of cancer, as well as the positive results achieved in a physician sponsored investigator study of 46 late-stage advanced cancer patients suffering from a range of malignancies, conducted by Chief Scientific Officer and Co-Founder, Dr. Julian Kenyon, MD, MB, ChB, "Substantially alters the risk profile for success," compared to new and untried technologies at a similar stage of development. This has been substantiated by a third-party valuation undertaken by a North American investment bank, coordinated by the Company, which valued Propanc’s intellectual property (IP) assets at $26 million, despite a relatively early stage of development, based on the Company’s initial target patient populations, including pancreatic, ovarian, prostate and colorectal cancers.

To date, the Company has completed pivotal safety toxicology studies, as well as undertaking significant process development and purification processes for the active pharmaceutical ingredients in the PRP formulation, trypsinogen and chymotrypsinogen. As the Company completed these pivotal activities to prepare for a clinical study, the Company conducted several scientific advice meetings with the Medicines and Healthcare Products Regulatory Agency (MHRA), UK, to gain an understanding of the regulatory requirements to support a clinical trial application for PRP, to be conducted at the Peter Mac Cancer Center, in Melbourne, Australia. As a result of planning to undertake the first clinical study in Melbourne, Australia, a Certificate for Advance Overseas Finding was received from the Board of Innovation and Science Australia to receive up to a 43.5% "cash back" benefit from overseas R&D expenses. To qualify for the advance overseas finding, R&D expenditure incurred overseas will not exceed expenditure on local, Australian R&D activities, which will also receive up to a 43.5% cashback benefit. In other words, overseas vs. Australian R&D expenses must not exceed a 50:50 split.

The Company also achieved Orphan Drug Designation Status from the US Food& Drug Administration (FDA) for the treatment of pancreatic cancer, which means that the Company qualifies for seven-year FDA-administered market Orphan Drug Exclusivity (ODE), tax credits of up to 50% of R&D costs, R&D grants, waived FDA fees, protocol assistance and may get clinical trial tax incentives.

"Over the last decade, our R&D team has left no stone unturned in preparing for our upcoming milestone in entering the clinical development stage for PRP," said Mr. Nathanielsz. "When we completed some pivotal milestones, such as receiving future tax credits from the Australian Government, as well as achieving ODE status from the USFDA, provides me with confidence that we are on track to achieve success in our first clinical study, given that clinical data, as well as compelling scientific evidence, is normally required to receive such a designation. As a result, our IP asset pricing reflects a decent valuation, which contrasts significantly to our current market price as a publicly listed entity, which I believe can change when our important R&D milestones are achieved."

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine and skin cancers.

On July 12, 2022 Neuraxpharm Group ("Neuraxpharm") reported that it has entered into a definitive agreement to acquire two product portfolios for CNS disorders, pain and vascular diseases from Sanofi (Press release, Sanofi, JUL 12, 2022, View Source [SID1234616635]). With the upcoming acquisition, Neuraxpharm will strengthen its position as a leading European specialty pharmaceutical company focused on CNS. The well-established products that Neuraxpharm will acquire are marketed globally in more than 50 countries.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

The first portfolio combines 15 products addressing CNS disorders and ranging across psychiatry and neurology. The second portfolio includes two products in pain and vascular diseases. Following the acquisition of these new portfolios, Neuraxpharm’s annual gross sales will be around EUR 0.6 billion.

The products benefit patients across a large spectrum of diseases including depression, anxiety, psychosis, alcohol dependence, myasthenia gravis and Parkinson disease. The CNS portfolio notably includes Nozinan, Tranxene, Tiapridal, Dogmatil, Largactil. The pain and vascular portfolio includes Topalgic and Trental.

Combined, both portfolios include 17 molecules representing 38 brands. These global brands will further solidify Neuraxpharm’s position as a leading CNS pharmaceutical company in Europe and increase the company’s global footprint and business.

Dr. Jörg-Thomas Dierks, CEO of Neuraxpharm, said: "There is significant growth potential in the pharmaceutical sector, especially in the CNS market driven by an ageing population and an increasing awareness of mental health. This phenomenon is a global trend. With the upcoming acquisition, we will not only strengthen our presence in Europe, but also lay the ground for further expanding our international presence."

On July 12, 2022 Oncotelic Therapeutics, Inc. (the "Company"), presented the Corporate Presentation (Presentation, Mateon Therapeutics, JUL 12, 2022, View Source [SID1234616702]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

On July 12, 2022 Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) ("Sirona") provides the following update (Press release, Sirona Biochem, JUL 12, 2022, View Source [SID1234616601]):

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Dear shareholders,

We are pleased to provide an outlook of our ongoing corporate development.

On June 13th we announced that we had successfully completed an exclusive global license for TFC-1067 and related family of compounds with Allergan Aesthetics (an AbbVie company). This deal represents a major milestone for Sirona and one we have been working on for some time. While this clearly validates our science and our chemistry platform, the deal also speaks volumes about the team we have here at Sirona. Although we are still a small organization, we were able to rise to the challenge of a long and intensive due diligence process while maintaining operations and moving other projects forward. We will continue to grow our team on the strong base we have built as a group.

The deal will make Sirona a profitable company and the value will be realized. Terms of the agreement were negotiated with the assistance of industry expert Linda Pullan of Pullan Consulting and our legal team from McMillan LLP. The agreement includes a long-term revenue stream in addition to significant upfront and milestone payments. We can now leverage the success of this deal and have already been provided opportunities to meet with institutional investors and analysts. We will continue to build this company and target rapid growth over the second half of 2022 and beyond.

We recently added Dr. Wolfgang Bieber to our strategic advisory board. He has started a review of the company on an operational level and will report on improvements to maximize the talent and value from our team and facilities. He will also assist in any management changes that take place. We plan to have further additions to this new board of advisors in order to improve operations and effectively manage and speed up the development of our promising product pipeline.

TFC-039 Animal Health
Our anti-diabetes drug, TFC-039, is being evaluated as a treatment in companion animals by a number of the top global animal healthcare companies. SGLT2 inhibitors provide an opportunity to treat inflicted animals with a once-daily oral medication as opposed to the traditional method of daily insulin injections. There are currently no alternatives to insulin injections in animal health.

Discussions and due diligence activities with global animal health companies continue to progress. As outlined in our previous CEO update, Wanbang Biopharmaceuticals has signed a binding Letter of Intent and remains committed to providing data and manufacturing information to potential partners. Discussions between Wanbang and a number of these companies are currently ongoing.

TFC-039 Other Indication
Studies on a new indication for TFC-039 have shown promising results and the next steps are being planned. Details of the new indication will not be disclosed until patented, but the opportunity as a valuable therapeutic exists in an area of great need.

Anti-Aging
Batch scale-up and formulation of our lead anti-aging compound are in preparation for a clinical trial. In parallel, we are working with a contract research organization to finalize the trial plan and determine the endpoints that will give us the most commercially viable results. The trial is expected to begin in H2 2022 and will take place in France. We are in discussions with several pharmaceutical / dermatology companies that may participate in the trial for a right-of-first-refusal to license the compound. This compound has the potential to revolutionize the antiaging market as BOTOX did with the antiwrinkle market. After many years of research, we are excited to reach the pivotal milestone of a clinical trial.

Antiviral
As announced on 20 December 2021, our library of 20 antiviral compounds was tested by Utah State University’s Institute of Antiviral Research and results were inconclusive. We have now identified a European institution with the potential to screen the antiviral library through customized development tests. TFChem is preparing the contract for this partnership which will be announced when completed. Testing is expected to start in H2 of 2022. We have expanded this library of compounds through ongoing work at our research facility in France. The need for new antivirals remains incredibly strong as vaccines struggle to combat continually evolving viruses like the SARS-CoV-2 virus. The antiviral market is estimated to reach $64 B US by 2028 .

On July 12, 2022 AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving quality of life for patients, reported that financial results for the fourth quarter and fiscal year 2022, which ended May 31, 2022 (Press release, AngioDynamics, JUL 12, 2022, View Source [SID1234616619]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"Our strong performance during the quarter, driven by our Med Tech portfolio, is a direct result of the continued hard work and commitment of our AngioDynamics team," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "We delivered on the strategic objectives for fiscal year 2022 that we laid out a year ago during our Investor and Technology Day while managing through a number of macro-related headwinds, including supply chain disruptions and ongoing inflationary pressures. During our fourth quarter, we reduced our backlog as our manufacturing capacity improved, exiting the quarter more than 40% above the lows we experienced in December. In addition, we launched two new AlphaVac products and initiated two important clinical trials — our PRESERVE Study for the use of NanoKnife in prostate cancer and our APEX study for the use of AlphaVac F18 in the treatment of pulmonary embolism. We remain committed to balancing and prioritizing investments in our business and enhancing our growth platforms while managing through ongoing inflationary pressures and other macroeconomic challenges. I am excited about the product launches and clinical milestones we expect to achieve in fiscal year 2023, and I look forward to the team’s continued transformation of AngioDynamics."

Fourth Quarter 2022 Financial Results

Net sales for the fourth quarter of fiscal year 2022 were $87.0 million, an increase of 13.2% compared to the prior-year quarter. Foreign currency translation did not have a significant impact on the Company’s net sales in the quarter.

Med Tech net sales were $22.6 million, a 40.0% increase from $16.2 million in the prior- year period, while Med Device net sales were $64.4 million, an increase of 6.1% compared to $60.7 million in the prior-year period. Med Tech includes the Auryon Peripheral Atherectomy platform, the thrombectomy platform and the NanoKnife irreversible electroporation platform.

Endovascular Therapies (formerly Vascular Interventions and Therapies) net sales were $45.1 million, an increase of 18.5%, compared to $38.1 million a year ago. Growth was driven by Auryon sales during the quarter of $9.6 million, continuing the sequential growth trend in the business as well as strength in the Company’s thrombectomy portfolio as compared to the prior year.

Oncology net sales were $15.1 million, an increase of 5.8%, compared to $14.3 million in the prior-year period. The year-over-year growth was largely due to increased net sales of disposables of NanoKnife and Microwave.

Vascular Access net sales were $26.7 million, an increase of 9.3%, compared to $24.5 million a year ago.

U.S. net sales in the fourth quarter of fiscal 2022 were $73.7 million, an increase of 15.9% from $63.6 million a year ago. International net sales were $13.3 million, an increase of 0.4%, compared to $13.2 million a year ago.

Gross margin for the fourth quarter of fiscal 2022 was 53.4%, a decrease of 170 basis points compared to the fourth quarter of fiscal 2021, but up sequentially from 52.2% in the third quarter. During the quarter, gross margin was negatively impacted by macro forces including labor shortages and increased costs for labor, raw materials, and freight.

The Company recorded a net loss of $6.3 million, or a loss per share of $0.16, in the fourth quarter of fiscal 2022. This compares to a net loss of $19.5 million, or a loss per share of $0.51, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the fourth quarter of fiscal 2022 was $0.3 million, and adjusted earnings per share was $0.01, compared to adjusted net loss in the prior-year period of $0.1 million and adjusted earnings per share of $0.00.

Adjusted EBITDA in the fourth quarter of fiscal 2022, excluding the items shown in the reconciliation table below, was $6.2 million, compared to $4.5 million in the fourth quarter of fiscal 2021.

In the fourth quarter of fiscal 2022, the Company generated $8.6 million in operating cash, had capital expenditures of $1.0 million and additions to Auryon placement and evaluation units of $2.7 million. At May 31, 2022, the Company had $28.8 million in cash and cash equivalents compared to $23.9 million in cash and cash equivalents at February 28, 2022. The Company had $25.0 million outstanding under its revolving credit facility at May 31, 2022 which was in line with February 28, 2022.

Full-Year 2022 Financial Results

For the twelve months ended May 31, 2022:

Net sales were $316.2 million, an increase of 8.7%, compared to $291.0 million for the same period a year ago.

Med Tech net sales were $78.7 million, a 41.2% increase from the prior year period. Med Device net sales were $237.5 million, an increase of 0.9% from the prior year period.

Gross margin declined 150 basis points to 52.4% from 53.9% a year ago due to elevated labor, material, and freight costs, as well as Auryon start-up costs.

The Company’s net loss from continuing operations was $26.5 million, or a loss per share of $0.68, compared to a net loss of $31.5 million, or a loss of $0.82 per share, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net loss was $0.2 million, with adjusted earnings per share of $0.00, compared to adjusted net income and adjusted earnings per share of $1.9 million, or $0.05 per share, a year ago. Adjusted net income and adjusted earnings per share in fiscal 2022 includes a $4.2 million, and $0.08 per share benefit, respectively, related to the reimbursement of certain expenses under the employee retention credit as part of the CARES Act. A similar reimbursement benefit of $1.9 million was included in the prior year period.

Adjusted EBITDA, excluding the items shown in the reconciliation table below, was $20.9 million, compared to $19.5 million for the same period a year ago.

Fiscal Year 2023 Financial Guidance

The Company expects its fiscal year 2023 net sales to be in the range of $342 to $348 million, gross margin to be approximately 52.5% to 54.5% and adjusted earnings per share in the range of $0.01 to $0.06 as it continues to invest in new product launches to drive future growth.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its fourth quarter and fiscal year 2022 results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13730672.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Tuesday, July 12, 2022, until 11:59 p.m. ET on Tuesday, July 19, 2022. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13730672.

Use of Non-GAAP Measures

Management uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported adjusted EBITDA, adjusted net income and adjusted earnings per share. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing AngioDynamics’ performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.