On December 14, 2020 Propanc Biopharma, Inc. (OTC: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported on the progress of the Company, recent developments and forecast for 2021, as the Company prepares for entering clinical development for its lead product candidate, PRP, for the treatment and prevention of metastatic cancer (Press release, Propanc, DEC 14, 2020, View Source [SID1234572822]). PRP represents a novel therapeutic approach, targeting and eradicating cancer stem cells, but leaving healthy stem cells alone, making it less toxic compared to current standard treatment options, like chemotherapy and radiotherapy. PRP does not suppress the immune system, and therefore in a post pandemic world, can offer support to cancer sufferers who are at risk of infection.

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"Whilst navigating the challenges presented during the global pandemic, Propanc management believes the Company has the fundamentals in place to progress PRP to a Phase Ib, First-In-Human (FIH) study in advanced cancer patients," said James Nathanielsz, Propanc’s Chief Executive Officer. "We continue to work on publishing our latest scientific research and exploiting further patent opportunities for our expanding intellectual property portfolio. PRP represents a novel approach that offers a real alternative to standard treatment options which is less toxic and supports immune function when compared to standard treatment options. In a post COVID world, we need to support cancer sufferers whose lives have been significantly affected by cancer and the threat of post treatment secondary infection, which can be life threatening. We look forward to expending every effort to meet our goals in 2021."

Recent Developments

The Company recently raised $209,000 for operating expenses. Furthermore, an S-1 Registration Statement received a notice of effectiveness from the Securities and Exchange Commission for a lead institutional investor as part of a financing agreement entered into earlier this year of up to $3 million with a total of $626,035 of securities purchased to date. The Company will continue to work with the lead institutional investor for future funding tranches to prepare the Company’s lead product candidate, PRP, for a Phase Ib, FIH study in advanced cancer patients suffering from solid tumors.

Forecast for 2021

In 2021, funds raised from the Company’s institutional investor will be used to undertake an engineering run and full scale Good Manufacturing Practice (GMP) manufacture of PRP, the Company’s lead product candidate, as well as validation of the pharmacokinetics method to analyze the distribution of the drug in advanced cancer patients for a Phase Ib, FIH study, which the Company intends to undertake in the second half of 2021, at the Peter Mac Center in Melbourne, Australia’s biggest cancer hospital.

Lead Product Candidate – PRP

PRP is a pharmaceutical composition consisting of two pancreatic proenzymes trypsinogen and chymotrypsinogen for treating cancer. PRP is a novel approach to prevent recurrence and metastasis of solid tumors by using pancreatic proenzymes that target and eradicate cancer stem cells in patients suffering from pancreatic, ovarian and colorectal cancers. PRP is a novel therapy based on the science that enzymes stimulate biological reactions in the body, especially enzymes secreted by the pancreas and could represent the body’s primary defense against cancer.

To date, preclinical development has been completed for PRP, including pharmacology and safety toxicology studies, process development activities and bioanalytical method development. Propanc Biopharma is collaborating with contract research organizations, manufacturing partners and its consultants to complete the activities prior to preparing the CTA for the Phase Ib, FIH study.

Joint Research and Drug Discovery Program – POP1

The POP1 joint research and drug discovery program is designed to produce a backup clinical compound to the lead product candidate, PRP. With the aim of producing large quantities of trypsinogen and chymotrypsinogen for commercial use, exhibiting minimal variation between lots and without sourcing the proenzymes from animals, Propanc Biopharma is undertaking a challenging research project in collaboration with the Universities of Jaén and Granada, led by research scientist Mr. Aitor González, supported by Dr. Macarena Perán, Ph.D. and Dr. Julian Kenyon, M.D. as joint supervisors, representing the Universities and Propanc, respectively.

One specific objective of the project will be to synthesize both proenzymes by an in vivo (i.e., a living organism) system to produce crystalized proteins that could be maintained for long periods without suffering degradation, even in absence of refrigeration. This will be particularly useful for a longer shelf life as well as global distribution of the drug product, particularly in warmer climates and developing regions where refrigeration may not be available.

The POP1 joint research and drug discovery program has produced synthetic recombinant versions of the two proenzymes, trypsinogen and chymotrypsinogen. Propanc Biopharma’s joint scientific researchers developed a novel expression system and are in the process of optimizing conditions to achieve high titers of recombinant trypsinogen and chymotrypsinogen. Further, the anticancer effects of the synthetic versions will be tested against the naturally derived proenzymes from bovine origin.

Propanc Biopharma recently entered into a second two-year joint research and collaboration agreement with the University of Jaén who are undertaking the research activities for the POP1 program.

On December 14, 2020 Addex Therapeutics Ltd (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development reported that it has filed a registration statement with the U.S. Securities and Exchange Commission (SEC) for a proposed underwritten public offering of shares, including those to be settled in the form of American Depositary Shares (ADSs) (Press release, Addex Therapeutics, DEC 14, 2020, View Source [SID1234572807]). Each ADS represents the right to receive six shares of Addex. The terms of the offering have not been determined, and the offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed. The Company will be concurrently offering the shares in Europe (other than Switzerland) in a private placement to qualified investors, and in Switzerland through private placements.

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H.C. Wainwright & Co. is acting as sole book-running manager for the offering.

The proposed offering will be made only by means of a prospectus. Once available, an electronic copy of the preliminary prospectus relating to, and describing the terms of, the offering may be obtained from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996 or e-mail at [email protected] or on the SEC’s website.

A registration statement on Form F-1 relating to the proposed sale of these securities has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. There is no intention or permission to publicly offer, solicit, sell or advertise, directly or indirectly, any securities of Addex Therapeutics Ltd in or into Switzerland within the meaning of the Swiss Financial Services Act ("FinSA"). Neither this document nor any other offering or marketing material relating to these securities, such as the shares, constitutes or will constitute a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the shares constitutes a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the shares may be publicly distributed or otherwise made publicly available in Switzerland.

On December 14, 2020 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported that it will be presenting at the 13th Annual LD Micro Main Event Conference on Tuesday, December 15, 2020 at 10:00 a.m. ET. Geert Kersten, Chief Executive Officer of CEL-SCI, will be presenting to a live virtual audience (Press release, Cel-Sci, DEC 14, 2020, View Source [SID1234572823]).

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CEL-SCI’s presentation will be broadcast live at View Source or on the Investor Relations section of CEL-SCI’s website at cel-sci.com/new-investor-information/.

LD Micro’s Main Event will feature a new format, with companies presenting for 10 minutes, followed by 10 minutes of Q&A by a panel of investors and analysts.

On December 14, 2020 Champions Oncology, Inc. (Nasdaq: CSBR), a leading global oncology technology solutions provider engaged in transforming drug discovery through innovative pharmacology, biomarker and data platforms, reported its financial results for the second fiscal quarter ended October 31, 2020 (Press release, Champions Oncology, DEC 14, 2020, View Source [SID1234572808]).

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Second Quarter and Recent Highlights:

•Launched our Lumin Bioinformatics proprietary SaaS platform
•Delivered record quarterly revenue of $10.1 million, an increase of 33% year-over-year
•Reported income from operations, excluding stock-based compensation, depreciation and amortization, of $400,000
•Raising our full-year revenue guidance to 20%-25%

Ronnie Morris, CEO of Champions, commented, "This quarter was highlighted by a significant milestone for Champions as we unveiled Lumin Bioinformatics, our proprietary SaaS program that provides customers with tools to interrogate our vast database and perform computational research in an effort to identify new targets in their drug discovery and development programs. Through both internal and public datasets, we have built tools and visualizations that provide a powerful mechanism for cancer biologists to leverage computational analytics in discovery and development programs."

David Miller, CFO of Champions added, "We reached another quarterly revenue record, exceeding $10 million for the first time equating to a 33% year over year revenue increase. The success of our recent product launches has led to continued bookings growth, positioning Champions to deliver further revenue milestones in the coming quarters. Accordingly, we are raising our full-year revenue guidance to 20%-25%. In addition, the launch of our Lumin platform represents another product rollout that Champions expects to become a meaningful contributor to the continued expansion of the Company over the coming years."

Second Fiscal Quarter Financial Results

For the second quarter of fiscal 2021, revenue increased 32.7% to $10.1 million compared to $7.6 million for the second quarter of fiscal 2020. The increase in revenue was due to a continued increase in sales, both in number and size of studies, and the expansion of both our platform and product lines. Our contract amounts have increased as we perform more complex studies and end point analysis testing. Total costs and operating expenses for the second quarter of fiscal 2021 were $10.1 million compared to $7.3 million for the second quarter of fiscal 2020, an increase of $2.8 million or 37.9%.

Exhibit 99.1

For the second quarter of fiscal 2021, Champions reported income from operations of $7,000, including $85,000 in stock-based compensation and $307,000 in depreciation and amortization expenses, a decrease of $284,000 compared to the income from operations of $291,000, inclusive of $77,000 in stock-based compensation and $178,000 in depreciation and amortization expenses, in the second quarter of fiscal 2020. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported non-GAAP income from operations of $401,000 for the second quarter of fiscal 2021 compared to non-GAAP income from operations of $546,000 in the second quarter of fiscal 2020, a decrease of $144,000.
Cost of oncology solutions was $5.6 million for the three-months ended October 31, 2020, an increase of $1.8 million, or 45.4% compared to $3.9 million for the three-months ended October 31, 2019. For the three- months ended October 31, 2020, gross margin was 44.2% compared to 49.1% for the three-months ended October 31, 2019. The increase in cost of oncology services for the three-month period was mainly due to an increase in compensation, lab supply, and outsourced lab service expenses. Outsourced lab services accounted for $1.4 million of the total increase. Excluding outsourced lab services, the overall expense increase in cost of sales is generally in line with the expected contribution based on the growth in revenue, study volume, and expansion into new services. Gross margin varies based on timing differences between expense and revenue recognition and was driven lower by the increase in costs on growing study volume in advance of revenue recognition. The cost of outsourced lab services amplified this impact.
Research and development expense for the three-months ended October 31, 2020 was $1.7 million, an increase of $308,000 or 23.0%, compared to $1.3 million for the three-months ended October 31, 2019, respectively. The increase was due to increased compensation and lab supply expense as we continued to develop new service capabilities and endpoint analysis testing. Additionally, we incurred sequencing costs as our investment in characterizing our TumorBank continued, adding valuable data to our platform. Sales and marketing expense for the three-months ended October 31, 2020 was $1.3 million, an increase of $371,000, or 38.0%, compared to $977,000 for the three-months ended October 31, 2019. The increase was primarily due to compensation expense driven by the continued investment in expanding our business development team. General and administrative expense for the three-months ended October 31, 2020 was $1.5 million, an increase of $333,000, or 29.3%, compared to $1.1 million for the three-months ended October 31, 2019, respectively. General and administrative expenses are primarily comprised of compensation, insurance, accounting fees, and depreciation expenses and have increased to support the overall infrastructure growth of the company.
Net cash generated from operating activities was $880,000 for the three-months ended October 31, 2020 compared to $360,000 for the same period last year. The increase in cash flow from operations is primarily due to the improvement in financial operating results.

The Company ended the quarter in a strong cash position with a $8.6 million cash balance compared to $2.8 million at the end of the same period last year. The Company has no debt.

Year-to-Date Financial Results

For the first six months of fiscal 2021, revenue increased 36.9% to $19.7 million, as compared to $14.4 million for the first six months of fiscal 2020. For the first six months of fiscal 2021, total operating expenses increased 33.7% to $19.6 million, as compared to $14.7 million for the first six months of fiscal 2020. The increase in revenue was due to increased sales, both in number and size of studies, an

Exhibit 99.1
increase in demand for our services, the growth of the platform, and the expansion of our product line. Our customers are seeking more complex study designs and end point analysis testing, contributing to the larger contract sizes.

For the first six months of fiscal 2021, Champions reported income from operations of $31,000, which includes $205,000 in stock-based compensation and $584,000 in depreciation and amortization expenses, an increase of $357,000 or 109.6%, compared to a loss from operations of $323,000, inclusive of $208,000 in stock-based compensation and $360,000 depreciation, for the first six months of fiscal 2020. Excluding stock-based compensation and depreciation, Champions reported operating income of $822,000 for the first six months of fiscal 2021 compared to income of $244,000 in the same period last year.

Cost of oncology solutions was $11.0 million for the first six months of fiscal 2021 compared to $7.6 million for the first six months of fiscal 2020, an increase of $3.3 million or 43.8%. Gross margin was 44.2% for the first six months of fiscal 2021 compared to 46.9% for the first six months of fiscal 2020. The increase in cost of oncology services for the six-month period was mainly due to an increase in compensation, lab supply and outsourced lab service expenses. Excluding outsourced lab services, the overall expense increase is generally in line with the expected contribution based on the growth in revenue, study volume, and expansion into new services. Gross margin varies based on timing differences between expense and revenue recognition and was driven lower by the increase in costs on growing study volume in advance of revenue recognition. The cost of outsourced lab services amplified this impact.

Research and development expense was $3.2 million for the first six months of fiscal 2021 an increase of $603,000, or 22.8% compared to $2.6 million for the first six months of fiscal 2020. The increase was due to increased compensation and lab supply expense as we continued to develop new service capabilities and endpoint testing analysis, and incurred sequencing costs as we continued to characterize our TumorBank. Sales and marketing expense for the first six months of fiscal 2021 was $2.6 million, an increase of $709,000, or 38.4% compared to $1.8 million for the first six months of fiscal 2020. The increase was primarily due to compensation expense driven by the continued investment in expanding our sales force. General and administrative expense was $2.9 million for the first six months of fiscal 2021 , an increase of $289,000, or 11.3% compared to $2.6 million for the first six months of fiscal 2020. General and administrative expenses are primarily comprised of compensation, insurance, accounting fees, and depreciation expenses and have increased to support the overall infrastructure growth of the company.

Net cash provided by operations was $164,000 for the first six months of fiscal 2021 compared to net
provided by operations of $81,000 in fiscal 2020, an increase of $45,000 or 55.6%.

Conference Call Information:
The Company will host a conference call today at 4:30 p.m. EST (1:30 p.m. PST) to discuss its third quarter financial results. To participate in the call, please call 877-407-8035 (domestic) or 201-689-8035 (international) ten minutes ahead of the call and give the verbal reference "Champions Oncology."
Full details of the Company’s financial results will be available Tuesday, December 15, 2020 in the Company’s Form 10-Q at www.championsoncology.com.
* Non-GAAP Financial Information

See the attached Reconciliation of GAAP net income (loss) to Non-GAAP net income (loss) for an explanation of the amounts excluded to arrive at Non-GAAP net income (loss) and related Non-GAAP earnings (loss) per share amounts for the three months ended October 31, 2020 and 2019. Non-GAAP financial measures provide investors and management with supplemental measures of operating performance and trends that facilitate comparisons between periods before and after certain items that would not otherwise be apparent on a GAAP basis. Certain unusual or non-recurring items that management does not believe affect the Company’s basic operations do not meet the GAAP definition of unusual or non-recurring items. Non-GAAP net income (loss) and Non-GAAP earnings (loss) per share are not, and should not, be viewed as a substitute for similar GAAP items. Champions defines Non-GAAP dilutive earnings (loss) per share amounts as Non-GAAP net earnings (loss) divided by the weighted average number of diluted shares outstanding. Champions’ definition of Non-GAAP net earnings (loss) and Non-GAAP diluted earnings (loss) per share may differ from similarly named measures used by other companies.

On December 14, 2020 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has commenced additional physical parameter testing of its CypCaps product for pancreatic cancer, in line with the recommendations provided by the U.S. Food and Drug Administration (FDA) (Press release, PharmaCyte Biotech, DEC 14, 2020, View Source [SID1234572824]).

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The FDA has asked that two additional methods be developed to determine the strength of PharmaCyte’s encapsulated cells (CypCaps) to be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). One method involves pressing down on the capsule and measuring either the pressure required for it to burst, or for it to deform. Since the CypCaps are very small, special machinery that can measure such tiny changes has to be used to demonstrate this. The necessary machinery is now being incorporated as a quality control test for the CypCaps.

The second method involves letting water flow into the CypCaps, effectively "blowing them up." The point at which the capsules explode will be used as a quality control parameter.

Previous work has shown the pressures and water conditions used in these tests to be well outside of the normal conditions encountered by the capsules inside the human body, so these tests are designed to simulate hypothetical conditions.

Earlier studies have shown that the capsules do not burst even when placed under very high pressure. Further, even in the very unlikely event that the capsule could break open, the cells inside will be recognized as foreign bodies by the immune system. Also, the encapsulated cells are primed for their suicide since they express the cytochrome P450 gene and thus would be killed by the low dose ifosfamide given as part of the treatment for LAPC.

Thus, these FDA mandated studies can be seen as additional release tests to ensure the reproducibility of the CypCaps.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "We are pleased to announce the development of these two new quality parameters and their incorporation into the quality testing as one of the additional studies requested by the FDA. In the meantime, PharmaCyte continues to work with its partners to address the other issues raised by the FDA that led to the clinical hold."

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source