On July 15, 2019 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that plans to report second quarter 2019 financial results on July 30, 2019. Ligand’s CEO John Higgins, President and COO Matt Foehr, and Executive Vice President and CFO Matt Korenberg will host the conference call (Press release, Ligand, JUL 15, 2019, View Source [SID1234537525]).

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Second Quarter 2019 Earnings Call

What:

Ligand conference call to discuss financial results and provide general business updates

When:

Tuesday, July 30, 2019

Time:

9:00 a.m. Eastern time (6:00 a.m. Pacific time)

Conference Call:

(833) 591-4752 within the U.S.

(720) 405-1612 outside the U.S.

Conference ID – 1997313

Webcast:

Live conference call webcast and replay accessible at www.ligand.com

On July 15, 2019 Champions Oncology, Inc. (Nasdaq: CSBR), engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs, reported its financial results for the fourth fiscal quarter and 12 months ended April 30, 2019 (Press release, Champions Oncology, JUL 15, 2019, View Source [SID1234537542]).

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Fiscal Year 2019 Financial and Recent Business Highlights:

Record annual revenue of $27.1 million, an increase of 34% year-over-year

Record quarterly revenue of $7.7 million, an increase of 57% year-over-year

Launched ex-vivo platform and clinical flow services

Forecast of revenue growth of 15% – 30% in FY 2020

Ronnie Morris, CEO of Champions, commented, "we’ve completed another year having achieved significant accomplishments for the Company. We’ve grown our year over year revenue by 34%, recorded annual profitable results while also adding to our product line by launching our ex-vivo platform and flow cytometry services. Expanding our suite of services is an important step in our long-term growth strategy for the Company."

David Miller, CFO of Champions added, "Our record quarterly and annual revenue demonstrates the continued strength in our core business lines. As we look ahead to fiscal year 2020, our PDx services will lead our anticipated revenue growth while sales of flow cytometry will set the stage for sustained financial success over the long term."

Fourth Fiscal Quarter Financial Results

For the fourth quarter of fiscal 2019, revenue increased 56.8% to $7.7 million compared to $4.9 million for the fourth quarter of fiscal 2018. The overall increase in revenue is due to the continuing increase in sales, both in number and size of studies, expanding our customer base, and demand for our services. Total costs and operating expenses for the fourth quarter of fiscal 2019 were $7.8 million compared to $5.5 million for the fourth quarter of fiscal 2018, an increase of $2.3 million or 42.0%.

For the fourth quarter of fiscal 2019, Champions reported loss from operations of $117,000, which includes $143,000 in stock-based compensation and $174,000 in depreciation, an improvement of $477,000, compared to the loss from operations of $594,000, inclusive of $172,000 in stock-based

Exhibit 99.1

compensation and $110,000 depreciation expense, in the fourth quarter of fiscal 2018. Excluding stock-based compensation and depreciation, Champions reported income from operations for the quarter of $200,000, an improvement of $512,000 compared to a loss of $312,000 in the year ago period.

Cost of oncology solutions was $4.3 million for the three months ended April 30, 2019, an increase of $1.5 million, or 52.6% compared to $2.8 million for the three months ended April 30, 2018. The increase in cost of sales was primarily due to an increase resulting from study volume as evidenced by the growth in revenue; and, approximately $500,000 in expenses due to repeating studies. For the three months ended April 30, 2019, gross margin was 44.3% compared to 42.7% for the three months ended April 30, 2018. The gross margin in the fourth quarter of fiscal 2019 was impacted by the additional expenses related to study delays.

Research and development expense was $1.2 million for the three months ended April 30, 2019 an increase of $154,000, or 14.1% compared to $1.1 million in the prior year. The increase is due to costs associated with the development of our ex-vivo and flow products. Sales and marketing expense for the three months ended April 30, 2019 was $918,000, an increase of $203,000, or 28.4% compared to $715,000 for the three months ended April 30, 2018. The increase is mainly due to an increase in salaries. General and administrative expense was $1.37 million for the three months ended April 30, 2019 compared to $888,000 for the three months ended April 30, 2018, an increase of $479,000 or 53.9%. The increase is mainly due to an increase in salaries and professional fees.

Year-to-Date Financial Results

For the twelve months of fiscal 2019, revenue increased 33.7% to $27.1 million, as compared to $20.2 million for the twelve months of fiscal 2018. For the twelve months of fiscal 2019, total operating expenses increased 24.1% to $26.8 million, as compared to $21.6 million for the twelve months of fiscal 2018.

For the twelve months ended April 30, 2019, Champions reported income from operations of $270,000, which includes $649,000 in stock-based compensation and $606,000 in depreciation, an improvement of $1.6 million, compared to the loss from operations of $1.4 million, inclusive of $1.0 million in stock-based compensation and $360,000 depreciation, for the twelve months ended April 30, 2018. Excluding stock-based compensation and depreciation, Champions reported operating income of $1.5 million for the twelve months ended April 30, 2019.

Net cash provided by operations was $1.9 million for the twelve months ended April 30, 2019 compared to the net cash used in operations of $1.2 million for the twelve months ended April 30, 2019, an increase of $3.1 million. The increase in cash is the result of our sales growth.

Cost of oncology solutions was $14.3 million for the twelve months ended April 30, 2019 compared to $10.6 million for the twelve months ended April 30, 2018, an increase of $3.7 million or 35.2%. The increase in cost of sales was due to an increase in salary and mice costs resulting from the increase in study volume along with expenses from repeating studies. Gross margin was 47.3% for the twelve months ended April 30, 2019 compared to 47.9% for the twelve months ended April 30, 2018.

Research and development expense was $4.8 million for the twelve months ended April 30, 2019 an increase of $397,000, or 9.0% compared to $4.4 million for the twelve months ended April 30, 2018. The increase was due to the costs associated with the development of new products. Sales and marketing expense for the twelve months ended April 30, 2019 was $3.1 million, an increase

Exhibit 99.1

of $486,000, or 18.9% compared to $2.6 million for the twelve months ended April 30, 2018. The increase is mainly due to commissions paid to the business development team on bookings. General and administrative expense was $4.7 million for the twelve months ended April 30, 2019, an increase of $607,000 or 14.9% compared to $4.1 million for the twelve months ended April 30, 2018. The increase was mainly due to an increase in recruiting and salary expenses.

Conference Call Information:

The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its fourth 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 Monday July 29, 2019 in the Company’s Form 10-K at www.championsoncology.com.

* Non-GAAP Financial Information

See the attached Reconciliation of GAAP to non-GAAP Net Income (Loss) (Unaudited) for an explanation of the amounts excluded to arrive at non-GAAP net income (loss) and related non-GAAP net income (loss) per share amounts for the three and twelve months ended April 30, 2019 and 2018. 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 income (loss) per share are not, and should not be viewed as a substitute for similar GAAP items. Champions’ defines non-GAAP dilutive income (loss) per share amounts as non-GAAP net income (loss) divided by the weighted average number of diluted shares outstanding. Champions’ definition of non-GAAP net income (loss) and non-GAAP diluted income (loss) per share may differ from similarly named measures used by others.

On July 15, 2019 Neon Therapeutics, Inc. (Nasdaq: NTGN), a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, reported top-line results, with at least 12-month median follow-up, from the ongoing, multicenter Phase 1b clinical trial evaluating NEO-PV-01, Neon’s personal neoantigen vaccine candidate, in combination with OPDIVO in patients with advanced or metastatic melanoma, smoking-associated non-small cell lung cancer (NSCLC) and bladder cancer (Press release, Neon Therapeutics, JUL 15, 2019, View Source [SID1234537527]). Across all three distinct tumor types, results demonstrated prolonged and consistent improvements in progression-free survival (PFS) that compare favorably to that observed with checkpoint inhibitor monotherapy, based on historical benchmark data. At 13.4-month median follow-up in 34 patients with metastatic melanoma, median PFS had not yet been reached. In 27 patients with metastatic NSCLC, median PFS was 5.6 months; and in 21 patients with metastatic bladder cancer, median PFS was 5.6 months. These top-line data, which come from 82 patients who received at least one dose of OPDIVO in the Phase 1b NT-001 trial (Intention-to-Treat analysis, or ITT), support further development of NEO-PV-01, including randomized Phase 2 trials of NEO-PV-01 in metastatic disease settings. The NT-001 trial was initiated in November 2016 and completed enrollment in July 2018.

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"Collectively, these data demonstrate a promising new approach in the field of cancer immunotherapy with the potential to further broaden and extend the benefits of checkpoint inhibitor treatment to improve patient outcomes in multiple cancer settings. Monotherapy checkpoint inhibitors have historically shown a range in median progression-free survival in metastatic melanoma, non-small cell lung and bladder cancers of approximately 3-7 months, 2-4 months and 2-3 months, respectively. With these NT-001 results, we are observing consistent prolongation of progression-free survival across all three tumor types compared with historical checkpoint inhibitor monotherapy studies involving patients with similar baseline characteristics. This is an exciting step in establishing the potential of neoantigen-based therapies as a vital component of the cancer treatment landscape," said Patrick Ott, M.D. Ph.D., Clinical Director, Melanoma Center, Center for Immuno-Oncology at the Dana-Farber Cancer Institute and a lead investigator in the NT-001 trial. "Importantly, these clinical outcome improvements, when coupled with the immune and pathological changes seen after vaccination that were presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2019 Annual Meeting, are consistent with the mechanism of action of NEO-PV-01."

NT-001 Clinical Trial Top-Line Results1
ITT analysis includes 82 patients receiving at least one dose of OPDIVO (as of April 2019 data cut)

Metastatic Melanoma
(N=34)
Metastatic Non-Small Cell Lung Cancer
(N=27)
Metastatic Bladder
Cancer
(N=21)
Median Follow-up (months)
13.4
12.0
14.7
Median PFS (months)
Not Yet Reached
(12-Month PFS = 56%)
5.6
5.6
Objective Response Rate
47%
22%
24%
Prior therapy %
41%
67%
71%
1 Please see accompanying presentation at View Source for additional details

As previously presented at the AACR (Free AACR Whitepaper) 2019 Annual Meeting, in data available from the melanoma cohort from an August 2018 data cut, evidence of patients experiencing immune pressure on their tumors in the form of both cascading immune response (epitope spread) and decreased tumor cellularity (biopsies obtained following vaccine treatment) was observed in a majority of patients in the trial who had not progressed at nine months. This evidence of complete histological response of biopsied tumor is a potential correlate for durable clinical benefit and suggests that traditional radiographic analyses may underrepresent the effect that a neoantigen vaccine may have on tumor killing.

"By targeting neoantigens that are specific to each patient’s tumor, we believe that our NEO-PV-01 personal cancer vaccine candidate is helping direct a patient’s immune system to these new cancer targets, which can lead to prolonged clinical benefit. Consequently, we believe that the evidence we are seeing in this clinical trial of broadened neoantigen immune response, epitope spread and histological response suggest that NEO-PV-01 may play an important role in prolonging clinical benefit in combination with checkpoint inhibition, as evidenced by the extended PFS reported in this trial," said Richard Gaynor, M.D., Neon’s President of Research and Development.

The safety data for NT-001 were consistent with the safety profile for OPDIVO monotherapy. In the 60 patients who had received at least one vaccine dose, no serious adverse events were observed that were related to the NEO-PV-01/OPDIVO combination. Low grade adverse events attributable to the NEO-PV-01/OPDIVO combination included injection site reactions, fatigue and influenza-like illness.

"Our NT-001 trial is the first demonstration of improved clinical outcomes for this new class of personal neoantigen therapies in metastatic cancer. We believe Neon is pioneering this exciting new potential approach to treating cancer. The dataset we are presenting today represents an important milestone for Neon and the entire neoantigen field. We believe these data further validate our neoantigen-based platform, including our class-leading RECON bioinformatics platform, and position us well to initiate Phase 2 development of NEO-PV-01 and advance our personal T cell therapy into the clinic," said Hugh O’Dowd, Neon’s Chief Executive Officer.

Continued Development of NEO-PV-01

These top-line results support further development of NEO-PV-01, including randomized Phase 2 trials of NEO-PV-01 in metastatic disease settings. Neon plans to present more detailed data from its NT-001 clinical trial at an upcoming medical society meeting.

Melanoma: Neon plans to initiate a randomized Phase 2 clinical trial in combination with checkpoint inhibitor therapy in a biomarker-defined population of first-line metastatic melanoma patients in 2020. Data analysis from the NT-001 trial is ongoing and will further inform potential biomarker selection. In addition, Neon is conducting its NT-003 trial to evaluate NEO-PV-01 and OPDIVO in combination with other agents, including a CD40 agonist or a CTLA-4 antagonist, to potentially further enhance NEO-PV-01-induced neoantigen immune response and improve clinical outcomes. Neon plans to present immune monitoring data from this trial in the second half of 2020.

NSCLC and Bladder Cancer: Neon also believes that the NT-001 results in advanced or metastatic NSCLC and bladder cancers support continued development of NEO-PV-01 in these settings. The NT-001 data provide increased confidence in NEO-PV-01’s potential to improve clinical benefit in combination with standard of care, such as with checkpoint inhibitor therapy and chemotherapy, for these difficult to treat cancers. As announced in April 2019, Neon has completed enrollment in NT-002, its Phase 1b clinical trial evaluating NEO-PV-01 in combination with the current standard of care, KEYTRUDA (pembrolizumab) and chemotherapy, in first-line patients with untreated advanced or metastatic NSCLC. Neon expects to

report immune monitoring and clinical outcome data from this trial by the end of the third quarter of 2020, which will inform future randomized clinical trials.

OPDIVO is a registered trademark of Bristol-Myers Squibb Company. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Conference Call Information

Neon will host a conference call and webcast today at 8:30 A.M. ET to discuss the top-line results from its Phase 1b NT-001 clinical trial. The live webcast can be accessed on the investor page of Neon’s website at View Source. The conference call can be accessed by dialing (866) 353-0265 and using the conference ID 5596197. A replay of the webcast will be available on Neon’s website approximately two hours after the completion of the event and will be archived for up to 30 days.

About NEO-PV-01

NEO-PV-01 is Neon’s investigational personal neoantigen vaccine, which is custom-designed and manufactured based on the unique mutational fingerprint of each individual patient. NEO-PV-01, which is designed to include up to 20 neoantigen-targeting peptides selected by Neon’s RECON bioinformatics engine, is intended to generate an anti-tumor immune response directing T cells to target particular neoantigens in the patient’s tumor. NEO-PV-01 is being studied in multiple ongoing Phase 1 clinical trials.

About Neon’s NT-001 Clinical Trial

NT-001 is a Phase 1b clinical trial evaluating Neon’s investigational personal neoantigen vaccine, NEO-PV-01, in combination with OPDIVO (nivolumab) in checkpoint-naïve patients with metastatic melanoma, smoking-associated NSCLC or bladder cancer. OPDIVO is a PD-1 immune checkpoint inhibitor designed to overcome immune suppression. Neon’s NT-001 trial is intended to evaluate the combination of NEO-PV-01 with OPDIVO and the potential to broaden a patient’s anti-tumor immune response, resulting in improved duration of clinical benefit. The NT-001 trial is being conducted at nine leading U.S. cancer centers and includes first-, second- and later-line metastatic patients who were eligible to participate if they had received no more than one prior systemic treatment. The primary endpoint of the trial is to evaluate the safety of NEO-PV-01 in combination with OPDIVO and secondary endpoints include the clinical efficacy of the combination over two years of follow-up. Exploratory endpoints include correlative immune response with clinical outcome endpoints.

On July 15, 2019 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary therapeutic prostate cancer vaccine immunotherapy and a CD71-targeted cancer therapy combining paclitaxel, gallium, and transferrin, or PGT, reported the results of in vitro data for PGT in models of multi-drug resistant lung, pancreatic, and ovarian cancer (Press release, Oncbiomune, JUL 15, 2019, View Source [SID1234537528]).

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The Company previously released results of initial in vitro proof-of-concept data for PGT in a multi-drug resistant ovarian cancer model. Cell proliferation assays were performed under hypoxic conditions on an additional 6 human cancer cell lines, including:

A549/Taxol, a multidrug-resistant lung cancer cell line that is a model for the study of drug resistance in lung cancer
A2780/Taxol, a multidrug-resistant ovarian cancer cell line that is a model for the study of drug resistance in ovarian cancer
MiaPaCa2, a pancreatic cancer cell line known to be resistant to paclitaxel when HIF1A (Hypoxia inducible factor 1a) is present
Jurkat, a T-cell leukemia cell line
U87, a human glioblastoma cell line
NCI-H322m, a bronchioalveolar cell line
Cells were treated separately with varying concentrations of either the standard chemotherapy agent paclitaxel or PGT for 72 hours. The IC50 (concentration of drug needed to inhibit the cell growth by 50%) was determined for paclitaxel and PGT, standardized by the concentration of paclitaxel. The IC50s were calculated from growth inhibition curves.

The IC50 of the A549/Taxol cells for paclitaxel was 2.976 micromolar and the IC50 for PGT was 0.04882 micromolar. The IC50 of the A2780/Taxol cells for paclitaxel was 2.728 micromolar and the IC50 for PGT was 0.03861 micromolar. The IC50 of the MiaPaCa2 cells for paclitaxel was not converged, meaning it did not achieve enough cell killing to estimate the IC50, whereas the IC50 for PGT was 0.05176 micromolar. For Jurkat, U87, and NCI-H322m, the IC50s for paclitaxel were 0.09534, 0.5677, and 0.4383, micromolar, respectively, whereas the IC50s for PGT were 0.01908, 0.0126, and 0.06934, respectively.

PGT is designed to deliver the chemotherapeutic agent paclitaxel to cancer cells over-expressing the transferrin receptor (aka CD71). Paclitaxel is currently FDA-approved in two forms: as solvent-based paclitaxel (sb-paclitaxel, Taxol) and protein-based paclitaxel (nab-paclitaxel, ABRAXANE ).

We believe PGT has a formulation similar to nab-paclitaxel by combining paclitaxel to the human protein transferrin, as opposed to albumin. However, PGT has a function similar to antibody-drug conjugates (ADCs), in that it provides targeted drug delivery. This creates the potential to target the paclitaxel to CD71, which has been shown to be highly over-expressed on many different types of cancer cells.

"We are very excited about these most recent results. Our data to date suggests that, in pre-clinical models, PGT is effective in 4 different cell line models of paclitaxel resistance across 3 separate types of cancer, namely ovarian, lung and pancreatic cancers. Additionally, all of these tumor types are very commonly treated clinically with paclitaxel-based therapy. Our observation of strong differential effect of PGT versus paclitaxel is very encouraging because it has the potential to address an area of high unmet need in a broad range of patients with refractory lung, ovarian and pancreatic cancers as well as other types of cancers that are treated with paclitaxel but become resistant to therapy. Further, our recent data supports PGT’s apparent ability to evade the P-glycoprotein pump, or P-gp, which is a well characterized cell membrane-associated efflux pump that renders cells resistant to chemotherapy by pumping the drug out of the cell as some of these models are known high P-gp expressors" commented Dr. Brian Barnett, Chief Executive Officer at OncBioMune.

"We have secured funding to begin pilot animal experiments to evaluate PGT in an in vivomodel," continued Dr. Barnett. "Additionally, these cell line data are helping us refine our IND and Phase 1 plans. To that point, we are already working to secure funding for clinical trials and actively seeking partnerships. We expect that, once we start the IND process, we should be about 16 months from first human dose in Phase 1. Given this data and the potential mechanism of action, we are hopeful that our initial indication will focus on a patient population with metastatic disease that has failed previous paclitaxel-based therapy. This population represents a group of patients with a high unmet medical need that we aspire to help."

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On July 15, 2019 Propanc Biopharma, Inc. (OTC: PPCBD) ("Propanc"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported an update on Propanc’s preparation of PRP, its anti-cancer lead product candidate, for clinical trial application submission and its recently completed reverse stock split (Press release, Propanc, JUL 15, 2019, View Source [SID1234537529]).

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Propanc plans to submit its first clinical trial application in the second half of 2019, followed by commencement of a First-In-Human ("FIH") study in advanced cancer patients for PRP during the first half of 2020.

Approximately 80% of cancers are from solid tumors and metastasis is the main cause of patient death. PRP targets cancer stem cells which are resistant to standard treatments, remain dormant for long periods, then migrate to other organs, triggering explosive tumor growth and causing patient relapse. PRP is the mixture of two proenzymes (trypsinogen and chymotrypsinogen) from bovine pancreas. A synergistic ratio of these proenzymes inhibits growth of most tumor cells. Efficacy has been shown in pancreatic, kidney, breast, brain, prostate, lung, liver, uterine, and skin cancers. Proenzyme therapy targets cancer stem cells not killed by radiation and chemotherapy. PRP addresses the global, unmet medical need for combating solid tumor recurrence and metastasis.

"To our knowledge, no other cancer drugs, or even cancer stem cell therapies, can make a claim of turning back malignant cells towards becoming benign. Our research has identified proenzymes, supported by nearly 100 years of use and numerous scientific publications supporting proenzymes as a treatment method for numerous inflammatory conditions, as well as cancer, that a synergistic ratio of these proenzymes may regulate cell proliferation as a means to control the growth and spread of malignant tumor cells," said James Nathanielsz, Propanc’s Chief Executive Officer. "Not only have we seen significant extension of life as a result of PRP demonstrated in a compassionate use study of advanced cancer patients, but almost all of the patients experienced a relief of symptoms without any severe, or even serious side effects from treatment. We are now planning for an FIH study by undertaking full scale manufacturing of PRP for human use and also currently developing a pharmacokinetic method to analyze distribution of PRP from human plasma."

In addition, Propanc’s 1-for-500 reverse stock split of its shares of common stock was consummated in the market at the open of business on June 24, 2019, and the company’s shares are now trading on the OTCQB on a post-split adjusted price. In connection with the split, Propanc’s trading symbol temporarily changed to "PPCBD." That "D" in Propanc’s current trading symbol will remain for 20 business days until approximately July 22, 2019, after which the company’s trading symbol will revert to its original symbol, "PPCB".