On May 12, 2020 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies, reported financial results for the first quarter ended March 31, 2020, and provided a corporate update (Press release, Black Diamond Therapeutics, MAY 12, 2020, View Source [SID1234557641]).

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"We are pleased with our first quarter progress which included advancing the Phase 1/2 clinical trial of our lead product candidate BDTX-189 and completing our successful initial public offering," said David M. Epstein, Ph.D., President and CEO. "All companies are being impacted by the COVID-19 pandemic and Black Diamond is no exception. Our priority is the safety and well-being of our patients, as well as employees and their families, and we have adjusted our operations accordingly. We have also put in place contingency plans and additional resources from third-party service providers to minimize the impact on our business and strategy. We believe we are well positioned not only to execute on the clinical development of BDTX-189 as planned, but also to continue to invest in our proprietary MAP platform and to progress our early stage pipeline of small molecule, tumor-agnostic precision medicine programs. We will continue to closely monitor the global COVID-19 situation and its impact on our business as it evolves."

Recent Developments
•In February 2020, Black Diamond completed an initial public offering (IPO) pursuant to which it issued and sold 12,174,263 shares of common stock, including full exercise of the underwriters’ over-allotment option, resulting in gross proceeds of $231.3 million before deducting underwriting discounts and commissions and other offering expenses.
•Black Diamond continued to enroll and dose patients in the Phase 1 portion of a Phase 1/2 clinical trial of BTDX-189 (MasterKey-01; NCT04209465) and expects to complete the Phase 1 portion of the trial by the first half of 2021. BDTX-189 is Black Diamond’s mutation spectrum-selective, oral, irreversible small molecule inhibitor product candidate, which targets cancer-causing driver mutations in human epidermal growth factor receptor 2 (HER2) and epidermal growth factor receptor (EGFR) that have not yet been drugged.
•Black Diamond continued to advance its program in glioblastoma multiforme (GBM) toward nomination of a development candidate targeting a range of driver mutations in GBM, as well as its earlier-stage programs derived from the Company’s Mutation-Allostery-Pharmacology (MAP) platform.
•Black Diamond implemented risk mitigation measures and adjusted operations in response to the COVID-19 pandemic.
Financial Highlights
•Black Diamond ended the first quarter of 2020 with $357.2 million in cash and cash equivalents, which included net proceeds from the Company’s IPO of $212.1 million, compared to $44.7 million for the first quarter of 2019. Net cash used in operations was $11.3 million for the first quarter of 2020 compared to $6.9 million for the first quarter of 2019.
•Research and development (R&D) expenses were $7.4 million for the first quarter of 2020 compared to $3.0 million for the first quarter of 2019. The increase in R&D expenses was primarily related to an increase in headcount, preclinical development, and advancement of the BDTX-189 Phase 1/2 clinical trial.
•General and administrative (G&A) expenses were $5.5 million for the first quarter of 2020 compared to $0.8 million for the first quarter of 2019. The increase in G&A expenses was primarily due to an increase in personnel and costs associated with operations as a public company.

Upcoming Events
•The Company will present a poster about the MasterKey-01 Phase 1/2 clinical trial design at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program:
◦Abstract Title: Masterkey-01: Phase I/II, open-label multicenter study to assess safety, tolerability, pharmacokinetics, and antitumor activity of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies (Abstract TPS3665; Poster 395)
◦Poster Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
•David M. Epstein, Ph.D., President and CEO, is scheduled to present at the following upcoming conferences:
◦Bank of America Global Research Health Care Conference 2020, on Tuesday, May 12, 2020, at 4:20 PM ET
◦Jefferies Global Healthcare Conference, on Wednesday, June 3, 2020, at 1:30 PM ET
◦BMO 2020 Prescriptions for Success Healthcare Virtual Conference, on Tuesday, June 23, 2020

On May 11, 2020 AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) reported that it has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab (Press release, AstraZeneca, MAY 11, 2020, View Source [SID1234557441]).

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Gastric cancer is the third leading cause of cancer mortality with a five-year survival rate of 5% for metastatic disease.1,2 Approximately one in five gastric cancers are considered HER2 positive.3,4

The Food and Drug Administration’s (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The new medicine needs to have shown encouraging early clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines.

José Baselga, Executive Vice President, R&D Oncology, said: "Current therapy options are limited for patients with HER2-positive metastatic gastric cancer and for those who relapse, there are no approved HER2-targeted medicines. We look forward to working with the FDA to further explore the potential of Enhertu to become an important new treatment and the first antibody drug conjugate for this devastating disease."

Gilles Gallant, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo, said: "DESTINY-Gastric01 represents the first randomised trial of Enhertu to demonstrate clinically meaningful and statistically significant results, including objective response and survival increases compared to physician’s choice of chemotherapy. We are thrilled that the FDA has granted Enhertu a second Breakthrough Therapy Designation."

The FDA granted BTD based on data from the registrational Phase II DESTINY-Gastric01 trial and data from the Phase I trial published in The Lancet Oncology.5,6 In DESTINY-Gastric01, patients treated with Enhertu, a HER2-directed antibody drug conjugate (ADC), demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR), the primary endpoint, and overall survival (OS), a key secondary endpoint, versus patients treated with investigator’s choice of chemotherapy (irinotecan or paclitaxel monotherapy).

The overall safety and tolerability profile of Enhertu (6.4 mg/kg) in DESTINY-Gastric01 was consistent with that seen in the Phase I trial. The most common adverse events were haematologic and gastrointestinal including neutrophil count decrease, anaemia, nausea and decreased appetite. There were cases of drug-related interstitial lung disease (ILD) and pneumonitis, the majority of which were Grade 1 and 2, with two Grade 3 and one Grade 4. No ILD-related deaths (Grade 5) occurred in patients with gastric cancer in the Phase I trial or in the Phase II DESTINY-Gastric01 trial.

The full results of DESTINY-Gastric-01 will be presented during the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program.

Enhertu received SAKIGAKE designation in March 2018 by Japan’s Ministry of Health, Labour and Welfare (MHLW) for potential use in the same HER2-positive gastric cancer patient population and was recently submitted to the MHLW for approval. This is the second BTD granted for Enhertu in the US. Enhertu received BTD in 2017 for HER2-positive metastatic breast cancer and received approval in December 2019.

Gastric cancer

Gastric (stomach) cancer is the fifth most common cancer worldwide and the third leading cause of cancer mortality; there were approximately one million new cases reported in 2018 and 783,000 deaths.1 In the US, it is estimated that 27,600 new cases of gastric cancer will be diagnosed in 2020 and more than 11,000 people will die from the disease.7

Approximately one in five gastric cancers are HER2 positive.2,4 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including gastric, breast and lung cancers. Gastric cancer is usually diagnosed in the advanced stage, but even when diagnosed in earlier stages of the disease the survival rate remains modest.8 Recommended 1st-line treatment for HER2-positive advanced or metastatic gastric cancer is combination chemotherapy plus trastuzumab, an anti-HER2 medicine, which has been shown to improve survival outcomes when added to chemotherapy. For gastric cancer that progresses on 1st-line treatment, there are no other approved HER2-targeting medicines.9

DESTINY-Gastric01

DESTINY-Gastric01 is a registrational Phase II, open-label, multi-centre trial testing the safety and efficacy of Enhertu in a primary cohort of 188 patients from Japan and South Korea with HER2-expressing, advanced gastric cancer or gastroesophageal junction adenocarcinoma (defined as IHC3+ or IHC2+/ISH+) who have progressed on two or more prior treatment regimens including fluoropyrimidine and platinum chemotherapy and trastuzumab. Patients were randomised 2:1 to receive Enhertu or investigator’s choice of chemotherapy (paclitaxel or irinotecan monotherapy). Patients were treated with Enhertu 6.4 mg/kg once every three weeks or chemotherapy. The primary endpoint of the trial is ORR, as assessed by an independent review committee. Secondary endpoints include OS, progression-free survival, duration of response, disease control rate and time to treatment failure as well as pharmacokinetic and safety endpoints.5

Enhertu

Enhertu (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the US) is a HER2-directed ADC and is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells.

Enhertu is approved in the US and Japan for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens based on the DESTINY-Breast01 trial.

Enhertu clinical development

A comprehensive development programme is underway globally with six registrational trials evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-driven cancers including breast, gastric and lung cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

Collaboration between AstraZeneca and Daiichi Sankyo

In March 2019, AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu worldwide, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is solely responsible for manufacturing and supply.

AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With six new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca’s main capabilities, the Company is actively pursuing innovative partnerships and investment that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and ADCs – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

On May 11, 2020 bluebird bio, Inc. (NASDAQ: BLUE) reported that it has amended its existing co-promotion/co-development agreement with Bristol Myers Squibb (BMS) to enable the companies to focus their efforts on efficient commercialization of idecabtagene vicleucel (ide-cel; bb2121) in the U.S., the companies’ lead investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, currently in review with the FDA (Press release, bluebird bio, MAY 11, 2020, http://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bio-announces-amended-bcma-car-t-collaboration [SID1234557484]).

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"Under our amended collaboration, we and BMS are redoubling our commitment to ide-cel and optimizing the relationship as we work together to bring this critical treatment to patients in the commercial setting," said Joanne Smith-Farrell, PhD, Chief Business Officer and Oncology Franchise Leader, bluebird bio. "With bluebird exiting the passive participation as supplier outside the U.S., we and BMS are taking steps to ensure an efficient and robust supply chain for this program. This, together with the monetization of our ex-U.S. royalties and milestones will allow bluebird to continue to participate in co-developing and co-commercializing ide-cel within the U.S. and to refocus resources on our internal programs and pipeline."

"Our collaboration with bluebird has resulted in the first CAR T cell therapy submitted for regulatory approval to target the B-cell maturation antigen and for multiple myeloma," said Krishnan Viswanadhan, Pharm.D., Senior Vice President, Global Cell Therapy Franchise Lead for Bristol Myers Squibb. "This amended partnership allows Bristol Myers Squibb to leverage our global manufacturing capabilities and consolidate all responsibilities outside the United States."

The companies will continue to share equally profits and losses in the U.S. Under the terms of the amended agreement, BMS will buy out its obligations to pay bluebird bio future ex-U.S. milestone and royalty payments for ide-cel and bb21217, the companies’ second BCMA-directed CAR T immunotherapy, for a one-time upfront payment of $200 million. bluebird bio is currently in the process of building out and qualifying its wholly-owned manufacturing facility in Durham, North Carolina for the production of lentiviral vector (LVV) to support the U.S. commercial market for ide-cel and for bluebird bio’s pipeline. Over time, BMS will assume responsibility for manufacturing of LVV outside the U.S.

On May 11, 2020 ChemoCentryx, Inc., (Nasdaq: CCXI), reported financial results for the first quarter ended March 31, 2020 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, MAY 11, 2020, View Source [SID1234557511]).

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"In the face of this global infection pandemic, we pause in sympathy for those suffering while we are reminded of the deep importance of our mission," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "A central tenet for our new medicines is ‘do not immune suppress,’ and the current crisis provides a stark reminder of exactly why this is so important. The use of immune suppressive therapies which are the current standard of care for autoimmune diseases like ANCA vasculitis puts people who are already struggling with serious, life threatening conditions at additional risk for infectious disease."

"We at ChemoCentryx are entirely devoted to a different and, we believe, better approach: highly targeted, non-immunosuppressive medicines such as avacopan. Such medicines are entirely unlike the current immune-destroying regimen of high doses of prednisone combined with other immune system dampeners. Our mission at ChemoCentryx continues with increased urgency. We are actively preparing our NDA submission to the FDA following the positive results of the Phase III ADVOCATE trial of avacopan for the treatment of ANCA vasculitis. We are also looking forward to topline data from our CCR2 inhibitor CCX140 in FSGS patients, as well as the rest of our data readouts expected this year in our ‘2020 4-Sight’ plan. For example, enrollment is complete with over 400 patients in the Phase II AURORA clinical trial of avacopan in HS, and we also expect to report topline data from our ACCOLADE trial of avacopan in C3G by the end of the year. Our mission to meet unprecedented disease challenges with innovative medicines continues."

Key Highlights

On track to file the NDA for avacopan in the treatment of ANCA-associated vasculitis in mid-2020, following the ADVOCATE Phase III pivotal clinical trial, which demonstrated avacopan’s statistical superiority in sustaining remission at 52 weeks over the prednisone-containing standard-of-care.

Fully-enrolled over 400 patients in the Company’s AURORA Phase IIb clinical trial of avacopan for the treatment of the chronic disabling skin disease Hidradenitis Suppurativa (HS). Topline data from AURORA continue to be expected in the third quarter 2020.

On track to report topline data from the LUMINA-1 Phase II randomized dose-ranging clinical trial of CCX140, an inhibitor of the chemokine receptor known as CCR2, in patients with sub-nephrotic primary FSGS, a rare kidney disease in the second quarter of 2020.

Open-label LUMINA-2 study continues to enroll, evaluating CCX140 in patients with nephrotic syndrome primary FSGS (³3 gram/day baseline proteinuria), the more severe and rarer form of the disease. Data from LUMINA-2 are expected in the second half of 2020.

Strengthened the balance sheet with an additional credit facility of up to $100 million secured in January 2020. Reported cash and investments exceeded $188 million at March 31, 2020.

First Quarter 2020 Financial Results

Revenue was $6.0 million for the first quarter of 2020, compared to $8.3 million for the same period in 2019. The decrease in revenue from 2019 to 2020 was primarily attributable to lower costs incurred due to the full enrollment of the avacopan ADVOCATE Phase III pivotal trial in 2018 and the CCX140 LUMINA-1 Phase II clinical trial in 2019.

Research and development expenses were $19.3 million for the first quarter of 2020, compared to $15.4 million for the same period in 2019. The increase from 2019 to 2020 was primarily attributable to patient enrollment of the avacopan AURORA Phase IIb clinical trial in patients with HS, professional fees associated with the preparation of submitting an NDA for avacopan for the treatment of ANCA vasculitis and higher research and drug discovery expenses, partially offset by decreases in expenses due to the full enrollment of the avacopan ADVOCATE Phase III pivotal trial in 2018 and the CCX140 LUMINA-1 Phase II clinical trial in 2019.

General and administrative expenses were $8.8 million for the first quarter of 2020, compared to $5.5 million for the same period in 2019. The increase from 2019 to 2020 was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, and higher professional fees.

Net loss for the first quarter of 2020 was $21.7 million, compared to net loss of $11.9 million for the same period in 2019.

Total shares outstanding at March 31, 2020 were approximately 61.8 million shares.

Cash, cash equivalents and investments totaled $188.8 million at March 31, 2020. The Company expects to utilize cash and investments in the range of $85 million to $95 million in 2020.

Conference Call and Webcast

The Company will host a conference call and webcast today, May 11, 2020 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial (877) 303-8028 (Domestic) or (760) 536-5167 (International). The conference ID number is 3992649. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.

On May 11, 2020 Propanc Biopharma, Inc. (OTC: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported on the progress of the Company, recent milestones, financial position, R&D activities and forecast till the end of 2020 and into 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, MAY 11, 2020, View Source [SID1234557528]). PRP represents a new therapeutic approach, supported by a 100-year history of scientific and clinical research. As the Company enters this exciting milestone, management reflects on the significant history which led to the establishment of its R&D operations.

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A Historical Perspective – Proenzymes for Treating Cancer

Back in the early 1900’s, an Embryologist, Professor John Beard, from Edinburgh University, first proposed that pancreatic enzymes represent the body’s primary defense against cancer and would be useful as a cancer treatment. As a result, physicians in the UK and US, began injecting trypsin into patients with specific cases being quoted as achieving remarkable success. A number of physicians wrote letters citing these cases to medical journals, like, Medical Record, and The General Practitioner. However, due to a limited understanding of tumor biology, the stability of enzymes in water, especially when heated to 600C, the approach obtained mixed results and was disregarded by conventional medicine. Despite this, pancreatic enzymes were used by alternative medicine as a way to ameliorate the side effects of standard anti-cancer regimens. The U.S. Food and Drug Administration banned injection of enzymes in 1966.

Since then, several scientists endorsed Beard´s hypothesis with encouraging data from patient treatment. From the late 1990’s, work from other scientists and clinicians, including Dr. Josef Novak in the U.S. and a since retired oncologist from the Czech Republic, Dr. Frantisek Trnka, shed new light on the therapeutic potential of Professor John Beard’s insights. Extensive laboratory work undertaken over a number of years by Novak and Trnka was reported in the journal Anticancer Research in 2005. The conclusion of Novak and Trnka was the discovery that proenzyme therapy mandated first by John Beard nearly 100 years ago, shows remarkable selective effects that result in growth inhibition of tumor cells with metastatic potential.

In 2007, Dr. Julian Kenyon, Medical Director of Dove Clinic in the UK further developed the therapeutic concepts of Beard and identified strategies that could improve upon the therapeutic potential of Beard’s original ground-breaking work. Through Dove Clinic, a number of cancer patients were treated with a suppository formulation of proenzymes. Clinical effects were studied in 46 terminal patients with advanced metastatic cancers of different origin, including prostate, breast, ovarian, pancreatic, colorectal, stomach, non-small cell lung, bowel cancers and melanoma. No severe or serious adverse events were observed, as reported in the journal Scientific Reports in 2017. To assess therapeutic activity, overall survival of patients was compared to life expectancy prior to commencing treatment, with 19 from 46 patients (41.3%) having a survival time significantly longer than expected. For the whole set of cancer types, mean survival (9.0 months) was significantly higher than mean life expectancy (5.6 months).

Today, these important scientific observations support management’s view that proenzymes are selective and effective in targeting malignant tumor cells and could become an effective tool in the fight against metastatic cancer. After 13 years of R&D operations, the Company’s lead product candidate, PRP, is now a readymade pharmaceutical formula for intravenous administration of two pancreatic proenzymes, trypsinogen and chymotrypsinogen.

Recent Corporate Achievements

Recent achievements include the entering of a financing agreement for up to $3 million with an institutional investor, which will enable the Company to complete the finished product manufacture of PRP in preparation for clinical trials. An Advance Overseas Finding from Innovation and Science Australia was received, qualifying the company to receive 43.5% "cash back" benefit on overseas R&D expenses, which would not have qualified for the "cash back" without having received the Advance Overseas Finding. A first allowance for a key patent family describing different dosage regimens of proenzymes was obtained from the Australian Patent Office. Further, the Company’s lead researcher, Dr Macarena Perán (of Jaén University, Spain), was recently awarded a Professorship position at Jaén University based on pioneering research on the development and validation of new anti-tumor drugs with selectivity against cancer stem cells using proenzymes, which forms the basis of the Company’s joint research and drug discovery program for developing a backup clinical compound to PRP.

Financial Position

Since entering the recent financing agreement, the Company received a cash injection of $450,000, with up to an additional $2.55 million available upon registering for resale of all shares of common stock, or underlying securities issued to the investor. Funds raised will be used for the preparation of PRP for clinical trials as well as other working capital requirements.

R&D Activities

Preclinical development has been completed for the Company’s lead product candidate, PRP, including pharmacology and safety toxicology studies, process development activities and bioanalytical method development. The engineering run and full scale GMP manufacture of PRP will be completed in preparation for clinical trials. Validation of the bioanalytical method will also be completed.

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

Forecast for 2020/early 2021

The Company’s management team are encouraged by recent advancements achieved with the Company’s R&D activities, its funding, and upcoming milestones as they look to enter clinical development stage for their lead product candidate, as well advancing their joint research program to expand their product pipeline and establish a backup clinical compound to PRP. In the second half of the year and leading into 2021, the Company plans to undertake the activities necessary to initiate patient trials for PRP.

"As we navigate through unprecedented times, I am pleased with our recent progress as we fund our R&D programs through institutional investment and government funding, which has taken some time to plan, prepare and execute, especially finding the right strategic investor," said James Nathanielsz, Propanc’s Chief Executive Officer. "Rest assured, my management team and I are expending every effort to advance PRP to clinical trials, expand our product pipeline through investment in research and continue making scientific discoveries to ensure the growth of our IP portfolio. We are thinking strategically about possible avenues to fast track PRP into the clinic safely to maximize value for shareholders. Most importantly, after 13 years of R&D operations, backed by more than 100 years of scientific and clinical research, we are genuinely excited about the future prospects of our technology and its benefits for human kind."