On March 12, 2020 INOVIO Pharmaceuticals, Inc. (NASDAQ: INO), a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat, cure, and protect people from diseases associated with HPV, cancer, and infectious diseases, reported financial results for the fourth quarter and year ended December 31, 2019 (Press release, Inovio, MAR 12, 2020, View Source [SID1234555518]). INOVIO’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss financial results and provide a general business update.

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INOVIO Highlights

VGX-3100: Cervical, vulvar, and anal HSIL

REVEAL 2 Phase 3 clinical trial evaluating VGX-3100 for treatment of HPV-related cervical high-grade squamous intraepithelial lesions (HSIL) has a total of 43 sites opened globally for recruitment, which includes newly opened sites in Brazil and South Africa, along with four new U.S.-based sites. Top-line efficacy data from REVEAL 1 Phase 3 clinical trial is expected to be reported by the fourth quarter of 2020.

INOVIO is also evaluating VGX-3100 in two Phase 2 trials for the treatment of vulvar HSIL and anal HSIL. Preliminary efficacy and safety data are planned to be presented later this month at The American Society for Colposcopy and Cervical Pathology (ASCCP) 2020 Scientific Meeting on Anogenital & HPV-Related Diseases.

INO-3107: Recurrent respiratory papillomatosis (RRP)

In February 2020, INOVIO announced that the U.S. Food and Drug Administration (FDA) accepted its Investigational New Drug (IND) application to evaluate INO-3107 in a Phase 1/2 trial for treatment of recurrent respiratory papillomatosis (RRP). The Phase 1/2 trial is expected to enroll approximately 63 subjects in the United States and will evaluate the efficacy, safety, tolerability, and immunogenicity of INO-3107 in subjects with HPV 6 and/or 11-associated RRP who have required at least two surgical interventions per year for the past three years for the removal of associated papilloma(s). As RRP is a rare, orphan disease, INOVIO plans to work with the FDA’s Office of Orphan Products Development (OOPD) in an effort to attain Orphan Disease designation for INO-3107.

INOVIO and its collaborators published data from a pilot, compassionate use clinical trial for the treatment of RRP in the scientific journal Vaccines (MDPI). The article, entitled "Immune Therapy Targeting E6/E7 Oncogenes of Human Papillomavirus Type 6 (HPV-6) Reduces or Eliminates the Need for Surgical Intervention in the Treatment of HPV-6 Associated Recurrent Respiratory Papillomatosis," detailed the clinical efficacy observed in the pilot study of two patients with RRP.

INO-4800: COVID-19

In January 2020, INOVIO was awarded a grant of up to $9 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to develop a vaccine against COVID-19, the disease caused by the novel coronavirus. This initial CEPI funding is anticipated to support INOVIO’s preclinical and clinical development through a Phase 1 clinical trial of INO-4800, INOVIO’s COVID-19 vaccine candidate, in the United States.

Subsequent to the grant from CEPI, INOVIO announced a collaboration agreement with Beijing Advaccine Biotechnology Co. to advance the development of INO-4800 in China. The goal of this collaboration is to leverage Beijing Advaccine’s expertise to run a Phase 1 trial in China in parallel with INOVIO’s ongoing clinical development efforts in the United States.

In March 2020, INOVIO received a new $5 million grant from the Bill and Melinda Gates Foundation anticipated to fund accelerated testing and scale up of INOVIO’s CELLECTRA 3PSP proprietary smart device for the intradermal delivery of INO-4800, in order to support large scale manufacturing of INO-4800 doses by end of 2020.

INO-5401: Newly diagnosed glioblastoma multiforme (GBM)

In November 2019, INOVIO reported positive interim data for INO-5401 from its ongoing Phase 2 trial in patients with newly diagnosed glioblastoma multiforme (GBM) at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019 Annual Meeting. The Phase 2 trial is evaluating INO-5401, a T cell-activating immunotherapy candidate encoding for three tumor-specific antigens (hTERT, WT1, and PSMA), and INO-9012, an immune activator encoding IL-12, in combination with Libtayo, a PD-1 blocking antibody produced by Regeneron Pharmaceuticals in collaboration with Sanofi.

Key interim data from the 52-patient clinical trial showed that 80% (16 of 20) of MGMT gene promoter methylated patients and 75% (24 of 32) of unmethylated patients were progression-free at six months measured from the time of their first dose, substantially exceeding historical standard-of-care data (approximately 60% of MGMT promoter methylated patients and 40% of unmethylated patients historically were progression-free at six months). INOVIO expects to report 12-month overall survival data in June 2020, followed by 18-month overall survival data in the fourth quarter of 2020.

Dr. J. Joseph Kim, INOVIO’s President & CEO, said, "The company remains well-positioned for 2020 to be a transformational year for INOVIO. Following our very encouraging, albeit early, positive data for INO-5401 in our GBM study, we look forward to presenting 12-month overall survival data next quarter. We also continue to expand our capabilities in treating HPV-associated diseases, with IND acceptance from the FDA for a Phase 2 trial evaluating INO-3107 for the rare, orphan disease RRP. We also look forward to sharing interim efficacy and safety data from our Phase 2 study in HPV-associated vulvar HSIL and anal HSIL at ASCCP later this month."

"The evolving situation following the outbreak of COVID-19 has allowed us to further showcase INOVIO’s technology capabilities and versatility in fighting emerging infectious diseases. We are very grateful for both the financial and moral support from CEPI to take steps toward tackling this global pandemic. Our DNA medicine platform has been selected among a small group of important vaccine technologies for rapidly impacting emerging infectious diseases outbreaks such as COVID-19, having already advanced INO-4700, our vaccine candidate against MERS-CoV, another coronavirus, to a Phase 1/2a clinical trial. We look forward to sharing more on INO-4800’s development along with our broader pipeline initiatives and achievements in the future."

Fourth Quarter 2019 Financial Results

Total revenue was $279,000 and $4.1 million for the quarter and year ended December 31, 2019, respectively, compared to $2.5 million and $30.5 million for the same periods in 2018, respectively. Total operating expenses were $30.7 million and $115.2 million for the quarter and year ended December 31, 2019, respectively, compared to $32.0 million and $124.6 million for the same periods in 2018, respectively.

INOVIO’s net loss for the quarter and year ended December 31, 2019 was $37.7 million, or $0.38 per basic and diluted share, and $119.4 million, or $1.21 per basic and diluted share, respectively, as compared to $33.0 million, or $0.34 per basic and diluted share, and $97.0 million, or $1.05 per basic and diluted share, for the same periods in 2018, respectively.

Revenue

The year-over-year decrease in revenue under collaborative research and development (R&D) arrangements was primarily due to the recognition of a one-time upfront payment of $23.0 million form ApolloBio during the second quarter of 2018.

Operating Expenses

R&D expenses for the quarter and year ended December 31, 2019 were $22.0 million and $88.0 million, respectively, compared to $26.4 million and $95.3 million for the same periods in 2018, respectively. The year-over-year decrease in R&D expenses was primarily due to decreases in employee compensation expense and drug manufacturing expense related to our partnership with AstraZeneca, among other variances. These decreases were offset by an increase in expenses related to clinical trials and a personnel-related restructuring charge in connection with the one-time employee termination costs incurred during the third quarter of 2019.

General and administrative expenses were $8.7 million and $27.2 million, respectively, for the quarter and year ended December 31, 2019 versus $5.6 million and $29.3 million, respectively, for the same periods in 2018.

Capital Resources

As of December 31, 2019, cash and cash equivalents and short-term investments were $89.5 million compared to $93.8 million as of September 30, 2019. As of December 31, 2019, the Company had 101.4 million common shares outstanding and 132.1 million common shares outstanding on a fully diluted basis, after giving effect to outstanding options, restricted stock units and convertible preferred stock.

During the year ended December 31, 2019, the Company sold 3,340,678 shares of common stock under its "at-the-market" (ATM) common stock sales agreement for aggregate net proceeds of $9.1 million.

From January 1, 2020 through March 11, 2020, the Company sold 43,148,952 shares of common stock under its ATM agreement for net proceeds of $208.2 million. The sales were made at a weighted average price of $4.92 per share. As of March 11, 2020, there is no remaining capacity under the ATM agreement.

INOVIO’s balance sheet and statement of operations are provided below. Additional information is included in INOVIO’s annual report on Form 10-K for the year ended December 31, 2019, which can be accessed at: View Source

Conference Call / Webcast Information

INOVIO’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss INOVIO’s financial results and provide a general business update.

The live webcast and a replay may be accessed by visiting INOVIO’s website at View Source Telephone replay will be available approximately one hour after the call at 877-344-7529 (US toll-free) or 412-317-0088 (international toll) using replay access code 10139836.

On March 12, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, reported business highlights and financial results for the three months ended December 31, 2019 and Fiscal Year 2019 (Press release, CNS Pharmaceuticals, MAR 12, 2020, View Source [SID1234555517]).

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Business highlights for the fourth quarter of 2019 and recent weeks include the following:

Selected a leading Polish institution for the Phase 1 pediatric trial with Berubicin in glioblastoma multiforme ("GBM"). In February 2020, CNS announced the selection of Children’s Memorial Health Institute, the largest pediatric hospital in Poland as the single site for this pediatric trial which is expected to commence in the second half of 2020.
Completed final Good Manufacturing Practice ("GMP") reprocessing and purity validation of the existing batch of its lead drug candidate Berubicin. In February 2020, the Company announced the final GMP reprocessing of the existing batch of Berubicin, reporting the GMP material met all specifications and analytical testing is now underway. The Company is continuing large-scale production of Berubicin and intends to utilize this supply to complete its planned Phase 2 clinical trial for patients with GBM.
Licensed a novel DNA-binding technology from The University of Texas MD Anderson Cancer Center to expand the clinical pipeline. In January 2020, CNS entered into a licensing agreement with MD Anderson, granting the Company rights to develop and commercialize WP1244, a new class of DNA-binding agent designed to cross the blood-brain barrier for the potential treatment of primary and metastatic brain cancers. WP1244 has been shown in preclinical studies to be 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.
Received positive feedback from the U.S. Food and Drug Administration ("FDA") for Pre-IND (Investigational New Drug) proposal. In its December 2019 positive response to the Company’s Pre-IND request, the FDA indicated that the proposal to use a previously manufactured and currently available supply of a lyophilized drug product (i.e., Berubicin) in the Phase 2 clinical trial appears reasonable. Furthermore, the FDA noted that the requested dosage regimen for the planned Phase 2 trial with Berubicin in GBM, which will be based on the Reata Phase 1 trial, was reasonable.
Closed initial public offering ("IPO") of common stock. The Company closed its IPO of 2,125,000 shares of common stock at an offering price of $4.00 per share on November 13, 2019 and an additional 318,750 shares pursuant to the exercise in full of the underwriters’ over-allotment option sold at the IPO price of $4.00 per share on November 20, 2019. Gross proceeds from the offering, including the exercise of the underwriters’ over-allotment option, were $9.8 million and will be used to fund CNS’ clinical trials and for working capital.
"Since completing our IPO we are very pleased with the progress we have made toward initiating our Phase 2 clinical study of Berubicin to treat GBM, which represents a significant unmet medical need," stated John M. Climaco, Chief Executive Officer of CNS Pharmaceuticals. "We believe Berubicin has the ability to cross the blood-brain barrier with positive responses in these types of tumors, as demonstrated in the Phase 1 study conducted by Reata. In the second half of this year, we look forward to initiating our Phase 2 clinical study in adults in the U.S., as well as two studies conducted in Poland by our sub-license partner, WPD Pharmaceuticals, including a Phase 2 study in adults which will mirror our U.S.-based study, and a first-ever Phase 1 study in children. In addition, we plan to perform further preclinical studies for our recently licensed WP1244 drug candidate, a novel and potent DNA binding agent with high potency to inhibit tumor cell proliferation."

Fourth Quarter Financial Results

General and administrative expense was $1.0 million for the fourth quarter of 2019, compared with $0.2 million for the prior-year period. The increase is largely attributable to the expanded corporate infrastructure implemented in order to advance the Company’s clinical development program following its IPO.

Research and development expense for the fourth quarter of 2019 was $1.5 million, compared with $0 for the fourth quarter of 2018. The expense in the quarter was largely related to the cost of reprocessing and validating the existing batch of Berubicin needed for the commencement of the Phase 2 clinical trial, as well as starting the production of a new batch of the drug necessary for the contemplated clinical trials, both in the U.S. and in Poland.

The net change in cash in the fourth quarter of 2019 was $6.3 million. As of December 31, 2019, CNS had cash and cash equivalents of $7.2 million, which includes $8.8 million in net proceeds from our IPO.

Conference Call

CNS senior management will provide a business update in a conference call and live audio webcast beginning at 4:30 p.m. Eastern time today, March 12, 2020. The conference call dial-in and webcast information is as follows:

DOMESTIC DIAL-IN:

(844) 535-4071

INTERNATIONAL DIAL-IN:

(706) 679-2458

PASSCODE:

1254059

WEBCAST:

CNS Business Update Conference Call.

For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 1254059. The replay can be accessed for a period of time on the CNS website at CNS Business Update Conference Call.

On March 12, 2020 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported financial results for the fourth quarter and year ended December 31, 2019 and provided a corporate update (Press release, Regulus, MAR 12, 2020, View Source [SID1234555516]).

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"We have made significant progress over the past few months, including receiving notification from FDA of their decision to lift the partial clinical hold on our Phase 1 multiple ascending dose clinical study for RGLS4326, enabling the initiation of dosing of the second cohort of that study for the treatment of autosomal dominant polycystic kidney disease this past February," said Jay Hagan, CEO of Regulus. "This important milestone, coupled with the closing of the second tranche of financing, enables us to advance the program toward key data read-outs."

Corporate Highlights

Closed $26 Million Second Tranche of Private Financing: In December 2019, following the announcement of the Company’s plan to recommence the Phase 1 Multiple Ascending Dose ("MAD") clinical study of RGLS4326 for the treatment of autosomal dominant polycystic kidney disease ("ADPKD") in the first quarter of 2020, the Company completed a second and final closing under the May 2019 securities purchase agreement, pursuant to which the Company sold and issued 3,288,390 shares of non-voting Class A-2 convertible preferred stock, in lieu of shares of common stock, at a price of $6.66 per share, and accompanying warrants to purchase an aggregate of 32,883,900 shares of common stock at a price of $0.125 for each share of common stock underlying such warrants. Each share of the non-voting Class A-2 convertible preferred stock is convertible into 10 shares of common stock, subject to certain beneficial ownership conversion limitations. The warrants are exercisable for a period of five years following the date of issuance and have an exercise price of $0.666 per share, pursuant to proportional adjustments in the event of stock splits or combinations or similar events. Together with the first tranche, which closed in May 2019, the Company raised a total of $42.7 million from the private financing, which the Company expects will provide cash resources to fund planned activities into mid-2021.

Program Highlights

Initiated Dosing of the Second Cohort in RGLS4326 Phase 1 for ADPKD: In February 2020, the Company initiated dosing of the second cohort of the MAD clinical study of RGLS4326, a novel oligonucleotide designed to inhibit miR-17 for the treatment of ADPKD. The Company expects to complete this study in mid-2020 with topline results available thereafter. The Company is also planning to initiate a Phase 1b short-term dosing study in patients with ADPKD in the second half of 2020 to evaluate RGLS4326 for safety, pharmacokinetics, and biomarkers of pharmacodynamic activity. The re-initiation of the MAD study was allowed following a satisfactory complete response provided to FDA in November 2019 to address the partial clinical hold placed on the clinical program in July 2019. A partial clinical hold on studies of RGLS4326 dosed for extended durations remains in effect until the second set of requirements outlined by FDA have been satisfactorily addressed. Information from the Phase 1 clinical studies, together with information from additional nonclinical studies, will be used to address the second set of requirements to support studies of extended duration.

Financial Results

Cash Position: As of December 31, 2019, Regulus had $34.1 million in cash and cash equivalents.

Research and Development (R&D) Expenses: R&D expenses were $2.1 million and $12.3 million for the quarter and year ended December 31, 2019, respectively, compared to $5.3 million and $34.0 million for the same periods in 2018. The decreases were largely driven by decreases in external development expenses, primarily attributable to the pause of the RGLS4326 MAD study in the third quarter of 2018 and transfer of the RG-012 program to Sanofi beginning in the fourth quarter of 2018. Additionally, the decreases were driven by reductions in personnel and internal expenses, primarily attributable to a reduction in costs subsequent to our corporate restructuring in the third quarter of 2018.

General and Administrative (G&A) Expenses: G&A expenses were $2.4 million and $11.3 million for the quarter and year ended December 31, 2019, respectively, compared to $2.7 million and $12.9 million for the same periods in 2018. The decreases were mostly driven by a reduction in costs subsequent to our corporate restructuring in the third quarter of 2018.

Revenue: Revenue was less than $0.1 million and $6.8 million for the quarter and year ended December 31, 2019, respectively, compared to less than $0.1 million and $0.1 million for the same periods in 2018. The increase for the year ended December 31, 2019 was attributable to revenue recognition of the upfront payments received under the 2018 Sanofi Amendment related to the transfer of the RG-012 program to Sanofi.

Net Loss: Net loss was $4.9 million and $18.6 million for the quarter and year ended December 31, 2019, respectively, compared to a net loss of $8.6 million and $48.7 million for the same periods in 2018. Basic and diluted net loss per share was $0.23 and $1.08 for the quarter and year ended December 31, 2019, respectively, compared to $0.98 and $5.59 for the same periods in 2018.

About ADPKD

ADPKD, caused by the mutations in the PKD1 or PKD2 genes, is among the most common human monogenic disorders and a leading cause of end-stage renal disease. The disease is characterized by the development of multiple fluid filled cysts primarily in the kidneys, and to a lesser extent in the liver and other organs. Excessive kidney cyst cell proliferation, a central pathological feature, ultimately leads to end-stage renal disease in approximately 50% of ADPKD patients by age 60.

About RGLS4326

RGLS4326 is a novel oligonucleotide designed to inhibit miR-17 and designed to preferentially target the kidney. Preclinical studies with RGLS4326 have demonstrated direct regulation of PKD1 and PKD2 in human ADPKD cyst cells, a reduction in kidney cyst formation, improved kidney weight/body weight ratio, decreased cyst cell proliferation, and preserved kidney function in mouse models of ADPKD. The RGLS4326 IND is currently on a Partial Clinical Hold for treatment of extended duration by the U.S. Food and Drug Administration.

On March 12, 2020 China Biologic Products Holdings, Inc. (NASDAQ: CBPO, "China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company in China, reported its financial results for the fourth quarter and fiscal year of 2019 (Press release, China Biologic Products, MAR 12, 2020, View Source [SID1234555515]).

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Fourth Quarter 2019 Financial Highlights

Total sales in the fourth quarter of 2019 decreased by 9.6% in RMB terms and 11.1% in USD terms to $102.2 million from $114.9 million in the same quarter of 2018.
Gross profit decreased by 17.2% to $64.0 million from $77.3 million in the same quarter of 2018. Gross margin decreased to 62.6% from 67.3% in the same quarter of 2018.
Income from operations decreased by 56.2% to $18.6 million from $42.5 million in the same quarter of 2018. Operating margin decreased to 18.2% from 37.0% in the same quarter of 2018.
Non-GAAP adjusted income from operations decreased by 28.9% in RMB terms and 30.2% in USD terms to $27.8 million from $39.8 million in the same quarter of 2018.
Net income attributable to the Company decreased by 64.1% to $12.5 million from $34.8 million in the same quarter of 2018. Diluted earnings per share decreased to $0.32 compared to $0.87 in the same quarter of 2018.
Non-GAAP adjusted net income attributable to the Company decreased by 31.2% in RMB terms and 32.6% in USD terms to $20.7 million from $30.7 million in the same quarter of 2018. Non-GAAP adjusted earnings per diluted share decreased to $0.53 from $0.76 in the same quarter of 2018.
Fiscal Year 2019 Financial Highlights

Total sales in 2019 increased by 12.3% in RMB terms and 7.9% in USD terms to $503.7 million from $466.9 million in 2018.
Gross profit increased by 2.8% to $329.1 million from $320.1 million in 2018. Gross margin decreased to 65.3% from 68.6% in 2018.
Income from operations increased by 11.9% to $163.6 million from $146.2 million in 2018. Operating margin increased to 32.5% from 31.3% in 2018.
Non-GAAP adjusted income from operations increased by 16.6% in RMB terms and 11.6% in USD terms to $198.3 million from $177.7 million in 2018.
Net income attributable to the Company increased by 8.4% to $138.8 million from $128.1 million in 2018. Diluted earnings per share remained stable at $3.53 in 2019 as compared to 2018.
Non-GAAP adjusted net income attributable to the Company increased by 20.5% in RMB terms and 15.4% in USD terms to $168.4 million from $145.9 million in 2018. Non-GAAP adjusted earnings per diluted share increased to $4.28 from $4.02 in 2018.
NOTE: Detailed financial statements and information are available through this link: View Source

"We are pleased to report that China Biologic surpassed our upwardly revised guidance for the full year 2019. As anticipated, however, we saw a year-over-year decline in the fourth quarter after exceptionally strong results for the first nine months of the year," said Joseph Chow, Chairman and CEO of China Biologic. "During the fourth quarter we continued our various initiatives to transform our business, including improving our earnings quality, distribution network, and credit policy management. We saw encouraging progress in several areas including distribution channel consolidation, plasma collection expansion and improving accounts receivable turnover. In 2020, we expect to face challenges including increasingly strict industry regulations, intensified market competition and disruptions to our operations as a result of the coronavirus outbreak. Despite these challenges, we are confident our newly-reorganized management team will successfully implement our strategies as we pursue our mission of raising standards in China’s plasma industry and improving lives through the application of groundbreaking medical science."

Financial Outlook

The COVID-19 outbreak has impacted various aspects of CBPO’s operations, including plasma collection, production of certain products, and sales and marketing activities. The Company is actively evaluating the overall impact on CBPO’s business, and has decided to postpone the release of financial guidance for the full year 2020. The Company will provide financial guidance to the market when it has better visibility.

Conference Call

The Company will host a conference call at 7:30 a.m. Eastern Time on Friday, March 13, 2020, which is 7:30 p.m. Beijing Time on March 13, 2020, to discuss its fourth quarter and fiscal year 2019 results and answer questions from investors. Listeners may access the call by dialing:

US:

1 888 346 8982

International:

1 412 902 4272

Hong Kong:

800 905 945

Mainland China:

400 120 1203

A telephone replay will be available one hour after the conclusion of the conference all through March 20, 2020. The dial-in details are:

US:

1 877 344 7529

International:

1 412 317 0088

Passcode:

10139946

A live and archived webcast of the conference call will be available through the Company’s investor relations website at View Source

On March 12, 2020 Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, reported findings from a sub-analysis of data from its PROCEED registry comparing overall survival (OS) in African American (AA) and Caucasian (CAU) men with metastatic castrate-resistant prostate cancer (mCRPC) who were treated with PROVENGE (sipuleucel-T) in a real-world treatment setting (Press release, Dendreon, MAR 12, 2020, View Source [SID1234555513]).

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When comparing PSA-matched AA men to CAU men with a baseline PSA less than or equal to the median (29.48 ng/mL), AA men in the PROCEED registry demonstrated a median OS of over 4.5 years (54.3 months) versus over 2.7 years (33.4 months) for CAU men – an improvement of 20.9 months and a 48% relative risk reduction in death.1,2

"Racial differences in the effectiveness of treatments in mCRPC are well documented," said Oliver Sartor, M.D., co-lead author of the publication, associate dean for oncology at Tulane University School of Medicine and medical director of the Tulane Cancer Center. "The high percentage of AA men enrolled in PROCEED compared to other trials provided a unique opportunity to evaluate the effectiveness of immunotherapy in extending survival in this patient population."

The PROCEED registry enrolled nearly 2,000 patients with mCRPC who received PROVENGE between 2011 and 2014 in everyday treatment settings, and followed them for three years. Approximately 12% of patients enrolled in PROCEED were AA. This analysis compared OS in a subset of AA patients (n=107) and CAU patients (n=222) matched by baseline PSA.3

"Black men tend to present with aggressive prostate cancer and have twice the mortality rate as compared to white men," said Andrew J. Armstrong, M.D., co-lead author of the publication, professor of medicine at Duke University School of Medicine and member of the Duke Cancer Institute. "However, in the context of immunotherapy for men with mCRPC, we observe that black men have significantly improved overall survival as compared to similar white men. While we do not yet understand the reasons for this improved survival by self-identified race, these data provide evidence to support the early use of sipuleucel-T immunotherapy regardless of race in order to improve long-term survival."

PROCEED evaluated the real-world use of PROVENGE in men with asymptomatic or minimally symptomatic mCRPC. These data were published online in Prostate Cancer and Prostatic Diseases (PCAN), a peer-reviewed Nature Research journal. The publication in PCAN is the first time these sub-group data have been published in a peer-reviewed journal.

"These findings add to the growing body of published clinical evidence that PROVENGE extends life in men with mCRPC and underscore its added effectiveness in African American men," said Bruce A. Brown, M.D., chief medical officer at Dendreon. "No other prostate cancer treatment has shown this level of added benefit in African American men with mCRPC, so these findings are exciting."

About the PROCEED Registry

PROCEED (NCT01306890) was a multicenter, open-label, observational registry conducted at urology and medical oncology clinics in private practice and academic sites. PROCEED enrolled 1,976 patients with mCRPC, of whom 1,902 received PROVENGE between 2011 and 2014 in everyday treatment settings. Of these, approximately 12% were African American. In the entire PROCEED population, patients were followed for a median of 46.6 months. Their median age was 72 years and their median baseline PSA was 15.0 ng/mL. The sub-analysis published in PCAN compared OS in a subset of African American patients (n=219) and Caucasian patients (n=438) matched by baseline PSA.

About Prostate Cancer in African American Men

Prostate cancer is the most frequently occurring non-cutaneous cancer among men in the United States and is second only to lung cancer among the leading causes of cancer-related deaths. In 2020, an estimated 191,930 new cases of prostate cancer will be diagnosed in the United States and 33,330 men will die from the disease.4

African American men have the highest prostate cancer incidence rate of any racial or ethnic group in the world.5 In the United States, the risk of prostate cancer is 74% higher in black men than non-Hispanic white men.6 The incidence of prostate cancer is about 60% higher in blacks than in whites for reasons that remain unclear.4 Prostate cancer death rates in blacks are more than double those of every other racial and ethnic group in the United States.4

About PROVENGE (sipuleucel-T)

PROVENGE is the only FDA-approved immunotherapy made from a patient’s own immune cells for the treatment of prostate cancer. More than 30,000 men have been prescribed PROVENGE, and it has been clinically proven to extend life for certain men in advanced stages of the disease.

INDICATION

PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION

Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.