On April 14, 2020 Ribon Therapeutics, a clinical stage oncology company developing first-in-class therapeutics targeting stress response pathways, reported the presentation of new data at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, taking place from April 27-28, 2020 (Press release, Ribon Therapeutics, APR 14, 2020, View Source [SID1234556309]).

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This meeting will feature a selection of high-impact proffered paper presentations, including:

Session: Advances in Cancer Drug Design and Discovery
Abstract ID: 3974
Title: A Potent and Selective PARP14 Inhibitor Decreases Pro-tumor Macrophage Function and Elicits Inflammatory Responses in Tumor Explants
Presenter: Laurie Schenkel, Ph.D.
Date/Time: April 27, 2020, 12:20 p.m. – 12:30 p.m.
Session: New Drugs on the Horizon – Part 2
Abstract ID: DDT02
Title: RBN-2397: A First-in-Class PARP7 Inhibitor Targeting a Newly Discovered Cancer Vulnerability in Stress-Signaling Pathways
Presenter: Melissa Vasbinder, Ph.D.
Date/Time: April 28, 2020, 10:50 a.m. – 11:10 a.m.
AACR Virtual Meeting I the first of two virtual meetings; the second, AACR (Free AACR Whitepaper) Virtual Meeting II, is taking place on June 22-24, 2020.

On April 14, 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 that the first allowance for an important patent family was received from the Australian Patent Office (Press release, Propanc, APR 14, 2020, View Source [SID1234556308]). The allowed claims capture different dosage regimens, including those to be the focus of ongoing research, as the Company’s lead product candidate, PRP, advances towards clinical trials for the treatment of patients with advanced solid tumors.

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The key patent application, citing proenzyme compositions, is one of four patent families, consisting of 65 patents either in force or pending, and is the first to be allowed covering high doses of two proenzymes trypsinogen and chymotrypsinogen for the treatment of cancer. As a result, examination of patent applications in a number of other jurisdictions can be expedited where the Australian claims will be utilized for supplementary examination.

"The approval of this key patent application in Australia is a significant step forward for our intellectual property portfolio and is especially important as we prepare for entering the clinic in Australia," said James Nathanielsz, Propanc’s Chief Executive Officer.

Dr Julian Kenyon, Propanc’s Chief Scientific Officer said, "The aim of our first clinical trial will be to identify the maximum tolerated dose patients with advanced solid tumors, knowing that we continue to expand our intellectual property portfolio as a world first in the cancer field using a novel proenzyme treatment approach, helps build confidence that we are on track with our research."

On April 14, 2020 Johnson & Johnson (NYSE: JNJ) reported results for first-quarter 2020 (Press release, Johnson & Johnson, APR 14, 2020, View Source [SID1234556307]). The Company also announced earlier today that its Board of Directors declared a 6.3% increase in the quarterly dividend rate, from $0.95 per share to $1.01 per share . At the new rate, the indicated dividend on an annual basis is $4.04 per share compared to the previous rate of $3.80 per share.

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"With Johnson & Johnson’s century-plus history of leading in times of great challenge, we are mobilizing our resources across the Company in the fight against the COVID-19 pandemic," said Alex Gorsky, Chairman and Chief Executive Officer. "Johnson & Johnson is built for times like this, and we are leveraging our scientific expertise, operational scale and financial strength in the effort to advance the work on our lead COVID-19 vaccine candidate. We are committed to beginning production at risk imminently and bringing an affordable and accessible vaccine to the public on a not-for-profit basis for emergency pandemic use."

Mr. Gorsky continued, "I am both proud and amazed at the level of dedication that I have witnessed from our more than 132,000 employees as we have focused on delivering on our commitments and responsibilities to the patients and consumers we serve. Our strong performance in the first quarter reflects the efforts of our teams around the world and the sustainability of our business model. Today, our Board of Directors approved an increase in our quarterly dividend for the 58th consecutive year, underscoring our commitment to delivering value for our shareholders and the confidence we have in our business now and in the future."

OVERALL FINANCIAL RESULTS:
q1chart1.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
4 Excludes intangible amortization expense and special items

REGIONAL SALES RESULTS:

regionalsales005.jpg

Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

SEGMENT SALES RESULTS:

a2020q1segments.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

SEGMENT COMMENTARY:

Consumer Health
Consumer Health worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 11.0%* driven primarily by over-the-counter products including TYLENOL and MOTRIN analgesics; upper respiratory products including ZYRTEC; digestive health products and ZARBEE’S NATURALS. Other contributors to growth were LISTERINE mouthwash in oral care products; NEUTROGENA and AVEENO in skin health/beauty products, as well as STAYFREE and o.b. in international women’s health. Consumer Health results across the majority of franchises were positively impacted by the increased demand related to the COVID-19 pandemic.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 10.2%* driven by STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, DARZALEX (daratumumab), for the treatment of multiple myeloma, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, OPSUMIT (macitentan), an oral endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to delay disease progression, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and PREZISTA/PREZCOBIX/REZOLSTA/SYMTUZA for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. This growth was partially offset by biosimilar and generic competition, with declines primarily in international VELCADE (bortezomib), a proteasome inhibitor for the treatment of multiple myeloma, REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, and PROCRIT (epoetin alfa), a treatment for chemotherapy-induced anemia and patients with chronic kidney disease.

Medical Devices
Medical Devices worldwide operational sales, excluding the net impact of acquisitions and divestitures, declined by 4.8%* driven by the estimated net negative impact of the COVID-19 pandemic and the associated deferral of medical procedures to our Surgery, Orthopaedics, Interventional Solutions and Vision businesses.

NOTABLE NEW ANNOUNCEMENTS IN THE QUARTER:
The information contained in this section should be read in conjunction with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases available online in the Investors section of the Company’s website at news releases.
Regulatory
Approvals

ERLEADA (apalutamide) – European Commission (EC) Approves Expanded Use for Treatment of Patients with Metastatic Hormone-Sensitive Prostate Cancer
(press release)
STELARA (ustekinumab) – EC Approves Expanded Use for Treatment of Pediatric Patients With Moderate To Severe Plaque Psoriasis

(press release)
Regulatory
Submissions
Ponesimod – Submission of New Drug Applications to the U.S. Food and Drug Administration (FDA) and European Marketing Authorization for Treatment of Adults with Relapsing Multiple Sclerosis

(press release)
DARZALEX (daratumumab) – Submission to U.S. FDA for Combination with carfilzomib and dexamethasone (DKd) For Patients with Relapsed/Refractory Multiple Myeloma

Other
Lead Vaccine Candidate for COVID-19; Landmark New Partnership with U.S. Department of Health & Human Services; and Commitment to Supply One Billion Vaccines Worldwide for Emergency Pandemic Use; Announced

(press release)
XARELTO (rivaroxaban) -Landmark Phase 3 VOYAGER PAD Study of XARELTO Plus Aspirin Shows Significant Benefit in Patients with Symptomatic Peripheral Artery Disease (PAD) after Lower-Extremity Revascularization
(press release)
Rilpivirine And Cabotegravir Results of Phase 3 FLARE Study Demonstrate the Safety and Efficacy of Long-Acting Injectable HIV Treatment Regimen through 96 Weeks
(press release)
Rilpivirine and Cabotegravir 48-week Results of Phase 3b ATLAS-2M Study Demonstrate the Safety and Efficacy of Long-Acting Injectable HIV Treatment Administered Every Two Months
(press release)
JNJ-6372 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Non-Small Cell Lung Cancer
(press release)
RPGR Gene Therapy Granted European Medicines Agency PRIME and Advanced Therapy Medicinal Product Designations for X-Linked Retinitis Pigmentosa
(press release)
HEARTLINE launched, the First-of-its-Kind, Virtual Study Designed to Explore if a New iPhone App and Apple Watch Can Help Reduce the Risk of Stroke1

(press release)
1 iPhone and Apple Watch are trademarks of their respective owners

FULL-YEAR 2020 GUIDANCE:

Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the Company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.
The impact of COVID-19, inclusive of the related investments the Company is making to combat the pandemic, is included in the guidance below.

1 Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures
2 Non-GAAP financial measure; excludes the impact of translational currency
3 Calculated using Euro Average Rate: April 2020 = $1.09 Euro Average Rate: January 2020 = $1.11 (Illustrative purposes only)
4 Non-GAAP financial measure; excludes intangible amortization expense and special items

Other modeling considerations will be provided on the webcast.

WEBCAST INFORMATION:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investors section of the Company’s website at events-and-presentations.

On April 14, 2020 Immunophotonics reported that it has received Swissmedic approval to commence a new clinical trial entitled "Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors (Press release, Immunophotonics, APR 14, 2020, View Source [SID1234556306])." This is a multicenter phase 1B/2A trial with expansion cohorts in melanoma and soft tissue sarcoma patients. The therapeutic approach taken by this trial (SAKK 66/17) is different from those already used in clinical practice and possibly offers patients a therapeutic benefit after failure of standard chemotherapy and immunotherapy.

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Patients with laser ablation-accessible solid tumors are treated by thermal ablation followed immediately by an intratumoral injection of IP-001 (1 % N-dihydro-galacto-chitosan, Immunophotonics Inc.) for injection). IP-001 is intended to trigger a tumor-specific systemic immune response when exposed to tumor antigens liberated by thermal ablation. There is strong preclinical and early clinical evidence that combining thermal ablation with IP-001 might be able to turn "cold" tumors into "hot" tumors, inducing a systemic immune response. This may result in shrinkage of the treated tumor, as well as long-term response mediated by the patient’s immunological defense system against any remaining tumor cells (residual primary and metastatic tumor cells) including tumor cells outside or distant from the treated area (also known as abscopal effect).

This trial will provide information on the safety and tolerability of thermal ablation followed immediately by an intratumoral IP-001 injection in patients with laser ablation-accessible solid tumors (6 patients, "all comers," Part 1, safety run in). Further information on safety and tolerability, as well as preliminary antitumor activity, will be evaluated in patients with soft tissue sarcoma (Part 2, Cohort1), whereas in melanoma patients, anti-tumor activity is a primary objective (Part 2, Cohort 2).

On April 14, 2020 Illumina, Inc. (NASDAQ: ILMN) reported preliminary revenue for the first quarter of fiscal year 2020 and withdrew its 2020 guidance (Press release, Illumina, APR 14, 2020, View Source [SID1234556305]).

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Subject to quarter-end closing adjustments, the Company expects to report first quarter revenue of approximately $858 million, compared to $846 million in the first quarter of 2019. Strong sequencing consumable revenue more than offset the impact of COVID-19 including disrupted system sales in the closing weeks of the quarter.

"Our priority in the midst of this global pandemic is the safety of our employees, partners and customers," said Francis deSouza, President and CEO. "We are also committed to ensuring continuity of supply for our customers, many of whom are performing critical clinical testing for patients. We share the commitment of the scientific community to do everything we can to fight COVID-19, and are supporting researchers using sequencing to track transmission, study the evolution of the virus’ genome and how it could impact the effectiveness of diagnostics and therapies, or explore how surveillance could be adopted to reduce the impact of future outbreaks of new infectious diseases."

"While our preliminary first quarter results were strong overall, we expect the second quarter to be significantly impacted by COVID-19 related disruption," said Sam Samad, Illumina’s Chief Financial Officer. "We are confident that this is a temporary disruption that in no way alters the long-term trajectory of sequencing adoption and demand. That said, it is not possible at this time to forecast the severity and duration of this outbreak. As a result, we believe it is prudent at this time to withdraw our 2020 revenue and earnings per share guidance."

Quarterly conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Thursday, April 30, 2020. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (866) 211-4597, or 1 (647) 689-6853 outside North America, both with conference ID 9492366.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.