On October 13, 2020 Johnson & Johnson (NYSE: JNJ) reported results for third-quarter 2020 (Press release, Johnson & Johnson, OCT 13, 2020, View Source [SID1234568387]. "Our third-quarter results reflect solid performance and positive trends across Johnson & Johnson, powered by better-than-expected procedure recovery in Medical Devices, growth in Consumer Health, and continued strength in Pharmaceuticals," said Alex Gorsky, Chairman and Chief Executive Officer. "I am proud of the relentless passion and Credo-led commitment to patients and customers that our colleagues around the world continue to demonstrate as we boldly fight the COVID-19 pandemic. Our world-class R&D team is working tirelessly to advance the Phase 3 trials of our COVID-19 vaccine and to uphold the highest standards of transparency, safety and efficacy; while other dedicated teams provide ongoing support to hospitals and patients as they return to sites of care, and ensure patients and consumers have the medicines and products they need. This resilient mindset, combined with our strategic capabilities and execution excellence, increase our optimism for continued recovery in 2020 and strong momentum entering into 2021."
OVERALL FINANCIAL RESULTS:

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REGIONAL SALES RESULTS:

SEGMENT SALES RESULTS:

SEGMENT COMMENTARY:

Consumer Health
Consumer Health worldwide operational sales, excluding the net impact of acquisitions and divestitures, increased by 3.1%*, inclusive of the net negative impact of COVID-19 primarily in international over-the-counter products. Sales growth was driven by U.S. growth in over-the-counter products including TYLENOL analgesics and digestive health products; LISTERINE mouthwash in oral care products; OGX in skin health/beauty products; and wound care products, primarily BAND-AID Brand Adhesive Bandages.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 4.7%* driven by DARZALEX (daratumumab), for the treatment of multiple myeloma, STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, 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, OPSUMIT (macitentan), an oral endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to delay disease progression, UPTRAVI (selexipag), an oral prostacyclin receptor agonist used to treat pulmonary arterial hypertension and reduce hospitalization, and ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer. This growth was partially offset by the negative impact of COVID-19 as well as biosimilar and generic competition, with declines primarily in REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, and ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer.

Medical Devices
Medical Devices worldwide operational sales, excluding the net impact of acquisitions and divestitures, declined by 3.3%*. The decline was primarily driven by the negative impact of the COVID-19 pandemic and the associated deferral of medical procedures to our Surgery, Orthopaedics, and Vision businesses. Results reflect market recovery versus the second quarter. The decline was partially offset by growth in the Interventional Solutions business led by electrophysiology products.

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
THERMOCOOL SMARTTOUCH – Biosense Webster Receives FDA Approval for SF Ablation Catheter for the Treatment of Persistent Atrial Fibrillation¹ (press release) SIMPONI ARIA (golimumab) – Approved by the U.S. Food and Drug Administration for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older (press release) SPRAVATO (esketamine) – Janssen Announces U.S. FDA Approval of CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior (press release) DARZALEX (daratumumab) – U.S. FDA Approves New DARZALEX-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma (press release) STELARA (ustekinumab) – U.S. Food and Drug Administration Approves Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis (press release) Regulatory
Submissions UPTRAVI (selexipag) – Janssen Submits New Drug Application (NDA) to U.S. FDA for Injection for Intravenous Use to Treat Pulmonary Arterial Hypertension (PAH) (press release) DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) – Janssen Submits Application Seeking U.S. FDA Approval for the Treatment of Patients with Light Chain (AL) Amyloidosis (press release) Other Johnson & Johnson Announces European Commission Approval of Agreement to Supply 200 Million Doses of Janssen’s COVID-19 Vaccine Candidate ¹ (press release) Johnson & Johnson Completes Acquisition of Momenta Pharmaceuticals, Inc.¹ (press release) Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen’s COVID-19 Vaccine Candidate (press release) CERENOVUS Launches New Suite of Technologies to Advance Stroke Treatment (press release) Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies (press release) Janssen to Discontinue Pimodivir Influenza Development Program (press release) Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine (press release) U.S. FDA Grants Ethicon Breakthrough Device Designation for Monarch-enabled NeuWave Microwave Ablation Technology (press release)
1 Subsequent to the quarter

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 estimated impact of the COVID-19 pandemic is included in the guidance below.

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 October 13, 2020 NantHealth, Inc. (NASDAQ: NH), a next-generation, evidence-based, personalized healthcare company, presented virtually with NantOmics and ImmunityBio on September 29-30 2020, a session entitled "Deep-learning image-based tumor, stroma and lymphocytes spatial relationships and clinical features that affect survival in pancreatic cancer patients," at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) virtual special conference on pancreatic cancer (Press release, NantHealth, OCT 13, 2020, View Source [SID1234568386]). This Nant technology is an example of how digital pathology solutions may support the treatment of cancer.

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Prepared in collaboration with NantOmics, ImmunityBio, and the University of Colorado School of Medicine, the presentation examined differential survival in pancreatic cancer patients via stromal and lymphocyte density. In this study, the contributing researchers developed an automated deep-learning system to provide risk assessment upon spatial relationships between tumor, stroma, and lymphocyte regions in pancreatic pathology images from 82 pancreatic adenocarcinoma patients who underwent chemotherapy. Using Gaussian mixture models, researchers identified optimal thresholds in the image-based features and organized patients into unsupervised clusters, then linked those to differences in survival. Risk models were generated on standard clinicopathological features and used to compare against the proposed image-based risk models.

The study’s key findings include:

Cox PH models trained on image features more significantly stratified risk on unseen test patients than an optimal set of clinicopathological features
Image-based models suggest low-risk patients have:
Higher tumor-infiltrating lymphocytes despite having fewer overall lymphocytes
Higher tumor-adjacent stroma
The combination of both risk-models proved to be superior in training and testing sets and achieved better separation in survival curves than either model by itself
Image-based risk-associated features are independently prognostic of clinicopathological features
Even with a limited sample-size, the results showed significance to warrant a larger study
"Our combined analysis with NantOmics, ImmunityBio and the University of Colorado School of Medicine, provided results with a level of significance that show great promise for future studies using deep-learning models as a prognostic tool for pancreatic cancer patients," said Christopher Szeto, Director of Machine Learning, NantHealth. "These results provide a strong clinical platform not only to better understand pancreatic cancer for evidence-based prognosis but also reinforce the essential nature of advanced technology in the continued evolution of medicine."

The AACR (Free AACR Whitepaper) Virtual Special Conference: Pancreatic Cancer is a conference focused on bringing together experts across industries to better understand and further advance pancreatic cancer research and treatment. The conference attracts a range of attendees, including those in government, clinical roles, patient advocacy, and companies who make groundbreaking technology and discoveries in oncology.

On October 13, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting significant unmet needs in the treatment of tumors and viruses, reported additional preliminary data from the Phase 1 clinical trial of its immuno-stimulating STAT3 inhibitor, WP1066, in patients with glioblastoma (GBM) (Press release, Moleculin, OCT 13, 2020, View Source [SID1234568385]). This supports the progression of the trial to the fourth and final dose escalation cohort. Three patients have completed treatment in the third cohort at a dose level of 8 mg/kg with no adverse events related to WP1066 and the study will now proceed to the next higher dose of 16 mg/kg.

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Walter Klemp, Chairman and CEO of Moleculin, stated, "On the heels of our recent positive announcement regarding the progress of the pediatric brain tumor trial of WP1066, we are pleased to also report on the progress of the adult GBM clinical trial for the same drug candidate. The trial in adults has been important in leading the way to establishing a safe and tolerable human dose level for what we believe is a first-in-class compound that crosses the blood-brain barrier and is being developed for the treatment of central nervous system malignancies. In animal models, WP1066 has been shown to stimulate immune responses that successfully modulate oncogenic transcriptional activity in tumor cells and repress their ability to drive tumor growth.

Mr. Klemp continued: "In addition to providing valuable pharmacokinetic data, this trial also creates the foundation for future studies in WP1066, including another investigator-initiated study, which is currently being proposed to examine the combination of WP1066 with radiation for the treatment of GBM. This next clinical trial is being proposed as a result of recent discoveries presented in a peer-reviewed article published in Clinical Cancer Research (Clin Cancer Res June 30 2020 DOI:10.1158/1078-0432.CCR-19-4092), which reported findings that Moleculin’s STAT3 inhibitor, WP1066, used in combination with traditional whole brain radiation therapy, resulted in long-term survivors and enhanced median survival time relative to monotherapy in mice with implanted human brain tumors."

Mr. Klemp concluded, "In keeping with our established clinical trial reporting policies, we look forward to updating investors on the continued progress of this trial once this final cohort is completed."

On October 13, 2020 Biomica, an emerging biopharmaceutical company developing innovative microbiome-based therapeutics, and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), reported the advancement to large-scale production of BMC128, its Live Bacterial Product (LBP) candidate consortium (Press release, Evogene, OCT 13, 2020, View Source [SID1234568384]). The microbes, which will be produced in large-scale are expected to support Biomica’s first-in-man proof-of-concept clinical trials for its immuno-oncology program, anticipated to begin in 2021. BMC128 is advancing to the GMP production stage following the successful completion of the initial R&D stage of drug product development and manufacturing, conducted by Biose Industrie (Aurillac, France).

Biomica’s immuno-oncology program is focused on its leading 4-strain candidate consortium BMC128. Biomica recently announced positive results in the program, demonstrating the efficacy of BMC128 in potentiating the response to immune-checkpoint inhibitors (ICI) in preclinical studies. In these studies, BMC128 was administered to mice bearing cancer tumors prior to and during ICI therapy, and the results showed that treatment with BMC128 significantly improved anti-tumor activity.

Biose Industrie is a drug-GMP certified manufacturer of bacteria-based APIs and clinical and commercial products. As previously announced earlier this year, Biomica engaged Biose for the scale-up development and GMP production of a clinical batch of its drug candidates.

Elran Haber, CEO of Biomica stated: "We are pleased with the continual advancements achieved with the production of our leading drug candidate, BMC128. The success seen in the R&D phase indicates that the production of these microbes is not only feasible but can be done efficiently in large scale. We will now be able to produce these microbes, which have demonstrated efficacy in pre-clinical trials, in large quantities in preparation for our proof-of-concept clinical trials in 2021."

Ofer Haviv, Chairman of Biomica and President & CEO of Evogene stated: "This is an additional important developmental milestone for Biomica. I am very proud of the progress that Biomica has achieved in 2020, and particularly that of its advancing immune-oncology program. We see significant opportunity in this program which has the potential to bring new solutions for patients currently uncurable under available therapies."

About BMC128

Developed as a Live Bacterial Product (LBPs), BMC128 is a rationally-designed LBP consortium comprised of four unique bacterial strains, natural inhabitants of the human intestinal tract, that harbor specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity through multiple biological processes.

Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a host’s microbial community with individually selected, cultured bacteria.

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On October 13, 2020 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, and Neogene Therapeutics, Inc., a biotechnology company pioneering a new class of fully personalized T cell therapies to treat cancer, reported a broad strategic partnership (Press release, Neogene Therapeutics, OCT 13, 2020, View Source [SID1234568383]). The companies will leverage Neogene’s proprietary expertise in targeting tumor neo-antigens, mutated proteins found in cancer cells due to cancer-associated DNA mutations, together with Twist’s DNA synthesis platform and product lines to develop personalized chimeric antigen receptor (CAR) T cell therapies and T cell receptor (TCR) therapies for patients with cancer.

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"Engineered T cell therapies have demonstrated benefit to patients with difficult-to-treat cancers. We are delighted to partner with Neogene, a company pioneering fully personalized T cell therapies for solid tumors," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "Putting our platforms together, we believe we will be able to expedite the identification and genetic engineering of TCR genes to create personalized T cell therapies for cancer, bringing new hope to address the current limitations of treatments available today."

"Neogene is committed to changing the treatment paradigm for solid cancers using our novel technology to provide access to tumor-specific TCRs for engineered T cell therapy on an individualized patient basis. Twist’s proven ability to make synthetic DNA products at scale provides a tremendous engine to power innovative, precise cancer therapeutics," said Carsten Linnemann, Ph.D., CEO and co-founder of Neogene Therapeutics. "We are confident that our proprietary platform for the development of personalized T cell therapies, combined with Twist’s diversified platform of synthetic DNA based tools, will allow us to expedite development of revolutionary treatment options for solid cancers."

Under the terms of the collaboration, Neogene and Twist will work together to develop novel tools for T cell therapies. Twist Biopharma, a division of Twist Bioscience, will create a specialized T cell receptor (TCR) library for Neogene with the goal of discovering engineered TCRs against two specified T cell targets in cancer for future Neogene personalized T cell therapies. Using its "Library of Libraries", Twist Biopharma also will discover antibodies with specific function, affinity and specificity to two oncology targets for future Neogene CAR-T therapies. These antibodies will have very fine (single point) specificity to their target providing the potential for novel CAR-T therapies against such targets.

Twist will receive technology access fees as well as milestones and royalties based on key preclinical, clinical and commercial milestones for any antibodies and T cell receptors resulting from the collaboration. Neogene will have exclusive rights to the synthetic TCR library for targeting viral and neo-antigens in the field of oncology.