On July 21, 2021 Johnson & Johnson (NYSE: JNJ) reported results for second-quarter (Press release, Johnson & Johnson, JUL 21, 2021, View Source [SID1234585014]). "Our second-quarter results showcase Johnson & Johnson’s diversified portfolio, driven by strong sales and earnings growth across our Medical Device, Consumer Health and Pharmaceutical businesses," said Alex Gorsky, Chairman and Chief Executive Officer. "I’m so proud of our 136,000 colleagues who remain focused on delivering our medicines and products to patients and consumers around the world, in addition to advancing our pipeline with new product launches and regulatory submissions. These accomplishments exemplify our commitment to advancing transformational innovations that improve the health of people and communities everywhere while continuing to deliver long-term value to all of our stakeholders."

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Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules

Excludes the impact of translational currency

Excludes the net impact of acquisitions and divestitures and translational currency

Note: values may have been rounded

Second Quarter 2021 SEGMENT COMMENTARY:

Consumer Health
Consumer Health worldwide operational sales, excluding the net impact of acquisitions and divestitures, increased 10.0%* inclusive of the market recovery from COVID-19 impacts, primarily in skin health/beauty. Sales growth was driven by skin health/beauty products including NEUTROGENA, AVEENO, and OGX; over-the-counter products including ZYRTEC in upper respiratory products, international analgesics, and digestive health products; and BAND-AID Brand Adhesive Bandages in wound care products.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 14.1%* 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, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and for adults with active psoriatic arthritis, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer, and INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults. This growth was partially offset by biosimilar and generic competition, with declines primarily in REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases.

Medical Devices
Medical Devices worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 58.7%*, primarily driven by the benefit of market recovery from COVID-19 impacts and the associated deferral of medical procedures in the prior year across all of our businesses including Surgery, Orthopaedics, Vision and Interventional Solutions.

NOTABLE NEW ANNOUCEMENTS 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.

FULL-YEAR 2021 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.

Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures

Non-GAAP financial measure; excludes the impact of translational currency

Calculated using Euro Average Rate: April 2021 = $1.19 and July 2021 = $1.19 (Illustrative purposes only)

Non-GAAP financial measure; excludes intangible amortization expense and special items

Note: % may have been rounded

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 July 21, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or the "Company") reported that its share purchase plan ("SPP"), details of which were announced to ASX on 21 June 2021, closed at 5.00pm on Monday, 19 July 2021 with the Company receiving total SPP application funds of A$7,175,720, exceeding the targeted amount sought to be raised under the SPP of A$5 million (Press release, Immutep, JUL 21, 2021, View Source [SID1234585013]).

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Following strong demand from eligible shareholders who participated in the SPP, Immutep’s board has exercised its discretion to increase the size of the SPP to accept the full amount of applications received from eligible shareholders under the SPP. Accordingly, there will be no scale back of ordinary shares ("Shares") applied for under the SPP, meaning applicants who submitted a valid application will receive the full number of Shares for which they applied.

Accordingly, the Company has raised A$7,175,720 before transaction-related expenses through the SPP. This is in addition to the A$60 million two-tranche institutional placement ("Placement") (details of which were announced to ASX on 21 June 2021) where the issue of Shares under the second tranche of the Placement (representing approximately A$46.3 million) is subject to shareholder approval at the Company’s upcoming EGM to be held on Monday, 26 July 2021.

The funds raised from the SPP and Placement will be used to support Immutep’s ongoing and planned immuno-oncology clinical development programs, its pre-clinical program in autoimmune disease and for general working capital purposes.

The Company expects that 13,799,149 new Shares issued under the SPP will be issued to eligible shareholders on Friday, 23 July 2021 and holding statements will be dispatched by Tuesday, 3 August 2021. The new Shares issued under the SPP are expected to commence trading on the ASX on Monday, 26 July 2021.

The Board of Immutep wishes to thank all shareholders who participated in the SPP.

This announcement was authorised for release by the Board of Immutep Limited.

On July 21, 2021 Dynavax Technologies Corporation (NASDAQ: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported that it will report second quarter 2021 financial results on Wednesday, August 4, 2021, after the U.S. financial markets close (Press release, Dynavax Technologies, JUL 21, 2021, View Source [SID1234585010]).

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Dynavax will host a conference call and live audio webcast on Wednesday, August 4, 2021 at 4:30 p.m. (ET)/1:30 p.m. (PT).

The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source Alternatively, participants may dial (866) 420-4066 (domestic) or (409) 217-8237 (international) and refer to conference ID 9970706. A replay of the webcast will be available for 30 days following the live event.

On July 21, 2021 Celyad Oncology SA (Euronext & Nasdaq: CYAD) (Brussels:CYAD) (Paris:CYAD) (NASDAQ:CYAD) (Celyad Oncology or the Company), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported a new preclinical allogeneic armored CAR T candidate developed from its shRNA platform and data updates to the shRNA-based allogeneic candidate CYAD-211 for r/r MM and allogeneic candidate CYAD-101 for mCRC today during a research and development day hosted by the Company’s management team (Press release, Celyad, JUL 21, 2021, View Source [SID1234585009]).

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"We are ushering in a new era of allogeneic CAR T candidates using novel technological advances, including our proprietary shRNA platform for allogeneic CAR T production and now the addition of our ‘armored’ CAR capabilities with co-expression of the cytokine IL-18," said Filippo Petti, Chief Executive Officer of Celyad Oncology. "We believe the advances we’re making may address many of the current modality limitations and have the potential to provide real-world benefits for patients, including more accessible CAR T cell treatment options, if approved. This continued technological innovation, which is currently being validated in ongoing clinical studies, establishes Celyad Oncology as a leader in this adoptive cell therapy space."

Latest Program Updates

CYAD-211 – Allogeneic shRNA-based, anti-BCMA CAR T for r/r MM

CYAD-211 is the Company’s first shRNA-based allogeneic CAR T candidate, which co-expresses a BCMA targeting chimeric antigen receptor while using shRNA to knockdown expression of the CD3ζ component of theT-cell receptor (TCR)
Currently, CYAD-211 is being evaluated in the Phase 1 IMMUNICY-1 trial in r/r MM following preconditioning with cyclophosphamide (300 mg/m²) and fludarabine (30 mg/m²) given three consecutive days.
In June, preliminary data from the Phase 1 IMMUNICY-1 trial was presented at the European Hematology Association (EHA) (Free EHA Whitepaper) congress demonstrating no dose limiting toxicity (DLT), Graft-versus-Host disease (GvHD) or CAR T-cell-related encephalopathy syndrome (CRES) in the first two dose levels (30×106 and 100×106 cells per infusion) of the trial. Two of the five evaluable patients at the first two dose levels achieved a partial response. In addition, CYAD-211 cells were detected by PCR-based methods in all six patients with evidence of a dose dependent increase in cell engraftment.
Recent data from the first patient at dose level three (300×106 cells per infusion) continues to show dose dependent engraftment with no GvHD reported to date.
Enrollment in the trial is ongoing with plans to explore higher doses of preconditioning regimens in future cohorts.
CYAD-203 – Allogeneic shRNA-based, IL-18-armored NKG2D CAR T for Solid Tumors

CYAD-203 is the Company’s first armored CAR T candidate engineered to co-express the cytokine interleukin-18 (IL-18) with the NKG2D CAR receptor. To the Company’s knowledge, this therapy is on track to be first ever IL-18 secreting allogeneic CAR T candidate.
IL-18 is a proinflammatory cytokine that directly potentiates the anti-cancer activity of CAR T cells while also altering the balance of pro- and anti-inflammatory cells within tumor tissue.
Investigational New Drug (IND)-enabling studies are currently ongoing. Submission of the IND application for CYAD-203 for treatment of solid tumors is expected in mid-2022.
CYAD-101 – Allogeneic TIM-based NKG2D CAR T for mCRC

To the Company’s knowledge, CYAD-101 is the first investigational allogeneic CAR T candidate to generate evidence of clinical activity for the treatment of a solid tumor indication. This is based on data from the dose-escalation segment of the alloSHRINK Phase 1 trial evaluating CYAD-101 following FOLFOX (combination of 5-fluorouracil, leucovorin and oxaliplatin) preconditioning chemotherapy for the treatment of advanced metastatic colorectal cancer (mCRC).
Initial data from the dose expansion cohort evaluating CYAD-101 (1×109 cells per infusion) following FOLFIRI (combination of 5-fluorouracil, leucovorin and irinotecan) preconditioning chemotherapy showed CYAD-101 was generally well-tolerated with no dose limiting toxicities or evidence of GvHD. Overall, nine out of ten evaluable mCRC patients showed stable disease at first tumor assessment.
Data also showed shorter persistence of CYAD-101 cells observed after FOLFIRI preconditioning as compared to FOLFOX preconditioning. Based on better CYAD-101 cell kinetics and clinical activity data from the alloSHRINK FOLFOX cohort, the Company submitted a protocol amendment to regulatory agencies to modify the Phase 1b KEYNOTE-B79 trial to incorporate FOLFOX as preconditioning chemotherapy.
The KEYNOTE-B79 trial to evaluate CYAD-101 with Merck’s anti-PD­1 therapy, KEYTRUDA (pembrolizumab), in refractory mCRC patients with microsatellite stable / mismatch-repair proficient disease is expected to be initiated during the fourth quarter of 2021.
Business Update

Celyad Oncology has acquired an exclusive license from the Moffitt Cancer Center for an antibody directed to Tumor-associated glycoprotein (TAG-72), which will form the basis of a T cell engager to be used with our proprietary shRNA platform technology. TAG-72 has been shown to be expressed in a wide variety of epithelial malignant tissues including breast, colon and pancreatic cells and will expand the Company’s program portfolio in solid tumor targets.
Upcoming Milestones

Additional clinical activity data for the Phase 1 IMMUNICY-1 trial of CYAD-211 for r/r MM are expected during second half 2021.
Study initiation for KEYNOTE-B79 Phase 1b is expected early fourth quarter 2021.
Submission of an IND application for CYAD-203 is expected in mid-2022.
Report additional data from the dose-escalation Phase 1 CYCLE-1 trial evaluating CYAD-02 in relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome in mid-2021.

On July 21, 2021 AmerisourceBergen (NYSE: ABC), Cardinal Health (NYSE: CAH) and McKesson (NYSE: MCK) reported that they have negotiated a comprehensive proposed settlement agreement which, if all conditions are satisfied, would result in the settlement of a substantial majority of opioid lawsuits filed by state and local governmental entities (Press release, Cardinal Health, JUL 21, 2021, View Source [SID1234585008]).

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While the companies strongly dispute the allegations made in these lawsuits, they believe the proposed settlement agreement and settlement process it establishes, which is outlined below, are important steps toward achieving broad resolution of governmental opioid claims and delivering meaningful relief to communities across the United States. The companies remain deeply concerned about the impact the opioid epidemic is having on individuals, families, and communities across the nation and are committed to being part of the solution.

The proposed settlement agreement is the result of years of negotiation with state attorneys general and representatives of the subdivisions. If the proposed settlement agreement and settlement process leads to final settlement through the process outlined below, it would collectively provide thousands of communities across the United States up to approximately $21 billion over 18 years. It would also establish a clearinghouse that consolidates data from all three distributors, which will be available to the settling states to use as part of their anti-diversion efforts.

Subject to certain future milestones described below and the level of participation, the companies would be responsible for up to the following contributions, payable over 18 years:

AmerisourceBergen: $6.4 billion
Cardinal Health: $6.4 billion
McKesson: $7.9 billion
The proposed settlement agreement would become binding only if all conditions outlined below are satisfied:

Approval of State and
Territorial Participation

For the next 30 days, all U.S. States, territories and Washington DC will have the opportunity to join the settlement, except West Virginia which settled previously with the companies. After the conclusion of the state sign-on period, each company will independently determine whether a sufficient number of states have joined to warrant continuing with the political subdivision sign-on period.

Approval of Political
Subdivision Participation

If the distributors decide that sufficient states have joined, each participating state will continue to offer its political subdivisions, including those that have not sued, the opportunity to participate in the settlement for an additional 120-day period. After the conclusion of the political subdivision sign-on period, each company will independently determine whether a sufficient number of states and a sufficient number of political subdivisions have joined for the settlement to proceed to implementation.

If the conditions are satisfied, the settlement would become effective 60 days after the distributors determine that there is sufficient participation to proceed. During this 60-day period, the participating states and the distributors would cooperate to obtain consent judgments in each participating state embodying the terms of the settlement. The companies will make their first annual settlement payment into escrow on or before September 30, 2021, and the payment will be disbursed following the effective date, or returned to distributors if the settlement does not become effective.

If, however, a settlement cannot be finalized and plaintiffs instead choose to pursue their claims in court, the companies will continue to assert their strong legal defenses in pending litigation.

This settlement process only addresses the claims of U.S. state attorneys general and political subdivisions in participating states. The West Virginia subdivisions and Native American tribes are not part of this settlement process.