On August 2, 2021 DBV Technologies S.A. (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, reported financial results for the second quarter of 2021 (Press release, DBV Technologies, AUG 2, 2021, View Source [SID1234585532]). The quarterly financial statements were approved by the Board of Directors on July 30, 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"DBV has continued to prioritize the advancement of Viaskin Peanut’s regulatory dossier. In 2Q 2021, we have made significant progress in developing and selecting modified Viaskin Peanut patches," said Daniel Tasse, Chief Executive Officer, DBV Technologies. "The two final modified patches demonstrate stronger adhesion as compared to the current system while preserving the structure of the occlusion chamber. Further, DBV advanced our clinical study efforts. We initiated a Phase I study intended to support EQUAL and submitted the STAMP study protocol to the FDA. In parallel, DBV has remained diligent about spend and I am confident that our cash on hand as of June 30, 2021 will support our operations until the second half of 2022."

Recent Business Developments

Viaskin Peanut US:
In 2Q 2021, DBV completed CHAMP (Comparison of adHesion Among Modified Patches), a trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches in order to identify the top performers. Based on the adhesion parameters studied, DBV was pleased to learn that all modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the current Viaskin Peanut patch. DBV then selected two modified patches that performed best out of the five modified patches studied for further development.

The difference between the two selected patches is their shape—one is circular and the other is rectangular with rounded corners. They are both approximately 50% larger than the current patch but maintain the same structure of the occlusion chamber (i.e., foam ring and backing). DBV also conducted advisory boards with patient caregivers and key opinion leaders to obtain qualitative feedback on the consumer experience with both patches.

DBV submitted the protocol for STAMP (Safety, Tolerability and Adhesion of Modified Patches), the 6-month adhesion and safety study of the modified patch, to the FDA in 2Q 2021 and is currently awaiting feedback.

Earlier this quarter, DBV initiated PREQUAL, a Phase 1 study in healthy adult volunteers to optimize the allergen sample collection methodologies and validate the assays DBV intends to use in EQUAL (EQuivalence in the Uptake of ALlergen). DBV continues to work closely with FDA on how to best demonstrate the protein transport comparability of the modified patch (mVP) to the reference patch (cVP).

Viaskin Peanut EU:
DBV received from the EMA Day 180 list of outstanding issues. The review of the Viaskin Peanut Marketing Authorization Application (MAA) is progressing according to established EMA processes and ongoing conversations with the EMA.

Many of EMA’s Objections and Major Objections have been answered; One Major Objection remains. DBV will provide a response to address the outstanding issues, including the mentioned Major Objection.

Based on the average length of an EMA evaluation of an MAA, DBV estimates the EMA could issue its decision on potential marketing authorization for Viaskin Peanut in the fourth quarter of 2021 or the first quarter of 2022.

Class Action Complaint:
As previously disclosed, a class action complaint was filed in January 2019 in the U.S. District Court, District of New Jersey, alleging that the Company and certain current and former executive officers violated certain U.S. federal securities laws. On July 29, 2021, immediately after a hearing, the Court entered an order granting the Company’s Motion to Dismiss the Second Amended Class Action Complaint without prejudice. The Court indicated that the Second Amended Complaint was deficient in a number of ways and granted Plaintiffs until September 30 to amend the complaint to try to cure the deficiencies.

Financial Highlights for the Second Quarter and the 6 Months Ended June 30, 20211

Cash and Cash Equivalents as of June 30, 2021 were $125.5 million, compared to $196.4 million as of December 31, 2020 and $152.5 million as of March 31, 2021. The net decreases of respectively $27.0 million and $70.9 million for the quarter and six months ended June 30, 2021 were primarily due to cash used in operating activities and the effect of exchange rates on cash and cash equivalents. Excluding restructuring amounts paid of $6.3 million in the first half of 2021, the cash used in operating activities amounts to $(60.2) million under U.S. GAAP and $(57.8) million under IFRS, reflecting the Company’s continued implementation of budget discipline measures. Based on its current assumptions, DBV expects that its current cash and cash equivalents will support its operations until the second half of 2022.

Operating Income is primarily generated from DBV’s Research Tax Credit (French Crédit Impôt Recherche, or CIR) and from revenue recognized by DBV under its collaboration agreement with Nestlé Health Science. Operating income was $(1.5) million for the quarter ended June 30, 2021 and $1.5 million for the six months ended June 30, 2021, compared to $3.6 million and $8.3 million respectively for the three months ended and six months ended June 30, 2020. The decrease in operating income is primarily attributable to the revision of the revenue recognized under Nestlé’s collaboration agreement, as the Company updated its measurement of progress of its Phase II clinical study conducted as part of the contract due to recruitments’ delays.

Operating Expenses for the three months ended June 30, 2021, were $(29.6) million, compared to $(51.3) million for the three months ended June 30, 2020, each under U.S. GAAP. For the six months ended June 30, 2021, operating expenses were $(62.2) million under U.S. GAAP and $(62.0) million under IFRS, compared to $(97.2) million and $(96.9) million under U.S GAAP and IFRS, respectively, for the six months ended June 30, 2020. The decrease in operating expenses for both periods is mainly attributable to the decrease in external clinical-related expenses and professional fees due to the budget discipline measures taken by DBV, as well as the decrease in employee-related costs, which is directly related to the workforce reduction DBV implemented as part of its 2020 global restructuring plan.

Excluding share-based payments expenses, employee-related costs decreased by $9.7 million, from $23.1 million for the six months ended June 30, 2020 to $13.4 million for the six months ended June 30, 2021, a 42% decrease, compared to a 64% decrease of the average number of headcounts between the two periods (111 and 311 full-time equivalent employees for the six months ended June 30, 2021 and 2020 respectively). As of June 30, 2021, DBV had 97 employees.

Net loss was $(30.7) million for the three months ended June 30, 2021, compared to $(48.2) million for the three months ended June 30, 2020.

Net loss per share (based on the weighted average number of shares outstanding over the period) was $(0.56) and $(0.88) for the three months ended June 30, 2021 and 2020, respectively.

For the six months ended June 30, 2021, net loss was $(60.1) million and $(60.2) million under U.S. GAAP and IFRS, respectively. Net loss per share was $(1.09) under U.S. GAAP and $(1.10) IFRS.

DBV will host a conference call and live audio webcast on Monday, August 2, 2021, at 5:00 p.m. ET to report second quarter 2021 financial results and provide a corporate update.

This call is accessible via the below teleconferencing numbers, followed by the reference ID: 50184237.

A live webcast of the call will be available on the Investors & Media section of the Company’s website: View Source A replay of the presentation will also be available on DBV’s website after the event.

On August 2, 2021 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational conditionally activated antibody therapeutics based on its Probody technology platform, reported that Sean McCarthy, D.Phil., president, chief executive officer, and chairman, will participate in the following virtual investor conferences in August (Press release, CytomX Therapeutics, AUG 2, 2021, View Source [SID1234585531]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

BTIG 5th Virtual Biotechnology Conference
Date: Monday, August 9, 2021
Presentation Time: 1:00 p.m. ET.

2021 Wedbush PacGrow Healthcare Virtual Conference
Date: Tuesday, August 10, 2021
Panel Discussion: 1:10 p.m. ET

In addition, management will be available for one-on-one meetings with investors who are registered to attend the conferences.

On August 2, 2021 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported a business update and reported financial results for the second quarter ended June 30, 2021 (Press release, Corvus Pharmaceuticals, AUG 2, 2021, View Source [SID1234585530]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to advance mupadolimab, our anti-CD73 antibody, with a focus on HPV positive (human papilloma virus) head and neck cancer and other viral associated cancers," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We believe mupadolimab is well positioned to improve patient outcomes based on its dual mechanism of inhibiting immunosuppressive adenosine and enhancing antibody responses to viruses, which have been shown to cause certain cancers. This is based on the known B cell stimulating properties of mupadolimab and data we have generated in cancer and viral diseases such as COVID-19. We also continue to advance our other oncology programs, including with our Chinese partner, Angel Pharmaceuticals, who recently filed an IND in China to initiate Phase 1/2 clinical development of CPI-818 for the treatment of T cell lymphomas."

2021 Key Areas of Focus
The Company is efficiently advancing its clinical programs – mupadolimab, CPI-818 and ciforadenant – along with pre-clinical programs in its pipeline. The highlights from the Company’s clinical pipeline include:

Mupadolimab Expansion Clinical Trial for HPV+ Oropharyngeal Cancer

The Company began enrollment of a Phase1b/2 clinical trial in patients with HPV+ oropharyngeal cancers that have failed previous treatment with anti-PD-1 therapy and chemotherapy. Up to 15 patients will be enrolled in this clinical trial and will receive mupadolimab in combination with pembrolizumab. The endpoint of the clinical trial is response rate and results are anticipated by year end 2021. HPV is a transmissible DNA virus that causes approximately 75% of head and neck cancers. The incidence of this disease has been increasing in the United States and elsewhere.
Mupadolimab Focus on Viral Associated Cancers

The Company plans to evaluate mupadolimab in other viral associated tumors such as cancer of the cervix and head and neck cancers caused by Epstein Barr virus (EBV), which is a member of the herpes virus family and one of the most common human viruses.
In July 2021, the Company discontinued its Phase 3 clinical trial of mupadolimab in COVID-19 due to positive trends exhibited by COVID-19 vaccines in lowering serious infection and hospitalizations. The discontinuation was not related to any safety or efficacy issues observed in trial patients. As a result, the Company’s projected 2021 net cash used in operating activities decreased by an estimated $11 million.
CPI-818 Phase 2 Clinical Trial for T cell Lymphoma in Partnership with Angel Pharmaceuticals

Angel Pharmaceuticals has filed an investigational new drug application (IND) for CPI-818 with the Center for Drug Evaluation (CDE) in China. If approved, Angel plans to initiate a Phase 2 clinical trial of CPI-818 for the treatment of refractory T cell lymphomas in late 2021, with the potential to expand into autoimmune diseases over time.
Ciforadenant Phase 2 Clinical Trial for Front Line RCC

Corvus is a leader in the development of precisely targeted therapies targeting the adenosine pathway. Ciforadenant is small molecule antagonist of the adenosine A2A receptor. It is designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. The Company also discovered the Adenosine Gene Signature, which has demonstrated the potential to serve as a biomarker to identify patients most likely to respond to treatment with ciforadenant.
The Company plans to collaborate with the Kidney Cancer Consortium to initiate a Phase 2 clinical trial of ciforadenant in first-line therapy for metastatic renal cell cancer (RCC) in combination with pembrolizumab and a tyrosine kinase inhibitor. The clinical trial is expected to enroll up to 60 patients and is intended to increase complete responses and deep responses in the front-line setting. Preclinical studies and data from earlier clinical trials with ciforadenant indicate adenosine may be a cause of resistance to current therapies with anti-PD(L)-1 and tyrosine kinase inhibitors. Tumor biopsies will be evaluated for expression of the Adenosine Gene Signature.
Financial Results

As of June 30, 2021, Corvus had cash, cash equivalents and marketable securities totaling $66.5 million. This compared to cash, cash equivalents and marketable securities of $44.3 million as of December 31, 2020. The increase in cash of $22.2 million resulted from the receipt of approximately $43.8 million in net proceeds from the sale of common stock through an underwritten offering and the Company’s at the market equity offering program, and was reduced by $21.4 million of cash used in operating activities in the six months ended June 30, 2021. With the discontinuation of the mupadolimab Phase 3 clinical trial in COVID-19, Corvus now expects full year 2021 net cash used in operating activities to be between $35 million and $37 million, a decrease of an estimated $11 million compared to the previously expected range of $46 million and $48 million and resulting in a projected balance of cash, cash equivalents and marketable securities of between $51.1 million to $53.1 million at December 31, 2021.

Research and development expenses for the three months ended June 30, 2021 totaled $9.1 million compared to $7.9 million for the same period in 2020. The increase of $1.2 million was primarily due to an increase in clinical trial costs for the Company’s mupadolimab Phase 3 COVID-19 clinical trial, which was partially offset by lower clinical trial costs for CPI-818 and ciforadenant.

The net loss for the three months ended June 30, 2021 was $11.8 million compared to a net loss of $10.6 million for the same period in 2020. Total stock compensation expense for the three months ended June 30, 2021 was $1.2 million compared to $1.4 million for the same period in 2020.

On August 2, 2021 Cardinal Health (NYSE: CAH) and Hellman & Friedman (H&F) reported the completion of the previously announced sale of Cardinal Health’s Cordis business to H&F (Press release, Cardinal Health, AUG 2, 2021, View Source;Friedman/default.aspx [SID1234585529]). The sale price of approximately $1 billion includes the buyer’s assumption of certain liabilities and the seller’s retention of certain working capital accounts.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide.

"We appreciate H&F’s partnership throughout the transaction, and we are excited about Cordis’s future under H&F’s ownership," said Mike Kaufmann, CEO of Cardinal Health. "As we shared previously, this divestiture demonstrates our disciplined portfolio evaluation approach, and we remain committed to investing in our strategic growth areas."

"We are thrilled to begin this next chapter for Cordis and value the partnership with Cardinal Health through the transition," said Shar Matin, CEO of Cordis. "We believe that an independent Cordis company, combined with an innovative approach to bring differentiated products to market, will allow us to create incremental value for teammates, customers and investors."

Cardinal Health plans to release its fourth-quarter and year-end financial results for its fiscal year 2021 on August 5 prior to the opening of trading on the New York Stock Exchange. The company will webcast a discussion of these results beginning at 8:30 a.m. Eastern.

On August 2, 2021 Celgene Corporation, now a wholly owned subsidiary of Bristol Myers Squibb, reported that it received accelerated approval by the U.S. Food & Drug Administration (FDA) for Istodax (romidepsin), a histone deacetylase (HDAC) inhibitor, as monotherapy for the treatment of peripheral T-cell lymphoma (PTCL) in adult patients who have received at least one prior therapy (Press release, Bristol-Myers Squibb, AUG 2, 2021, View Source [SID1234585528]). This accelerated approval was based upon results from two clinical studies, assessing the effect of Istodax on the surrogate endpoint of overall response rate. Bristol Myers Squibb conducted a subsequent confirmatory Phase 3 study evaluating romidepsin plus CHOP (Ro-CHOP) versus CHOP in first-line PTCL patients, but the trial did not meet the primary efficacy endpoint of progression free survival.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Based on this outcome, Bristol Myers Squibb made the decision to withdraw the PTCL indication from the U.S. market. The company took this action in accordance with the FDA’s requirements for evaluating accelerated approvals that have not demonstrated sufficient clinical benefit.

Bristol Myers Squibb is notifying healthcare professionals about the withdrawal. Istodax remains on the market for treatment of patients with cutaneous T-cell lymphoma (CTCL) who have received at least one prior systemic therapy. Patients who are being treated with Istodax for PTCL should consult with their healthcare provider in all aspects of their medical care and may remain on treatment if deemed clinically appropriate by the treating physician. For patients who are currently being treated with Istodax for PTCL, and who have questions about access and reimbursement support, please contact BMS Access Support at 1-800-861-0048 or visit www.bmsaccesssupport.com.

"While the outcome of the confirmatory study in peripheral T-cell lymphoma is disappointing, Bristol Myers Squibb will continue to provide Istodax for patients with cutaneous T-cell lymphoma, where it remains an approved and important treatment option," said Noah Berkowitz, M.D., Ph.D., senior vice president, Hematology Development, Bristol Myers Squibb. "As always, our efforts across blood cancer research and development remain centered on delivering better outcomes for patients in need."

Since the initial approval of Istodax, nearly a decade ago, more options have been made available for patients, many of which have redefined treatment across PTCL and other hematologic conditions.

Bristol Myers Squibb continues to evaluate the potential of its therapies for people with blood cancers and disorders who may benefit, while pursuing the next breakthroughs for patients.

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

About Istodax

Istodax (romidepsin) for injection is an epigenetic therapy and a member of a class of cancer drugs known as histone deacetylase (HDAC) inhibitors. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. HDACs also deacetylate non-histone proteins, such as transcription factors. In vitro, Istodax causes the accumulation of acetylated histones, and induces cell cycle arrest and apoptosis of some cancer cell lines. The mechanism of the antineoplastic effect of romidepsin observed in nonclinical and clinical studies has not been fully characterized. For full prescribing information, visit www.ISTODAX.com.

Indication

ISTODAX (romidepsin) for injection is indicated for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

This indication is based on response rate. Clinical benefit such as improvement in overall survival has not been demonstrated.

Important Safety Information

WARNINGS AND PRECAUTIONS

Myelosuppression: ISTODAX (romidepsin) for injection can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia; monitor blood counts regularly during treatment with ISTODAX; interrupt and/or modify the dose as necessary
Infections: fatal and serious infections, including pneumonia, sepsis and viral reactivation, including reactivation of Epstein Barr and hepatitis B viruses, have been reported during and after treatment with ISTODAX in clinical trials. The risk of life-threatening infections may be greater in patients with a history of prior treatment with monoclonal antibodies directed against lymphocyte antigens and in patients with disease involvement of the bone marrow. Reactivation of hepatitis B virus infection was reported in 1% of patients in clinical trials. Reactivation of Epstein Barr viral infection leading to liver failure has occurred, including after ganciclovir prophylaxis. Consider monitoring for reactivation and antiviral prophylaxis in patients with evidence of prior hepatitis B infection.
Electrocardiographic (ECG) changes: ECG changes have been observed with ISTODAX. In patients with congenital long QT syndrome, patients with a history taking anti-arrhythmic medicines or medicinal products that lead to significant QT prolongation, consider cardiovascular monitoring of ECGs at baseline and periodically during treatment. Confirm that potassium and magnesium levels are within the normal range before administration of ISODAX
Tumor lysis syndrome (TLS): TLS has been reported during treatment with ISTODAX. Patients with advanced stage disease and/or high tumor burden are at greater risk and should be closely monitored and managed as appropriate
Embryo-fetal toxicity: ISTODAX can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS

Cutaneous T-Cell Lymphoma

The most common adverse reactions (≥30%), excluding laboratory abnormalities, are nausea, fatigue, infections, vomiting, anorexia, electrocardiogram ST-T wave changes, dysgeusia, constipation and pruritis. Grade 3‐4 laboratory abnormalities (≥10%) include lymphopenia, neutropenia, anemia and thrombocytopenia.

DRUG INTERACTIONS

Monitor more frequently prothrombin time and international Normalized Ratio in patients concurrently administered ISTODAX and warfarin or coumarin derivatives
Romidepsin is metabolized by CYP3A4
>> Monitor patients for toxicity related to increased romidepsin exposure and follow dose modifications for toxicity when ISTODAX is initially co-administered with strong CYP3A4 inhibitors

>> Avoid co-administration of ISTODAX (romidepsin) with rifampin and other potent inducers of CYP3A4

Exercise caution with concomitant use of ISTODAX and P-glycoprotein (P-gp, ABCB1) inhibitors
USE IN SPECIFIC POPULATIONS

Pregnancy Category D:If this drug is used during pregnancy, of if the patient becomes pregnant while taking ISTODAX, the patient should be apprised of the potential hazard to the fetus
Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ISTODAX, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother
Patients with moderate and sever hepatic impairment and/or patients with the end-stage renal disease should be treated with caution