On August 4, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will host a conference call and webcast on Wednesday, August 11, 2021 at 5:00 p.m. (EDT) to discuss financial results and corporate developments for the second quarter ended June 30, 2021 (Press release, Navidea Biopharmaceuticals, AUG 4, 2021, View Source [SID1234585729]).

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Jed Latkin, Chief Executive Officer, Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

To participate in the call and webcast, please refer to the information below:

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On August 4, 2021 Strand Therapeutics, a privately held developer of next-generation, programmable mRNA therapeutics for cancer immunotherapy and other diseases, reported that the company was awarded two Phase I Small Business Innovation Research (SBIR) grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) to develop mRNA-based therapeutics for melanoma and triple negative breast cancer (TNBC) (Press release, Strand Therapeutics, AUG 4, 2021, View Source [SID1234585745]). The total funding amount awarded to Strand is approximately $800,000.

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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

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While there have been advances in the development of treatment options for melanoma, the number of diagnoses continues to increase. Furthermore, standard of care using anti-PD-1 immunotherapy has been limited with not all patients responding to the therapy. To address this need, the first award granted to Strand will support the development of programmable mRNA circuits that express cytokines which regulate the activation of immune cells, to stimulate an adaptive immune response as a neoadjuvant therapy for melanoma.

TNBC is an aggressive form of breast cancer, accounting for 10-15% of all cases, and is another cancer indication in need of more targeted and effective medicines. Patients have a poor prognosis with limited treatment options. While checkpoint inhibitor therapies including anti-PD-1 antibodies have improved outcomes in patients, only a small percentage respond to this treatment strategy. The second award will allow Strand to engineer synthetic self-replicating mRNA therapies expressing locally-acting cytokines with the goal of improving anti-PD-1 therapy responses.

"It is well known that cytokines can be utilized to achieve an anti-tumor effect in cancer patients. However, treatment strategies that involve cytokines can be highly toxic, and therefore, its efficacy can be limited. To that end, we can use our programmable, self-replicating mRNA therapeutic platform to localize cytokine expression that will potentially enable more precise and longer-lasting anti-cancer immune responses," said Jake Becraft, PhD, co-founder and CEO of Strand. "This generous support from NIH’s NCI will enable us to create synthetic mRNA-based therapeutics that can be safer and more effective than currently available treatment options for both melanoma and breast cancer patients."

On August 4, 2021 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, reported that the first patient has been screened in a new phase III trial that uses its personalized, tumor-informed molecular residual disease (MRD) test, Signatera, to identify early-stage breast cancer patients eligible for investigational treatment with GSK’s PARP inhibitor niraparib (ZEJULA) (Press release, Natera, AUG 4, 2021, View Source [SID1234585787]).

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The ZEST study, sponsored by GSK, is a randomized, multicenter, phase III, placebo-controlled clinical trial to evaluate the efficacy and safety of treatment with niraparib following surgery or completion of adjuvant therapy in 800 patients with either triple-negative breast cancer or HR-positive/HER2-negative, BRCA-mutated breast cancer. After definitive upfront treatment, serial testing with Signatera will be used to identify patients who have detectable MRD to evaluate therapy with niraparib versus placebo in a setting where relapse is detected early ahead of radiologically defined disease progression.

"We are delighted to partner with GSK, a leader in oncology drug development, to help bring personalized medicine to patients with early-stage breast cancer," said Solomon Moshkevich, general manager of oncology at Natera. "Our vision is that early-stage breast cancer patients will be monitored regularly using Signatera, with access to effective treatment upon the detection of molecular recurrence."

This is the second phase III registrational trial to incorporate Signatera as a companion diagnostic. Signatera has been designated as a Breakthrough Device by the FDA for three different clinical indications, including one designation for the early-stage breast cancer intended use being evaluated in the ZEST trial.

About Signatera
Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes Signatera’s accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions.

Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

On August 4, 2021 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported financial results for the second quarter of 2021, and associated Company developments (Press release, Supernus, AUG 4, 2021, View Source [SID1234585714]).

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"The approval and commercial launch of Qelbree for pediatric patients with ADHD mark an important milestone for children and families searching for new treatment options for ADHD," said Jack Khattar, President and CEO of Supernus Pharmaceuticals. "As a non-controlled substance that has a unique profile of proven efficacy, safety and tolerability, Qelbree provides patients living with ADHD a novel treatment option like no other ADHD medication."

Net Product Sales

Second quarter 2021 net product sales were $138.6 million, 12% higher than the same period in 2020.

(1) Net product sales of APOKYN, MYOBLOC and XADAGO from June 9, 2020 to June 30, 2020.

Qelbree Launch Update

At the end of May 2021, Supernus launched Qelbree for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age. Net product sales for the second quarter of 2021 were $0.3 million.
The early performance of Qelbree is on track with our expectations. Current trends in prescriptions reflect the heavy sampling programs with patients. Over 25,000 starter kits have been distributed to physicians since the launch and in preparation for the back-to-school season.
Early clinical feedback about the performance of Qelbree in patients is positive and in line with the Phase III clinical results.
Product Pipeline Update

Qelbree (viloxazine, extended-release capsules) – Novel non-stimulant for the treatment of ADHD in adults

The Company recently submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Qelbree for adult patients with ADHD.
SPN-830 (apomorphine infusion pump) – Continuous treatment of motor fluctuations ("on-off" episodes) in Parkinson’s disease (PD)

The Company continues to plan to resubmit the SPN-830 NDA in the second half of 2021.
SPN-820 – Novel first-in-class activator of mTORC1

A randomized Phase II clinical study of SPN-820 in treatment-resistant depression is expected to start by the end of 2021.
Financial Highlights

Second quarter 2021 operating earnings were $34.1 million, as compared to $45.5 million in the second quarter of 2020. Operating earnings for the second quarter of 2021 included amortization of intangible assets expense of $5.9 million, compared to $2.4 million in the second quarter of 2020.

Second quarter 2021 net earnings and diluted earnings per share were $23.7 million and $0.43, respectively, as compared to $34.7 million, or $0.65 per diluted share, in the same period last year.

As of June 30, 2021, the Company had $855.3 million in cash, cash equivalents, current and long-term marketable securities, compared to $772.9 million as of December 31, 2020.

Full Year 2021 Financial Guidance

For full year 2021, the Company reiterates its prior financial guidance including an increase to the lower end of its operating earnings guidance as set forth below:

(1) Total revenues include net product sales and royalty revenue. Includes $10 million for Qelbree net product sales.
(2) Combined research and development and selling, general and administrative expenses.
(3) Operating earnings include amortization of intangible assets and contingent consideration expense (gain). Reflects an increase from the original guidance of $65 – $90 million.
(4) The full year 2021 effective tax rate guidance of 28% – 31% is above the normally expected range of 26% – 28% due to the effect of discrete tax items in the period.

Conference Call Details

The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer and Jim Kelly, Executive Vice President and Chief Financial Officer, to discuss these results at 4:30 p.m. Eastern Time, today, August 4, 2021.

Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call.

Following the live call, a replay will be available on the Company’s website, www.supernus.com, under "Investor Relations".

On August 4, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will host a conference call and webcast on Wednesday, August 11, 2021 at 5:00 p.m. (EDT) to discuss financial results and corporate developments for the second quarter ended June 30, 2021 (Press release, Navidea Biopharmaceuticals, AUG 4, 2021, View Source [SID1234585730]).

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!

Jed Latkin, Chief Executive Officer, Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

To participate in the call and webcast, please refer to the information below:

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.