On August 3, 2021 Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, reported financial results for the second quarter ended June 30, 2021 (Press release, Pain Therapeutics, AUG 3, 2021, View Source [SID1234585595]). Net loss for the second quarter ended June 30, 2021, was $5.1 million, or $0.13 per share, compared to a net loss of $1.1 million, or $0.05 per share, for the same period in 2020. Net cash used in operations was $7.4 million during the first six months of 2021. Net cash use for operations for full-year 2021 is expected to be approximately $20 to $25 million, consistent with previous financial guidance. Cash and cash equivalents were $278.3 million as of June 30, 2021, with no debt.

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Remi Barbier, President & CEO, and Eric Schoen, Chief Financial Officer, will host a conference call to review financial results and to preview the Company’s growth strategy.

The conference call is scheduled to begin at 9:00 am ET on Tuesday, August 3, 2021. Please dial in 15 minutes in advance to ensure a timely connection to the call.

Financial Highlights for Second Quarter 2021

At June 30, 2021, cash and cash equivalents were $278.3 million, compared to $93.5 million at December 31, 2020, with no debt.

Net cash used in operations during the six months ended June 30, 2021 was $7.4 million, net of reimbursements received from the National Institutes of Health (NIH) grant awards.

Research grant funding reimbursements of $0.9 million were received from NIH and recorded as a reduction in research and development (R&D) expenses. This compared to $1.1 million of NIH grant receipts received for the same period in 2020.

Net cash use for operations for full year 2021 is expected to be approximately $20 to $25 million. Net cash use in 2021 is expected to be driven by higher headcount and personnel expenses, manufacturing costs around large-scale drug supply, professional services expenses related to clinical programs, and operating costs such as insurance, office space and IT related expenses.

R&D expenses were $3.9 million compared to $0.6 million for the same period in 2020. This increase was due primarily to costs related to manufacture of clinical trial supplies in anticipation of launching a Phase 3 clinical program in simufilam, costs of an on-going open-label study in simufilam, as well as increased personnel expenses.

General and administrative (G&A) expenses were $1.2 million compared to $0.8 million for the same period in 2020. This increase was due primarily to higher annual shareholder meeting and insurance costs compared to the prior year.
About Simufilam
Simufilam is a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA), a scaffolding protein, in the brain. Altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. The underlying science for simufilam is published in peer-reviewed journals, including Journal of Neuroscience, Neurobiology of Aging, Journal of Biological Chemistry, Neuroimmunology and Neuroinflammation and Journal of Prevention of Alzheimer’s Disease. Cassava Sciences is also developing an investigational diagnostic, called SavaDx, to detect Alzheimer’s disease with a simple blood test. Simufilam and SavaDx were both developed in-house. Both product candidates are substantially funded by peer-review research grant awards from the National Institutes of Health (NIH).

Cassava Sciences owns worldwide development and commercial rights to its research programs in Alzheimer’s disease, and related technologies, without royalty obligations to any third party.

About Alzheimer’s Disease
Alzheimer’s disease is a progressive brain disorder that destroys memory and thinking skills. As of 2020, there were approximately 50 million people worldwide living with dementia, a figure expected to increase to 150 million by 2050.1 The annual global cost of dementia is now above $1 trillion, according to Alzheimer’s Disease International, a charitable organization.

On August 3, 2021 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported financial results for the second quarter 2021 (Press release, Alector, AUG 3, 2021, View Source [SID1234585611]). As of June 30, 2021, Alector’s cash, cash equivalents and investments totaled $319.6 million.

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"With the recent presentation of encouraging Phase 2 data for our lead program, AL001 in people with FTD-GRN, at the Alzheimer’s Association International Conference and our announcement of a significant collaboration with GlaxoSmithKline to expand and accelerate the development of AL001 and AL101, we move much closer to realizing the vast potential of our progranulin franchise programs," said Arnon Rosenthal, Ph.D., co-founder and chief executive officer of Alector. "Our earlier-stage pipeline is also steadily progressing and based on our immuno-neurology expertise and insights into human genetics, we continue working to advance new programs to the clinic, all with the aim of halting the degeneration associated with serious neurological disease."

Clinical and Corporate Updates

Progranulin Franchise Portfolio

Twelve-month data from up to twelve patients with frontotemporal dementia with a progranulin mutation (FTD-GRN) from the open-label INFRONT-2 Phase 2 clinical trial of AL001 were presented at the 2021 Alzheimer’s Association International Conference (AAIC).
Once monthly treatment with 60mg/kg of AL001 was shown to have a favorable safety profile and resulted in sustained elevation of progranulin to normal levels for greater than one year.
Clinical outcome assessments of AL001-treated patients showed slowing of clinical progression by 47% compared to a matched control cohort of participants from the Genetic FTD Initiative (GENFI2). Additionally, multiple disease-relevant biomarkers of lysosomal function, complement activation and neuronal health trended toward normalization or remained stable, suggesting that treatment with AL001 may slow disease progression. (1)

Alector and GlaxoSmithKline (GSK) entered into a global collaboration to co-develop and co-commercialize AL001 and AL101 for the treatment of neurodegenerative diseases, including FTD-GRN, as well as other forms of frontotemporal dementia, amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease.
The collaboration brings together Alector’s leading immuno-neurology expertise with GSK’s commitment to immunology and human genetics, proven drug development capabilities and global footprint, to help expand and accelerate the development of AL001 and AL101 into large indications.
Under the terms of the agreement, Alector will receive $700 million in upfront payments. Alector will also be eligible for up to $1.5 billion in potential development, regulatory and commercial launch milestone payments, as well as profit-sharing in the U.S. and royalties on any ex-U.S. sales.

Alector is actively enrolling the Phase 3 INFRONT-3 pivotal clinical study of AL001 in at-risk and symptomatic carriers of frontotemporal dementia with a progranulin mutation. An ongoing Phase 2 study in frontotemporal dementia includes a cohort of patients with a C9orf72 mutation, and there are plans to begin testing AL001 in amyotrophic lateral sclerosis (ALS) patients with a C9orf72 mutation in the second half of 2021. AL101, Alector’s second progranulin-elevating monoclonal antibody, is designed to treat people suffering from more prevalent neurodegenerative diseases and is currently in a Phase 1a study in healthy volunteers.
Alzheimer’s Disease Portfolio

Two posters were presented at the 2021 AAIC for Alector’s AL002 program targeting TREM2. TREM2 loss of function is associated with a three-fold increase in the risk of developing Alzheimer’s disease (2). AL002 is Alector’s first-in-class anti-TREM2 monoclonal antibody that is being developed in collaboration with AbbVie in a global Phase 2 study.
The first poster detailed results of the AL002 Phase 1 study in healthy volunteers. AL002 was generally well tolerated and demonstrated dose-dependent and robust target engagement in the brain.
A second poster reviewed the study design of the ongoing Phase 2 INVOKE-2 trial in people with early Alzheimer’s disease. The global, multi-center, double-blind Phase 2 clinical trial is enrolling approximately 265 patients randomized to receive AL002 or placebo. The study is designed to investigate the efficacy and safety of AL002 for the treatment of Alzheimer’s disease.
Data from the Phase 1b study evaluating AL003 in participants with Alzheimer’s disease is expected in the second half of 2021. The AL003 clinical development program is being developed in collaboration with AbbVie.
Second Quarter 2021 Financial Results

Revenue. Collaboration revenue for the quarter ended June 30, 2021, was $6.6 million, compared to $3.2 million for the same period in 2020. Revenue is recognized as the program costs are incurred by measuring actual costs incurred to date compared to the overall total expected costs to satisfy the performance obligation. Changes in estimates for revenue recognized over time are recognized on a cumulative basis.

R&D Expenses. Total research and development expenses for the quarter ended June 30, 2021, were $47.8 million, compared to $34.1 million for the same period in 2020. This change was mainly driven by an increase in expenses to support advancement of several clinical and preclinical programs, as well as in increase in personnel-related expenses

G&A Expenses. Total general and administrative expenses for the quarter ended June 30, 2021, were $14.1 million, compared to $15.7 million for the same period in 2020. This decrease was primarily due to reduced legal fees associated with the conclusion of our arbitration proceedings for certain intellectual property matters.

Net Loss. For the quarter ended June 30, 2021, Alector reported a net loss of $55.1 million, compared to a net loss of $45.3 million for the same period in 2020.

Cash Position. Cash, cash equivalents, and marketable securities were $319.6 million as of June 30, 2021.

Updated Cash guidance. Based on the company’s cash position as of the end of the second quarter, combined with the anticipated net proceeds expected from the GSK collaboration beginning in the third quarter of 2021, Alector anticipates sufficient cash to fund currently planned operations into mid-2024.

On August 3, 2021 4SC AG (4SC, FSE Prime Standard: VSC) reported that it will publish its half-year report 2021 on 10 August 2021 (Press release, 4SC, AUG 3, 2021, View Source [SID1234585626]). On this day, the Management of 4SC AG will host a conference call at 2 pm CEDT (8 am EDT) to inform about important developments in the reporting period and beyond.

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Investors, financial analysts, and journalists interested in participating in the conference call can access via the telephone numbers stated below. Please join the event conference 5-10 minutes prior to the start time. You will be asked to provide the confirmation code.

On August 3, 2021 NantHealth, Inc. (NASDAQ: NH), a provider of enterprise solutions that help businesses transform complex data into actionable insights, reported the appointment of Tiffany Avery, MD, MPH, as Chief Medical Officer (Press release, NantHealth, AUG 3, 2021, View Source [SID1234585643]). In her new position, Dr. Avery will be responsible for providing clinical strategic direction and guiding the development and deployment of NantHealth’s Eviti decision support platform and other innovative products and services.

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"Appointing Dr. Avery to our leadership team is an incredibly valuable addition to the organization, particularly as we expand into areas like population health and additional disease states for Eviti," said Ron Louks, Chief Operating Officer, NantHealth. "With her background in medical oncology, epidemiology, and cancer and health disparities, Dr. Avery will play a key role in helping NantHealth to deliver valuable, equitable care and improved outcomes to the patients and populations we serve."

Dr. Avery joined NantHealth in January of 2019 as Medical Director of Oncology. Prior to her role at NantHealth, she served as an Assistant Professor of Oncology at Thomas Jefferson University and Wake Forest Baptist Health. After completing fellowship training at The University of Texas MD Anderson Cancer Center in Houston, Texas, Dr. Avery focused and lectured on clinical research and the care of breast cancer patients. In the community, Dr. Avery is a recognized expert and invited speaker on topics including cancer prevention, treatments, clinical trials, and survival disparities. Over the course of her career, Dr. Avery has produced peer-reviewed publications, conference abstracts, editorials, and served as an investigator on numerous breast cancer clinical trials.

"I’m excited to be a part of NantHealth to reach our collective goal of improving health outcomes and providing value-based, quality healthcare," said Dr. Avery. "As an advocate for equitable care, in cancer but certainly in all of healthcare, not only does it make financial sense to all stakeholders, but it’s absolutely the right thing to do. Our technology helps deliver on that mission, and I’m honored to help guide us on this journey."

Dr. Avery earned her BS and MPH in Epidemiology from Tulane University, and MD from LSU Health Sciences Center New Orleans. She completed fellowship training in Hematology and Medical Oncology at MD Anderson Cancer Center. Dr. Avery recently earned certification in Lifestyle Medicine and is a co-host of 3 Black Docs, a podcast aimed at addressing health and cancer disparities.

On August 3, 2021 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) reported that it will release second quarter 2021 financial results and provide a Company update after the market closes on Tuesday, August 10, 2021 (Press release, Cumberland Pharmaceuticals, AUG 3, 2021, View Source [SID1234585660]). A conference call and live internet webcast will be held on Tuesday, August 10, 2021, at 4:30 p.m. Eastern Time to discuss the results.

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To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 3985462. The live webcast and rebroadcast can be accessed via Cumberland’s website at View Source

Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the delivery of branded prescription products to improve patient care. The Company develops, acquires and commercializes brands for the hospital acute care, gastroenterology and rheumatoid arthritis markets.

The Company’s portfolio of FDA-approved brands includes:

Acetadote (acetylcysteine) Injection, for the treatment of acetaminophen poisoning;
Caldolor (ibuprofen) Injection, for the treatment of pain and fever;
Kristalose (lactulose) for Oral Solution, a prescription laxative, for the treatment of constipation;
Omeclamox-Pak, (omeprazole, clarithromycin, amoxicillin) for the treatment of Helicobacter pylori (H. pylori) infection and related duodenal ulcer disease;
RediTrex (methotrexate) Injection, for the treatment of active rheumatoid, juvenile idiopathic and severe psoriatic arthritis, as well as disabling psoriasis;
Vaprisol (conivaptan) Injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and
Vibativ (telavancin) Injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections.
The Company also has Phase II clinical programs underway evaluating its product candidates in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy ("DMD"), Systemic Sclerosis ("SSc"), and Aspirin-Exacerbated Respiratory Disease ("AERD").

For more information on Cumberland’s approved products, including full prescribing information, please visit links to the individual product websites, which can be found on the Company’s website www.cumberlandpharma.com.