On December 9, 2020 Biochain reported that There have been tremendous advances in cancer treatment since President Richard Nixon declared war on malignancies in 1971 (Press release, Biochain, DEC 9, 2020, View Source [SID1234572520]). Despite having treatments such as targeted radiation, estrogen blockers, and CAR-T cell immunotherapies, early detection of cancer remains one of the most important factors. For instance, the five-year relative survival rate for non-small cell lung cancer is 61% when cancer has not yet spread outside the lung. The survival rate drops to 35% once the cancer invades nearby structures, and to 6% once it metastasizes to other organ systems.

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!

However, early detection of cancer has proven easier said than done, and not without risks. When screening for cancer certain number of patients experience anxiety and undergo unnecessary invasive procedures based on false positives. While some cancers make for relatively easy screening such as cervical cancer via the Pap test, many cancers are inaccessible, and tissue biopsy too invasive for population-level screenings.

The oncologist’s objective is to come up with a less invasive way of screening the healthy population for specific and accurate indications of early-stage cancer. This motivated scientists to develop "liquid biopsy," where doctors hope to detect tumor-specific protein biomarkers or cancer-associated genetic mutations in circulating free DNA (cfDNA) blood samples.

In an article published in the journal Science, Johns Hopkins researchers Bert Vogelstein and Nickolas Papadopoulos and their colleagues appear to have done exactly that.

A leap in early cancer detection

A breakthrough was achieved using a liquid biopsy test called "DETECT-A" ̶̶ Detecting cancers Earlier Through Elective mutation-based blood Collection and Testing ̶ which involved more than 9,911 women who had no history of cancer. The study used a multi-cancer blood test, to identify 26 undiagnosed cancers in 10 different organ systems: appendix, breast, colorectal, kidney, lung, lymphomas, ovary, thyroid, uterine and unknown primary site. The tumors were then localized using techniques such as PET-CT, a combination that was 99.6% specific.

Importantly, 17 of the cancers detected by the blood test were diagnosed at an early stage. Twelve of the 26 patients were in remission and eight were still in treatment or had stable disease nine months post-diagnosis.

This was a landmark result for the liquid biopsy field and the industry took note. A more advanced version of the multi-cancer blood test known as CancerSEEK had been licensed by Johns Hopkins to Thrive Earlier Detection Corp for development. On Oct. 27, Exact Sciences announced it would acquire Thrive for $2.15 billion.

Foundational technology

Although much of the liquid biopsy breakthrough has come from next-generation sequencing (NGS) and machine learning, the fundamentals of the field are still focused on an accurate and successful sampling process. If there is no adequate sample in the first place, no algorithm can support it. The DETECT-A study made use of the cfPure extraction kit from BioChain, a magnetic bead-based technology that demonstrated high yields in extracting cfDNA from blood plasma. "In order to get that cfDNA, you need to have the right tools," says BioChain’s Production and R&D Manager Dr. Franklin Chin, "and we have them. Our extraction kit is the first step in any research that involves cfDNA biomarker discovery"

The cfPure kits are available from BioChain in three different sizes for the extraction of a maximum of 250 ml of cfDNA from human plasma samples. The kit has two different versions: the original cfPure kit which maximizes yield, and the "V2," which minimizes carryover of genomic DNA into the final elution.

Dr. Bert Vogelstein and his colleagues used the original version of cfPure kits, and the fact that such pioneering researchers used BioChain’s technology in a groundbreaking study to process tens of thousands of samples is a source of pride for BioChain. "Dr. Vogelstein is one of the pioneers of liquid biopsy research," Chin says, "that he is using our kit is pretty big for us."

Detection of early-stage cancer using the DETECT-A test is just the first of many breakthroughs BioChain hopes their technology will enable. Beyond early diagnosis, for instance, there are efforts at precision tumor treatment and companion diagnostics, according to Chin. Many cancers are drug-resistant, and that resistance is based on their mutational profile. Pairing the cfPure kit with NGS using specific biomarker panels can help identify the mutational landscape for a patient, indicating the therapies best suited to treating their specific cancer.

Chin also hopes to see BioChain’s technology used in the creation of biomarker panels to help identify mutations with a strong correlation to oncogenesis. "You need to have a solid foundation," he says. "You need to collect as many samples as possible, analyze them, and come up with a panel of biomarkers." That will expand the reach and accuracy of liquid biopsy, and, ultimately, the success of cancer treatments. That’s something Chin and BioChain are excited to be a part of.

A menu of research solutions

Whatever your research needs, BioChain offers a cfPure cell-free DNA extraction kit providing market-leading yields for the best possible input for NGS or other processing.

BioChain also offers blood plasma and tissue samples for researchers who need inputs to develop and test their technologies and offers the cfPure cell-free DNA extraction process as a service for those who cannot perform the extractions themselves.

On December 9, 2020 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that data from the FOCUS trial that show the clinical utility of MammaPrint in older breast cancer patients at the 2020 San Antonio Breast Cancer Symposium (SABCS 2020) (Press release, Agendia, DEC 9, 2020, View Source [SID1234572539]).

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!

The poster, The 70-gene signature (MammaPrint) accurately predicts distant breast cancer recurrence risk in older patients, outlines data from the FOCUS trial, a population-based cohort of over 2,000 people that included all consecutive breast cancer patients over 65 years old diagnosed between 1997 and 2004 in the Comprehensive Cancer Center region West, the Netherlands. The purpose of the study was to assess the stratification of breast cancers by MammaPrint in women over 70 years of age.

Treating older breast cancer patients can be challenging, as they generally have more indolent tumors and a higher likelihood of developing additional conditions that negatively affect their health than younger patients. Current treatment guidelines recommend therapy for these patients based on clinicopathological risk, but these factors are insufficient for accurate determination of prognosis. MammaPrint has been shown to accurately predict recurrence in younger women with breast cancer, and for this study, the 70-gene signature was assessed in women 70 years and older with breast cancer. MammaPrint was found to accurately stratify patients according to their 10-year distant recurrence free interval, as previously demonstrated in younger populations.

Further, the results in the poster show that even clinically high risk patients who were classified as MammaPrint UltraLow Risk – meaning they can have excellent survival without chemotherapy and only limited or no tamoxifen treatment – did not develop any recurrent disease 10 years after diagnosis, opening up treatment options and considerations for doctors and their patients, allowing them to make more informed decisions about the path ahead.

"These data show the importance of knowing everything you can about a cancer, especially when you are working with older patients who may be more fragile or susceptible to harsh treatment," said Dr. Gerrit-Jan Liefers, Surgeon, Head of the Department of Surgical Oncology of Leiden University Medical Center and the principal investigator of the FOCUS study. "We see genomically low risk patients do very well long-term, which gives us confidence to de-escalate their treatment to something more tolerable and achieve the same success, even if they are clinically high risk. We are pleased to make these data available to the breast cancer community and show the importance of research in all types of breast cancer patients."

For post-menopausal women who are identified as MammaPrint UltraLow Risk, these results have meaningful implications for their treatment paths.

"This analysis of the FOCUS cohort adds to the growing body of data demonstrating the validity of MammaPrint’s UltraLow Risk threshold," said Laura Esserman, M.D., Director of the UCSF Carol Franc Buck Breast Care Center, and winner of this year’s Brinker award for Scientific Distinction in Clinical Research. "The data confirm our findings from the STO-3 Trial, as well as data from the IKA tamoxifen trial cohort presented at ESMO (Free ESMO Whitepaper) earlier this year for node negative hormone positive breast cancer patients. These data should give confidence to patients and their physicians that the UltraLow molecular signature is associated with excellent prognosis even without extended endocrine therapy. De-escalation based on biologic features can be used to reduce the length of treatment, providing more precise treatment. Most important, the UltraLow signature can be used to substantially reduce the burden of treatment in those destined not to benefit. And certainly this can make a huge difference in the quality of life and the anxiety experience over the diagnosis."

These data are part of a large suite of 13 posters, spotlight sessions and an oral presentation on MammaPrint and BluePrint that were accepted to SABCS 2020, and underscore Agendia’s mission to help guide the diagnosis and personalized treatment of breast cancer for all patients throughout their treatment journey.

On December 9, 2020 Bolt Biotherapeutics, a clinical-stage immuno-oncology company developing tumor-targeted therapies that leverage the power of the innate and adaptive immune systems, reported the presentation of a poster detailing the design of its ongoing Phase 1/2 clinical trial for BDC-1001 in patients with HER2-expressing solid tumors at the San Antonio Breast Cancer Symposium (SABCS) 2020 Virtual Meeting, being held Dec. 8-11, 2020 (Press release, Bolt Biotherapeutics, DEC 9, 2020, View Source [SID1234572555]). The poster will be presented today, Wednesday, Dec. 9, at 8:00 a.m. CT/9:00 a.m. ET.

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!

The in-progress clinical trial poster titled, "Phase 1/2 study of a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), BDC-1001, as a single agent and in combination with an immune checkpoint inhibitor in patients with advanced HER2-expressing solid tumors," discusses the framework of Bolt’s Phase 1/2 clinical trial. The actively enrolling global clinical study is for patients with refractory HER2-expressing solid tumors and its primary objectives are to evaluate safety, tolerability and to determine the recommended Phase 2 dose for both monotherapy and combination with a checkpoint inhibitor. BDC-1001 is a novel treatment which combines the targeting and antitumor effect of trastuzumab with stimulation of the immune system via TLR 7/8 agonism. Based on initial clinical observations to date, there have been no dose-limiting toxicities and no drug-related severe adverse events.

Edith Perez, M.D., Chief Medical Officer at Bolt, commented, "Preclinical data support that BDC-1001 may enable a patient to recruit their own immune system to fight their cancer with intravenous administration of BDC-1001. We continue to see strong interest in participation in our trial from both investigators and potential patients based on our compelling preclinical data and ongoing clinical observations."

About Bolt Biotherapeutics’ Immune-Stimulating Antibody Conjugate (ISAC) Platform Technology
The Boltbody ISAC platform technology harnesses the ability of innate immune agonists to convert cold tumors into immunologically hot tumors, thereby illuminating tumors to the immune system and allowing them to be invaded by tumor killing cells. Boltbody ISACs have demonstrated the ability to eliminate tumors following systemic administration as monotherapy in preclinical models and have also led to the development of immunological memory, which is predicted to translate into more durable clinical responses for patients.

About the Ongoing BDC-1001 Phase 1/2 Study in Patients with HER2-Expressing Solid Tumors
The Phase 1/2, multi-center, open-label study is evaluating the safety, pharmacokinetics, pharmacodynamics and proof of mechanism of BDC-1001 in patients with HER2-expressing solid tumors. The first portion of the study includes a monotherapy dose-escalation phase in which cohorts of patients will receive ascending intravenous doses of BDC-1001 to determine the maximum tolerated dose and/or the recommended dose to advance into expansion cohorts and Phase 2 based on safety and tolerability. The second portion of the study is a dose expansion phase in which patients will receive BDC-1001 monotherapy to further evaluate the safety, tolerability and clinical antitumor activity of the recommended Phase 2 dose. Please refer to www.clinicaltrials.gov NCT04278144 for additional clinical trial information.

On December 9, 2020 Grand Pharmaceutical and Healthcare Holdings Limited reported that Group’s associate Sirtex Medical US Holding, Inc. ("Sirtex") has entered into several transactions and strategic cooperation with two U.S. based innovative companies Nanospectra Biosciences, Inc. and BlackSwan Vascular, Inc. respectively with an aim to enrich the Group’s highly innovative and high-barrier pipeline, and therefore will acquire certain shares of the two investees and carry out cooperation on related products, which helps to expand Sirtex’s and the Group’s strategic planning in the field of precision interventional diagnostics and treatment (Press release, Grand Pharmaceutical, DEC 9, 2020, View Source [SID1234653968]).

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!

Precision interventional diagnostics and treatment is one of the Group’s focus areas in strategic planning, which can be further divided into three sub-fields: precision anti-tumor intervention, precision vascular intervention and precision neurointervention. In the field of precision anti-tumor intervention, Sirtex, plus OncoSec Medical Incorporated (NASDAQ: ONCS), another associate of the Group in the US specializing in anti-tumor intervention and DNA immunotherapy, are both important associates and international research and development ("R&D") and production platforms of the Group. The Group together with Sirtex owns or has access to six world-class innovative products for treatment of five solid tumors including colorectal cancer, prostate cancer, melanoma, triple negative breast cancer and squamous cell carcinoma in this field.

1) Subscribe Shares of Nanospectra and Entered into Cooperation Agreement

Sirtex entered into a strategic investment arrangement (the "Nanospectra Agreement") with Nanospectra, pursuant to which Sirtex has made US$1.5 million equity investment for approximately 6% of first round series B-1 preferred shares in Nanospectra. In addition, Sirtex can appoint a member in the board of director of Nanospectra, and has a limited duration exclusive right to negotiate for access to Nanospectra’s world-class innovative product AuroLase in regions outside the U.S. Sirtex also has the exclusive right of first negotiation should Nanospectra seek to transfer a controlling interest in the future. In the event of declaration of dividend (subject to the conditions stated in the articles of Nanospectra) or liquidation, Sirtex, along with holders of other Preferred series B-1 shares will carry a dividend or entitle to the assets respectively in preference to the holders of other classes of shares. The preferred series B-1 shares also carry the same voting rights as other classes of shares of Nanospectra.

Based in Houston, Texas, Nanospectra is an innovative medical device company, of which the lead product AuroLase was initially developed by a team composed of scientists led by Professor Naomi Halas, a member of the National Academy of Sciences and the National Academy of Engineering and Jennifer West, also a member of the National Academy of Engineering. Nanospectra launched a pivotal trial in prostate tissue ablation in the first quarter of this year. Professor Naomi Halas is the founding director of the Laboratory for Nanophotonics at Rice University and Director of the Smalley-Curl Institute. As one of the pioneering researchers in the field of plasmonics, Professor Naomi Halas created the concept of the "tunable plasmon" and invented a family of nanoparticles with the applications in biomedicine, optoelectronics, chemical sensing, photocatalysis, and most recently in solar energy. In conjunction with Professor West, they co-founded Nanospectra to advance the clinical development of targeted photothermal treatment of soft tissue using nanoparticles.

AuroLase, Nanospectra’s innovative medical device, for the ablation of solid tumors, utilizes the unique "optical tunability" of a new class of nanoparticles. AuroLase for prostate tissue ablation is expected to the world’s first and only ultra-focal tissue ablation therapy. Compared with surgery, radiotherapy or alternative focal therapy approaches, AuroLase therapy can maximize treatment effectiveness while minimize side effects typically associated with surgery, radiation, and alternative focal therapies. The AuroLase project for the treatment of prostate cancer tissue ablation is conducting a multi-site pivotal clinical trial in the US, with clinical safety and effectiveness among patients being demonstrated preliminarily. It is expected to become the first marketed innovative product in the field of ultra-focal thermal ablation to treat prostate cancer tissue ablation. AuroLase technology is highly scalable and is expected to be applied to various solid tumors such as thyroid cancer and breast cancer.

2) Purchase Certain Shares of BlackSwan and Obtain the Rights of Full Acquisition

Sirtex and BlackSwan have entered into a shares purchase agreement. Under the agreement, Sirtex will invest US$5 million in exchange for approximately 12.5% preferred shares in BlackSwan and Sirtex will appoint an observer member to the board of directors. In addition, Sirtex has an option to purchase the remaining shares of BlackSwan at a consideration of no more than US$41.5 million in aggregate, within a certain period of time upon the submission of pre-market approval ("PMA") application of BlackSwan’s products.

BlackSwan’s core product LavaTM is a global leading innovative medical device in the field of precision vascular intervention, and is indicated for peripheral vascular applications. LavaTM has radiopacity with low imaging artifact. Its rapid mixing leads to a short 3 minutes preparation time, increasing its ease of use and enabling emergent procedures to improve patients’ chances of survival.

In the future, it also has the potential to expand into other indications in anti-tumor field in combination with SIR-Spheres Y-90. The potential of radiolabeling LavaTM with radioisotopes creates synergies for additional brachytherapy and interventional therapies for Y-90 and other radioisotopes. LavaTM received an investigational device exemption ("IDE") approval from the United States Food and Drug Administration ("FDA") in September this year, and it has the potential to become the first liquid embolic approved for commercialization in the US for peripheral vascular applications.

KonaTM, BlackSwan’s second liquid embolic product candidate, has a target indication for neurovascular applications. It has potential to become drug loadable with chemotherapeutics or radioisotopes for controlled drug delivery in multiple treatment, providing the ability to compete with particle-based transcatheter arterial chemoembolization ("TACE"), ablation and brachytherapy combined with surgery. In addition, KonaTM also has the potential to be used in combination with SIR-Spheres Y-90 and chemical drugs.

The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented: "Sirtex’s cooperation with Nanospectra and BlackSwan and acquiring multiple world-class high-tech innovative products have expanded its product portfolio in oncology and precise intervention and enhanced its connection to research and development capabilities in tumor treatment and precision interventional diagnostics and treatment, strengthened its core competitiveness and propelled the Group’s technological innovation and global planning process."

"Sticking to patients-centered and innovation-driven, the Group has increased its investment in the world-class innovative products and advanced technologies to meet unmet clinical needs in recent year. After years of development, the Group has built its global ‘precision diagnostics + treatment’ strategic platform integrating ‘oncological, vascular, and neurological’. It also becomes a rare innovative global pharmaceutical company that exhibits rapid development with interventional products covering ‘oncological, vascular, and neurological’ in China. The Group will continue to develop world-class innovative products and advanced technologies in the field of precision interventional diagnostics and treatment, striving to build a leading ‘paninterventional diagnostic and therapeutic platform’ in China as well as the world."

"With the continuous expansion of global innovative product portfolio, the Group’s technological advancements have shown their effects. Multiple progresses have demonstrated the Group’s hardcore advantages, which is, in the first step stable operations laying a solid foundation of capital and resource for global expansion. Then in turn the innovative products with high barriers and high added value which are developed by the Group’s multiple global R&D centers generate momentum for future business growth once these products are launched to the market. Meanwhile, through adopting the strategy of ‘global expansion and dual-cycle operation’, the Group has gradually formed a new pattern of domestic and international cycles that synergize with each other. With synergistic effects from multiple global R&D centers, the Group will provide patients with more advanced and diverse treatment options in the world.

On December 9, 2020 Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of cancer, reported record net revenues and gross profit for its fiscal 2020 fourth quarter and full year ended September 30, 2020 (Press release, Veru, DEC 9, 2020, View Source [SID1234572505]).

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!

Fourth-Quarter Financial Highlights: Fiscal 2020 vs Fiscal 2019

Net revenues increased 35% to $11.7 million from $8.7 million
FC2 prescription net revenues climbed 87% to $8.7 million from $4.7 million
Gross profit rose 64% to $9.6 million from $5.8 million
Gross margin increased to 81% of net revenues from 67% of net revenues
Operating loss was $11.3 million, which includes a $14.1 million non-cash impairment charge related to intangible assets. Adjusted operating income, which excludes the non-cash impairment charge, was $2.8 million versus an operating loss of $1.5 million
Net loss, which includes the non-cash impairment charge, was $11.8 million, or $0.17 per share, compared with $3.1 million, or $0.05 per share
Full-Year Financial Highlights: Fiscal 2020 vs Fiscal 2019

Net revenues rose 34% to $42.6 million from $31.8 million
FC2 prescription sales climbed 93% to $27.1 million from $14.1 million
Gross profit rose 42% to $30.8 million from $21.7 million
Gross margin increased to 72% of net revenues from 68% of net revenues
Operating loss was $14.7 million, which included a $14.1 million non-cash impairment charge related to intangible assets. Adjusted operating loss, which excludes the non-cash impairment charge, narrowed to $0.6 million from $6.4 million
Net loss, which includes the non-cash impairment charge, was $19.0 million, or $0.28 per share, compared with $12.0 million, or $0.19 per share
"We reported stellar financial results for both the fiscal 2020 fourth quarter and full year largely driven by strong sales of our FC2 product," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer. "In particular, prescription sales of FC2 sharply increased, helping to raise our gross margin in the recently completed fourth quarter to more than 81% of total net revenues. We anticipate further growth of prescription FC2 sales in the coming year."

Company Sells PREBOOST Business

The Company has completed the sale of its PREBOOST for the treatment of premature ejaculation business to Roman Health Ventures Inc. for $20 million in cash, consisting of $15 million paid at closing, $2.5 million payable 12 months after closing and $2.5 million payable 18 months after closing.

"Proceeds from the transaction, along with current cash and anticipated cash flow from operations, are expected to be sufficient to self-fund our existing drug product development program, without the need for a new equity financing, until at least the end of fiscal year 2022," said Dr. Steiner. "We plan to continue to generate robust growing revenues from our sexual health business which as a standalone business would be very valuable. Coming off a record year of $42.6 million in net revenues with a gross margin of 72%, and expecting another record year in fiscal year 2021, we could have options to monetize the business as we did with the PREBOOST business."

"Veru has evolved into a late clinical stage oncology drug development and commercialization company, having made excellent progress on our development program. Our multiple drug candidates continue to advance, and we are confident that we will achieve significant milestones in 2021. The Company expects it will have sufficient resources generated from our sexual health business and existing sources of cash to fund clinical development of all our registration clinical trials without the need for new equity financing through the end of fiscal year 2022."

Some Pharmaceutical Pipeline Recent Highlights:

The Company expects to issue a news release later today with a more detailed update on its pipeline of late clinical stage drug candidates including the in-licensing of a novel late clinical stage breast cancer drug product entering a Phase 3 clinical trial.

TADFYN (Tadalafil 5mg and Finasteride 5mg Combination Capsule) for the Treatment of Lower Urinary Tract Symptoms Caused by Benign Prostatic Hyperplasia (BPH)

The Company had a successful pre-NDA meeting with the FDA last year and the 12-month stability testing on three manufacturing / commercial batches required by the FDA is being completed. We expect to submit the NDA for TADFYN in the first quarter of calendar year 2021 and plan to launch, if approved, via telemedicine channels in late calendar year 2021.

VERU-111 for Metastatic Castration and Androgen Targeting Agent Resistant Prostate Cancer

In September, the Company announced that it had fully enrolled a Phase 2 clinical trial of VERU-111, its novel, oral, targeting alpha and beta tubulin of microtubules to disrupt the cytoskeleton (cytoskeleton disruptor for metastatic castration and androgen receptor targeting agent resistant prostate cancer. In both the Phase 1b study (n=39) and in the Phase 2 study (n=41), VERU-111 63mg oral daily continuous dosing for 21 day cycles has been well tolerated with no reports of neutropenia and neutrotoxicity and has demonstrated promising efficacy with evidence of PSA declines and objective and durable tumor responses. The Company has received input from the FDA and anticipates initiating a Phase 3 VERU-111 VERACITY registration clinical trial during the first quarter of calendar 2021.

VERU-100 Androgen Deprivation Therapy for Advanced Prostate Cancer

VERU100 is a long-acting GnRH antagonist peptide formulation administered as a small volume, three-month depot subcutaneous injection without a loading dose. There are no GnRH antagonist depot injectable formulations commercially approved beyond a one-month duration. The Company anticipates initiating a Phase 2 trial to evaluate VERU-100 dosing in the first quarter of calendar year 2021 and a Phase 3 registration clinical trial during the second half of calendar year 2021.

VERU-111 COVID-19: Phase 2 Clinical Trial

The Company is also developing VERU-111 for COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS). The drug’s dual antiviral and anti-inflammatory action has the potential to broadly treat the cytokine storm associated with high COVID-19 mortality rates. The Company is close to completing enrollment of a Phase 2 clinical trial to assess the efficacy of VERU-111 in combating COVID-19 in patients at high risk for ARDS.

Impairment Charge

During the fourth quarter the Company took a one-time, non-cash impairment charge of $14.1 million related to in process research and development associated with the financial accounting for the Aspen Park Pharmaceuticals, Inc. acquisition, all as further described in the Company’s Form 10-K for the fiscal year ended September 30, 2020. The non-cash charge is primarily related to the Company’s decision to prioritize clinical development for late clinical stage oncology drug development candidates with greater market differentiation, larger markets, and higher profit potential.

Non-GAAP Financial Information

Certain financial results for fiscal years 2020 and 2019 are presented on both a reported and a non-GAAP, adjusted basis. Reported results were prepared in accordance with U.S. GAAP and include all revenue and expenses recognized during the period. The non-GAAP results are adjusted to exclude the one-time, non-cash impairment charge in the fourth quarter of fiscal year 2020. Management believes non-GAAP financial measures provide useful information to investors regarding the Company’s results of operations and assist management, analysts, and investors in evaluating the performance of the Company’s business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. The Company has reconciled these non-GAAP financial measures to the nearest reported GAAP measures in the reconciliation table below.

Event Details
Veru Inc. will host a conference call today at 8 a.m. ET to review the Company’s performance. Interested investors may access the call by dialing 800-341-1602 from the U.S. or 412-902-6706 from outside the U.S. and asking to be joined into the Veru Inc. call. The call will also be available through a live, listen-only audio broadcast via the Internet at www.verupharma.com. A playback of the call will be archived and accessible on the same website for at least three months. A telephonic replay of the conference call will be available, beginning the same day at approximately 12 p.m. (noon) ET by dialing 877-344-7529 for U.S. callers, or 412-317-0088 from outside the U.S., passcode 10149625, for one week.

The Company does not expect to update the guidance provided above regarding its expectation that it will not need a new equity financing. The Company notes that the statements of future performance made in this release are based upon current expectations and are subject to factors that could cause actual results to differ materially from those suggested here, including those factors set forth in the "Safe Harbor" Statement below.