On March 10, 2020 CNS Pharmaceuticals presented the corporate presentation (Presentation, CNS Pharmaceuticals, MAR 10, 2020, View Source [SID1234555362]).

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On March 10, 2020 ChemoCentryx, Inc., (Nasdaq: CCXI), reported financial results for the fourth quarter and full year ended December 31, 2019 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, MAR 10, 2020, View Source [SID1234555361]).

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"The power of data to transform the world was evident in the results of our Phase III ADVOCATE trial of avacopan in ANCA-associated vasculitis," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "The ADVOCATE data marked a critical turning point, in my view, in the treatment of this debilitating disease, with avacopan demonstrating superiority over the current standard of care which employs daily dosing of glucocorticoids. Those results transformed not just thousands of lives potentially, but changed the face of our enterprise as well. We intend to file an NDA for avacopan with the FDA by the middle of this year, and are laying the groundwork for US commercialization. Furthermore, the success of ADVOCATE not only validated the biology of C5a receptor inhibition by avacopan as a powerful therapy but it surpassed expectations and may open doors to additional renal disease opportunities in underserved indications such as lupus nephritis. The momentous readout in ADVOCATE now sets the stage for a data-rich 2020, during which we expect to share topline results from four additional ongoing clinical trials. An epochal year for CCXI was 2019, and we expect 2020 to be extraordinary as well."

Key Highlights

Exceeded expectations for avacopan with topline data from the ADVOCATE Phase III pivotal clinical trial announced in the fourth quarter of 2019, which demonstrated avacopan’s statistical superiority in sustaining remission at 52 weeks over the prednisone-containing standard-of-care, eliminating the need for daily noxious steroids. Avacopan was shown to lower all four aspects of the total burden of disease: stopping active vasculitis; significantly lowering current therapy-induced illness, with a statistically significant reduction in the Glucocorticoid Toxicity Index (GTI) and other accepted assessments of glucocorticoid toxicity; significantly improving kidney function as evidenced by a marked improvement in Estimated Glomerular Filtration Rate, or eGFR; and statistically significant improvements in quality of life, assessed by the SF-36 QOL instrument and the EuroQOL-5D-5L instrument (Visual Analogue Scale and EQ Index).

On track to announce topline data from the LUMINA-1 Phase II randomized clinical trial of CCX140, an inhibitor of the chemokine receptor known as CCR2, in patients with sub-nephrotic primary Focal Segmental Glomerulosclerosis (FSGS), another rare kidney disease, in the second quarter of 2020. The single-arm, open label LUMINA-2 study continues to enroll, evaluating CCX140 in primary FSGS patients with the more severe nephrotic levels of proteinuria, and we expect to announce topline data by year-end 2020.

Advanced enrollment in our ACCOLADE Phase II clinical trial of avacopan in patients with the rare kidney disease C3 Glomerulopathy (C3G). C3G often afflicts the young, requiring dialysis and often kidney transplant with recurring disease common. There is no approved effective treatment for C3G. In 2019 we were awarded a two-year $1 million grant from the orphan drug office of the FDA to support advancement in the ongoing ACCOLADE trial. Topline data from ACCOLADE are expected in the second half of 2020.

Surpassed 90 percent target enrollment in our AURORA Phase IIb clinical trial of avacopan for the treatment of the chronic disabling skin disease Hidradenitis Suppurativa (HS). Topline data from AURORA are expected in the third quarter 2020.

Maintained a strong balance sheet, with reported cash and investments exceeding $202 million at December 31, 2019, and an additional credit facility of up to $100 million secured in January 2020.

Fourth Quarter and Full Year 2019 Financial Results

Cash and investments, totaled $202.2 million at December 31, 2019, excluding the credit facility of up to $100 million that was secured in January 2020.

Revenue was $10.0 million for the fourth quarter of 2019, compared to $9.3 million for the same period in 2018. For the full year ended December 31, 2019, revenue was $36.1 million, compared to $42.9 million for 2018. The quarterly increase in revenue from 2018 to 2019 was primarily due to the full enrollment of the CCX140 LUMINA-1 Phase II trial in patients with FSGS in 2019. Revenue in 2019 also included $176,000 of grant revenue from the FDA to support the clinical development of avacopan in patients with C3G.

Research and development expenses were $19.2 million for the fourth quarter of 2019, compared to $15.1 million for the same period in 2018. Full year 2019 research and development expenses were $70.3 million compared to $62.7 million in 2018. The increase in research and development expenses from 2018 to 2019 was primarily attributable to (i) an increase in Phase II clinical study expense driven by patient enrollment in the avacopan AURORA trial in patients with HS and the two CCX140 LUMINA trials in patients with FSGS, and (ii) an increase in Phase I clinical study expense due to the initiation of avacopan ancillary studies. These increases were partially offset by decreases in 2019 in research and drug discovery expenses and expenses for the avacopan ADVOCATE Phase III pivotal trial as the study was fully enrolled in 2018.

General and administrative expenses were $7.0 million for the fourth quarter of 2019, compared to $5.6 million for the same period in 2018. Full year 2019 general and administrative expenses were $24.2 million, compared to $20.4 million in 2018. The increase from 2018 to 2019 was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, and higher professional fees.

Net loss for the fourth quarter of 2019 was $15.5 million, compared to net loss of $10.8 million for the same period in 2018. Full year 2019 net loss was $55.5 million, compared to net loss of $38.0 million in 2018.

Total shares outstanding at December 31, 2019 were approximately 60.2 million shares.

We expect to utilize cash and investments in the range of $85 million to $95 million in 2020.

Conference Call and Webcast

The Company will host a conference call and webcast today, March 10, 2020 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial (877) 303-8028 (Domestic) or (760) 536-5167 (International). The conference ID number is 5494029. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.

On March 10, 2020 Cellectis (Euronext Growth: ALCLS; Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported that a new patent from the US Patent and Trademark Office (USPTO) had been granted to Cellectis for methods of preparing allogeneic T-cells for immunotherapy with CRISPR-Cas9 technology (Press release, Cellectis, MAR 10, 2020, https://www.cellectis.com/en/press/us-patent-covering-crispr-edited-allogeneic-car-t-cells-granted-to-cellectis/ [SID1234555360]).

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The patent US10,584,352 issued today claims "a method of preparing and administering T-cells for immunotherapy comprised of providing primary human T-cells from a healthy donor and genetically modifying the primary human T-cells to eliminate expression of the T-cell receptor (TCR), which contains expression on the Cas9 endonuclease fused to a nuclear localization signal (NLS) and guide RNA that directs said endonuclease to at least one targeted locus encoding the TCR in the T-cell genome, and further the expansion of the genetically modified T-cells, as well as the administration of at least 10,000 of the expanded genetically modified T-cells to a patient."

This patent complements the European patent EP3004337, claiming a method of preparing T-cells for immunotherapy using the CRISPR-Cas9 system, initially granted on August 2, 2017 and upheld by the EPO in November 2019 following an opposition procedure initiated in May 2018.

In January 2020, Cellectis was also granted European Patent EP3116902, which claims "an engineered isolated CAR T-cell, which expression of beta 2-microglobulin (B2M) is inhibited, while at least one gene encoding a component of the T-cell receptor (TCR) is inactivated."

"These patents highlight Cellectis’ long-term expansion of expertise in various gene-editing technologies, including CRISPR-Cas9," said Dr. André Choulika, Chairman and CEO, Cellectis. "Cellectis invented the gene-edited CAR-T allogeneic approach, and over the past decade, we have remained committed to developing the most safe and efficacious therapeutic products on a global scale."

The Cellectis inventors of US10,584,352 and EP3004337 patents are Dr. André Choulika, Chairman and CEO, Dr. Philippe Duchateau, Chief Scientific Officer and Dr. Laurent Poirot, VP, Immunology Department. Inventors from Cellectis of the EP3116902 patent include Dr. Laurent Poirot, VP, Immunology Department, Dr. David Sourdive, EVP, Strategic Initiatives, Dr. Philippe Duchateau, Chief Scientific Officer and Dr. Jean-Pierre Cabaniols, Head of Analytical Department.

On March 10, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported its financial results for the fourth quarter and twelve months ended December 31, 2019 (Press release, Castle Biosciences, MAR 10, 2020, View Source [SID1234555359]).

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"The Castle Biosciences’ team delivered very strong results in 2019, with growth in test report volume and revenue, continued evidence development for DecisionDx-Melanoma and DecisionDx-UM tests and advancement of our pipeline products," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Our team also delivered on two commercial expansions, with all 32 outside sales territories filled as of December 2019, establishing a solid base for execution of our 2020 plan.

"We presented data on our late-stage pipeline test, DecisionDx-SCC, for use in patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC), as defined by the National Comprehensive Cancer Network (NCCN). The data demonstrated the ability of the test to stratify patients presenting as high-risk into those who are truly high-risk patients and those who are lower-risk patients. DecisionDx-SCC is designed to aid physicians in the development of appropriate, risk-aligned treatment plans. Our DecisionDx-SCC test remains on track for expected commercial launch in the second half of 2020.

"Additionally, development of our third skin cancer product, for use in patients with a suspicious pigmented lesion, remains on track for expected commercial launch in the second half of 2020. We estimate that combined, our three skin cancer products, DecisionDx-Melanoma, DecisionDx-SCC and our test for suspicious pigmented lesions, will have a total addressable U.S. market of approximately $2.0 billion."

Fourth Quarter Ended December 31, 2019, Financial Highlights
•Revenue was $17.6 million in the fourth quarter of 2019, compared to $11.4 million in the fourth quarter of 2018.
•Adjusted revenue was $17.6 million in the fourth quarter of 2019, compared to $6.2 million in the fourth quarter of 2018.
•Delivered 4,480 DecisionDx-Melanoma test reports in the fourth quarter of 2019, which represents 37% growth compared to the 3,270 reports delivered during the fourth quarter of 2018.
•Delivered 434 DecisionDx-UM test reports in the fourth quarter of 2019, which represents 13% growth compared to 385 reports during the fourth quarter of 2018.
•Gross margin in the fourth quarter of 2019 was 89%.
•Operating cash flow was $4.5 million in the fourth quarter of 2019, compared to $(3.2) million in the fourth quarter of 2018.

Twelve Months Ended December 31, 2019, Financial Highlights
•Revenue was $51.9 million for the full year 2019, compared to $22.8 million in 2018.
•Delivered 15,529 DecisionDx-Melanoma test reports for the full year 2019, compared to 12,032 reports during the full year 2018, representing growth of 29%. In 2019, new ordering clinicians for DecisionDx-Melanoma increased 24% compared to 2018. Additionally, total ordering clinicians in 2019 for DecisionDx-Melanoma increased 32% to 3,927, year-over-year.
•Delivered 1,526 DecisionDx-UM test reports for the full year 2019, compared to 1,413 reports during the full year 2018, representing growth of 8%.
•Gross margin for the full year 2019 was 86%.
•Operating cash flow was $7.0 million for the full year 2019, compared to $(12.3) million in 2018.

Cash and Cash Equivalents

As of December 31, 2019, the Company’s cash and cash equivalents totaled $99 million, and the outstanding principal balance on the Company’s bank term loan was $26.7 million.

2020 Revenue Guidance

Castle Biosciences anticipates generating $61-64 million in revenue in 2020.

Supplemental Revenue Information

Affecting the year-over-year comparability of our revenues were (a) the issuance of the Medicare Local Coverage Determination (LCD) for our DecisionDx-Melanoma test, effective December 3, 2018, and (b) confirmation of the Medicare Contractor rate for DecisionDx-Melanoma. As a result of timing of these two elements, all 2018 Medicare claims covered under the LCD were recognized as revenue in the fourth quarter of 2018. Medicare revenues for DecisionDx-Melanoma associated with test reports delivered in the first three quarters of 2018, but not recorded until the fourth quarter of 2018, were $5.2 million. Also, included in revenues for the quarters ended December 31, 2019 and 2018, were positive (negative) revenue adjustments related to tests delivered in prior periods of $4.3 million and $(1.2) million, respectively. For the twelve months ended December 31, 2019, and 2018, these amounts totaled $2.5 million and $0.3 million, respectively.

Fourth Quarter Business and Clinical Evidence Updates

•The Company more than doubled the number of commercial and medical affairs personnel between December 2018 and December 2019. The most recent expansion occurred in December 2019, with an increase in the number of outside sales territories to 32 from 23, along with commensurate increases in other commercial and medical affairs support roles. The Company previously expanded the number of outside sales territories to 23 from 14 in February 2019.
•Results from a study designed to perform a systematic review of the literature and establish the level of evidence for the Company’s DecisionDx-Melanoma gene expression profile test were published in the December 2019 issue of the American Journal of Clinical Dermatology. The results suggest that the DecisionDx-Melanoma test achieves a higher level of evidence than required by major organizations that publish guidelines on melanoma management. The evaluation of seven development and validation studies led the authors to

classify DecisionDx-Melanoma as level I/II, 1-3B and IIA according to the American Joint Committee on Cancer (AJCC), National Comprehensive Cancer Network (NCCN) and American Academy of Dermatology (AAD) criteria, respectively, which are higher than the official unrated status conferred by the AJCC and NCCN and the II/IIIC rating designated by the AAD in the latest version of their melanoma guidelines.
•The NCCN Guidelines for Cutaneous Melanoma were updated in the fourth quarter, with a positive shift in the inclusion language indicating that the DecisionDx-Melanoma test may provide information that is an adjunct to AJCC staging, with a category 2A level of evidence recommendation. This level of evidence is consistent with the systematic review study published in December 2019 (see American Journal of Clinical Dermatology publication noted earlier).
•The Company received notification that the American Medical Association’s (AMA) Current Procedural Terminology (CPT) Editorial Panel accepted Castle’s application for a Category I Multianalyte Assays with Algorithmic Analyses (MAAA) CPT code for its DecisionDx-Melanoma test. The CPT Editorial Panel is an independent group of expert volunteers representing various sectors of the health care industry. Its role is to ensure that code changes undergo evidence-based review and meet specific criteria. The code will be effective on January 1, 2021. With this acceptance, both of the Company’s proprietary MAAA tests, DecisionDx-UM and DecisionDx-Melanoma, have met the criteria required for a Category I MAAA CPT code.
•Data from a second, multi-center, prospectively tested patient cohort study of 1,166 patients supporting clinical use of the DecisionDx-Melanoma test to inform discussions and recommendations regarding sentinel lymph node biopsy (SLNB), as well as data from a separate multi-center prospective outcomes study were presented during the 16th International Congress of the Society for Melanoma Research.
In the expanded, multi-center prospectively tested patient cohort study:
•In SLNB-assessed patients 65 years of age or older with T1-T2 tumors and a Class 1A test result, SLN positivity was 2.7%, significantly less than patients with a Class 1B-2A (p<0.01) or Class 2B result (p<0.0001), and below the 5% threshold at which guidelines do not recommend the procedure.
In the multi-center prospective outcomes study:
•In a prospective cohort with median follow-up of 3.2 years for patients without an event, Class 1A patients with T1-T2 melanoma, at three years, had overall survival of 99.4%, distant metastasis-free survival of 98.7% and recurrence-free survival of 96.6%, adding further support that this population can safely avoid the SLNB surgical procedure.
•DecisionDx-SCC, the Company’s late stage pipeline product expected to be commercially available in the second half of 2020, is designed to predict a low risk of metastasis in patients with cutaneous squamous cell carcinoma (SCC), who are identified as high risk by traditional clinicopathologic staging criteria. Results of the clinical validation study (n=321) for DecisionDx-SCC were presented in October 2019 at the American Society for Dermatologic Surgery (ASDS) Annual Meeting. The development goal for DecisionDx-SCC was to enable a clinician to consider de-escalating treatment plans in patients with one or more high-risk clinical or pathologic features who are at low biological risk of metastasis, and with the remaining patients having a significantly higher risk of metastasis, enabling more accurate implementation of risk directed treatment plans.

event Developments

•In January 2020, the Company presented data supporting a framework for integration of DecisionDx-SCC into risk-appropriate management of high-risk cutaneous SCC patients (as defined by NCCN) at the 2020 Winter Clinical Dermatology Conference. The study found that integration of DecisionDx-SCC for NCCN-defined high-risk cutaneous SCC patients with T staging identified a group of patients (Class 1, T1-T2) with a 7.5% rate of metastasis, which approaches that of the general cutaneous SCC patient population. A low intensity management strategy, within the broad NCCN high-risk guidelines, could spare this patient group unnecessary adjuvant procedures and potential adverse effects.

•Earlier this March, the first U.S. Patent related to the Company’s DecisionDx-Melanoma test was issued (Patent No. 10,577,660) by the United States Patent and Trademark Office (USPTO). This patent brings the total number of issued or allowed patents related to DecisionDx-Melanoma to 10 and covers methods of treating cutaneous melanoma in patients having high-risk cutaneous melanoma tumors.

Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Tuesday, March 10, 2020, at 4:30 p.m. Eastern time to discuss its fourth quarter and full-year 2019 results and provide a corporate update.

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website (www.castlebiosciences.com). Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until April 1, 2020.

To access the live conference call via phone, please dial 877-282-2581 from the United States and Canada, or +1 470-495-9479 internationally, at least 10 minutes prior to the start of the call, using the conference ID 5836318.

On March 10, 2020 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported financial results for the third quarter and first nine months of fiscal 2020 ended January 31, 2020 (Press release, Avid Bioservices, MAR 10, 2020, View Source [SID1234555358]).

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Highlights Since October 31, 2019

"During the third quarter of 2020, Avid strengthened both its project pipeline and backlog, and the fundamentals of the business remained strong," said Rick Hancock, interim president and chief executive officer of Avid. "However, the company faced production challenges during the period related to a problem with a specific piece of equipment which resulted in the termination of in-process manufacturing runs, and the postponement of several other manufacturing runs scheduled to commence during the third quarter. Though we are now implementing the necessary corrections, the temporary production interruption resulted in lower revenue and profits for the third quarter, and we expect it to also impact revenues and profits for the fourth quarter of fiscal 2020. For this reason, we are adjusting our revenue guidance for fiscal 2020 to $55 – $59 million versus our prior guidance of $64 – $67 million. It is our expectation that this problem will be behind us soon, and as such, we anticipate that the impact will be contained to fiscal 2020.

"While we are disappointed that this temporary operational setback will negatively impact our fiscal 2020 results, we anticipate that we will be able to recover those revenues in fiscal 2021. We remain optimistic about Avid’s growth potential.

"Critical to achieving this growth is the continued expansion of Avid’s customer and project base. To lead this effort, we recently welcomed Timothy Compton to the Avid team as our chief commercial officer. During the third quarter, Tim launched the first phase of an aggressive business development campaign. As a result, we signed agreements to add one new customer and multiple additional manufacturing campaigns with existing customers during the period.

"With respect to operations, we continue to make progress on projects to optimize our existing Myford facility while finalizing plans for its future expansion. We will continue to update you moving forward as these plans progress."

Financial Highlights and Guidance

The company is adjusting revenue guidance for the full fiscal year 2020 to $55 million to $59 million from prior full fiscal year 2020 guidance of $64 million to $67 million.

Revenue was $13.6 million for the third quarter of fiscal 2020, consistent with $13.8 million for the third quarter of last fiscal year. For the nine months ended January 31, 2020, revenues were $47.2 million, a 29% increase as compared to revenues of $36.5 million during the same prior year period. The slight decrease during the third quarter of fiscal 2020 can primarily be attributed to a decrease in process development revenue, combined with the impact of the production interruption described above, which were largely offset by an increase in the number of in-process and completed manufacturing runs conducted during the quarter compared to the same prior year quarter. Likewise, the increase during the first nine months of fiscal 2020 was primarily due to an increase in the number of in-process and completed manufacturing runs, a result of growing demand from a more diverse client base, partially offset by a decrease in process development revenue and the third quarter production interruption.

As of January 31, 2020, revenue backlog was approximately $58 million, an increase of 12% compared to the second quarter of fiscal 2020. The company expects to recognize the majority of this backlog within the next 12 months.

Gross margin for the third quarter of fiscal 2020 was 6%, a decrease compared to the 15% gross margin for the third quarter of fiscal 2019. The decrease in gross margin for the quarter was primarily attributed to the costs associated with the aforementioned production interruption, an increase in depreciation expense from the acquisition of new equipment, and a net decrease in revenues. Gross margin for the nine months ended January 31, 2020 was 11%, up slightly compared to 10% in the prior year period. This increase was primarily due to an increase in manufacturing runs, partially offset by costs associated with payroll and related costs, higher facility and equipment related costs primarily associated with the production interruption described above, increased depreciation expense from the acquisition of new equipment, and general equipment repairs and maintenance costs.

Selling, general and administrative expenses ("SG&A") for the third quarter of fiscal 2020 were $3.0 million, a decrease of 8% compared to $3.2 million for the third quarter of fiscal 2019. This decrease was primarily due to a decrease in accrued bonuses for fiscal 2020, partially offset by an increase in employee separation costs. For the first nine months of fiscal 2020, SG&A expenses were $11.0 million, an 19% increase compared to $9.3 million for the first nine months of fiscal 2019. The increase in SG&A was primarily attributed to employee separation-related expenses and increased stock-based compensation. When excluding the separation-related expenses, SG&A increased by 10% during the first nine months of fiscal 2020 as compared to the prior year.

For the third quarter of fiscal 2020, the company recorded a consolidated net loss attributable to common stockholders of $3.5 million or $0.06 per share, compared to a consolidated net loss attributable to common stockholders of $2.6 million or $0.05 per share, for the third quarter of fiscal 2019. For the first nine months of fiscal 2020, the company recorded a consolidated net loss attributable to common stockholders of $9.3 million or $0.17 per share, compared to a consolidated net loss attributable to common stockholders of $8.2 million or $0.15 per share, for the first nine months of fiscal 2019.

Avid reported $30.7 million in cash and cash equivalents as of January 31, 2020, compared to $32.4 million on April 30, 2019.
More detailed financial information and analysis may be found in Avid Bioservices’ Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

Recent Corporate Developments

Appointed Timothy (Tim) Compton as chief commercial officer. Mr. Compton has extensive experience in commercial operations, including sales team management, business development, marketing and corporate development. In his new role, he will be responsible for driving the continued growth of Avid’s CDMO business, including the ongoing expansion of the company’s commercial and clinical client base.

Expanded our customer base with the addition of one new customer and executed multiple project expansion orders with existing customers representing additional revenue backlog of $20 million during the third quarter.

Advanced planning and design to both enhance our Myford facility, and support its future expansion. These near-term improvements include installing a pharmaceutical grade water system, and upgrading key IT systems and general infrastructure. We expect the installation and validation of the water system to take place in late calendar year 2020 and the IT system enhancements and general infrastructure upgrades to be complete by the end of fiscal 2021.
Conference Call

Avid will host a conference call and webcast this afternoon, March 10, 2020, at 4:30 PM EDT (1:30 PM PDT).

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices conference call. To listen to the live webcast, or access the archived webcast, please visit: View Source