Curis to Present at H.C. Wainwright & Co. 6th Annual Israel Conference

On November 4, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that James Dentzer, President and Chief Executive Officer of Curis, will present at the H.C. Wainwright & Co. 6th Annual Israel Conference on Thursday, November 12, 2020 at 12:00 pm ET (Press release, Curis, NOV 4, 2020, View Source [SID1234569803]).

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A live webcast of the presentation will be available under "Events & Presentations" in the Investors section of the Company’s website at www.curis.com. A replay of the webcast will be available on the Curis website for 90 days following the event.

Bio-Techne To Present At The Stifel 2020 Virtual Healthcare Conference

On November 4, 2020 Bio-Techne Corporation (NASDAQ: TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at the Stifel 2020 Virtual Healthcare Conference on Monday, November 16, 2020 at 1:20 p.m. EST (Press release, Bio-Techne, NOV 4, 2020, View Source [SID1234569802]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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Aclaris Therapeutics Reports Third Quarter 2020 Financial Results and Provides a Corporate Update

On November 4, 2020 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported its financial results for the third quarter of 2020 and provided a corporate update (Press release, Aclaris Therapeutics, NOV 4, 2020, View Source [SID1234569800]).

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"We have continued to meet our milestones and meaningfully advance our pipeline," said Dr. Neal Walker, President & CEO of Aclaris. "We recently announced that we dosed our first subject in our Phase 2a trial of ATI-1777 for the treatment of moderate to severe atopic dermatitis. In addition, we initiated our Phase 2a trial of ATI-450 as a potential treatment for cryopyrin-associated periodic syndrome, an orphan immuno-inflammatory indication. We look forward to progressing these trials as well as our ongoing trial of ATI-450 for rheumatoid arthritis."

Research and Development Highlights:
The global outbreak of COVID-19 continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its research and development and regulatory activities listed below.

ATI-450, an investigational oral small molecule MK2 inhibitor compound:
ATI-450-RA-201: An ongoing Phase 2a clinical trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450 in subjects with moderate to severe rheumatoid arthritis. Aclaris’ planned enrollment for this trial is up to 25 subjects.
Aclaris anticipates reporting data from this trial in the first half of 2021.
ATI-450-CAPS-201: An ongoing Phase 2a open-label, single-arm clinical trial to investigate the safety, tolerability, efficacy and pharmacodynamics of ATI-450 for the maintenance of remission in subjects with cryopyrin-associated periodic syndrome (CAPS) previously managed with anti-IL1 therapy. Aclaris’ planned enrollment for this trial is up to 10 subjects. The primary endpoint of the trial is an assessment of safety and tolerability. The key secondary efficacy endpoint of the trial is the proportion of subjects who maintain disease remission.
Aclaris initiated this trial and filed for orphan drug designation for the indication in November 2020.
IIT-2020-ATI-450-COVID-19: An ongoing investigator-initiated Phase 2a, randomized, double-blind, placebo-controlled clinical trial to investigate the safety and efficacy of ATI-450, when used in addition to standard of care therapy, as a potential treatment for cytokine release syndrome in approximately 36 hospitalized patients with COVID-19. Aclaris is providing funding and clinical drug supply to the University of Kansas Medical Center (KUMC), the sponsor of the trial. The primary endpoint in this trial is the proportion of subjects who are free from respiratory failure by day 14.
ATI-1777, an investigational topical "soft" Janus Kinase (JAK) 1/3 inhibitor compound:
ATI-1777-AD-201: An ongoing Phase 2a multicenter, randomized, double-blind, vehicle-controlled, parallel-group clinical trial to investigate the efficacy, safety, tolerability and pharmacokinetics of ATI-1777 in subjects with moderate or severe atopic dermatitis. Aclaris’ planned enrollment for this trial is approximately 42 subjects. The primary endpoint is the percentage change from baseline in the Eczema Area and Severity Index (EASI) score at week 4.
The first subject was dosed in October 2020.

ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound:
Aclaris is developing ATI-2138 as a potential treatment for psoriasis and/or inflammatory bowel disease and expects to submit an Investigational New Drug (IND) Application for ATI-2138 in 2021.
Business Development Highlights:

Aclaris continues to pursue strategic alternatives, including seeking partners for:
A-101 45% Topical Solution: to obtain regulatory approval and commercialize A-101 45% Topical Solution, an investigational compound, as a potential treatment for common warts (verruca vulgaris);
ATI-501 & ATI-502: to further develop, obtain regulatory approval and commercialize ATI-501 (oral) and ATI-502 (topical), investigational JAK 1/3 inhibitor compounds, as potential treatments for alopecia; and
ESKATA: to commercialize ESKATA (hydrogen peroxide) topical solution, 40% (w/w).
Financial Highlights:
Liquidity and Capital Resources

As of September 30, 2020, Aclaris had aggregate cash, cash equivalents, restricted cash and marketable securities of $55.2 million compared to $75.0 million as of December 31, 2019. For the three and nine months ended September 30, 2020, net cash used in operating activities was $12.2 million and $29.8 million, respectively. As of September 30, 2020, Aclaris had approximately 42.9 million shares of common stock outstanding.

In August 2020, Aclaris entered into an equity purchase agreement with Lincoln Park Capital Fund, LLC (Lincoln Park). The agreement allows Aclaris to sell, at its discretion, up to $15.0 million of its common stock to Lincoln Park.

Aclaris anticipates that its cash, cash equivalents, restricted cash and marketable securities as of September 30, 2020 will be sufficient to fund its operations through the first quarter of 2022, without giving effect to any potential business development transactions or financing activities.

Third Quarter 2020 and Year-to-Date Financial Results

The accompanying condensed consolidated statements of operations and selected consolidated balance sheet data have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to Aclaris’ commercial products as discontinued operations.
Net loss was $10.7 million for the third quarter of 2020 compared to $55.3 million for the third quarter of 2019, and was $37.8 million for the nine months ended September 30, 2020 compared to $142.8 million for the nine months ended September 30, 2019.
Total revenue was $1.4 million for the third quarter of 2020 compared to $1.0 million for the third quarter of 2019, and was $4.9 million for the nine months ended September 30, 2020 compared to $3.1 million for the nine months ended September 30, 2019.
Research and development (R&D) expenses were $6.9 million for the quarter ended September 30, 2020 compared to $16.2 million for the prior year period, and were $22.8 million for the nine months ended September 30, 2020 compared to $53.3 million for the prior year period.

The quarter-over-quarter decrease of $9.3 million was primarily the result of the substantial completion of Aclaris’ various Phase 2 clinical trials of ATI-501 and ATI-502 and two pivotal Phase 3 clinical trials of A-101 45% Topical Solution in 2019, and the corresponding reduction in personnel costs to support these programs. Additionally, Aclaris made a $4.0 million milestone payment for the achievement of a development milestone in the third quarter of 2019 which also contributed to the decrease quarter-over-quarter.
R&D expenses in the third quarter of 2020 included non-cash stock-based compensation expense of $0.4 million compared to $1.4 million in the prior year period.
General and administrative (G&A) expenses were $3.9 million for the quarter ended September 30, 2020 compared to $6.8 million for the prior year period, and were $15.6 million for the nine months ended September 30, 2020 compared to $21.8 million for the prior year period.

The quarter-over-quarter decrease of $3.0 million was primarily the result of lower personnel costs resulting from Aclaris’ decision to discontinue commercial operations in September 2019.
G&A expenses in the third quarter of 2020 included non-cash stock-based compensation expense of $1.3 million compared to $2.6 million in the prior year period.
Loss from continuing operations was $10.7 million for the quarter ended September 30, 2020 compared to $23.1 million for the prior year period, and was $37.6 million for the nine months ended September 30, 2020 compared to $94.1 million for the prior year period. Loss from discontinued operations was $0 for the third quarter of 2020 compared to $32.2 million for the third quarter of 2019, and was $0.3 million for the nine months ended September 30, 2020 compared to $48.7 million for the nine months ended September 30, 2019.

Third-quarter-of-2020-

On November 3, 2020 Bayer reported that it has confirmed its targets for full-year 2020 following a challenging third quarter due to seasonal factors (Press release, Bayer, NOV 3, 2020, View Source [SID1234572468]). "Despite the weak quarter and the substantial impact of the pandemic, our currency- and portfolio-adjusted sales and core earnings per share in the first nine months of the year were level with the prior-year period thanks to stringent cost management and the acceleration of our structural measures. We can therefore confirm our currency-adjusted Group outlook for 2020," said Werner Baumann, Chairman of the Board of Management, on Tuesday during a conference call. Summarizing the company’s business performance, Chief Financial Officer Wolfgang Nickl said: "We saw a challenging quarter in our agricultural business, a recovery in our pharmaceuticals business and strong growth at Consumer Health." Employee safety during the pandemic remains a top priority for Bayer. The company has implemented a wide range of protective measures to ensure that it can continue to provide patients, farmers and consumers with a reliable supply of products, especially life-saving medicines.

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"The impact of the pandemic is placing additional strain on our Crop Science Division. We are also facing negative currency effects, such as the massive depreciation of the Brazilian real, which is weighing heavily on business in the world’s second-largest agricultural market," said Nickl. In view of the headwinds in the agriculture business, the company has taken non-cash impairment charges for the division, as announced on September 30.

AskBio acquisition strengthens long-term growth prospects

Bayer last week announced the acquisition of Asklepios BioPharmaceuticals, marking a very important strategic step for the company. AskBio is a U.S.-headquartered biopharmaceutical company specialized in the research, development and manufacture of gene therapies across different therapeutic areas. "The acquisition significantly strengthens our position in cell and gene therapies," Baumann said. "Bayer is better positioned than almost any other company to harness the long-term innovation potential of the bio-revolution in health and agriculture, and thus make a key contribution to solving some of the most pressing questions facing humanity: How can we feed up to 10 billion people by 2050 in a world impacted by climate change? And how can we ensure quality of life for a growing number of elderly people? Finding answers to these questions – that’s what underpins our attractive long-term growth prospects."

Group sales in the third quarter came in at 8.506 billion euros, down 5.1 percent on a currency- and portfolio-adjusted basis (Fx & portfolio adj.). Group EBITDA before special items decreased by 21.4 percent to 1.795 billion euros. This figure included a negative currency effect of 205 million euros. EBIT came in at minus 9.399 billion euros (Q3 2019: plus 1.208 billion euros) after taking into account the non-cash impairment charges on intangible assets in the Crop Science Division, including goodwill, that amounted to 9.251 billion euros in total.

EBIT included net special charges of 10.181 billion euros (Q3 2019: 13 million euros) that pertained to the aforementioned impairment charges and provisions in connection with potential future Roundup litigation as part of the glyphosate litigations. Other special charges resulted from the ongoing restructuring program and litigations at Pharmaceuticals. Net income came in at minus 2.744 billion euros (Q3 2019: plus 1.036 billion euros). Core earnings per share from continuing operations fell by 30.2 percent to 0.81 euros in the third quarter but were level year on year in the first nine months at 5.07 euros.

Free cash flow declined by 2.1 percent to 1.237 billion euros in the third quarter. At 28.268 billion euros, net financial debt as of September 30, 2020, was down 21.5 percent from the end of June 2020, mainly thanks to the proceeds from the divestment of the Animal Health business unit.

Crop Science impacted by high product returns

In the agricultural business (Crop Science), sales declined by 11.6 percent (Fx & portfolio adj.) to 3.028 billion euros. Business was down in North America in particular, while sales increased in the Asia/Pacific region. Global sales at Corn Seed & Traits fell by 39.9 percent (Fx & portfolio adj.), with substantial declines in North America in particular due to higher product returns and lower license revenues arising from lower than anticipated planted acreages for corn this year. At Herbicides, sales declined by 12.7 percent (Fx & portfolio adj.) against the strong prior-year quarter. Business was primarily down in the North America region, where sales in the prior year had shifted into the third quarter due to extreme weather conditions in the first half of the year.

Sales at Soybean Seed & Traits were level with the prior-year period (Fx & portfolio adj. plus 0.2 percent), with growth in Latin America offsetting lower volumes in North America. Sales at Fungicides advanced by 12.0 percent (Fx & portfolio adj.), with growth across all regions. In Latin America, Bayer primarily benefited from the market switching to the Fox Xpro product in Brazil.

EBITDA before special items at Crop Science decreased to minus 34 million euros (Q3 2019: plus 500 million euros). The decline was mainly due to the decrease in sales in North America, which was primarily attributable to the developments relating to product returns. There was also a negative currency effect of 123 million euros.

In October there was some encouraging news from the United States, with the country’s Environmental Protection Agency (EPA) announcing a new five-year registration for the dicamba-based XtendiMax herbicide with VaporGrip Technology, an important weed-control tool for many U.S. growers. The news puts an end to the uncertainty following a U.S. court decision in June that prohibited the use of dicamba.

There are approximately 88,500 claims in the litigation involving glyphosate-based Roundup products that are either covered by fully executed master settlement agreements (MSAs), MSAs to be executed, or agreements in principle. At the end of June, Bayer had reported that there were approximately 125,000 filed and unfiled claims. Given uncertainties about eligibility and participation, this number will not be finalized until the settlement process is completed. The company is also continuing to work on a joint proposal to address potential future Roundup claims together with plaintiffs’ counsel and is working in good faith to address the issues raised by the court to the satisfaction of all parties. Though progress is being made, it will take more time to complete this process. Bayer took an additional provision in the third quarter to cover the increased cost of a revised class plan, as it is far enough along in the negotiations to know that the new plan will come in at approximately 2 billion U.S. dollars, an increase over the original cost of 1.25 billion U.S. dollars. Upon completion of the formal agreement, the company will file a motion for preliminary approval.

Pharmaceuticals increases earnings

Sales of prescription medicines (Pharmaceuticals) declined by 1.8 percent (Fx & portfolio adj.) to 4.229 billion euros. In China, the negative effects from the implementation of new tender procedures for the products Glucobay and Avelox were partly offset by strong volume increases for Glucobay and sales gains for other products. The modest signs of recovery from the global impact of COVID-19 which had already become apparent toward the end of the previous quarter largely continued, especially in ophthalmology and women’s health.

Sales of the oral anticoagulant Xarelto increased by 13.8 percent (Fx & portfolio adj.), mainly as a result of higher volumes in China, Germany and Russia. Sales of the ophthalmology drug Eylea advanced by 2.2 percent (Fx & portfolio adj.), driven by the launch of Eylea prefilled syringes and strong demand in China. Despite sales recovering slightly from the previous quarter, growth in Europe continued to be held back by negative factors related to COVID-19. Sales of Aspirin Cardio, Bayer’s product for secondary prevention of heart attacks, climbed by 20.8 percent (Fx & portfolio adj.), mainly due to a sharp increase in demand in China. The cancer drug Stivarga continued to deliver substantial sales gains (Fx & portfolio adj. plus 17.5 percent), especially in the United States. Among other factors, sales benefited from the product’s oral administration, enabling treatment to continue outside of hospitals and doctor’s offices during the ongoing pandemic. By contrast, the division recorded significant declines for the cancer drugs Nexavar (Fx & portfolio adj. minus 14.1 percent) and Xofigo (Fx & portfolio adj. minus 14.8 percent), especially in the United States. Sales of Xofigo were weighed down by restrictions related to COVID-19, among other factors.

EBITDA before special items at Pharmaceuticals rose by 0.9 percent to 1.515 billion euros. Thanks to stringent cost management, the division was able to grow its earnings and margin despite the decline in sales due to the negative overall impact of COVID-19 as well as negative currency effects of 48 million euros that additionally weighed on earnings.

Consumer Health well ahead of industry market growth

Sales of self-care products (Consumer Health) increased by 6.2 percent (Fx & portfolio adj.) to 1.205 billion euros putting the division’s growth well ahead of industry market growth. After the expected reduction of trade inventories in the second quarter following an exceptionally strong first quarter, the growth trend continued across all regions. This development was driven by the Nutritionals category in particular, with sales rising 21.4 percent (Fx & portfolio adj.) due to the greater focus on health and prevention in connection with the COVID-19 pandemic as well as the launch of new products. The Digestive Health category also registered especially strong growth, with sales rising by 14.2 percent (Fx & portfolio adj.) By contrast, declines were recorded in the Allergy & Cold category (Fx & portfolio adj. minus 6.8 percent) in particular.

EBITDA before special items at Consumer Health increased by 12.3 percent to 301 million euros, primarily due to the substantial increase in sales and positive contributions from the efficiency program launched in late 2018. Earnings were diminished by a negative currency effect of 30 million euros and the absence of contributions from the businesses divested in 2019.

Currency-adjusted Group outlook for 2020 confirmed

Bayer has confirmed its revised currency-adjusted Group outlook for full-year 2020. On a currency-adjusted basis, the company aims to grow sales to between 43 and 44 billion euros and increase its EBITDA margin before special items to around 28 percent. This would correspond to EBITDA before special items of around 12.1 billion euros after adjusting for currency effects. Core earnings per share are expected to rise to between 6.70 and 6.90 euros on a currency-adjusted basis. However, due to revised growth assumptions, the company now expects to post currency- and portfolio-adjusted sales growth of 1 percent (previously: 2 percent) at Crop Science and 5 percent (previously: 4 percent) at Consumer Health. Bayer expects full-year sales and earnings to come under even greater pressure from currency headwinds.

Context Therapeutics Announces First Patient Dosed in Window of Opportunity Study

On November 3, 2020 Context Therapeutics, a clinical-stage biopharmaceutical company dedicated to advancing medicines for hormone driven cancers, reported that the first patient has been dosed in a Window of Opportunity study (title: "ONAWA") in primary breast cancer (Press release, Context Therapeutics, NOV 3, 2020, View Source [SID1234570454]). Meritxell Bellet, MD, PhD, of Group SOLTI (Barcelona, Spain), is the study’s Primary Investigator.

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This clinical collaboration, being supported by Context and sponsored by SOLTI, is a Window of Opportunity study (WOO) in the neoadjuvant setting for breast cancer. During the study, patients participating in the ONAWA (ONApristone Window Assessment) trial will receive oral doses of the progesterone receptor antagonist, Apristor (onapristone ER). Patients will be biopsied on day one, followed immediately by treatment and a final biopsy after three weeks, on the day of their full lumpectomy or mastectomy. Data generated from this study is intended to confirm the Recommended Phase 2 Dose (RP2D) of Apristor and to provide comprehensive biomarker data to further validate that the antitumor activity of Apristor is driven through downregulation of progesterone receptor and associated signaling pathways. This data will support Context’s ongoing and planned Phase 2 studies in breast, ovarian, and endometrial cancers.

"We are thrilled to enter into this collaboration with SOLTI and facilitate this window of opportunity study. We expect that this study will provide additional biomarker data to support our planned Phase 2 studies in progesterone receptor positive (PR+) female cancers," said Martin Lehr, CEO of Context Therapeutics.

The study, conducted within SOLTI’s network, has two Principal Investigators, both members of SOLTI Governing Board: Dr. Meritxell Bellet, Senior Consultant at Breast Cancer Unit at Vall d’Hebron University Hospital and Dr. Cristina Saura, Head of Breast Cancer Unit at Vall d’Hebron University Hospital. "The majority of breast cancer patients have an hormone-dependent disease. The hormones estrogen and progesterone drive breast cancer progression in those patients, but antiestrogens are the only antihormonal therapy available to clinicians. As such, antiestrogen resistance is now a major clinical challenge," said Dr. Bellet. "We believe that a progesterone receptor antagonist has the potential to address antiestrogen resistance and/or potentiate antiestrogen activity, which we believe will lead to better outcomes for patients. This window of opportunity provides us with the first clinical opportunity to delve deep into how progesterone receptor antagonists modulate the breast cancer tumor and its microenvironment."

About Onapristone Extended Release
ONA-XR (onapristone extended release) is a potent and specific antagonist of the progesterone receptor that is orally administered. Currently, there are no approved therapies that selectively target PR+ cancers. Preliminary preclinical and clinical data suggest that ONA-XR has anticancer activity by inhibiting progesterone receptor binding to chromatin, downregulating cancer stem cell mobilization and blocking immune evasion. ONA-XR is currently the subject of an ongoing Phase 2 clinical trials in progesterone receptor positive breast, ovarian, and endometrial cancers. ONA-XR is an investigational drug that has not been approved for marketing by any regulatory authority.