On May 6, 2021 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata," the "Company," "our," "us," or "we"), a clinical-stage biopharmaceutical company, reported financial results for the quarter ended March 31, 2021, and provided an update on the Company’s business operations and clinical development programs (Press release, Reata Pharmaceuticals, MAY 6, 2021, View Source [SID1234579394]).

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Recent Company Highlights

Bardoxolone Methyl ("Bardoxolone") in Patients with Alport Syndrome

In April 2021, we announced that the U.S. Food and Drug Administration ("FDA") accepted for filing Reata’s New Drug Application ("NDA") for bardoxolone for the treatment of patients with chronic kidney disease ("CKD") caused by Alport syndrome. The FDA will review the application under a Standard Review timeline. The Prescription Drug User Fee Act ("PDUFA") date, the FDA action date for the application, is scheduled for February 25, 2022. The FDA also advised us that it is currently planning to hold an Advisory Committee meeting to discuss the application. If approved, bardoxolone may become the first therapy specifically indicated for the treatment of CKD caused by Alport syndrome.

"We made significant progress during the first quarter of 2021 with the submission of our NDA for bardoxolone for the treatment of CKD caused by Alport syndrome coming less than four months after reporting positive results from Year 2 of our Phase 3 CARDINAL trial," said Warren Huff, Reata’s President and Chief Executive Officer. "Alport syndrome is a devastating disease that affects 30,000 to 60,000 patients in the United States. We are pleased with the FDA’s recent decision to accept our application for filing and look forward to continuing to work with the FDA during its review of our application."

Bardoxolone in Patients with Autosomal Dominant Polycystic Kidney Disease ("ADPKD")

FALCON is an international, multi-center, randomized, double-blind, placebo-controlled, registrational Phase 3 trial studying the safety and efficacy of bardoxolone in patients with ADPKD randomized one-to-one to bardoxolone or placebo. More than 290 patients are currently enrolled in the study and we expect to complete enrollment in FALCON by the end of 2021.

Bardoxolone in Patients with CKD at Risk of Rapid Progression

MERLIN is a proof of concept, multi-center, double-blind, placebo-controlled, Phase 2 trial to evaluate the safety and efficacy of bardoxolone in patients with CKD due to multiple etiologies at meaningful risk of progression to end-stage kidney disease. Enrollment began in February 2021, and we expect to complete enrollment by the end of the second quarter of 2021 with results expected in the second half of 2021. If the results of this study are positive, we would potentially proceed to a larger Phase 3 with similar eligibility criteria.

Omaveloxolone in Patients with Friedreich’s Ataxia ("FA")

Data from the registrational Part 2 portion of the MOXIe Phase 2 trial of omaveloxolone in patients with FA ("MOXIe Part 2") and the open-label extension study (the "MOXIe Extension") were analyzed in additional exploratory analyses (the "Delayed-Start Analyses"), whereby parallel trajectories between the patients randomized to placebo (placebo-to-omaveloxolone group) and those randomized to omaveloxolone (omaveloxolone-to-omaveloxolone group) in the double-blind period from MOXIe Part 2 through 48 weeks in the MOXIe Extension could provide evidence of disease-modifying activity. A total of 73 out of 75 (97%) patients without pes cavus who completed MOXIe Part 2 enrolled in the MOXIe Extension. A longitudinal analysis used to calculate annualized slopes incorporating all available data from the MOXIe Extension showed similar slopes in Modified Friedreich’s Ataxia Rating Scale for the placebo-to-omaveloxolone group when compared to the omaveloxolone-to-omaveloxolone group with no significant difference between slopes (p=0.75). The resulting parallel trajectories between both treatment groups is consistent with disease-modifying activity.

We believe that the results of the Delayed-Start Analyses suggest disease-modifying activity with omaveloxolone, provide evidence supporting the positive primary endpoint findings in MOXIe Part 2, and provide additional evidence of the effectiveness of omaveloxolone in patients with FA. The FDA has granted us a Type C meeting, which is scheduled to occur in the second quarter of 2021, to discuss the Delayed-Start Analyses and the FA development program. We plan to initiate a second pivotal study in the fourth quarter of 2021, incorporating input from both the FDA and the European Medicines Agency into the protocol before we initiate enrollment.

Recent Presentations

Abstracts highlighting results from our various programs in CKD and FA have been selected for presentation at recent international medical conferences. Posters that have been presented can be found on our website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Chronic Kidney Disease

Two abstracts were selected for poster presentations at the National Kidney Foundation Spring Clinical Meetings 2021 which was held virtually from April 6 – 10, 2021. The first poster highlighted the trial design for FALCON, a Phase 3 trial of bardoxolone in patients with ADPKD. The second poster presented results from KIDNEYCODE, a genetic testing program for patients with CKD.
An abstract was selected for poster presentation at the World Congress of Nephrology 2021 which was held virtually from April 15 – 19, 2021 presenting results from an interim analysis of the EAGLE trial, an open-label study to assess the long-term safety and tolerability of bardoxolone in patients with CKD caused by Alport syndrome.
Two abstracts were selected for poster presentations at the Pediatric Academic Societies 2021 Virtual Meeting which was held virtually from April 28 – May 5, 2021. The first poster highlighted results from pediatric patients in the Phase 3 CARDINAL trial. The second poster presented results from pediatric patients in KIDNEYCODE, a genetic testing program for patients with chronic kidney disease.
Upcoming Presentation in Chronic Kidney Disease

An abstract describing pediatric data from the Phase 3 CARDINAL trial of bardoxolone in patients with CKD caused by Alport syndrome was selected for oral presentation at the 58th ERA-EDTA Congress being held virtually from June 5 – 8, 2021, to be presented by Dr. Bradley A. Warady, MD, Director, Division of Pediatric Nephrology, Children’s Mercy Kansas City, Kansas City, MO.
Upcoming Presentation in Friedreich’s Ataxia

An abstract describing results from the baseline-controlled study of omaveloxolone in patients with FA was selected for an oral presentation at the National Ataxia Foundation’s Ataxia Investigators Meeting 2021 being held virtually from May 24 – 27, 2021, to be presented by Dr. David Lynch, MD, PhD, Director, Friedreich’s Ataxia Program, Division of Neurology, Children’s Hospital of Philadelphia, Philadelphia, PA.
First Quarter Financial Highlights

"We have maintained our strong balance sheet and anticipate our current cash runway to last through mid-2024," said Manmeet S. Soni, Reata’s Chief Operating Officer and Chief Financial Officer. "With the FDA’s acceptance for filing of our NDA, we plan to continue advancing disease state awareness and education through our medical affairs organization and our online platforms."

Cash and Cash Equivalents

At March 31, 2021, we had cash and cash equivalents of $777.6 million, as compared to $818.2 million at December 31, 2020.

Collaboration Revenue

Collaboration revenue was $0.9 million in the first quarter of 2021, as compared to $1.4 million for the same period of the year prior.

GAAP and Non-GAAP Research and Development ("R&D") Expenses

R&D expenses according to generally accepted accounting principles in the U.S. ("GAAP") were $34.9 million for the for the first quarter of 2021, as compared to $47.7 million, for the same period of the year prior.

Non-GAAP R&D expenses were $28.1 million for the first quarter of 2021, as compared to $36.1 million, for the same period of the year prior.1

GAAP and Non-GAAP General and Administrative ("G&A") Expenses

GAAP G&A expenses were $20.7 million for the first quarter of 2021, as compared to $20.8 million, for the same period of the year prior.

Non-GAAP G&A expenses were $12.8 million for the first quarter of 2021, as compared to $13.0 million for the same period of the year prior.1

GAAP and Non-GAAP Net Loss

The GAAP net loss for the first quarter of 2021, was $67.5 million, or $1.86 per share, on both a basic and diluted basis, as compared to a GAAP net loss of $48.9 million, or $1.47 per share, on both a basic and diluted basis, for the same period of the year prior.

The non-GAAP net loss for first quarter of 2021, was $41.9 million, or $1.16 per share on both a basic and diluted basis, as compared to a non-GAAP net loss of $29.6 million, or $0.89 per share, on both a basic and diluted basis, for the same period of the year prior.1

The increases in GAAP and non-GAAP net loss are driven primarily by an income tax benefit recognized in the first quarter of 2020, offset by a decrease in research and development spend.
____________________________
1 See "Non-GAAP Financial Measures" below for a description of non-GAAP financial measures and a reconciliation between GAAP and non-GAAP R&D expenses, GAAP and non-GAAP G&A expenses, and GAAP and non-GAAP net loss, respectively, appearing later in the press release.

Non-GAAP Financial Measures

This press release contains non-GAAP financial measures, including non-GAAP R&D expenses, non-GAAP G&A expenses, non-GAAP operating expenses, non-GAAP net loss and non-GAAP net loss per common share – basic and diluted. These measures are not in accordance with, or an alternative to, GAAP, and may be different from non-GAAP financial measures used by other companies.

The Company defines non-GAAP R&D expenses as GAAP R&D expenses, which excludes stock-based compensation expense; non-GAAP G&A expenses as GAAP G&A expenses, which excludes stock-based compensation expense; non-GAAP operating expenses as GAAP operating expenses, which excludes stock-based compensation expense; non-GAAP net loss as GAAP net loss, which excludes stock-based compensation expense, non-cash interest expense from liability related to sale of future royalties, loss on extinguishment of debt, and gain on lease termination; and non-GAAP net loss per common share – basic and diluted as GAAP net loss per common share – basic and diluted, which excludes stock-based compensation expense, non-cash interest expense from liability related to sale of future royalties. The Company has excluded the impact of stock-based compensation expense, which may fluctuate from period to period based on factors including the variability associated with performance-based grants for stock options and restricted stock units and changes in the Company’s stock price, which impacts the fair value of these awards. The Company has excluded the impact of accreted non-cash interest expense from liability related to sale of future royalties as it may be calculated differently from, and therefore may not be comparable to, peer companies who also provide non-GAAP disclosures. The Company has excluded the impact of loss on extinguishment of debt and gain on lease termination as they are non-recurring transactions that make it difficult to compare its results to peer companies who also provide non-GAAP disclosures. The Company has excluded the impact of stock-based compensation expense, non-cash interest expense from liability related to sale of future royalties, loss on extinguishment of debt, and gain on lease termination because the Company believes its impact makes it difficult to compare its results to prior periods and anticipated future periods. Because management believes certain items, such as stock-based compensation expense, non-cash interest expense from liability related to sales of future royalties, loss on extinguishment of debt, and gain on lease termination, can distort the trends associated with the Company’s ongoing performance, the following measures are often provided, excluding special items, and utilized by the Company’s management, analysts, and investors to enhance consistency and comparability of year-over-year results, as well as to industry trends, and to provide a basis for evaluating operating results in future periods: non-GAAP net loss; non-GAAP net loss per common share – basic and diluted; non-GAAP R&D expenses; non-GAAP G&A expenses; and non-GAAP operating expenses.

The Company believes the presentation of these non-GAAP financial measures provides useful information to management and investors regarding the Company’s financial condition and results of operations. When GAAP financial measures are viewed in conjunction with these non-GAAP financial measures, investors are provided with a more meaningful understanding of the Company’s ongoing operating performance and are better able to compare the Company’s performance between periods. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating performance, allocating resources and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided later in this press release.

Conference Call Information

Reata’s management will host a conference call on May 6, 2021, at 8:30 am ET. The conference call will be accessible by dialing (866) 270-1533 (toll-free domestic) or (412) 317-0797 (international) using the access code: 10153548. The webcast link is View Source

First quarter financial results to be discussed during the call will be included in an earnings press release that will be available on the company’s website shortly before the call at View Source and will be available for 12 months after the call. The audio recording and webcast will be accessible for at least 90 days after the event at View Source." target="_blank" title="View Source." rel="nofollow">View Source

On May 6, 2021 Bio-Techne Corporation (NASDAQ:TECH) reported its financial results for the third quarter ended March 31, 2021 (Press release, Bio-Techne, MAY 6, 2021, View Source [SID1234579393]).

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Third Quarter FY2021 Snapshot

Third quarter organic revenue increased by 22% (25% reported) to $243.6 million and 17% (19% reported) in the first nine months of fiscal 2021 to $672.0 million.
GAAP EPS was $1.12 versus $0.92 one year ago. Delivered adjusted earnings per share (EPS) of $1.79 versus $1.39 one year ago.
Adjusted Operating Margin increased to 40.1% in the third quarter of fiscal 2021 compared to 36.4% in the third quarter of fiscal 2020.
Excellent commercial execution in both operating segments with Protein Sciences achieving record organic growth of 24% and Diagnostics and Genomics delivering 17% organic growth.
Enhanced Bio-Techne’s Diagnostics and Genomics segment through the acquisition of Asuragen, Inc., which closed April 6th, 2021, adding a portfolio of best-in-class molecular diagnostic and research products and its experienced leadership team.
The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). Adjusted EPS, adjusted earnings, adjusted gross margin, adjusted operating income, adjusted tax rate, organic growth, and adjusted operating margin are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of non-GAAP Adjusted Financial Measures." A reconciliation of GAAP to non-GAAP financial measures is included in this press release.

"Congratulations to the entire global Bio-Techne team for delivering another consecutive record quarter," Said Chuck Kummeth, President and CEO of Bio-Techne. "Our 22% organic growth reflects strong execution across geographies and segments, while our financial discipline delivered an impressive adjusted operating margin of 40.1%. This strength speaks to increasing demand for our portfolio of life science tools and diagnostic solutions, delivering productivity enhancing solutions that are ideal for the current environment and positioning the Company for continued leadership in our platforms as we exit the pandemic."

Kummeth added, "Our end-markets continued to improve during Q3, with biopharma remaining strong and academic labs continuing the reopening process. Our ProteinSimple brand of proteomic analytical tools and ACD brand of tissue biopsy products were standouts in the quarter, with these platforms growing approximately +50% and +40% year-over-year, respectively. The continued rapid adoption of these solutions, combined with our quality reagents and emerging Exosome Dx and Cell and Gene Therapy opportunities, gives us much excitement about what the future still brings for Bio-Techne and all of its stakeholders."

Third Quarter Fiscal 2021

Revenue

Net sales for the third quarter increased 25% to $243.6 million. Organic growth was 22% compared to the prior year, with foreign currency exchange having a favorable impact of 3% and acquisitions contributing an immaterial amount to revenue growth.

GAAP Earnings Results

GAAP EPS increased to $1.12 per diluted share, versus $0.92 in the same quarter last year. GAAP operating income for the third quarter of fiscal 2021 increased 43.6% to $68.6 million, compared to $47.8 million in the third quarter of fiscal 2020. GAAP operating margin was 28.2%, compared to 24.5% in the third quarter of fiscal 2020. GAAP operating margin compared to prior year was positively impacted by volume leverage and cost management.

Non-GAAP Earnings Results

Adjusted EPS increased to $1.79 per diluted share, versus $1.39 in the same quarter last year, an increase of 29%. Adjusted EPS increased due to revenue growth and operating margin expansion. Adjusted operating income for the third quarter of fiscal 2021 increased 37% compared to the third quarter of fiscal 2020. Adjusted operating margin was 40.1%, compared to 36.4 % in the third quarter of fiscal 2020. Adjusted operating margin compared to the prior year was favorably impacted by volume leverage and cost management.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the Company’s business segments, as highlighted below.

Protein Sciences Segment

The Company’s Protein Sciences segment is one of the world’s leading suppliers of specialized proteins such as cytokines and growth factors, immunoassays, antibodies and reagents, to the biotechnology and academic research communities. Additionally, the segment provides an array of platforms useful in various areas of protein analysis. Protein Sciences segment’s third quarter fiscal 2021 net sales were $185.6 million, an increase of 28% from $145.5 million for the third quarter of fiscal 2020. Organic growth for the segment was 24%, with foreign currency exchange having a favorable impact of 4% on revenue growth and acquisitions contributing an immaterial amount to revenue growth. Protein Sciences segment’s operating margin was 47.6% in the third quarter of fiscal 2021 compared to 44.7% in the third quarter of fiscal 2020. The segment’s operating margin compared to the prior year was positively impacted by volume leverage and cost management.

Diagnostics and Genomics Segment

The Company’s Diagnostics and Genomics segment provides blood chemistry and blood gas quality controls, hematology instrument controls, immunoassays and other bulk and custom reagents for the in vitro diagnostic market. The Diagnostics and Genomics segment also develops and provides in situ hybridization products as well as exosome-based diagnostics for various pathologies, including prostate cancer. The Diagnostics and Genomics segment’s third quarter fiscal 2021 net sales were $58.1 million, an increase of 18% from $49.4 million for the third quarter of fiscal 2020. Organic growth for the segment was 17% with foreign currency exchange having a 1% favorable impact on revenue. The Diagnostics and Genomics segment’s operating margin was 17.9% in the third quarter of fiscal 2021 compared to 14.3% in the third quarter of fiscal 2020. The segment’s operating margin was favorably impacted by volume leverage and cost management.

Conference Call

Bio-Techne will host an earnings conference call today, May 6, 2021 at 8:00 a.m. CDT. To listen, please dial 1-877-407-9208 or 1-201-493-6784 for international callers, and reference conference ID 13718437. The earnings call can also be accessed via webcast through the following link View Source

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512-2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 13718437. The replay will be available from 11:00 a.m. CDT on Thursday, May 6, 2021 until 11:00 p.m. CDT on Sunday, June 6, 2021.

Use of non-GAAP Adjusted Financial Measures:

This press release contains financial measures that have not been calculated in accordance with accounting principles generally accepted in the U.S. (GAAP). These non-GAAP measures include:

Organic growth
Adjusted diluted earnings per share
Adjusted tax rate
Adjusted gross margin
Adjusted operating income
Adjusted operating margin
We provide these measures as additional information regarding our operating results. We use these non-GAAP measures internally to evaluate our performance and in making financial and operational decisions, including with respect to incentive compensation. We believe that our presentation of these measures provides investors with greater transparency with respect to our results of operations and that these measures are useful for period-to-period comparison of results.

Our non-GAAP financial measure of organic growth represents revenue growth excluding revenue from acquisitions within the preceding 12 months as well as the impact of foreign currency. Excluding these measures provides more useful period-to-period comparison of revenue results as it excludes the impact of foreign currency exchange rates, which can vary significantly from period to period, and revenue from acquisitions that would not be included in the comparable prior period.

Our non-GAAP financial measures for adjusted gross margin, adjusted operating margin, and adjusted net earnings, in total and on a per share basis, exclude the costs recognized upon the sale of acquired inventory, amortization of acquisition intangibles, acquisition related expenses inclusive of the changes in fair value of contingent consideration, and other non-recurring items including non-recurring costs and gains. The Company excludes amortization of purchased intangible assets, purchase accounting adjustments, including costs recognized upon the sale of acquired inventory and acquisition-related expenses inclusive of the changes in fair value contingent consideration, and other non-recurring items including gains or losses on legal settlements and one-time assessments from this measure because they occur as a result of specific events, and are not reflective of our internal investments, the costs of developing, producing, supporting and selling our products, and the other ongoing costs to support our operating structure. Additionally, these amounts can vary significantly from period to period based on current activity.

The Company’s non-GAAP adjusted operating margin and adjusted net earnings, in total and on a per share basis, also excludes stock-based compensation expense, which is inclusive of the employer portion of payroll taxes on those stock awards, restructuring, impairments of equity method investments, gain and losses from investments, and certain adjustments to income tax expense. Stock-based compensation is excluded from non-GAAP adjusted net earnings because of the nature of this charge, specifically the varying available valuation methodologies, subjective assumptions, variety of award types, and unpredictability of amount and timing of employer related tax obligations. Impairments of equity investments are excluded as they are not part of our day-to-day operating decisions. Additionally, gains and losses from other investments that are either isolated or cannot be expected to occur again with any predictability are excluded. Costs related to restructuring activities, including reducing overhead and consolidating facilities, are excluded because we believe they are not indicative of our normal operating costs. The Company independently calculates a non-GAAP adjusted tax rate to be applied to the identified non-GAAP adjustments considering the impact of discrete items on these adjustments and the jurisdictional mix of the adjustments. In addition, the tax impact of other discrete and non-recurring charges which impact our reported GAAP tax rate are adjusted from net earnings. We believe these tax items can significantly affect the period-over-period assessment of operating results and not necessarily reflect costs and/or income associated with historical trends and future results.

Investors are encouraged to review the reconciliations of adjusted financial measures used in this press release to their most directly comparable GAAP financial measures as provided with the financial statements attached to this press release.

On May 6, 2021 Zionexa reported to join GE Healthcare to further develop molecular imaging agents in oncology, all aimed at enabling more precise diagnosis, improved treatment decision-making and ultimately better clinical outcomes for patients (Press release, Zionexa, MAY 6, 2021, View Source [SID1234579390]).​

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Our mission has always been to help physicians personalize treatment to improve patients’ pathway and quality of life. We are delighted to be joining an organization rooted in precision health.

Kevin O’Neill, President and CEO of GE Healthcare Pharmaceutical Diagnostics, said: "Like GE Healthcare, Zionexa’s products are aimed at enabling more precise diagnosis, improved treatment decision-making and ultimately better clinical outcomes for patients. This acquisition further demonstrates our commitment to enabling precision health and providing innovations that support oncologists, nuclear medicine specialists and other physicians throughout a cancer patient’s journey, from initial screening and diagnosis to informing therapy selection and monitoring the effectiveness of treatment."

Olivier Carli, President of Denos, the majority owner of Zionexa, said: "We expect GE Healthcare Pharmaceutical Diagnostics’ acquisition to allow Zionexa to accelerate the development of its promising R&D pipeline as well as its commercial footprint, while providing Zionexa’s team with access to global and complementary expertise

On May 6, 2021 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported that it will host a conference call and live audio webcast on Thursday, May 13, 2021 at 4:30 p.m. Eastern Time to discuss financial results for the first quarter ended March 31, 2021 and to provide a business update (Press release, CymaBay Therapeutics, MAY 6, 2021, View Source [SID1234579389]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Conference Call Details
To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13718350. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On May 6, 2021 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported the Company will release its first quarter 2021 financial results before the market opens on Thursday, May 13, 2021 (Press release, Synlogic, MAY 6, 2021, View Source [SID1234579388]). The press release will be followed by a conference call at 8:30 am ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a corporate update.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The conference call dial-in numbers are (844) 815-2882 for domestic callers and (213) 660-0926 for international callers. The conference ID number for the call is 2526209. Participants may access the live webcast via a link on the Synlogic website in the Events Calendar of the Investors and Media section. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Company’s website.