On May 4, 2021 twoXAR Inc., a Delaware corporation, focused on discovering and bringing first-in-class small molecules to market, reported that the company will rebrand as Aria Pharmaceuticals (Press release, Aria Pharmaceuticals, MAY 4, 2021, View Source [SID1234635533]). The name reflects the artistry and complexity that defines how the company and its scientific teams approach medicine from discovery to FDA approval in a way that is scientifically sound. Aria Pharmaceuticals also announced a pipeline update that includes novel preclinical compounds targeting fibrotic and immunological diseases.

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"We’ve built a significant and promising pipeline and assembled a team of top pharmaceutical R&D talent over the last few years, radically changing the trajectory of the company and how we approach pharmaceutical development," said Andrew Radin, CEO of Aria Pharmaceuticals. "Our name should reflect our commitment to sound science and our ability to not only discover but to develop and research novel treatments from preclinical to clinical studies."

Since its founding in 2015, the company has built its own proprietary pipeline as well as focused its partnership strategy on working with biotechnology companies on drug discovery research. With successful preclinical efficacy and safety data emerging from several of the company’s proprietary candidates, Aria Pharmaceuticals will transition from discovery collaborations with pharmaceutical companies to advancing its own pipeline into clinical research, starting with IND-enabling studies for novel candidates in chronic kidney disease, lupus and idiopathic pulmonary fibrosis.

To help validate and progress its pipeline through to clinical testing, in March 2020 Aria Pharmaceuticals hired pharmaceutical research leaders Mark Eller, Ph.D. as the Senior Vice President of Research and Development and Anjali Pandey, Ph.D. as the Senior Vice President of Nonclinical R&D and Chemistry. Both Dr. Eller and Dr. Pandey have led multiple successful pharmaceutical research and development programs from discovery through to approval and post marketing studies.

"We have made record progress in the last year in building and developing an exciting pipeline with very promising early data," said Mark Eller, Senior Vice President of Research and Development. "With our rapid progress in identifying potential treatments, we’re now exploring not only the addition of new therapeutic areas to our pipeline but building out our research programs for our existing pipeline."

To date, Aria Pharmaceuticals has identified 18 potential novel treatment candidates for complex diseases including, lupus, glioblastoma, chronic kidney disease and glaucoma. The company has announced positive preclinical safety and efficacy data in seven of its candidates with an average timing to complete predictions, select hits and begin in vivo testing of four weeks, significantly faster than traditional drug discovery processes which typically take years to reach similar milestones. In addition, Aria Pharmaceuticals’ approach to R&D has been proven to produce a 30-fold increase in hit rates at in vivo efficacy milestones over traditional methods. For more information, please visit www.ariapharmaceuticals.com

On May 4, 2021 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a biotech innovator and biologics contract manufacturing organization, reported that it has successfully resolved its lawsuit with Fraunhofer USA, Inc. ("Fraunhofer USA") (Press release, iBioPharma, MAY 4, 2021, View Source [SID1234585482]). The parties’ settlement confirms iBio’s ownership of certain intellectual property related to plant-based biopharmaceutical production. As part of the settlement, iBio granted Fraunhofer USA a fully paid-up license to use the recombinant protein manufacturing technologies that were the subject of litigation.

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Tom Isett, Chairman and CEO of iBio, said, "We are pleased to see this matter resolved and to receive compensation for the use our intellectual property. iBio remains committed to relentlessly innovating in the area of plant-made biologics, while respecting fair competition and protecting our IP. As a result, this settlement gives assurance to our licensees and clients that they can continue to depend upon us to develop and enhance our FastPharming Technologies to provide them with the speed, scalability, and eco-friendly advantages of plant-based biologics development and manufacturing from iBio."

The Settlement concludes the lawsuit that began in March 2015 in the Delaware Court of Chancery. In addition to an initial payment at signing which will cover iBio’s significant legal fees and expenses, Fraunhofer USA will make additional cash payments to iBio in March 2022 and March 2023. Certain details of the settlement are confidential.

On May 4, 2021 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported financial results for the first quarter of 2021 (Press release, Concert Pharmaceuticals, MAY 4, 2021, View Source [SID1234584684]).

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"We are committed to advancing CTP-543, our breakthrough therapy candidate for moderate to severe alopecia areata. Patients currently lack effective, approved treatment options. We believe we have the potential to provide patients with a new, clinically meaningful and best-in-class treatment option," stated Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. "We remain on track with our THRIVE-AA Phase 3 clinical program with CTP-543, in support of our New Drug Application that we anticipate filing in early 2023."

Recent Business Highlights and Upcoming Milestones

CTP-543: An Investigational Treatment for Moderate to Severe Alopecia Areata

THRIVE-AA1 Phase 3 Trial in Alopecia Areata On Track to Report Topline Data in 2022. The THRIVE-AA1 Phase 3 trial is a randomized, double-blind, placebo-controlled clinical trial of CTP-543 to evaluate hair regrowth after 24 weeks of dosing in approximately 700 adults with moderate to severe alopecia areata. The trial is evaluating 8 mg and 12 mg twice-daily doses of CTP-543 compared to placebo at sites in the U.S., Canada and Europe. The Company expects to report topline results from the THRIVE-AA1 trial in 2022. Additional information about the THRIVE-AA1 trial (NCT04518995) is available at clinicaltrials.gov.
Initiation of THRIVE-AA2 Phase 3 Trial in Alopecia Areata Expected in May 2021. The Company expects to initiate a second pivotal Phase 3 trial of CTP-543, THRIVE-AA2, later this month. The planned THRIVE-AA2 Phase 3 trial is a randomized, double-blind, placebo-controlled clinical trial of CTP-543 to evaluate hair regrowth after 24 weeks of dosing in approximately 440 adults with moderate to severe alopecia areata. The trial will evaluate 8 mg and 12 mg twice-daily doses of CTP-543 compared to placebo at sites in the U.S., Canada and Europe. Additional information about the THRIVE-AA2 trial (NCT04797650) is available at clinicaltrials.gov.
Update on CTP-543 Open Label, Long-Term Extension Study to be Presented at JAK Summit. Concert’s Chief Development Officer, James V. Cassella, Ph.D., will present an update on the ongoing open label, long-term extension study of CTP-543 at the 2nd JAK Inhibitors Drug Development Summit scheduled for July 1, 2021. The presentation will provide an update on the extension study, building on the data presented at the late-breaking news session at the European Academy of Dermatology and Venereology (EADV) in October 2020, during which the Company showed the maintenance of hair regrowth in patients on treatment for at least one year. Details about the upcoming meeting are available at https://jak-drugdevelopment.com/.
First Quarter 2021 Financial Results

Cash and Investment Position. Cash, cash equivalents and investments as of March 31, 2021 totaled $111.8 million as compared to $130.0 million as of December 31, 2020. Under its current operating plan, the Company expects its cash, cash equivalents and investments to fund the Company through 2021.
R&D Expenses. Research and development expenses were $18.5 million for the quarter ended March 31, 2021, compared to $14.0 million for the same period in 2020. The increase in research and development expenses relates primarily to the ongoing CTP-543 Phase 3 THRIVE-AA clinical program.
G&A Expenses. General and administrative expenses were $5.5 million for the quarter ended March 31, 2021, compared to $4.7 million for the same period in 2020, an increase of $0.8 million due to an increase in external professional service expenses and non-cash stock-based compensation expense.
Net Loss. Net loss applicable to common stockholders was $22.7 million, or $0.67 per share, for the quarter ended March 31, 2021, as compared to net loss applicable to common stockholders of $20.5 million, or $0.70 per share, for the quarter ended March 31, 2020.
Conference Call and Webcast

The Company will host a conference call and webcast today at 8:30 a.m. ET to provide an update on the Company and discuss its first quarter 2021 financial results. To access the conference call, please dial (855) 354-1855 (U.S. and Canada) or (484) 365-2865 (International) five minutes prior to the start time.

A live webcast may be accessed in the Investors section of the Company’s website at www.concertpharma.com. Please log on to the Concert website approximately 15 minutes prior to the scheduled webcast to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Concert’s website for three months.

On May 4, 2021 Invectys Inc., a clinical-stage immunotherapy company headquartered in Houston and dedicated to the development of a new generation of products for cancer patients, reported that Praveen Tyle, Ph.D., Invectys Inc. President and CEO, and Julien Caumartin, Ph.D. CSO of Invectys SA, will participate in the Roth Virtual Healthcare Private Company Forum, on Monday, June 28th, 2021 (Press release, Invectys, MAY 4, 2021, View Source [SID1234584362]).

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Dr. Tyle will speak on the panel titled "Novel Approaches to Tumor Eradication" at 9:00am a.m. ET. Invectys, Inc focuses on a multi-modality approach to targeting HLA-G on tumor cells and also an approach with universal tumor antigen telomerase.

On May 4, 2021 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported that it will webcast its presentation at the BofA Securities 2021 Healthcare Conference at 8:00 a.m. PT on Wednesday, May 12, 2021 (Press release, Sana Biotechnology, MAY 4, 2021, View Source [SID1234584005]). The presentation will feature a business overview and update by Steve Harr, Sana’s President and Chief Executive Officer.

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The webcast will be accessible on the Investor Relations page of Sana’s website at www.sana.com. A replay of the presentation will be available at the same location for 30 days following the conference.