On May 6, 2022 Orion Corporation reported that it has entered into an agreement with Chinese Jemincare, through which Orion will receive exclusive global development and commersialisation rights, excluding the Greater China area (mainland China, Hong Kong, Macau and Taiwan), for a potent and selective NaV 1.8 blocker for the treatment of acute and chronic pain (Press release, Orion , MAY 6, 2022, View Source [SID1234613783]). Orion will also receive ownership to certain key patent applications relating to the compound within its own territory.

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According to the agreement, Orion has the right to develop and commercialise the asset in its territory. Orion will be fully responsible for its own development and commercialisation costs. In addition, Orion will manufacture the products, including active pharmaceutical ingredient, for its markets.

Under the terms of the agreement, Orion will pay Jemincare a EUR 15 million upfront payment, in addition to which Jemincare is upon achievement of certain development, commercialisation and sales targets entitled to receive milestone payments, which may be significant. In addition, Jemincare is eligible to receive tiered royalty of 8% to 15% on future sales in Orion territory.

"We are excited about this agreement and are looking forward to taking this compound to clinical studies later this year. Pain is one of the most frequently reported reasons for a patient to visit a health care provider and it generates a significant societal burden in terms of health care utilisation and lost productivity. There is a high unmet need for new non-addictive treatment options with improved efficacy and safety profiles. NaV 1.8 channel is known pain transmission pathway and is thus a promising target for novel pain treatments", said Professor, M.D., Ph.D. Outi Vaarala, Senior Vice President of Research and Development at Orion.

"JMKX000623 is a potent and selective Nav1.8 blocker independently developed by Jemincare and we have received IND approval in China in March 2022. We are delighted to enter into collaboration with Orion Corporation to bring this promising therapy to benefit patients in the rest of the world. This is our second innovative therapy partnered globally. We look forward to work closely with Orion, a partner having rich experience in the development of therapeutics in neurology and pain area, to take this compound to clinical trials", said Mr. Hong Liang, President of Jemincare Pharmaceutical Group.

About NaV 1.8 as a target for the treatment of pain

Electrical activation of nociceptive sensory neurons is essential physiological process for pain transmission where information is relayed from peripheral tissues to central nervous system and to brain where pain perception takes place. NaV 1.8 is one of the pivotal sodium channel subtypes modulating excitability of pain fibers. The fundamental role NaV 1.8 plays in pain transmission has been demonstrated in preclinical studies and validated genetically and pharmacologically in acute and chronic pain clinical trials investigating selective NaV 1.8 blocking agent. Currently no drugs selectively targeting NaV 1.8 are in the market yet.

On May 6, 2022 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will present at the following conferences (Press release, BioCryst Pharmaceuticals, MAY 6, 2022, View Source [SID1234613781]):

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The Bank of America Securities 2022 Healthcare Conference in Las Vegas, NV on Tuesday, May 10, 2022, at 11:00 a.m. ET.

The RBC Capital Markets Global Healthcare Conference in New York on Wednesday, May 18, 2022 at 1:35 p.m. ET.

The H.C. Wainwright Global Investment Conference – pre-recorded fireside chat available beginning Tuesday, May 24, 2022 at 7:00 a.m. ET.
Links to a live audio webcast and replay of these presentations may be accessed in the Investors & Media section of BioCryst’s website at http://www.biocryst.com.

On May 6, 2022 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) ("Aurinia" or the "Company") reported a change to the dial-in number(s) for the upcoming first quarter financial and operational results announcement on Tuesday, May 10, 2022 (Press release, Aurinia Pharmaceuticals, MAY 6, 2022, View Source [SID1234613780]). The new numbers for interested participants to dial in are: (866) 682-6100 / (862) 298-0702 (Toll-free U.S. & Canada).

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The audio webcast can also be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

On May 6, 2022 Athersys, Inc. (NASDAQ: ATHX) reported its financial results for the three months ended March 31, 2022 (Press release, Athersys, MAY 6, 2022, View Source [SID1234613779]). In anticipation of the announcement in May of topline data from Athersys’ partner, HEALIOS K.K. (Healios), for its Phase 2/3 TREASURE study evaluating MultiStem (invimestrocel, HLCM051) for the treatment of ischemic stroke, Athersys will host its next investor conference call after the data are released. Athersys will share the conference call details in its news release reporting the data.

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"Since joining the Company in February, I’ve immersed myself in all aspects of the business to gain a better understanding of MultiStem, our clinical trial progress and our performance to date," commented Dan Camardo, Chief Executive Officer of Athersys. "I have had numerous introductory calls and discussions with stockholders who have been very supportive and patient of the work we’re doing to advance MultiStem and bring this unique cell therapy to market. I’ve also had discussions with the Board and I’m confident that we have the right strategy in place. With thoughtful and timely execution, we will be well-positioned to meet our long-term goals."

First quarter 2022 highlights and recent events:

Received approval from the U.S. Food and Drug Administration (FDA) to use bioreactor manufactured MultiStem product in our MACOVIA and MATRICS studies, enabling the generation of critical clinical data with this next-generation bioreactor-based product and laying the groundwork for subsequent clinical work with the larger-scale bioreactor format. The approval of the bioreactor process represents a significant milestone in transitioning from small scale 2-dimensional manufacturing to large scale 3-dimensional manufacturing, thereby allowing significantly more product to be produced at lower cost of goods. The ability to produce product at these large scales represents a significant competitive advantage in the cell therapy field;
Appointed Daniel A. Camardo as Chief Executive Officer, effective February 14, 2022. Mr. Camardo is a senior pharmaceutical and biotech executive with more than 25 years of commercial leadership experience. He joins Athersys to lead the Company forward to complete the development, approval, launch and commercialization of the Company’s MultiStem cell therapy;
Noted completion by the last patient in the Healios TREASURE study of the 365-day visit, fulfilling the required secondary endpoint measures and completing the data set for the study. Topline data are expected in May;
Continued enrollment in the Athersys Phase 3 MASTERS-2 study evaluating MultiStem cell therapy to treat ischemic stroke in the United States, Europe and other regions. Initiated new clinical sites in Europe and Asia;
Reached agreements with both the FDA and the European Medicinal Agency (EMA) on the pediatric development plan with MultiStem for the stroke program;
Filed for a new patent application that covers multiple aspects of the large scale bioreactor process for MultiStem production, building on our extensive intellectual property portfolio; and
Held a virtual investor event titled "MultiStem Clinical Programs: An In-Depth Look". The program provided an understanding of the anticipated program milestones and why the Company is well-positioned to deliver on its mission to change the future of regenerative medicine.
"Receiving FDA approval to use the bioreactor manufactured product gives us confidence as we further scale our third-generation bioreactor manufacturing process to be able to produce product to meet potential commercial demand. I’m very proud of everyone involved in helping make this achievement a reality," commented Dr. John Harrington, Executive Vice President and Chief Scientific Officer.

"An important priority for us is to continue strengthening the partnership we have with Healios. We are working closely together to advance the clinical programs in stroke and acute respiratory distress syndrome and establish appropriate manufacturing supply for potential commercialization in Japan," added Mr. Camardo. "With the last TREASURE trial patient completing their 365-day visit, we are now actively planning with Healios for the release of topline data in May. This is an important milestone for both companies and we plan to host a conference call soon after the data are released to discuss the details."

First Quarter Results

Revenues increased to $2.9 million for the three months ended March 31, 2022 compared to no revenues for the three months ended March 31, 2021. Our collaboration revenues currently fluctuate from period to period based on the delivery of services under our arrangement with Healios.

Research and development expenses increased to $20.9 million for the three months ended March 31, 2022 from $17.5 million for the comparable period in 2021. The $3.4 million increase is associated with increases in clinical trial and manufacturing process development costs of $1.8 million, personnel costs of $0.8 million, outside service costs of $0.7 million and internal research supplies of $0.4 million. These increases were partially offset by decreases in other research and development costs of $0.3 million. Our clinical development, clinical manufacturing and manufacturing process development expenses vary over time based on the timing and stage of clinical trials underway, manufacturing campaigns for clinical trials and manufacturing process development projects.

General and administrative expenses decreased to $4.1 million for the three months ended March 31, 2022 from $8.8 million for the comparable period in 2021. The decrease is primarily related to legal expenses incurred in connection with the complaint filed by Dr. Hardy Kagimoto against the Company, its settlement, and the expenses associated with Dr. Gil Van Bokkelen’s separation letter agreement, including $2.3 million of one-time non-cash stock compensation expense in the first quarter of 2021.

Net loss for the first quarter of 2022 was $22.2 million compared to a net loss of $26.5 million in the first quarter of 2021. The difference primarily results from the above variances.

During the three months ended March 31, 2022, net cash used in operating activities was $20.2 million compared to $17.1 million in the three months ended March 31, 2021. At March 31, 2022, we had $21.8 million in cash and cash equivalents, compared to $37.4 million at December 31, 2021.

Conference Call

Members of the management team will host a conference call soon after the TREASURE data are released. The details for the conference call will be included in the data release.

On May 6, 2022 AnPac Bio-Medical Science Co., Ltd. ("AnPac Bio," the "Company" or "we") (ANPC), a biotechnology company with operations in the United States and China focused on early cancer screening and detection, reported that the Nasdaq Hearings Panel (the "Panel") has granted the request of AnPac Bio to transfer the Company’s American Depositary Shares from The Nasdaq Global Market to The Nasdaq Capital Market, effective May 6, 2022 and to continue its listing on The Nasdaq Stock Market, subject to various conditions (Press release, Anpac Bio, MAY 6, 2022, View Source [SID1234613778]). The Nasdaq Capital Market has lower listing requirements than those of The Nasdaq Global Market, while both are a part of The Nasdaq Stock Market.

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Under the terms of the decision, the Panel has stated that on or before May 31, 2022, the Company must evidence compliance with The Nasdaq Capital Market’s $2.5 million stockholder’s equity requirement, by filing a Form 6-K with the U.S. Securities and Exchange Commission, containing: 1) a description of the completed transactions or events that enabled the Company to satisfy the stockholder’s equity requirement for continued listing; and 2) a balance sheet, no older than 60 days with pro forma adjustments for any significant transactions or events occurring on or before the report date, which evidences compliance with the stockholders’ equity requirement; and 3) a disclosure that the Company believes it also satisfies the stockholders’ equity requirement as of the report date. The transfer to The Nasdaq Capital Market does not resolve the dollar bid requirement, which remains outstanding.

In order to fully comply with the terms of this decision, the Company must be able to demonstrate compliance with all applicable requirements for continued listing on The Nasdaq Capital Market by May 31, 2022. In that regard, the Company is currently in a grace period for the $1 bid price requirement that runs through September 5, 2022. As a result, the Company does not have to regain compliance with the bid price requirement in order to satisfy the decision. Companies listed on The Nasdaq Capital Market may be eligible for a second 180-day grace period for bid price if they meet certain standards, including a demonstration that stockholders’ equity is at least $5 million. In the event the Company is unable to meet the terms of the decision, the Company may seek a further extension from the Panel not to exceed September 20, 2022; however, there can be no assurance that the Panel would grant a further extension or that the Company will return to compliance.