I-Mab’s Announcement on Unusual Price Movement

On January I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics (Press release, I-Mab Biopharma, JAN 28, 2022, View Source [SID1234607480]). The Company has noted the recent unusual fluctuations in the price and trading volume of the American depositary shares (the "ADSs") of the Company and emphasizes that its business and pipeline developments are all well on track and have no adverse changes . The Company has strong confidence in its global competitive pipeline and is accelerating ongoing transformation towards an integrated global biopharma as planned.

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Latest Development of Lemzoparlimab and Uliledlimab:

Lemzoparlimab: multiple clinical studies are ongoing in both the U.S. and China, including lemzoparlimab in combination with azacytidine in myelodysplastic syndrome (MDS) and acute myelocytic leukemia (AML), in combination with rituximab in non-Hodgekin’s lymphoma (NHL), and in combination with pembrolizumab (Keytruda ) or toripalimab (TUOYI ) in advanced solid tumors. Based on data from multiple on-going clinical trials so far, approximately 180 patients, including 120 patients with hemetological maglinancies, have been treated with lemzoparlimab without the need for priming dosing, and showed anti-tumor activity and a favorable safety profile and lack of a unwanted "sink effect". Data readout from MDS, NHL and solid tumor clinical trials is expected in 2022.

Uliledlimab in combination with toripalimab (TUOYI) : The China phase 2 cohort expansion study in patients with advanced or metastatic cancers who are refractory to or intolerant of all available therapies is ongoing. The company expects to submit the preliminary data to ASCO (Free ASCO Whitepaper) 2022.

In 2022, the Company expects to deliver a series of significant clinical milestones. As a result, the pipeline will be advanced to include 3—4 registrational clinical trials (lemzoparlimab, estansomatropin, felzartamab), 11 Phase 2 clinical trials (including 8 new trials) and 3 Phase 1 clinical trials by end of 2022.

Financial Position:

The company has strong cash position with approximately $700 million, as of 31 December, 2021.

Between 2022 to 2023, the company expects to receive over $100 million cash from the existing out-licensing deals. The current cash on hand is sufficient to fund the Company’s operations for three years.

The Company’s fundamentals remain very strong. In 2021, I-Mab has successfully delivered planned important clinical and corporate milestones and will continue building on the strong momentum to deliver critical new milestones, including reporting multiple key clinical data readouts, initiating new registrational trials and accelerating dual listing on The Main Board of The Stock Exchange of Hong Kong Limited, continually creating value for patients and shareholders.

Enveric Biosciences to Participate in Upcoming Investor Conferences in February 2022

On January 27, 2022 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a patient-centric biotechnology company developing next-generation mental health and oncology treatments by leveraging psychedelic-derived molecules for the mind and synthetic cannabinoids for the body, reported that Dr. Joseph Tucker, Chief Executive Officer of Enveric Biosciences, will participate in two upcoming investor conferences (Press release, Enveric Biosciences, JAN 27, 2022, View Source [SID1234607447]):

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Citi’s Psychedelic Drug Call Series
Tuesday, February 8th at 10:00 a.m. ET
A fireside chat hosted by Neena Bitritto-Garg, Citi’s Biotech analyst.

Aegis Capital Corp. Virtual Conference
Friday, February 25th at 3:00 p.m. ET
To access the event, please download and import the following iCalendar (.ics) files to your calendar system: Aegis Virtual Conference Calendar.

For more information about the events, or to schedule a one-on-one meeting with Enveric’s management team, please contact your appropriate Citi or Aegis representative, respectively, or send an email to KCSA Strategic Communications at [email protected].

FDA Grants Breakthrough Therapy Designation for Dizal Pharmaceutical’s DZD9008 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon20 Insertion

On January 27, 2022 Dizal Pharmaceutical Co., Ltd. (SHEX:688192) ("Dizal"), reported that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation to DZD9008 (Sunvozertinib) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy (Press release, Dizal Pharma, JAN 27, 2022, View Source [SID1234607464]).

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"Lung cancer patients with exon20 insertion mutations need better treatment. Sunvozertinib was specifically designed with high selectivity for inhibiting mutated EGFR, which causes cancers. Available clinical evidence shows that Sunvozertinib has the potential to provide the patients with a new and much improved targeted therapy," said Dr. Xiaolin Zhang, Chief Executive Officer at Dizal. "We are very pleased with FDA’s decision. Now Sunvozertinib has received Breakthrough Therapy Designation from both US FDA and China CDE, which validates Sunvozertinib’s differentiated profile. At Dizal, we are committed to discover and develop innovative medicines for the benefit of cancer patients globally."

Breakthrough Therapy designation is a process designed by US FDA, China CDE, and other regulatory agencies to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)[1].

About DZD9008 (Sunvozertinib)

DZD9008 is a rationally designed selective, irreversible, novel EGFR inhibitor. In global Phase 1/2 studies, it has demonstrated promising antitumor efficacy in pre-treated NSCLC patients with EGFR exon20 insertion mutations. Its confirmed ORR is 45.5% at 200 mg and 41.9% at 300 mg (data cut-off by July 30, 2021). It also shows efficacy among patients with brain metastasis or previously treated by Amivantamab. It was well tolerated with a manageable AE profile.

Dizal is conducting Phase 2 pivotal clinical trials in China, U.S., EU, Japan, Australia, South Korea and other countries and regions.

Beyond Air® Schedules Third Fiscal Quarter 2022 Financial Results Conference Call and Webcast

On January 27, 2022 Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported that it will report financial results for its third fiscal quarter ended December 31, 2021 on Thursday, February 10, 2022 (Press release, Beyond Air, JAN 27, 2022, View Source [SID1234607449]). The Company’s management team is scheduled to host a conference call and webcast at 4:30 pm Eastern Time the same day.

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Conference Call & Webcast
Thursday, February 10th @ 4:30 PM ET
Domestic: 877-407-0784
International: 201-689-8560
Passcode: 13726696
Webcast: View Source;tp_key=78e079398f

Insmed to Host Fourth Quarter and Full Year 2021 Financial Results Conference Call and Provide a Business and Pipeline Update on Thursday, February 17, 2022

On January 27, 2022 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, reported that it will release its fourth quarter and full year 2021 financial results on Thursday, February 17, 2022 (Press release, Insmed, JAN 27, 2022, View Source [SID1234607465]).

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Insmed management will provide a business and pipeline update in addition to a discussion of the financial results in a conference call for investors from 8:00 to 9:30 a.m. ET on Thursday, February 17, 2022.

Shareholders and other interested parties may participate in the conference call by dialing (844) 200-6205 (U.S. toll free), (646) 904-5544 (U.S. local), or +1-929-526-1599 (international) and referencing access code 359415. The call will also be webcast live on the company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately 1 hour after its completion through March 17, 2022, by dialing (866) 813-9403 (U.S. toll free), (929) 458-6194 (U.S. local), or +44-204-525-0658 (international) and referencing access code 838814. A webcast of the call will also be archived for 90 days under the Investor Relations section of the company’s website at www.insmed.com.