On April 14, 2022 BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a clinical stage global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have high unmet medical needs, reported its financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update (Press release, BeyondSpring Pharmaceuticals, APR 14, 2022, View Source;utm_medium=rss&utm_campaign=beyondspring-announces-fourth-quarter-and-year-end-2021-financial-results-and-provides-a-corporate-update [SID1234612218]). At the start of 2022, the Company took steps to streamline its operations and is focused on executing on near-term opportunities for value creation.

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"We are pleased with the ongoing discussions with China NMPA on the NDA review of the Plinabulin and G-CSF combination for the prevention of chemotherapy-induced neutropenia (CIN). The G-CSF market in China is significant, with $1.2B in sales in 2020 and approximately 30% annual growth since 2017," said Dr. Lan Huang, co-founder, chairman and chief executive officer of BeyondSpring. "We are also moving forward to target an NDA filing in China by year-end for Plinabulin in the non-small cell lung cancer (NSCLC) indication. In addition, we are continuing our discussions with the FDA regarding the clinical and regulatory pathway for Plinabulin in CIN and NSCLC in the U.S. Above all, we remain committed to bringing Plinabulin to market to help many patients in need."

Recent Clinical and Corporate Highlights

Business Development Update

In August 2021, entered into an exclusive commercialization and co-development partnership with Jiangsu Hengrui Pharmaceuticals Co., Ltd. ("Hengrui’) for Plinabulin in Greater China
Hengrui, a leading oncology R&D and commercial company in China, has exclusive commercialization and co-development rights to all indications for Plinabulin;
In September 2021, the Company received a 200M RMB (est. US$31M) upfront payment and will be eligible to receive up to 1.1B RMB (est. US$171M) upon achieving certain regulatory and sales milestones;
The Company will supply Plinabulin, retaining manufacturing rights. The Company will receive all proceeds from sales of Plinabulin and pay Hengrui a pre-determined percentage of such sales.
Clinical Development Update

In September 2021, presented new data on Plinabulin from the CIN prevention program with three posters at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2021 Congress
Severe Neutropenia (Grade 4) as a Population-Based Predictor for Adverse Clinical Outcome of CIN;
Prediction of Febrile Neutropenia, Hospitalization Rates, and Infection Rates in CIN Patients Treated with the Plinabulin and Pegfilgrastim Combination using a Meta-Analysis -based Tool;
Impact of Adding Plinabulin to Pegfigrastim for the Prevention of CIN, on Patient Quality of Life.
In September 2021, presented positive top-line final Phase 3 DUBLIN-3 data in 2nd/3rd line NSCLC patients with EGFR Wild Type at the ESMO (Free ESMO Whitepaper) 2021 Congress
The combination (Plinabulin + docetaxel) showed superior efficacy benefit in overall survival (OS), progression-free survival (PFS), objective response rate (ORR) with statistical significance and a significant reduction of grade 4 neutropenia vs. docetaxel alone.
IIT Studies of Plinabulin combined with PD-1/PD-L1 inhibitors in multiple cancers
In October 2021, initiated Phase 2 study of Plinabulin in combination with nivolumab and ipilimumab in extensive stage small cell lung cancer (SCLC) who failed platinum and checkpoint inhibitors (Big Ten Cancer Research Consortium). In the Phase 1 portion of the study, this combination showed encouraging efficacy of 43% ORR and long duration of treatment in the same patient population;
In June 2021, initiated Phase 1 study of Plinabulin in combination with PD-1/PD-L1 inhibitor and radiotherapy for patients in seven advanced solid tumors (MD Anderson Cancer Center).
Fourth Quarter 2021 Financial Results `

General and administrative (G&A) expenses were $5.0 million for the quarter ended December 31, 2021, which included a non-cash credit of $2.0 million related to the reversal of share-based compensation expense. For the same period in the prior year, G&A expenses were $10.4 million, which included $2.1 million in non-recurring personnel costs. The decrease was primarily driven by lower share-based compensation expense.
Net loss attributable to the Company was $9.5 million for the quarter ended December 31, 2021, compared to $17.6 million for the quarter ended December 31, 2020.
Full Year 2021 Financial Results

R&D expenses were $36.9 million for the year ended December 31, 2021, compared to $41.8 million for the year ended December 31, 2020. The $4.9 million decrease was primarily due to lower clinical development expense and non-cash share-based compensation expense, partially offset by higher personnel costs, pre-clinical and professional services expenses, as well as the $2.9 million NDA application fee paid to the FDA, which is expected to be refunded during the second quarter of 2022.
G&A expenses were $30.7 million for the year ended December 31, 2021, compared to $22.6 million for the year ended December 31, 2020. The majority of the $8.1 million increase was due to higher pre-commercialization expenses for Plinabulin. We do not expect to continue to incur pre-commercialization expenses during the next year. There were also increases in personnel costs, administrative expenses and other costs, which were partially offset by lower non-cash share-based compensation expense.
Net loss attributable to the Company was $64.2 million for the year ended December 31, 2021, compared to $61.0 million for the year ended December 31, 2020.
As of December 31, 2021, the Company had cash, cash equivalents, and short-term investments of $72.4 million. The Company believes it has sufficient cash to support its ongoing operations and clinical programs over the next year.
Fourth Quarter and Full Year 2021 Results Conference Call and Webcast Details
The management of BeyondSpring will host a conference call and webcast for the investment community today, April 14, 2022, at 8:00 am ET. The conference call can be accessed by dialing 877-451-6152 (U.S. and Canada) or +1-201-389-0879 (International). The passcode for the conference call is 13728822. To access the live webcast or subsequent archived recording, click here or visit the "investors" section of the BeyondSpring website at www.beyondspringpharma.com. The webcast will be recorded and available for replay on the Company’s website for 90 days.

On April 14, 2022 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported that it will release financial results for the first quarter of 2022 after the market close on Thursday, May 5th, 2022 (Press release, Akoya Biosciences, APR 14, 2022, View Source [SID1234612217]). Company management will host a conference call to discuss financial results at 5:00 p.m. ET.

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Investors interested in listening to the conference call may do so by dialing (833) 562-0146 for domestic callers or (661) 567-1226 for international callers, followed by Conference ID: 7363649. A live and archived webcast of the event will be available on the "Investors" section of the Akoya website at View Source

On April 14, 2022 AbbVie (NYSE: ABBV) reported that it will announce its first-quarter 2022 financial results on Friday, April 29, 2022, before the market opens. AbbVie will host a live webcast of the earnings conference call at 8 a.m. CT (Press release, AbbVie, APR 14, 2022, View Source [SID1234612216]). It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.

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On April 14, 2022 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported the initiation of two Phase 2 clinical studies evaluating SRF388, a potential first-in-class antibody against IL-27 (Press release, Surface Oncology, APR 14, 2022, View Source [SID1234612214]). The trials include a randomized Phase 2 clinical study evaluating SRF388 in combination with Roche’s atezolizumab and bevacizumab in patients with treatment-naïve hepatocellular carcinoma (HCC) and a Phase 2 monotherapy study in patients with previously-treated non-small-cell lung cancer (NSCLC).

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"While important progress has been made in recent years, unfortunately the prognosis for the majority of patients with hepatocellular carcinoma and previously-treated non-small cell lung cancer remains very poor," said Alison O’Neill, M.D., chief medical officer. "We have generated strong translational and early clinical data supporting a role for IL-27 blockade in these diseases, and we are pleased to be able to evaluate SRF388’s potential to improve patient outcomes in these indications."

Randomized Phase 2 Study in Patients with Treatment-Naive Unresectable or Metastatic Hepatocellular Carcinoma in Clinical Collaboration with Roche
The blinded, randomized Phase 2 study is enrolling approximately 100 patients with treatment-naïve unresectable or metastatic HCC. Patients are randomized to receive either SRF388 or a placebo in combination with atezolizumab and bevacizumab. The study will evaluate the ability of SRF388 to improve progression-free survival in combination with atezolizumab and bevacizumab compared to placebo plus atezolizumab and bevacizumab. Key secondary endpoints will include the safety, overall response rates and duration of response of the combinations. Due to the blinded nature of the study, Surface does not expect to have detailed clinical data prior to study conclusion but anticipates a futility analysis in early 2023 and final data in the first half of 2024.

Single-Arm Phase 2 Study in Patients with Non-Small-Cell Lung Cancer
The single-arm, Phase 2 study is enrolling up to 40 patients with NSCLC who have previously received treatment with one or more lines of therapy, including PD-1 blockade-based regimens or targeted therapies in disease cases with driver mutations. The primary endpoint will be overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.) with an anticipated data readout in 2023.

About SRF388
SRF388 is a fully human anti-IL-27 antibody designed to inhibit the activity of this immunosuppressive cytokine. Surface Oncology has identified particular tumor types, including liver, kidney and lung cancer, where IL-27 appears to play an important role in the immunosuppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. SRF388 targets the rate-limiting p28 subunit of IL-27, and preclinical studies have shown that treatment with SRF388 blocks the immunosuppressive biologic effects of IL-27, resulting in immune cell activation in combination with other cancer therapies including anti-PD-1 therapy, as well as potent anti-tumor effects as a monotherapy. Furthermore, Surface Oncology has identified a potential biomarker associated with IL-27 that may be useful in helping to identify patients most likely to respond to SRF388. In November 2020, Surface announced that SRF388 was granted Orphan Drug designation and Fast Track designation for the treatment of hepatocellular carcinoma from the FDA.

On April 14, 2022 CTI BioPharma Corp. (Nasdaq: CTIC) reported that VONJO (pacritinib), its novel oral kinase inhibitor with specificity for JAK2 and IRAK1, without inhibiting JAK1, has been included as a recommended treatment in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Myeloproliferative Neoplasms (Press release, CTI BioPharma, APR 14, 2022, View Source [SID1234612213]).

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"We are grateful that NCCN acted quickly to include VONJO with a Category 2A designation in its Clinical Practice Guidelines in Oncology as a first line treatment for high-risk patients with myelofibrosis with platelet counts <50 x 109/L who are not candidates for transplant. This therapeutic option helps address an unmet medical need for patients who previously have no other treatment options. There is no other FDA-approved first line treatment for these patients with a 2A designation within the NCCN guidelines," said Adam R. Craig, M.D., Ph.D., President, and Chief Executive Officer of CTI BioPharma. "Additionally, VONJO was included as a Category 2A designation as second line treatment for lower-risk and higher-risk patients with myelofibrosis with platelet counts ≥50 x 109/L who are not candidates for transplant. This placement provides additional treatment options for patients with myelofibrosis."

The new NCCN Guidelines are available online at www.nccn.org.

About VONJO (pacritinib)
Pacritinib is an oral kinase inhibitor with activity against wild type Janus Associated Kinase 2 (JAK2), mutant JAK2V617F form and FMS-like tyrosine kinase 3 (FLT3), which contribute to signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. Myelofibrosis is often associated with dysregulated JAK2 signaling. Pacritinib has higher inhibitory activity for JAK2 over other family members, JAK3 and TYK2. At clinically relevant concentrations, pacritinib does not inhibit JAK1. Pacritinib exhibits inhibitory activity against additional cellular kinases (such as CSF1R and IRAK1), the clinical relevance of which is unknown.

VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Important VONJO Safety Information
Hemorrhage:
Serious (11%) and fatal (2%) hemorrhages have occurred in VONJO-treated patients with platelet counts <100 × 109/L. Serious (13%) and fatal (2%) hemorrhages have occurred in VONJO-treated patients with platelet counts <50 × 109/L. Grade ≥3 bleeding events (defined as requiring transfusion or invasive intervention) occurred in 15% of patients treated with VONJO compared to 7% of patients treated on the control arm. Due to hemorrhage, VONJO dose-reductions, dose interruptions, or permanent discontinuations occurred in 3%, 3%, and 5% of patients, respectively.

Avoid use of VONJO in patients with active bleeding and hold VONJO 7 days prior to any planned surgical or invasive procedures. Assess platelet counts periodically, as clinically indicated. Manage hemorrhage using treatment interruption and medical intervention.

Diarrhea:
VONJO causes diarrhea in approximately 48% of patients compared to 15% of patients treated on the control arm. The median time to resolution in VONJO-treated patients was 2 weeks. The incidence of reported diarrhea decreased over time with 41% of patients reporting diarrhea in the first 8 weeks of treatment, 15% in Weeks 8 through 16, and 8% in Weeks 16 through 24. Diarrhea resulted in treatment interruption in 3% of VONJO-treated patients. None of the VONJO-treated patients reported diarrhea that resulted in treatment discontinuation. Serious diarrhea adverse reactions occurred in 2% of patients treated with VONJO compared to no such adverse reactions in patients in the control arm.

Control pre-existing diarrhea before starting VONJO treatment. Manage diarrhea with antidiarrheal medications, fluid replacement, and dose-modification. Treat diarrhea with anti–diarrheal medications promptly at the first onset of symptoms. Interrupt or reduce VONJO dose in patients with significant diarrhea despite optimal supportive care.

Thrombocytopenia:
VONJO can cause worsening thrombocytopenia. VONJO dosing was reduced due to worsening thrombocytopenia in 2% of patients with pre–existing moderate to severe thrombocytopenia (platelet count <100 × 109/L). VONJO dosing was reduced due to worsening thrombocytopenia in 2% of patients with pre–existing severe thrombocytopenia (platelet count <50 × 109/L).

Monitor platelet count prior to VONJO treatment and as clinically indicated during treatment. Interrupt VONJO in patients with clinically significant worsening of thrombocytopenia that lasts for more than 7 days. Restart VONJO at 50% of the last given dose once the toxicity has resolved. If toxicity recurs hold VONJO. Restart VONJO at 50% of the last given dose once the toxicity has resolved.

Prolonged QT interval:
VONJO can cause prolongation of the QTc interval. QTc prolongation of >500 msec was higher in VONJO-treated patients than in patients in the control arm (1.4% vs 1%). QTc increase from baseline by 60 msec or higher was greater in VONJO-treated patients than in control arm patients (1.9% vs 1%). Adverse reactions of QTc prolongation were reported for 3.8% of VONJO-treated patients and 2% of control arm patients. No cases of torsades de pointes were reported.

Avoid use of VONJO in patients with a baseline QTc of >480 msec. Avoid use of drugs with significant potential for QTc prolongation in combination with VONJO. Correct hypokalemia prior to and during VONJO treatment. Manage QTc prolongation using VONJO interruption and electrolyte management.

Major Adverse Cardiac Events (MACE):
Another Janus associated kinase (JAK)-inhibitor has increased the risk of MACE, including cardiovascular death, myocardial infarction, and stroke (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which VONJO is not indicated.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with VONJO particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur.

Thrombosis:
Another JAK-inhibitor has increased the risk of thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which VONJO is not indicated.

Patients with symptoms of thrombosis should be promptly evaluated and treated appropriately.

Secondary Malignancies:
Another JAK-inhibitor has increased the risk of lymphoma and other malignancies excluding non-melanoma skin cancer (NMSC) (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which VONJO is not indicated. Patients who are current or past smokers are at additional increased risk.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with VONJO, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.

Risk of Infection:
Another JAK-inhibitor has increased the risk of serious infections (compared to best available therapy) in patients with myeloproliferative neoplasms. Serious bacterial, mycobacterial, fungal and viral infections may occur in patients treated with VONJO. Delay starting therapy with VONJO until active serious infections have resolved. Observe patients receiving VONJO for signs and symptoms of infection and manage promptly. Use active surveillance and prophylactic antibiotics according to clinical guidelines.

Interactions with CYP3A4 Inhibitors or Inducers:
Co-administration of VONJO with strong CYP3A4 inhibitors or inducers is contraindicated. Avoid concomitant use of VONJO with moderate CYP3A4 inhibitors or inducers.

Drug interruptions due to an adverse reaction occurred in 27% patients who received VONJO 200 mg twice daily compared to 10% of patients treated with BAT. Dosage reductions due to an adverse reaction occurred in 12% of patients who received VONJO 200 mg twice daily compared to 7% of patients treated with BAT. Permanent discontinuation due to an adverse reaction occurred in 15% of patients receiving VONJO 200 mg twice daily compared to 12% of patients treated with BAT.

Please visit View Source for full Prescribing Information and the Medication Guide.