On March 3, 2022 Helsinn Group (Helsinn), a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track-record of commercial execution, and BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company that focuses on genetic diseases and cancers, reported an update to their existing strategic collaboration to develop, manufacture and commercialize infigratinib for oncology indications (Press release, BridgeBio, MAR 3, 2022, View Source [SID1234609476]).

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Under the terms of the amended and restated agreement, Helsinn will gain an exclusive license to commercialize infigratinib in the U.S. and will be responsible for developing, manufacturing and commercializing infigratinib in oncology indications worldwide except for achondroplasia or any other skeletal dysplasias and except in mainland China, Hong Kong and Macau. BridgeBio will be eligible to receive regulatory and commercial milestone payments as well as tiered royalties on adjusted net sales from Helsinn. BridgeBio will retain all rights to develop, manufacture and commercialize infigratinib in skeletal dysplasia, including achondroplasia.

In 2021, Helsinn and BridgeBio obtained accelerated approval for TRUSELTIQ (infigratinib) from the U.S. Food and Drug Administration (FDA) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. Additionally, the two parties received conditional approval by Health Canada and provisional approval by the Therapeutics Goods Association in Australia for TRUSELTIQ (infigratinib) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement. Continued approval in the U.S., Canada and Australia for this indication may be contingent upon confirmatory trials.

Infigratinib is not FDA-, Health Canada- or Therapeutics Goods Association-approved for any other indication in the United States, Canada and Australia, and is not approved for use by any other health authority.

Giorgio Calderari, Helsinn Group CEO commented, "We are delighted to gain the exclusive license to commercialize infigratinib in the U.S. This perfectly complements our recently announced Fully Integrated Targeted Therapy (FITT) Strategy and will utilize our unique capabilities and expertise to take products through development and to patients living with cancer across the globe. BridgeBio is a great partner, and we are looking forward to continuing our relationship with them through our non-exclusive collaboration framework to propose co-development and co-commercialization opportunities for preclinical precision oncology programs."

"We are expanding our partnership with Helsinn so that even more patients with FGFR-driven cancers will ultimately be able to access infigratinib. Focused execution means reducing the scope of our internal activity. We will continue to advance high-quality programs in our pipeline, while allowing Helsinn to develop and commercialize infigratinib in cancer indications for patients in need," said Neil Kumar, Ph.D., founder and CEO of BridgeBio.

In March 2021, Helsinn and BridgeBio entered into a global license and collaboration agreement to co-commercialize infigratinib for oncology in the U.S. and to co-develop, manufacture and commercialize infigratinib for such indications outside the U.S., excluding mainland China, Hong Kong and Macau. BridgeBio previously entered a strategic collaboration with LianBio for development and commercialization of infigratinib in oncology indications in mainland China, Hong Kong and Macau.

In November 2021, Helsinn and BridgeBio entered into a strategic collaboration to co-develop and co-commercialize a potentially first-in-class inhibitor designed to target glutathione peroxidase 4 (GPX4), which will be investigated in patients with difficult-to-treat tumors. Alongside this, Helsinn and BridgeBio established a new non-exclusive collaboration framework agreement that allows the companies to propose co-development and co-commercialization opportunities for preclinical precision oncology programs. The terms in this strategic collaboration have not changed.

About Infigratinib

Infigratinib is a potent orally administered, selective, ATP‐competitive, kinase inhibitor of FGFRs, with highest affinity for FGFR 1, 2, and 3. The therapy is currently under investigation as a potential first-line treatment for individuals with FGFR2-altered cholangiocarcinoma (bile duct cancer) and in the adjuvant setting for individuals with FGFR3-altered urothelial carcinoma (bladder cancer). Infigratinib is also in development in skeletal dysplasias for the treatment of individuals with FGFR3-altered achondroplasia. BridgeBio retains full rights to develop and commercialize infigratinib in skeletal dysplasias for the treatment of individuals with FGFR3-altered achondroplasia.

About Cholangiocarcinoma (CCA)

CCA represents an aggressive group of malignancies that form in the bile ducts. Although rare in most countries (with a worldwide estimated incidence of <6 per 100,000 people), the incidence of this malignancy is increasing worldwide. Because the disease is usually asymptomatic at early-stages, diagnosis may be delayed until advanced stages, when CCA typically presents as locally advanced or metastatic disease. Despite continuing advances in treatments, the prognosis for this disease remains poor, with a 5-year survival rate of <20%. FGFR2 genetic alterations are present in approximately 15% to 20% of CCA patients and represent potential targets for treatments.1,2

U.S. Indication and Important Safety Information for TRUSELTIQ (infigratinib)

TRUSELTIQ (infigratinib) capsules 25mg/100mg is indicated for the treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

Accelerated approval was granted based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Warnings and precautions

Ocular toxicity: Retinal pigment epithelial detachment (RPED), which may cause blurred vision, occurred in 11% of 351 patients treated with TRUSELTIQ, including patients with asymptomatic RPED, with a median onset of 26 days. Perform comprehensive ophthalmological exam including optical coherence tomography prior to initiating, at 1 month, at 3 months, and then every 3 months during treatment with TRUSELTIQ. Urgently evaluate patients for onset of visual symptoms and follow up every 3 weeks until resolved or TRUSELTIQ is discontinued. Withhold TRUSELTIQ as recommended. Dry eye occurred in 29% of 351 patients; treat with ocular demulcents as needed
Hyperphosphatemia and soft tissue mineralization: Hyperphosphatemia, which can lead to soft tissue mineralization, cutaneous calcinosis, non-uremic calciphylaxis, vascular calcification, and myocardial calcification, occurred in 82% of 351 patients treated with TRUSELTIQ, with a median time to onset of 8 days (range 1-349); 83% of 351 patients treated with TRUSELTIQ received phosphate binders. Monitor for hyperphosphatemia throughout treatment. Initiate phosphate-lowering therapy for serum phosphate >5.5 mg/dL; withhold TRUSELTIQ and initiate phosphate-lowering therapy for serum phosphate >7.5 mg/dL; withhold, reduce the dose, or permanently discontinue TRUSELTIQ based on duration and severity of hyperphosphatemia
Embryo-fetal toxicity: TRUSELTIQ can cause fetal harm. Advise pregnant women of the potential risk to the fetus; advise females of reproductive potential and men who are partnered with women of reproductive potential to use effective contraception during treatment with TRUSELTIQ and for 1 month after the final dose
Adverse reactions

Most common adverse reactions (incidence ≥20%, all grades): nail toxicity, stomatitis, dry eye, fatigue, alopecia, palmar-plantar erythrodysesthesia syndrome, arthralgia, dysgeusia, constipation, abdominal pain, dry mouth, eyelash changes, diarrhea, dry skin, decreased appetite, blurred vision, and vomiting
Most common laboratory abnormalities (incidence ≥20%, all grades): increased creatinine, increased phosphate, decreased phosphate, increased alkaline phosphatase, decreased hemoglobin, increased alanine aminotransferase, increased lipase, increased calcium, decreased lymphocytes, decreased sodium, increased triglycerides, increased aspartate aminotransferase (AST), increased urate, decreased platelets, decreased leukocytes, decreased albumin, increased bilirubin, and decreased potassium
Drug interactions

CYP3A inhibitors: Avoid use with strong and moderate CYP3A inhibitors
CYP3A inducers: Avoid use with strong and moderate CYP3A inducers
Gastric acid–reducing agents: Avoid coadministration with proton pump inhibitors, histamine-2 receptor antagonists (H2RA), and locally acting antacids. If coadministration of H2RA or locally acting antacids cannot be avoided, separate TRUSELTIQ administration
H2RA: Take TRUSELTIQ 2 hours before or 10 hours after
Locally-acting antacid: Take TRUSELTIQ 2 hours before or 2 hours after
Dosage and administration

Prior to initiating TRUSELTIQ: Confirm FGFR2 fusion or rearrangement; perform comprehensive ophthalmic exam including OCT; confirm negative pregnancy test in females of reproductive potential
Starting dose: Take TRUSELTIQ orally once daily on Days 1-21 of 28-day cycles; continue treatment until disease progression or unacceptable toxicity. Take TRUSELTIQ on an empty stomach with a glass of water at least 1 hour before or 2 hours after food
No renal or hepatic impairment
125 mg (one 100 mg capsule and one 25 mg capsule)
Mild and moderate renal impairment (creatinine clearance 30-89 mL/min)
100 mg (one 100 mg capsule)
Mild hepatic impairment (total bilirubin >upper limit of normal [ULN] to 1.5 x ULN or AST > ULN)
100 mg (one 100 mg capsule)
Moderate hepatic impairment (total bilirubin >1.5 to 3 x ULN with any AST)
75 mg (three 25 mg capsules)
Dose modification: Consult the TRUSELTIQ full Prescribing Information for dose modifications and monitoring recommendations for RPED, hyperphosphatemia, and other Grades 3-4 adverse reactions
For additional information, please see the U.S. Full Prescribing Information for TRUSELTIQ

References
1Banales, J., Cardinale, V., Carpino, G. et al. Cholangiocarcinoma: current knowledge and future perspectives consensus statement from the European Network for the Study of Cholangiocarcinoma (ENS-CCA). Nat Rev Gastroenterol Hepatol 13, 261–280 (2016). View Source

2 Banales, J.M., Marin, J.J.G., Lamarca, A. et al. Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol 17, 557–588 (2020). View Source

On March 3, 2022 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13), the innovative, commercial-stage biopharmaceutical company, reported its audited financial results for the year ended December 31, 2021 and provides updates on key clinical and commercial developments since the start of 2022 (Press release, Hutchison China MediTech, MAR 3, 2022, View Source [SID1234609475]).

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All amounts are expressed in U.S. dollars unless otherwise stated.

2021 FULL YEAR Results & Business Updates
"2021 was an exceptional year for HUTCHMED," said Mr. Simon To, Chairman of HUTCHMED. "Commercial success on ELUNATE and the launches of SULANDA and ORPATHYS contributed to an almost four-fold increase in consolidated oncology/immunology revenues to $119.6 million, with momentum continuing in 2022.

ORPATHYS took a major step forward in 2021 with its first approval and important, and as yet unpublished, data from the SAVANNAH study in combination with TAGRISSO. We and our partner AstraZeneca[1] initiated four Phase III studies and one Phase II study, with registration potential, for ORPATHYS during 2021. These actions have triggered $40 million in milestone payments to HUTCHMED since mid-2021. A seventh registration study, a global Phase III in NSCLC[2], the SAFFRON study, is set to initiate in mid-2022.

We are rapidly progressing our plan to expand our oncology assets into global markets. Led by our team of over 800-personnel in discovery, development and manufacturing operations, we have an un-equaled fifteen-year track-record of producing highly quality novel oncology/immunology drug candidates.

Seven of our assets are now being developed outside China. In addition to the global progress of ORPATHYS, surufatinib’s U.S. NDA[3] and EU MAA[4] are in the later stages of regulatory review for advanced NETs; enrollment was completed for fruquintinib in a fourteen-country global Phase III study, the FRESCO-2 study, in CRC[5] which reads-out later in 2022; positive and differentiated POC data was presented for amdizalisib and sovleplenib; and our FGFR[6], IDH1/2[7], ERK[8], third generation BTK[9] and CSF-1R[10] inhibitors all made good progress in early development.

With a strong track record in bringing innovative drugs to patients through rigorous clinical trials, our seasoned clinical team is now enrolling 13 registration studies for six assets with an additional 5 registration studies set to initiate in 2022. With over $1 billion in cash, and the intention to divest further non-core assets, we anticipate having sufficient runway to see our plans through.

Our strategy is to launch a stream of new products in both the China and global markets over the coming years, helping patients with unmet needs and creating value for all our stakeholders."

I. COMMERCIAL OPERATIONS
Total revenues increased 56% to $356.1 million in 2021 (2020: $228.0m), driven by commercial progress on our three in-house developed oncology drugs ELUNATE, SULANDA and ORPATHYS;
Full year 2021 Oncology/Immunology consolidated revenues of $119.6 million, up 296% (2020: $30.2m), and in line with 2021 guidance of $110-130 million;
Continuing expansion of in-house oncology commercial organization in China, which at the end of 2021 numbered about 630 personnel (end 2020: ~390) covering over 2,500 oncology hospitals and over 29,000 oncology physicians;
ELUNATE (fruquintinib in China) in-market sales[11] increased 111% to $71.0 million (2020: $33.7m), reflecting a full year of HUTCHMED management of all on-the-ground medical detailing, promotion and local and regional marketing activities in China;
SULANDA (surufatinib in China) launched for both extra-pancreatic NET and pancreatic NET with in-market sales in 2021 of $11.6 million (2020: nil). An encouraging start in the self-pay market and positioned well for national reimbursement which started in January 2022;
ORPATHYS (savolitinib in China) launched in mid-2021 through AstraZeneca’s extensive oncology commercial organization, with in-market sales of $15.9 million (2020: nil). Rapid initial self-pay uptake due to being the first-in-class selective MET[12] inhibitor in China;
Successful management of the NRDL[13] process to expand access to our key products in January 2022. Concluded ELUNATE NRDL renewal and first time NRDL inclusion of SULANDA; and
S. commercial team continued to build for the potential surufatinib U.S. approval in 2022. The team, more than 30 personnel, is fully engaged on all aspects of launch readiness including supply chain, market access, marketing, sales and commercial operations.

II. REGULATORY ACHIEVEMENTS
China
Received China NMPA[15] NDA approval for ORPATHYS (savolitinib) as a treatment for patients with MET exon 14 skipping alteration NSCLC in June 2021, making savolitinib the first-in-class selective MET inhibitor in China.
Received second China NMPA NDA approval for SULANDA (surufatinib) in June 2021 as a treatment for patients with advanced pancreatic NET;
A $25 million milestone payment was made to us by AstraZeneca in July 2021 upon first sale of ORPATHYS in China;
Received Breakthrough Therapy Designation in China for amdizalisib (HMPL-689) in September 2021 for the treatment of relapsed or refractory follicular lymphoma; and
Received Breakthrough Therapy Designation in China for sovleplenib (HMPL-523) in January 2022 for the treatment of ITP[16].

United States and Europe
Surufatinib U.S. FDA[17] NDA process update:
Completed submission of U.S. FDA NDA for surufatinib, which was accepted in June 2021, for the treatment of both pancreatic and extra-pancreatic NET;
S. FDA NDA review, as well as the clinical site inspections and pre-approval inspections of our manufacturing facilities, are ongoing, several inspections have been completed with others pending subject to COVID-19 travel restrictions and security requirements for foreign visitors; and
The PDUFA[18] goal date is April 30, 2022 and mid- and late-cycle review meetings with the FDA have completed. Timing of completion of the NDA review is subject to FDA scheduling limitations.
Surufatinib EMA[19] MAA process update:
Fully submitted EMA MAA for surufatinib, which was validated and accepted in July 2021, for the treatment of both pancreatic and non-pancreatic NET; and
Completed the 120-day assessment, and now entering the later stages of MAA review.
Savolitinib: conducted U.S. FDA EOP2[20] meeting for SAVANNAH study of savolitinib plus TAGRISSO in EGFR[21] TKI[22] refractory NSCLC.
Continued evaluation of SAVANNAH study for potential accelerated approval use; and
Completed clinical trial applications in U.S., EU and Japan for the SAFFRON study, a global pivotal Phase III study of savolitinib and TAGRISSO in patients with NSCLC who have progressed following TAGRISSO treatment due to MET amplification.

III. CLINICAL DEVELOPMENT ACTIVITIES
Savolitinib (ORPATHYS), a highly selective oral inhibitor of MET being developed broadly across MET-driven patient populations in lung and gastric cancer and renal cell carcinoma

Major clinical milestones for savolitinib in 2021:

Initiated SAMETA, a global Phase III pivotal study of the savolitinib plus IMFINZI combination in MET-driven, unresectable and locally advanced or metastatic PRCC in October 2021 (NCT05043090);
Initiated SANOVO, a pivotal Phase III study in China for the savolitinib plus TAGRISSO combination in treatment naïve patients with EGFR mutant NSCLC with MET aberration in September 2021 (NCT05009836);
Initiated SACHI, a pivotal Phase III study in China for the savolitinib plus TAGRISSO combination in patients with EGFR mutant NSCLC who have progressed following EGFR TKI treatment due to MET amplification in November 2021 (NCT05015608);
Initiated Phase II study with potential for registration (NCT04923932) for savolitinib in metastatic gastric cancer with MET amplification in China in mid-2021;
Initiated a confirmatory China Phase IIIb post-approval study (NCT04923945) of savolitinib monotherapy in MET exon 14 skipping alteration patients in mid-2021; and
A further $15 million milestone payment, to us by AstraZeneca, was triggered in February 2022 upon initiation of start-up activities for SAFFRON.

Major savolitinib clinical data presentations in 2021:

Presented CALYPSO Phase II study data in MET-driven PRCC patients (NCT02819596) for savolitinib in combination with IMFINZI at the 2021 ASCO (Free ASCO Whitepaper)[23] Annual Meeting;
Published in The Lancet Respiratory Medicine updated data from the Phase II study in patients with MET exon 14 skipping alteration NSCLC (NCT02897479); and
Presented final Phase II data at WCLC[24] 2020 for the TATTON study (NCT02143466) in NSCLC patients with MET amplification who had progressed after prior treatment with EGFR inhibitors.

Potential upcoming clinical and regulatory milestones for savolitinib in 2022:

Submit for presentation the SAVANNAH Phase II study (NCT03778229) for the savolitinib plus TAGRISSO combination in NSCLC patients harboring EGFR mutation and MET amplification or overexpression at a scientific conference in the second half of 2022; and
Commence enrollment in SAFFRON, a global, pivotal Phase III study for the savolitinib plus TAGRISSO combination in mid-2022 (NCT05261399).

Surufatinib (SULANDA in China), an oral inhibitor of VEGFR[25], FGFR and CSF-1R designed to inhibit tumor angiogenesis and promote the body’s immune response against tumor cells via tumor associated macrophage regulation; approved and launched in China

Major clinical milestones for surufatinib in 2021:

Initiated the SURTORI-01 Phase III trial in NEC[26] patients in China, the first pivotal study combining SULANDA and TUOYI, Junshi’s[27] anti-PD-1 antibody, in September 2021 (NCT05015621);
Initiated a bridging study in NET patients in Japan in September 2021 (NCT05077384) based on dialogue with the Japanese PMDA[28]; and
Initiated an international Phase Ib/II study of surufatinib combined with tislelizumab (NCT04579757), BeiGene’s[29] PD-1[30] antibody, in the U.S. and Europe in March 2021.

Major surufatinib clinical data presentations in 2021:

Presented NEC cohort data from the China Phase II study of surufatinib plus TUOYI (NCT04169672) at the 2021 ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) IO[31] 2021 annual meetings;
Presented data from the gastric and gastroesophageal junction cancers cohort of the China Phase II study of surufatinib plus TUOYI (NCT04169672) at the 2021 ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) IO 2021 annual meetings;
Presented data from two additional cohorts of the China Phase II study of surufatinib plus TUOYI (NCT04169672) at the ESMO (Free ESMO Whitepaper) IO 2021 for esophageal and small cell lung cancer;
Presented updated results from U.S. Phase Ib monotherapy NET cohorts (NCT02549937) in heavily pretreated patients with NET at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting;
Presented a subgroup analysis by Ki-67 and baseline CgA[32] of the Phase III monotherapy study in pancreatic NET (SANET-p) (NCT02589821) at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting; and
Presented Phase II data for surufatinib monotherapy in BTC[33] patients (NCT02966821) at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting in U.S. patients after first-line chemotherapy.

Potential upcoming clinical and regulatory milestones for surufatinib in 2022:

Submit for presentation data from the Phase Ib/II combination study with tislelizumab at a scientific conference in the second half of 2022;
Submit for presentation further Phase II data for the TUOYI combination study for biliary tract, thyroid cancer, non-small cell lung cancer, endometrial cancer and sarcoma cohorts at a scientific conference in the second half of 2022, and
Plan to initiate SURTORI-02, a Phase III study of surufatinib in combination with TUOYI in esophageal cancer in China in the second half of 2022.

Fruquintinib (ELUNATE in China), a highly selective oral inhibitor of VEGFR 1/2/3 designed to improve kinase selectivity to minimize off-target toxicity and thereby improve tolerability; approved and launched in China

Major clinical milestones for fruquintinib in 2021:

Completed enrollment in the FRESCO-2 global Phase III registration study (NCT04322539) in refractory metastatic CRC in late 2021, with 691 patients recruited in 15 months, across 14 countries including U.S., EU, Japan and Australia, ahead of schedule;
Initiated registration-intent Phase II study in endometrial cancer for fruquintinib in combination with TYVYT (NCT03903705) following discussion with the NMPA;
Initiated a Phase II study in China and Korea for fruquintinib in combination with tislelizumab (NCT04716634) with advanced or metastatic, unresectable gastric cancer, CRC or NSCLC;
Initiated a Phase Ib/II study in the U.S. for fruquintinib in combination with tislelizumab (NCT04577963) in patients with triple negative breast or endometrial cancer and metastatic CRC; and
Completed enrollment in four cohorts of the Phase II study of fruquintinib combined with TYVYT (NCT03903705), in CRC, endometrial cancer, HCC[34] and RCC[35] in China.

Major fruquintinib clinical data presentations in 2021:

Presented preliminary endometrial cancer, HCC and RCC cohorts data from the Phase Ib/II studies of fruquintinib combined with TYVYT at CSCO[36] 2021 (NCT03903705);
Presented preliminary CRC cohorts data from the Phase Ib/II studies of fruquintinib combined with TYVYT and of fruquintinib combined with geptanolimab, Genor’s[37] PD-1 antibody, at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting (NCT04179084 and NCT03977090, respectively); and
Presented Phase Ib U.S. monotherapy data in two different cohorts of patients with refractory metastatic CRC (NCT03251378) at the 2022 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium.

Potential upcoming clinical and regulatory milestones for fruquintinib in 2022:

Complete enrollment of the FRUTIGA China Phase III registration study (NCT03223376) in advanced gastric cancer in 2022, which is expected to enroll about 700 patients in China;
Report outcome of the FRESCO-2 trial (NCT04322539) in the second half of 2022 when the event-driven primary endpoint, OS[38], is reached;
If FRESCO-2 is positive, HUTCHMED plans to initiate a simultaneous submission program to apply for fruquintinib marketing authorization with the U.S. FDA, the EMA and the PMDA; and
Plan to initiate Phase III studies of fruquintinib plus TYVYT combination in HCC, RCC and endometrial cancer in China.

Amdizalisib (HMPL-689), an investigative and highly selective oral inhibitor of PI3Kδ[39] designed to address the gastrointestinal and hepatotoxicity associated with currently approved and clinical-stage PI3Kδ inhibitors

Major clinical milestones for amdizalisib in 2021:

Initiated two Phase II studies with potential for registration in China for the treatment of patients with follicular lymphoma and patients with marginal zone lymphoma in April 2021; and
Initiated dose expansion portion of the Phase I/Ib study in the U.S. and Europe (NCT03786926) in the second half of 2021 in multiple types of non-Hodgkin’s lymphoma.

Major amdizalisib clinical data presentation in 2021:

Presented initial dose expansion data at ESMO (Free ESMO Whitepaper) in September 2021 at the RP2D[40], in patients with multiple types of non-Hodgkin’s lymphoma in China.

Potential upcoming clinical and regulatory milestones for amdizalisib in 2022:

Initiate additional Phase II studies with potential for registration intent in China in additional relapsed/refractory non-Hodgkin’s lymphoma indications in the second half of 2022;
Initiate studies in combination with other anti-cancer therapies in China in early 2022; and
Complete recruitment of patients for Phase II studies with potential for registration intent in China for the treatment of follicular lymphoma and marginal zone lymphoma in late 2022.

Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk[41], an important component of the B-cell receptor signaling pathway, for the treatment of hematological cancers and immune diseases

Major clinical and regulatory milestones for sovleplenib in 2021:

Initiated the ESLIM-01 Phase III pivotal study in ITP (NCT03951623) in China in October 2021; and
Initiated dose expansion portion of the international Phase I study in the second half of 2021 in multiple non-Hodgkin’s lymphoma indications.

Major sovleplenib clinical data presentations in 2021:

Presented initial Phase Ib ITP study (NCT03951623) in China at ASH (Free ASH Whitepaper) 2021[42]; and
Presented initial data from the dose escalation portion of the international Phase I study (NCT03779113) in lymphoma patients in the U.S. and Europe at ASH (Free ASH Whitepaper) 2021.

Potential upcoming clinical milestone for sovleplenib in 2022:

Complete U.S. IND and initiate Phase I study in the U.S. in patients with ITP.

Tazemetostat (TAZVERIK in the U.S. and Japan), an inhibitor of EZH2 licensed from Epizyme for which HUTCHMED is collaborating to research, develop, manufacture and commercialize in Greater China

Potential upcoming clinical and regulatory milestones for tazemetostat in 2022:

Initiate a bridging study in follicular lymphoma in China for conditional registration based on U.S. approvals;
Initiate the China portion of the global SYMPHONY-1 Phase III trial (NCT04224493) of tazemetostat combined with lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma after at least one prior line of therapy;
Initiate Phase II combination studies with other HUTCHMED assets; and
Engage with NMPA on potential path for regulatory approval for the treatment of patients with epithelioid sarcoma, a rare disease for which TAZVERIK has FDA approval.

HMPL-453, an investigative and highly selective oral inhibitor of FGFR 1/2/3

Initiated combination studies with other anti-cancer therapies, including chemotherapies and/or PD-1 antibodies, in China in January 2022 (NCT05173142).

HMPL-306, an investigative and highly selective oral inhibitor of IDH1/2 designed to address resistance to the currently marketed IDH inhibitors

Major clinical and regulatory milestones for HMPL-306 in 2021:

Initiated Phase I dose escalation study in China in hematological malignancies;
Initiated dose escalation portion of a Phase I study (NCT04764474) in the U.S. and Europe in patients with hematological malignancies with an IDH1 and/or IDH2 mutation in early 2021; and
Initiated dose escalation portion of a Phase I study (NCT04762602) in the U.S. and Europe in patients with solid tumors with an IDH1 and/or IDH2 mutation in early 2021.

Potential upcoming clinical and regulatory milestones for HMPL-306 in 2022:

Submit for presentation data from the dose escalation portion of the Phase I study (NCT04272957) in China at a scientific conference in mid-2022; and
Initiate dose expansion portion of the Phase I study in China in mid-2022; and
Initiate dose expansion portion of the Phase I studies in the U.S. and Europe in mid-2022.

HMPL-295, an investigative and highly selective oral inhibitor of ERK in the MAPK pathway [43] with the potential to address intrinsic or acquired resistance from upstream mechanisms such as RAS-RAF-MEK

Initiated Phase I trial (NCT04908046) in patients with advanced solid tumors in China in July 2021.

HMPL-760, an investigative, highly selective, third-generation oral inhibitor of BTK with improved potency versus first generation BTK inhibitors against both wild type & C481S mutant enzymes

Initiated Phase I trials in China (NCT05190068) and the U.S. (NCT05176691) in patients with advanced hematological malignancies in January 2022.

HMPL-653, an investigative, highly selective, and potent CSF-1R inhibitor designed to target CSF-1R driven tumors as a monotherapy or in combinations

Initiated Phase I trial in China (NCT05190068) in patients with advanced malignant solid tumors and tenosynovial giant cell tumors in January 2022.

HMPL-A83, a differentiated, red blood cell sparing CD47 monoclonal antibody

Completed IND submission for HMPL-A83 in China in early 2022.

IV. MANUFACTURING
Commercial scale-up and launches of SULANDA and ORPATHYS, alongside ongoing supply of ELUNATE;
Completed all relevant amdizalisib and sovleplenib manufacturing process studies, in preparation for potential NDA submissions; and
Rapid progress in building our new flagship Shanghai manufacturing facility, designed to increase our novel drug product manufacturing capacity by over five-fold. Small molecule and large molecule equipment installation is planned for late 2022, with GMP compliance targeted for late 2023.

V. OTHER VENTURES
Other Ventures include our profitable prescription drug marketing and distribution platforms covering about 290 cities and towns in China with around 2,900 mainly manufacturing and commercial personnel.

Other Ventures delivered encouraging growth with consolidated revenues up 20% (13% at CER[44]) to $236.5 million (2020: $197.8m). This does not include revenues from our non-consolidated joint venture SHPL[45], which also grew by 20% (12% at CER) to $332.6 million (2020: $276.4m);
Consolidated net income attributable to HUTCHMED from our Other Ventures grew by 24% (16% at CER) to $54.4 million (2020: $44.0m), excluding one-time gains; and
One-time gains totaled $88.5 million (2020: $28.8m), including $82.9 million (2020: nil) from the divestment of HBYS[46] and $5.6 million (2020: $28.8m) from land compensation, before withholding tax.

VI. OTHER CORPORATE DEVELOPMENTS
Completed listing on the Main Board of HKEX[47], raising net proceeds of approximately $585 million;
Completed divestment of interest in HBYS, a non-core and non-consolidated over-the-counter drug joint venture business for $159.1 million in cash, representing about 22 times HBYS’s adjusted net profit attributable to HUTCHMED equity holders in 2020 with an additional $46.4 million related to declared dividends expected to be collected in 2022;
Entered into a collaboration with Epizyme in August 2021 to research, develop, manufacture and commercialize in Greater China its drug TAZVERIK, an EZH2 inhibitor approved by the U.S. FDA for the treatment of certain patients with epithelioid sarcoma and follicular lymphoma;
Changed our group company name/corporate identity to HUTCHMED in April 2021, unifying the names of the majority of our key subsidiaries;
Announced a strategic partnership with Inmagene[48] in January 2021 to further develop four novel preclinical drug candidates discovered by HUTCHMED for the potential treatment of multiple immunological diseases; and
Arbitral award in favor of Hutchison Sinopharm[49] in connection with the termination of its distribution rights for SEROQUEL in mainland China by Luye Pharma Hong Kong Ltd. In 2021, the Hong Kong International Arbitration Centre made a final award in favor of Hutchison Sinopharm against Luye Pharma Hong Kong Ltd. in the amount of RMB253.2 million ($39.6 million), plus costs and interest. Payment of the award is expected in 2022.
Potential upcoming corporate developments:

Divestment of further non-core operations, we continue to look for opportunities to divest non-core businesses, including SHPL, to better focus on the development and global commercialization of our innovation-driven assets; and
Large molecule advancement, we continue to evaluate opportunities which might accelerate our capabilities in the large molecule arena.

VII. IMPACT OF COVID-19
COVID-19 did not impact our research, our clinical studies or our commercial activities in any material manner in 2021. Certain regulatory inspections of our manufacturing facilities in China by the U.S. FDA have, however, been postponed due to travel restrictions. We will continue to closely work with regulators and monitor the evolving situation.

VIII. SUSTAINABILITY

As an innovative, commercial-stage biopharmaceutical company, HUTCHMED embraces sustainability at the core of how we operate. Over the past two decades, we worked hard to strengthen healthcare systems by providing quality and accessible drugs. As the world is gradually adapting to the changes brought about by COVID-19, the pandemic has highlighted the importance of building sustainability and environmental, social and governance factors into business strategy. HUTCHMED has embarked on our sustainability journey in 2020 by publishing our inaugural ESG report to demonstrate our efforts, and establishing a board level Sustainability Committee in 2021 to support the Board of Directors in fulfilling their responsibilities. We plan to publish our second sustainability report for 2021 at the end of May 2022.

Going forward, HUTCHMED will be working with our stakeholders to embrace sustainable business practices and develop a sustainability strategy that will help focus our efforts on areas which are most relevant to our business. Through a materiality assessment exercise for 2021, priority areas include: Business ethics; Drug research-related topics; Drug development; Commercial operations responsibilities; Environmental topics; and Management of our people. Over the course of 2022, we will continue to engage our stakeholders to identify areas for improvement to building a more sustainable and responsible future.

FULL YEAR 2021 Financial Results
Cash, Cash Equivalents and Short-Term Investments were $1,011.7 million as of December 31, 2021 compared to $435.2 million as of December 31, 2020.

Adjusted Group (non-GAAP[50]) net cash flows excluding financing activities were -$73.5 million (2020: -$78.4m), with the net decrease mainly due to $159.1 million in proceeds from the divestment of HBYS, which offset the increasing Oncology/Immunology R&D spending and lower dividends received from our non-consolidated joint ventures totaling $49.9 million (2020: $86.7m); and
Net cash generated from financing activities totaled $650.0 million (2020: $296.4m) mainly resulting from the global offering of shares and listing on the HKEX in June 2021 and a private placement in April 2021 to a fund affiliated with Baring Private Equity Asia.

Revenues for the year ended December 31, 2021 were $356.1 million compared to $228.0 million in 2020.

Oncology/Immunology consolidated revenues increased 296% (287% at CER) to $119.6 million (2020: $30.2m) resulting from:
ELUNATE revenues increased 168% to $53.5 million (2020: $20.0m) in manufacturing revenues, promotion and marketing service revenues and royalties, as our in-house sales team increased in-market sales 111% to $71.0 million (2020: $33.7m), as provided by Lilly[51];

SULANDA sales revenues of $11.6 million since mid-January 2021 launch, initially approved to treat patients with advanced extra-pancreatic (non-pancreatic) NET and subsequently also approved to treat patients with pancreatic NET in June 2021;

ORPATHYS revenue of $36.3 million since mid-July 2021 launch, which was comprised of a $25.0 million first sale milestone payment and $11.3 million in manufacturing revenues and royalties. AstraZeneca reported $15.9 million in-market sales (2020: nil) of ORPATHYS in 2021; and

Other R&D service fee revenues of $18.2 million (2020: $10.2m), which were primarily fees from AstraZeneca and Lilly for the management of development activities in China.

Other Ventures consolidated revenues increased 20% (13% at CER) to $236.5 million (2020: $197.8m), mainly due to continued sales growth of third-party prescription drug products.

Net Expenses for the year ended December 31, 2021 were $550.7 million compared to $353.7 million in 2020.

Cost of Revenues were $258.2 million (2020: $188.5m), the majority of which were the cost of third-party prescription drug products marketed through our profitable Other Ventures, as well as full year costs associated with ELUNATE, including the provision of promotion and marketing services to Lilly which commenced in October 2020, and the costs for SULANDA and ORPATHYS which commenced commercial sales in 2021;
R&D Expenses were $299.1 million (2020: $174.8m), which increased mainly as a result of an expansion in the active development of eleven novel oncology drug candidates. Our rapidly scaling international clinical and regulatory operations in the U.S. and Europe incurred expenses of $140.1 million (2020: $63.3m), while R&D expenses in China were $159.0 million (2020: $111.5m);
SG&A Expenses[52] were $127.1 million (2020: $61.3m), which increased primarily due to higher staff costs and share-based compensation expense to support rapidly expanding operations. This included the build-up of a large-scale national oncology commercial infrastructure in China and commercial launch readiness in the U.S. to support our oncology products; and
Other Items generated net income of $133.7 million (2020: $70.9m), which increased primarily due to a one-off gain on the divestment of HBYS attributable to the Group of $82.9 million (comprised of a gain of $121.3 million offset in part by related taxes of $14.4 million and amounts attributable to a non-controlling interest of $24.0 million), offset in part by lower one-time land compensation of $5.6 million (2020: $28.8m) recognized for HBYS.

Net Loss attributable to HUTCHMED for the year ended December 31, 2021 was $194.6 million compared to $125.7 million in 2020.

As a result, the net loss attributable to HUTCHMED in 2021 was $0.25 per ordinary share / $1.23 per ADS[53], compared to net loss attributable to HUTCHMED of $0.18 per ordinary share / $0.90 per ADS, in 2020.

FINANCIAL GUIDANCE
We provide financial guidance for 2022 below reflecting expected revenue growth of ELUNATE, SULANDA and ORPATHYS in China. We intend to update guidance to include ex-China consolidated revenues, upon the occurrence of surufatinib U.S. and EU approval (if granted) and to reflect any developments in the non-core market out-licensing of our products.

While we are not providing net cash flow guidance for 2022, we do expect an increase in investment to support global clinical and organizational expansion. To support our cash needs, we continue to engage in active discussions regarding the potential divestment of non-core assets, such as SHPL, as well as evaluate equity capital markets action, such as a potential future listing on the STAR Market of the Shanghai Stock Exchange.

Shareholders and investors should note that:

we do not provide any guarantee that the statements contained in the financial guidance will materialize or that the financial results contained therein will be achieved or are likely to be achieved; and

we have in the past revised our financial guidance and reference should be made to any announcements published by us regarding any updates to the financial guidance after the date of publication of this announcement.

Use of Non-GAAP Financial Measures and Reconciliation – References in this announcement to adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the "Use of Non-GAAP Financial Measures and Reconciliation" below for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.

Conference Call and Audio Webcast Presentation scheduled today at 9 p.m. HKT / 1 p.m. GMT / 8 a.m. EST – Investors may participate in the call as follows: +852 3027 6500 (Hong Kong) / +44 20 3194 0569 (U.K.) / +1 646 722 4977 (U.S.), or access a live audio webcast of the call via HUTCHMED’s website at www.hutch-med.com/event/.

On March 3, 2022 Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, reported its fourth quarter and year end 2021 financial results and provides pipeline updates (Press release, Arbutus Biopharma, MAR 3, 2022, View Source [SID1234609474]).

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"2021 was a transformative year for Arbutus as we greatly expanded our development efforts in Hepatitis B and coronavirus infections, including SARS-CoV-2," said William Collier, Arbutus’ President and Chief Executive Officer. "We formed strategic and clinical partnerships that allowed us to explore several combination therapies with AB-729, our RNAi therapeutic, as a potential cornerstone agent in a functional cure for Hepatitis B, expand the reach of AB-729 to greater China and broaden our pipeline to include programs targeting coronaviruses. In addition, we have expanded our preclinical programs in HBV with our oral PD-L1 inhibitor, AB-101, and our oral RNA destabilizer, AB-161, both of which are expected to complete IND-enabling studies this year. Multiple key clinical trial data read-outs expected later this year for AB-729 and AB-836 will inform our go-forward clinical and regulatory strategy for HBV Phase 2b development."

Pipeline Update

AB-729 (RNAi Therapeutic)

Arbutus is currently dosing patients in the last cohort of its Phase 1a/1b clinical trial to evaluate the safety and tolerability of AB-729 in patients with chronic Hepatitis B (cHBV) infection (AB-729-001 Trial). Data observed to-date show that AB-729 continues to reduce HBsAg across all doses and dosing intervals with a favorable safety and tolerability profile. Additionally, long term dosing of AB-729 has increased HBV-specific immune responses in some patients.
The Company intends to present updated and new on-treatment data on multiple cohorts of patients included in the AB-729-001 Trial, as well as long-term follow-up data for patients in the AB-729-001 Trial who completed treatment and have discontinued AB-729 and standard-of-care nucleos(t)ide analogues (NA) therapy at a medical conference this year.
In-line with the Company’s strategy to combine multiple therapies that target different points of the viral replication cycle to develop a curative treatment regimen for cHBV, Arbutus is currently enrolling patients in its Phase 2a randomized, open-label, proof-of-concept clinical trial designed to evaluate the safety and tolerability of AB-729 in combination with ongoing NA therapy and short courses of PEG-IFNα-2a in 40 patients with cHBV infection. The Company is expecting initial data from this clinical trial in the second half of 2022.
Also, in line with the Company’s strategy, Arbutus has entered into separate clinical collaboration agreements with Assembly Biosciences, Inc. (Assembly), Vaccitech plc (Vaccitech) and Antios Therapeutics, Inc. (Antios) to evaluate AB-729 as the cornerstone agent in combination with Assembly’s capsid inhibitor, Vaccitech’s T-cell stimulating therapeutic vaccine, and Antios’ Active Site Polymerase Inhibitor Nucleotide (ASPIN), respectively, in patients with cHBV infection.
Enrollment is on-going in the Phase 2a proof-of-concept triple combination clinical trial evaluating AB-729, vebicorvir (VBR), Assembly’s lead HBV core inhibitor (capsid inhibitor), and an NA. Assembly is conducting this clinical trial and expecting initial data in the second half of 2022.
Arbutus is on-track to initiate a triple combination Phase 2a clinical trial in the first half of 2022 to evaluate AB-729, combined with VTP-300, Vaccitech’s therapeutic vaccine and an NA.
Enrollment is complete in a cohort of patients in Antios’ Phase 2a clinical trial evaluating AB-729, ATI-2173, Antios’ ASPIN, and Viread (tenofovir disoproxil fumarate). With the majority of patients in this cohort enrolled in Ukraine, which is currently in a state of war, they may be lost to follow-up before completing the trial. Therefore, Arbutus and Antios may report limited data on a reduced number of patients from this clinical trial.
AB-836 (Oral Capsid Inhibitor)

AB-836 is Arbutus’ novel, next generation oral capsid inhibitor with improved intrinsic potency, activity against resistant variants and an enhanced ability to starve replenishment of cccDNA, which is responsible for HBV persistence.
Arbutus is enrolling patients in part 3 of its on-going Phase 1a/1b clinical trial evaluating the safety and tolerability of multiple doses of AB-836 in patients with cHBV infection. The Company is on-track to report additional data from patients with cHBV infection in the first half of 2022.
AB-101 (Oral PD-L1 Inhibitor)

AB-101 is Arbutus’ oral PD-L1 inhibitor that is designed to reawaken the immune system, which the Company believes may be a key component in developing a functional cure for HBV.
Arbutus has commenced IND-enabling studies for AB-101 and intends to complete those studies in the second half of 2022.
AB-161 (Oral RNA destabilizer)

AB-161 is Arbutus’ next-generation oral HBV specific RNA destabilizer, which is being developed to create an all-oral treatment regimen to functionally cure HBV.
Arbutus has conducted extensive non-clinical safety evaluations with AB-161 that provide confidence in the molecule’s ability to circumvent the peripheral neuropathy findings seen in non-clinical safety studies with the Company’s first-generation oral RNA destabilizer, AB-452.
Arbutus has commenced IND-enabling studies for AB-161 and intends to complete those studies in the second half of 2022.
COVID-19 and Pan-Coronavirus Programs

Leveraging its extensive antiviral drug discovery experience, Arbutus is focused on the discovery and development of new pan-coronavirus molecular entities to treat COVID-19 and future coronavirus outbreaks by targeting essential viral proteins including the nsp12 viral polymerase and the nsp5 viral protease.
Arbutus intends to nominate a candidate that inhibits the SARS-CoV-2 nsp5 main protease (Mpro) in the first half of 2022 and advance that candidate into IND-enabling studies. In addition, the Company intends to continue lead optimization activities for an Nsp12 viral polymerase candidate.
Corporate Update

In April 2018, Arbutus entered into an agreement with Roivant Sciences Ltd. (Roivant), its largest shareholder, to launch Genevant Sciences Ltd. (Genevant), a company focused on a broad range of RNA-based therapeutics enabled by Arbutus’ LNP and ligand conjugate delivery technologies. Arbutus licensed rights to its LNP and ligand conjugate delivery platforms to Genevant for RNA-based applications outside of HBV, except to the extent certain rights had already been licensed to other third parties. Arbutus retained all rights to its LNP and conjugate delivery platforms for HBV and owns approximately 16% of the common equity of Genevant.

In February 2022, Arbutus and Genevant filed a lawsuit in the U.S. District Court for the District of Delaware against Moderna, Inc. and a Moderna affiliate seeking damages for infringement of U.S. Patent Nos. 8,058,069, 8,492,359, 8,822,668, 9,364,435, 9,504,651, and 11,141,378 in the manufacture and sale of MRNA-1273, Moderna’s vaccine for COVID-19. The patents relate to nucleic acid-lipid particles and lipid vesicles, as well as compositions and methods for their use. Arbutus, and Genevant, do not seek an injunction or otherwise seek to impede the sale, manufacture or distribution of MRNA-1273. However, the parties seek fair compensation for Moderna’s use of their patented technology that was developed with great effort and at a great expense, without which Moderna’s COVID-19 vaccine would not have been successful.

Under the license agreement with Genevant, as amended, if Genevant receives proceeds from an action for infringement by any third parties of Arbutus’ intellectual property licensed to Genevant, Arbutus would be entitled to receive, after deduction of litigation costs, 20% of the proceeds received by Genevant or, if less, tiered low single-digit royalties on net sales of the infringing product (inclusive of the proceeds from litigation or settlement, which would be treated as net sales).
Financial Results

Cash, Cash Equivalents and Investments

As of December 31, 2021, the Company had cash and cash equivalents of $109.3 million and investments in marketable securities of $81.7 million, totaling $191.0 million, as compared to $123.3 million as of December 31, 2020. The ending cash, cash equivalents and marketable securities as of December 31, 2021 do not include a $40 million upfront payment and a $15 million equity investment from Qilu Pharmaceutical as part of an exclusive licensing agreement and strategic partnership to develop and commercialize AB-729 in China, received in January 2022.

During the year ended December 31, 2021, Arbutus used $67.5 million in operating activities, which was offset by $134.7 million of net proceeds from the issuance of common shares under Arbutus’s "at-the-market" offering program. Arbutus expects a net cash burn between $90 to $95 million in 2022 and believes its cash runway, including $55 million of gross proceeds received from Qilu Pharmaceutical in January 2022, will be sufficient to fund the Company’s operations into the second quarter of 2024.

Net Loss

For the year ended December 31, 2021, the Company’s net loss attributable to common shares was $88.4 million, or a loss of $0.83 per basic and diluted common share, as compared to a net loss of $75.9 million, or a loss of $1.00 per basic and diluted common share, for the year ended December 31, 2020. Net loss attributable to common shares for the year ended December 31, 2021 and 2020 included $12.1 million of non-cash expense in both periods for the accrual of coupon on the Company’s convertible preferred shares, which converted into 22.8 million common shares in October 2021.

Operating Expenses

Research and development expenses were $65.5 million for the year ended December 31, 2021 compared to $49.3 million for the same period in 2020. The increase of $16.2 million in research and development expenses for the year ended December 31, 2021 versus the same period in 2020 was due primarily to an increase in expenses related to the Company’s multiple, ongoing AB-729 clinical trials, including its collaboration with Assembly, an increase in expenses for its ongoing AB-836 Phase 1a/1b clinical trial, and an increase in expenses for its early stage development programs, including its coronavirus programs.

Outstanding Shares

As of December 31, 2021, the Company had approximately 145.0 million common shares issued and outstanding, as well as approximately 11.4 million stock options outstanding. Following the conversion of preferred shares in October 2021, Roivant owned approximately 27% of the Company’s outstanding common shares as of December 31, 2021.

COVID-19 Impact

The COVID-19 virus, first identified in December 2019, has been declared a pandemic by the World Health Organization and has spread to nearly every country in the world. The impact of this pandemic has been, and will likely continue to be, extensive in many aspects of society. The pandemic has resulted in and will likely continue to result in significant disruptions to businesses. A number of countries and other jurisdictions around the world have implemented extreme measures to try and slow the spread of the virus. These measures include the closing of businesses and requiring people to stay in their homes, the latter of which raises uncertainty regarding the ability to travel to hospitals in order to participate in clinical trials. Additional measures that have had, and will likely continue to have, a major impact on clinical development, at least in the near-term, include shortages and delays in the supply chain, and prohibitions in certain countries on enrolling subjects and patients in new clinical trials. While we have been able to progress with our clinical and pre-clinical activities to date, it is not possible to predict if the COVID-19 pandemic will materially impact our plans and timelines in the future.

Conference Call and Webcast Today

Arbutus will hold a conference call and webcast today, Thursday, March 3, 2022, at 8:45 AM Eastern Time to provide a corporate update. You can access a live webcast of the call through the Investors section of Arbutus’ website at www.arbutusbio.com. Alternatively, you can dial (866) 393-1607 or (914) 495-8556 and reference conference ID: 3977368.

An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID: 3977368.

About AB-729

AB-729 is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens, including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. AB-729 targets hepatocytes using Arbutus’ novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. Clinical data generated thus far has shown single- and multi-doses of AB-729 to be generally safe and well-tolerated while providing meaningful reductions in hepatitis B surface antigen and hepatitis B DNA. AB-729 is currently in multiple Phase 2a clinical trials.

About AB-836

AB-836 is a next generation oral hepatitis B virus (HBV) capsid inhibitor that interacts with HBV core protein, which in turn is required for viral replication. The current standard-of-care therapy for HBV is primarily nucleos(t)ide analogues that inhibit the viral polymerase and significantly reduce, but do not eliminate viral replication. AB-836 in combination with nucleos(t)ide analogues is designed to completely eliminate viral replication in infected cells by preventing the assembly of functional viral capsids. In addition, AB-836 has been shown to inhibit the replenishment of covalently closed circular DNA (cccDNA), the viral genetic reservoir which the virus needs to replicate itself. Preliminary data from an on-going Phase 1a/1b clinical trial has shown that AB-836 is generally safe and well-tolerated and provides robust antiviral activity.

About HBV

Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that over 290 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2.4 million people in the United States suffer from chronic HBV infection. Approximately 820,000 people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options.

On March 3, 2022 Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), an immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, reported that company management will participate in the 32nd Annual Oppenheimer Healthcare Conference, taking place virtually March 15-17, 2022 (Press release, Sensei Biotherapeutics, MAR 3, 2022, View Source [SID1234609473]).

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John Celebi, MBA, president and chief executive officer of Sensei Biotherapeutics, and Erin Colgan, chief financial officer, will participate in a virtual presentation beginning at 10:40 am ET on Tuesday, March 15, 2022. A webcast of the presentation will be available on the Events & Presentations section of the Sensei website. A replay of the webcast will be on the website for approximately 90 days following the event.

On March 3, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a U.S. clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported it will sponsor and present an industry satellite symposium at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Therapeutics Conference, being held in-person March 10-12, 2022 at the Hyatt Regency, New Orleans, Louisiana (Press release, Cytori Therapeutics, MAR 3, 2022, View Source [SID1234609472]).

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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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Details of the symposium are as follows:

Title Radiolabeled NanoLiposomes: A Novel Targeted Treatment for Rare and Central Nervous System Cancers
Date March 12, 2022 at 7:15 – 8:00 a.m. CT
Location Hyatt Regency, Elite B Main Meeting Room, New Orleans, Louisiana
Presenter Norman LaFrance, MD, ME, FACP, FACNP, FACNM; Chief Medical Officer and Senior Vice President at Plus Therapeutics
A copy of the presentation will be made available under the Presentations tab of the Investors section of the Company’s website following the symposium at View Source