On November 10, 2022 ImmunityBio, Inc. (NASDAQ: IBRX),– NEJM Evidence reported that has published results from the QUILT 3.032 trial studying N-803 plus BCG in adults with NMIBC CIS with or without Ta/T1 papillary disease (Press release, ImmunityBio, NOV 10, 2022, View Source [SID1234623729]). These positive data form the basis of ImmunityBio’s BLA for BCG-unresponsive NMIBC CIS, which the FDA accepted for review in July 2022.

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The published results demonstrate that in patients with BCG-unresponsive NMIBC CIS and papillary disease, BCG plus N-803 (referred to as NAI) CRs were achieved with a persistence of effect with 90% probability of avoiding cystectomies in responders, a life-changing procedure of removing the bladder, and 100% bladder cancer-specific survival at 24 months. This investigational therapy represents an important clinical benefit addressing an unmet need of avoiding a cystectomy in this high-risk bladder cancer population.

"The peer review and publication of data in NEJM Evidence highlights the significance of the positive results of the QUILT 3.032 trial in patients with BCG-unresponsive NMIBC," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "We’re targeting the 10th most commonly diagnosed cancer and the one with the highest lifetime treatment costs per patient as a result of the prolonged course of the disease and the need for repeated surgical and treatment intervention. These data further our understanding of N-803’s unique role in potentially boosting the proliferation of natural killer and T cells while synergistically enhancing BCG efficacy."

Patients with intermediate or high-risk NMIBC typically receive a treatment of transurethral resection of the bladder tumor (TURBT) followed by BCG intravesical instillation. However, cancer will recur in 30% to 40% of patients with NMIBC despite adequate treatment with BCG. Moreover, even among those in whom a complete response is achieved with BCG, up to 50% see their cancer return.

Treatment options for BCG-unresponsive NMIBC patients are limited. Pembrolizumab was approved by the FDA for this indication in 2020, based on findings from the KEYNOTE-057 study in which the CR rate in NMIBC CIS patients was 41% with a median response duration of 16.2 months. The combination of N-803 plus BCG produced both a higher CR rate and more durable responses.

In patients who received intravesical N-803 plus BCG (cohort A), a CR was achieved in 58 (71%) of 82 patients (95% confidence interval [CI]=59.6 to 80.3; median follow-up, 23.9 months), with a median duration of 26.6 months 95% CI 59.9 months to [upper bound not reached]). At 24 months in patients with CR, the Kaplan–Meier–estimated probability of avoiding cystectomy and of disease-specific survival was 89.2% and 100%, respectively.

In patients with BCG-unresponsive high-grade Ta/T1 papillary NMIBC who received N-803 plus BCG (cohort B), the Kaplan–Meier–estimated disease-free survival (DFS) rate was 55.4% (95% CI=42.0% to 66.8%) at 12 months, with median DFS of 19.3 months (95% CI=7.4 months to [upper bound not reached]).

Most adverse events for patients receiving BCG plus NAI were grade 1 to 2 (86%) and comparable to adverse events associated with BCG alone.

About the QUILT 3.032 Trial

In this phase 2/3, open-label, multicenter study, patients with BCG-unresponsive bladder carcinoma in situ (CIS) with or without Ta/T1 papillary disease were treated with intravesical N-803 plus BCG (cohort A) or N-803 alone (cohort C). Patients with BCG-unresponsive high-grade Ta/T1 papillary NMIBC also received N-803 plus BCG (cohort B). The primary end point was the incidence of CR at the 3- or 6-month assessment visit for cohorts A and C, and the disease-free survival (DFS) rate at 12 months for cohort B. Durability, cystectomy avoidance, progression-free survival, disease-specific survival, and overall survival were secondary end points for cohort A.

The results of this phase 2/3 study are currently being reviewed by the FDA, and a decision from the FDA regarding approval for use of the biologics N-803 plus BCG in adults with BCG-unresponsive NMIBC CIS is expected on May 23, 2023.

ImmunityBio’s IL-15 superagonist N-803

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of the natural killer (NK) and T cells. N-803 (generic name nogapendekin alfa inbakicept or NAI) is a novel IL-15 superagonist complex consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion protein. Its mechanism of action is direct specific stimulation of CD8+ T cells and NK cells through beta gamma T-cell receptor binding (not alpha) while avoiding T-reg stimulation. N-803 has improved pharmacokinetic properties, longer persistence in lymphoid tissues and enhanced anti-tumor activity compared to native, non-complexed IL-15 in vivo.

N-803 has been studied in more than 700 patients in multiple phase 1 and 2 trials in both liquid and solid tumors. In addition to the study in NMIBC, it is currently being studied in trials for pancreatic cancer, non-small-cell lung cancer, non-Hodgkin’s lymphoma, and HIV.

N-803 has received both Breakthrough Therapy and Fast Track designations by the FDA for the treatment of BCG-unresponsive NMIBC CIS, as well as Fast Track designation for BCG-unresponsive NMIBC papillary and BCG-naïve NMIBC CIS. However, it is important to note such designations may not lead to a faster development process or regulatory review and may not increase the likelihood that a product candidate will receive approval. Seminal patents covering intravesical administration of BCG and N-803 were issued (US 11,173,191 B2 and US 9,925,247 B2) providing term coverage until 2035.

On November 10, 2022 Inventiva (Euronext Paris and Nasdaq: IVA) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of patients with non-alcoholic steatohepatitis ("NASH") and other diseases with significant unmet medical needs, reported its cash position as of September 30, 2022 and its revenues for the first nine months of 2022 (Press release, Inventiva Pharma, NOV 10, 2022, View Source [SID1234623728]).

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Cash Position

As of September 30, 2022, Inventiva’s cash position stood at €72.6 million, compared to €87.2 million as
of June 30, 2022 and €95.4 million as of December 31, 2021.

Net cash used in operating activities amounted to €40.0 million for the first nine months of 2022 compared to
€31.6 million for the same period in 2021. R&D expenses, mainly driven by the development of lanifibranor in NASH, were up 27% compared to the same period in 2021. This significant increase was driven mostly by the costs associated with the NATiV3 Phase III clinical trial of lanifibranor in NASH including a full nine months of operation for the U.S. affiliate and, to a lesser extent, with the Legend Phase IIa combination trial with lanifibranor and empagliflozin in patients with NASH and type 2 diabetes.

Cash flow from operating activities was also positively impacted in the first half of 2022 by the €4 million milestone payment from AbbVie in January 2022 following the inclusion of the first patient in the Phase IIb clinical trial with cedirogant (formerly ABBV-157) in adult patients with moderate to severe chronic plaque psoriasis, though this trial has since been discontinued by AbbVie3 as previously disclosed, and the 2021 French Research tax credit ("CIR") for €3.6 million received in April 2022.

Net cash generated from investing activities for the first nine months of 2022 amounted to €0,7 million, compared to (€1.2) million net cash consumed for the same period in 2021.

Net cash generated from financing activities for the first nine months of 2022 amounted to €13.1 million compared to €23.9 million in the same period in 2021, mainly driven by the proceeds of €9.3 million (gross proceeds) raised through the Company’s At-The-Market Program on June 15, 2022, and three loan agreements with a syndicate of French banks for a total amount of €5.3 million. One of the loans was contracted as part of a French state-guaranteed loan facility ("Prêt Garanti par l’Etat" or "PGE") with Bpifrance, and the two others obtained as part of a French state stimulus economic plan ("Prêts Participatifs Relance" or "PPR") granted by Crédit Agricole Champagne-Bourgogne and Société Générale.

In the third quarter of 2022, the Company recorded a positive exchange rate effect on cash and cash equivalents of €3.5 million for the nine-month period ending September 30, 2022, versus €1.5 million for the same period in 2021, due to the strengthening of USD versus Euro.

Considering its current R&D and clinical development programs, and additional financial resources that may originate from funding activities, the Company estimates that its existing cash, cash equivalents and short-term deposits including the $12,6 million received from Sino Biopharm on November 4th and the €25 million from the EIB credit first tranche facility4 should allow the Company to fund its operations through Q4 2023.

Revenues

The Company’s revenues for the first nine months of 2022 amounted to €0.1 million, as compared to €0.2 million for the same period in 2021. The Company’s development agreement with Sino Biopharm was executed on September 21, 2022 as previously announced and the $12.6 million upfront payment was received on November 4, 2022.

Next expected key milestones

Publication of the topline results of the investigator-initiated study with lanifibranor in patients with Non-Alcoholic Fatty Liver Disease ("NAFLD") and T2D – planned for the first quarter of 2023
Publication of the topline results of the Phase IIa LEGEND of lanifibranor in combination with empagliflozin in patients with NASH and T2D – planned for the second half of 2023
Last Patient First Visit of the Phase III NATiV3 clinical trial evaluating lanifibranor in NASH – targeted for the second half of 2023
Upcoming investor conference participation

Jefferies 2022 London Healthcare Conference – November 15-17 – London
B Riley’s Cardiometabolic Health Mini Symposium – November 28 – Virtual
Degroof Petercam’s Healthcare Conference 2023 – January 24-27 – Virtual
Guggenheim Health Altitudes Summit 2023 – March 13-16 – Telluride, Colorado
Upcoming scientific conference participation

6th Obesity and NASH Drug Development Summit – November 29 through December 1, Boston, MA
MOSAIC Conference – December 5-6, Washington, DC
Next financial results publication

Full-Year 2022 Revenues and cash position: Tuesday, February 14, 2022 (after U.S. market close).

On November 10, 2022 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), to create novel therapies with potent and differentiated mechanisms of action for cancer and other serious diseases, reported financial results and business updates for the third quarter of 2022 (Press release, Molecular Templates, NOV 10, 2022, View Source [SID1234623727]).

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"We are excited with the progress we continue to make across all our clinical and pre-clinical programs. We have now seen evidence of monotherapy clinical activity with MT-6402, MT-5111, and MT-0169 in heavily pretreated relapsed/refractory patients — in both solid and hematological cancer settings — demonstrating the broad potential utility of this novel scaffold," said Eric Poma, PhD., Chief Executive and Chief Scientific Officer of Molecular Templates. "We look forward to providing further updates on our MT-6402, MT-5111, and MT-0169 programs throughout 2023 and look forward to our anticipated IND submission for MT-8421 all while we continue to advance our development of additional ETB candidates targeting TROP2, TIGIT, and BCMA."

Company Highlights and Upcoming Milestones

Corporate

MTEM expects to provide periodic updates on MT-6402, MT-5111, MT-8421, and MT-0169 throughout 2023.
Dose escalation continues with MT-6402 with dose dependent pharmacodynamic (PD) effects observed. One patient in cohort 1 (16 mcg/kg) with non-small cell lung cancer (NSCLC) and osseous metastases demonstrated tumor regression. This patient is the only patient treated thus far with high tumor PD-L1 expression and HLA-A*02/ CMV+.
MT-5111 has declared Maximum Tolerated Dose (MTD) at 23 mcg/kg with a dose limiting toxicity (DLT) of grade 3 rash. The HER2-positive breast cancer (BC) dose expansion cohort (DEC) continues to enroll patients at a dose of 10 mcg/kg. Three of five evaluable BC patients treated at 10 mcg/kg have had prolonged Stable Disease for 40, 22, and 22 weeks, respectively. One of the patients treated for 22 weeks has experienced a 43% reduction in mediastinal lymphadenopathy and a halt in the growth of her pulmonary lesions. Overall, the patient has had a 14% reduction in index lesions. This patient has been previously treated with multiple HER2-targeting therapies including trastuzumab, pertuzumab, trastuzumab emtasine, lapatinib, trastuzumab deruxtecan, and tucatinib.
MT-0169 completed the 5 mcg/kg dose escalation cohort (N=4) without any cardiac adverse events (AEs) or DLTs and is enrolling at 10 mcg/kg. One patient with IgA myeloma treated at 5 mcg/kg has had a marked reduction in IgA serum protein, conversion from immunofixation positive to negative and marked improvement of hemoglobin to normal values, demonstrating at least a Partial Response. A PET scan is pending to determine if the patient is in a Complete Response.
Of the over 80 patients treated across MTEM’s three clinical programs to date, there has been no instance of capillary leak syndrome (CLS). One patient treated at 63 mcg/kg with MT-6402 showed a grade 2 decrease in albumin that may potentially represent a subclinical manifestation of CLS.
All toxicities seen to date appear to be target-mediated and unrelated to the underlying scaffold.
ETB Technology

ETBs represent a novel platform with unique biology for therapeutic development in oncology. ETBs have the target specificity of antibodies, can force their own internalization, even against non-internalizing receptors, and can induce tumor cell death through the novel mechanism of enzymatic and irreversible ribosomal destruction. Because of this unique biology, ETBs to targets like HER2 and CD38 have the potential to drive clinical benefit in patients that have progressed after all available therapeutics. ETBs also represent a unique approach to immuno-oncology. Unlike current approaches to PD-L1 that only block the steric interaction of PD-1 and PD-L1, MT-6402, MTEM’s ETB targeting PD-L1, is designed to directly kill PD-L1+ tumors cells, destroy immune cells that inhibit T-cell function and propagate tumor growth, and alter the immunophenotype of tumor cells.

MT-6402 (PD-L1 ETB with Antigen Seeding Technology)

The Phase 1 study of MT-6402 is a multi-center, open-label, dose escalation and dose expansion trial. Patients with confirmed PD-L1 expressing tumors or confirmed PD-L1 expression in the TME are eligible for enrollment, irrespective of HLA genotype or CMV status.
As of November 2022, 19 patients with relapsed/refractory tumors that express PD-L1 have been treated across four dose cohorts: 16 mcg/kg (n=6), 24 mcg/kg (n=6), 32 mcg/kg (n=4), and 42 mcg/kg (n=3). One DLT of grade 2 rash was observed in cohort 2 whereas no DLTs were reported in cohorts 1, 3 and 4. Enrollment continues in cohort 5 at 63 mcg/kg.
One patient in cohort 1 (16 mcg/kg) with NSCLC demonstrated tumor regression of osseous metastases. This patient is the only patient treated thus far with high tumor PD-L1 expression and who is also HLA-A*02/ CMV+.
MTEM continues to observe PD effects not seen with PD-L1 antibodies and consistent with the dismantling of the TME including PD-L1+ immune cell depletion and T cell activation, as well as cytokine changes in TNF-α, IL-2, and vascular endothelial growth factor (VEGF) in all dose escalation cohorts evaluated to date. The extent and timing of these PD effects appear dose-dependent with higher dose levels showing more rapid and profound PD effects, including MDSC depletion and T cell activation. These effects were seen across the majority of patients irrespective of HLA genotype or level of tumor or immune cell PD-L1 staining.
Treatment-related AEs including immune related AEs have been largely restricted to grade 1-2.
MT-5111 (HER2 ETB)

As of November 2022, the Phase 1 study of MT-5111 has enrolled 48 patients across 10 dose escalation cohorts ranging from 0.5 mcg/kg to 23 mcg/kg. One DLT of grade 3 acneiform rash was observed at 23 mcg/kg, which improved to grade 1 with topical steroids, and the patient continued treatment at the same dose. 23 mcg/kg has been declared the MTD.
Serum concentration of MT-5111 showed predictable and dose-proportional increasing exposure starting at 6.75 mcg/kg doses and higher.
The HER2-positive BC DEC continues to enroll patients at a dose of 10 mcg/kg. Six patients have been treated, three of whom for 40, 22, and 22 weeks, respectively, at 10 mcg/kg.
One of the patients treated for 22 weeks came on study with two nodal lesions and two non-nodal necrotic pulmonary lesions. The patient has seen a continued reduction in her nodal lesions while on therapy with a 43% reduction in mediastinal lymphadenopathy and a halt in the growth of her pulmonary lesions. Overall, the patient has had a 14% reduction in index lesions. This patient has been previously treated with multiple HER2-targeting therapies including trastuzumab, pertuzumab, trastuzumab emtasine, lapatinib, trastuzumab deruxtecan, and tucatinib. The next monotherapy cohort for BC patients is planned at 17 mcg/kg.
No clinically significant cardiac AEs have been observed at any dose; grade 1 hs-troponin elevations have been observed at various doses.
MT-0169 (CD38 ETB)

The Phase 1 study in patients with relapsed/refractory multiple myeloma (MM) or non-Hodgkin’s lymphoma explores MT-0169 at doses lower than the initial dose of 50 mcg/kg to reduce the risk of AEs and to enable patients to continue MT-0169 therapy for a longer duration that may drive tumor benefit.
The 5 mcg/kg cohort completed recruitment (N=4) and analysis with no related AEs higher than grade 1. CD38+ Natural Killer (NK) cell depletion was observed in cycle 1 and in cycle 2 for patients continuing therapy. Nadir levels of NK cells were delayed and lower in magnitude than observed at 50 mcg/kg. Enrollment at 10 mcg/kg has commenced.
One patient with IgA myeloma treated at 5 mcg/kg has had a marked reduction in IgA serum protein, conversion from immunofixation positive to negative and marked improvement of hemoglobin to normal values, demonstrating at least a Partial Response. A PET scan is pending to determine if the patient is in a Complete Response.
Research and Development

Preclinical data from MTEM’s MT-8421 program targeting CTLA-4 was featured in an abstract at the 2022 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting held November 8-12, 2022, in Boston, Massachusetts. Clinical studies for MT-8421 are expected to commence in mid-2023.
MTEM continues to expand its unique approach to immuno-oncology targets with lead optimization ongoing for several targets.
Lead optimization continues on ETBs targeting TROP-2 incorporating Antigen Seeding Technology, a TIGIT-targeting ETB and BCMA.
Upcoming Conferences

MTEM will present four posters (736, 764, 817, and 1379) and provide an in-person R&D Day presentation at the SITC (Free SITC Whitepaper) annual meeting, Friday, November 11, 2022, 11:30am – 12:30pm ET. SITC (Free SITC Whitepaper) posters can be accessed via MTEM’s corporate website. The webcast can be accessed here.
MTEM will present a fireside chat at the virtual ISI HealthCONx Conference, Wednesday, November 30, 2022, at 9:15am ET. The webcast will be live-streamed and can be accessed here.
MTEM will present at the 2022 San Antonio Breast Cancer Symposium (SABCS) taking place December 6 – December 10, 2022, in San Antonio, Texas.
MTEM will participate at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s 64th annual meeting taking place December 10 – 13, 2022 in New Orleans, Louisiana. One-on-one meetings may be scheduled directly with MTEM.
Financial Results

The net loss attributable to common shareholders for the third quarter of 2022 was $24.6 million, or $0.44 per basic and diluted share. This compares with a net loss attributable to common shareholders of $30.4 million, or $0.54 per basic and diluted share, for the same period in 2021.

Revenues for the third quarter of 2022 were $4.2 million, compared to $2.4 million for the same period in 2021. Revenues for the third quarter of 2022 were comprised of revenues from collaborative research and development agreements with Bristol Myers Squibb.

Total research and development expenses for the third quarter of 2022 were $22.0 million, compared with $22.9 million for the same period in 2021. Total general and administrative expenses for the third quarter of 2022 were $5.9 million, compared with $9.0 million for the same period in 2021.

As of September 30, 2022, MTEM’s cash and investments totaled $79.4 million.

For more details on MTEM’s financial results for the third quarter 2022, refer to Form 10-Q filed with the SEC.

On November 10, 2022 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a clinical-stage precision oncology company, reported financial results for the quarter ended September 30, 2022, and recent corporate updates (Press release, Kinnate Biopharma, NOV 10, 2022, View Source [SID1234623726]).

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"We continue to make advances with our proprietary programs, and are encouraged by what we’re seeing thus far in the ongoing dose escalation for KIN-2787 monotherapy, our pan-RAF inhibitor," said Nima Farzan, chief executive officer, Kinnate Biopharma Inc. "We are actively investigating multiple targets as part of the Kinnate Discovery Engine and look forward to having a third program enter the clinic next year. We remain well funded to continue to innovate and progress our pipeline of novel small molecule drug candidates."

Pipeline Updates

Announced an update from the ongoing dose escalation for KIN-2787 monotherapy in the global Phase 1 clinical trial, KN-8701. Detailed dose escalation data is expected in the first half of 2023. (View Release)

Subsequent to the KIN-2787 data release, the company anticipates disclosing its next program from the Kinnate Discovery Engine, which is expected to enter the clinic in 2023.

Announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for KIN-2787 for treatment of patients with BRAF Class II or III alteration-positive and/or NRAS mutation-positive stage IIb to IV malignant melanoma that is metastatic or unresectable. (View Release)

Corporate Highlights

Expanded the organization to 86 full-time employees as of September 30, 2022, of which 64 were engaged in research and development activities.

Third Quarter 2022 Financial Results

Cash and Cash Equivalents and Investments Position: As of September 30, 2022, the total of cash and cash equivalents and investments was $262.1 million, excluding cash from its China joint venture, Kinnjiu, and is expected to fund current operations into mid-2024.

Research and Development Expenses: Third quarter research and development expenses for 2022 were $23.5 million, compared to $18.7 million for the same period in 2021.

General and Administrative Expenses: Third quarter general and administrative expenses for 2022 were $7.8 million, compared to $6.1 million for the same period in 2021.

Net Loss: Third quarter net loss for 2022 was $30.7 million, compared to $24.7 million for the same period in 2021.

On November 10, 2022 LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, reported financial results for the third quarter ended September 30, 2022 and provided a corporate update (Press release, LianBio, NOV 10, 2022, View Source [SID1234623725]).

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"The LianBio team continues to execute across our clinical development strategies, and we have initiated three pivotal trials of our late-stage, clinically validated programs year-to-date," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "We believe the progress we are making across our pipeline ensures we are well-positioned to bring innovative medicines to patients in China, with our first launch anticipated in 2024. We are investing in our team and in our commercial infrastructure, and working closely with patient communities, healthcare professionals and regulators in anticipation of the topline results from our Phase 3 EXPLORER-CN study next year that we expect will support potential registration of mavacamten in China."
Recent Business Highlights and Clinical Development Updates
Following enrollment completion in the Phase 3 EXPLORER-CN trial of mavacamten in Chinese oHCM patients in August 2022, launch and market building initiatives are underway in China
•In August 2022, LianBio submitted a New Drug Application (NDA) to the Department of Health, the Hong Kong Special Administrative Region, China, for mavacamten for the treatment of adults with symptomatic New York Heart Association Class II-III obstructive hypertrophic cardiomyopathy (oHCM). The submission was based on the U.S. Food and Drug Administration approval of mavacamten.
•In September 2022, LianBio collaborated with Beijing Lisheng Cardiovascular Health Foundation to launch Joy from Heart, a hypertrophic cardiomyopathy (HCM) disease awareness campaign in China. Joy from Heart is China’s first disease awareness program dedicated to improving HCM diagnosis rates and supporting HCM education initiatives for patients and healthcare providers.
•In September 2022, mavacamten was added as a Class Ib recommended drug in the 2022 Chinese Guidelines on Hypertrophic Cardiomyopathy published in the Chinese Journal of Heart Failure and Cardiomyopathy.

•LianBio has hired key leadership roles to support the expected mavacamten commercial launch in China, including medical affairs personnel, medical science liaisons, and business unit leaders for key regions.
Phase 3 NANORAY-312 clinical trial of NBTXR3 for the treatment of head and neck cancer initiated in Asia
•In September 2022, LianBio began treating patients in Asia in the global Phase 3 NANORAY-312 trial evaluating NBTXR3 for the treatment of head and neck cancer. LianBio expects this trial to support registration of NBTXR3 in China and other LianBio-licensed territories in Asia.
Phase 3 LIBRA clinical trial of TP-03 for the treatment of Demodex blepharitis initiated in China
•In September 2022, LianBio’s development partner Tarsus submitted an NDA to the U.S. FDA for TP-03 for the treatment of Demodex blepharitis. The submission was based on two pivotal studies of TP-03 demonstrating disease resolution. Tarsus subsequently communicated that the FDA accepted the NDA with a Prescription Drug User Fee Act (PDUFA) target action date of August 25, 2023.
•In November 2022, LianBio announced the initiation of the Phase 3 LIBRA clinical trial of TP-03 in Demodex blepharitis. LianBio expects the LIBRA trial to support registration in China.
Phase 1 clinical trial of BBP-398 SHP2 inhibitor initiated in China
•In November 2022, LianBio announced that it began treating patients with advanced solid tumors in a Phase 1 monotherapy dose escalation trial of BBP-398.
Business is well-positioned to achieve anticipated milestones
•Current cash runway is projected to extend into the second half of 2024.
Key Milestones Anticipated in 2023
Mavacamten
•LianBio expects to report topline data from the Phase 3 EXPLORER-CN trial of mavacamten in Chinese patients with symptomatic oHCM in mid-2023.
TP-03
•LianBio expects to report topline data from the Phase 3 LIBRA trial in the fourth quarter of 2023.
Infigratinib
•LianBio expects to report topline data from the ongoing Phase 2a clinical trial of infigratinib in locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification and other advanced solid tumors with FGFR genomic alterations in the second half of 2023.

BBP-398
•LianBio expects to initiate a Phase 1 clinical trial of BBP-398 in combination with an EGFR-inhibitor in non-small cell lung cancer in the first half of 2023.
Third Quarter 2022 Financial Results
Research & Development Expenses
Research and development expenses were $8.3 million for the third quarter of 2022 compared to $4.7 million for the third quarter of 2021, and $49.2 million for the nine month period ended September 30, 2022 compared to $151.0 million for the nine month period ended September 30, 2021. The decrease was primarily attributable to increased milestone payments in 2021, and was offset by higher development activities to support clinical trials and personnel-related expenses in 2022.
General & Administrative Expenses
General and administrative expenses were $16.3 million for the third quarter of 2022 compared to $8.9 million for the third quarter of 2021, and $46.9 million for the nine month period ended September 30, 2022 compared to $22.5 million for the nine month period ended September 30, 2021. The increase was primarily attributable to increases in payroll and personnel-related expenses (including share-based compensation expense) for increased employee headcount and higher expense for legal, consulting and accounting services.
Net Loss
Net loss was $21.9 million for the third quarter of 2022 compared to net loss of $13.1 million for the third quarter of 2021, and $92.0 million for the nine month period ended September 30, 2022 compared to $175.1 million for the nine month period ended September 30, 2021.
Cash Balance
Cash, cash equivalents, marketable securities and restricted cash at September 30, 2022 totaled $331.8 million compared to $403.2 million as of December 31, 2021. LianBio projects its current cash, cash equivalents, marketable securities, and restricted cash will be sufficient to fund its current operating plan into the second half of 2024.