On May 10, 2022 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported financial results for the first quarter ended March 31, 2022 (Press release, Cogent Biosciences, MAY 10, 2022, View Source [SID1234614055]).

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"We continue to make significant progress towards our strategic priorities for 2022," said Andrew Robbins, President and CEO of Cogent Biosciences. "We look forward to presenting initial clinical data from our APEX trial of bezuclastinib in advanced systemic mastocytosis patients at the annual EHA (Free EHA Whitepaper) meeting this June. This presentation will include patient data from each dose cohort of bezuclastinib, including levels of serum tryptase, a validated biomarker of mast cell activity. We also continue to enroll patients in the SUMMIT and PEAK trials with bezuclastinib. In addition, our research team has rapidly advanced our pipeline with the addition of our FGFR2 and ErbB2 programs, each with clear differentiation from other programs in development and best-in-class potential. With these important advances, we believe we are well positioned to build on our momentum to bring important therapies to patients with genetically defined diseases."

Upcoming Milestones and Recent Business Highlights

On track to report initial clinical data from APEX, a global, multicenter, Phase 2 clinical trial of bezuclastinib, a potent, highly selective, minimally brain-penetrant KIT mutant inhibitor in patients with Advanced Systemic Mastocytosis (AdvSM) in the second quarter of 2022.
Data to be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Annual Congress will include safety and tolerability from patients across each dose cohort, as well as levels of serum tryptase, a validated biomarker of mast cell activity. The hybrid conference will take place in Vienna, Austria from June 9-12, 2022.

Presented early data and outlined Cogent’s strategy to create best-in-class small molecules from the company’s growing pipeline of novel, targeted therapy programs at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting and Cogent R&D investor event.
Advancing a potent, selective FGFR2 inhibitor toward candidate selection with a product profile that includes best-in-class selectivity and potency against all known FGFR2 primary driver and secondary resistance mutations. On track for first internally developed Investigational New Drug application (IND) in the second half of 2023.
Announced development of an ErbB2 mutant selective inhibitor for patients with mutations that are not well addressed by therapies currently approved or in clinical development.

Shared additional nonclinical data demonstrating bezuclastinib’s potential as a best-in-class KIT mutant inhibitor during the 2022 AACR (Free AACR Whitepaper) annual meeting.
Presentations demonstrated bezuclastinib has a unique profile as a potent, mutant KIT inhibitor (including KIT D816V) with minimal brain penetration and no activity against related kinases including PDGFR, FLT3 and CSF1R, which have been linked to off-target toxicities including edema and pleural effusions.

Actively enrolling patients in SUMMIT, a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 clinical trial with bezuclastinib for nonadvanced systemic mastocytosis (NonAdvSM).
SUMMIT is designed to evaluate the safety and efficacy of bezuclastinib in patients with moderate to severe Indolent Systemic Mastocytosis (ISM) or Smoldering Systemic Mastocytosis (SSM).
Actively enrolling patients in PEAK, a registrational randomized, open-label, global, Phase 3 clinical trial in patients with Gastrointestinal Stromal Tumors (GIST).
PEAK is designed to evaluate the efficacy and safety of bezuclastinib in combination with sunitinib compared to sunitinib alone in patients with locally advanced, unresectable or metastatic GIST who have received prior treatment with imatinib.
First Quarter 2022 Financial Results

Cash and Cash Equivalents: As of March 31, 2022, cash and cash equivalents were $191.0 million as compared to $219.7 million as of December 31, 2021. Based on its current plans, the company expects that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into 2024.

R&D Expenses: Research and development expenses were $25.5 million for the first quarter of 2022 compared to $8.2 million for the first quarter of 2021. The increase was primarily due to costs associated with the on-going APEX, SUMMIT and PEAK clinical trials and costs related to expanding the Cogent Research Team, which was formed in the second quarter of 2021.

G&A Expenses: General and administrative expenses were $5.9 million for the first quarter of 2022 compared to $4.6 million for the first quarter of 2021. The increase was primarily due to the growth of the organization.

Net Loss: Net loss was $30.6 million for the first quarter of 2022 compared to a net loss of $11.7 million for the first quarter of 2021.

On May 10, 2022 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported financial results for the first quarter ended March 31, 2022 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, MAY 10, 2022, View Source [SID1234614054]).

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Chief Executive Officer John Valliant, Ph.D. commented, "We entered 2022 with strong momentum using our platform technology and research engine to build a diverse pipeline of targeted alpha therapies (TATs) from different classes of targeting molecules to pursue validated cancer targets, all while continuing to maintain sharp focus on actinium supply and manufacturing capabilities. Our top priority continues to be executing on our Phase 1 clinical studies. We are progressing our Phase 1 trial of FPI-1434 and look forward to reporting data from the study in the second half of this year. In addition, we continue to expect to dose our first patient in the Phase 1 study of FPI-1966 in the second quarter of this year. In parallel, we are advancing additional programs with the investigational new drug application (IND) filing for FPI-2059 anticipated in the second quarter of 2022 and the first novel TAT under our collaboration agreement with AstraZeneca in IND-enabling studies."

Portfolio Update

FPI-1434

In the Phase 1 study, Fusion is exploring various dosing levels of FPI-1434 as well as two dosing regimens: one with FPI-1434 alone, and another in which a small dose of cold antibody (naked IGF-1R antibody without the isotope) is administered prior to each dose of FPI-1434. The Company continues to anticipate reporting Phase 1 safety, pharmacokinetics, and imaging data, including any clinical efficacy, and details on the dosing regimen, in the second half of 2022. Fusion continues to anticipate the initiation of a Phase 1 combination study with FPI-1434 and KEYTRUDA (pembrolizumab) to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy.

FPI-1966

The Phase 1, non-randomized, open-label clinical trial of FPI-1966 in patients with solid tumors expressing FGFR3, intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose, has been initiated. Fusion expects to dose the first patient in the second quarter of 2022 and expects preliminary pharmacokinetic, imaging and safety data from the first patient cohort in the second quarter of 2023.

FPI-2059

FPI-2059 is a small molecule radioconjugate in development as a targeted alpha therapy for various solid tumors, including neuroendocrine differentiated (NED) prostate cancer. The molecule targets neurotensin receptor 1 (NTSR1), a promising target for cancer treatment, that is overexpressed in several solid tumors. FPI-2059 combines Ipsen’s IPN-1087 (previously studied in a Phase 1 clinical trial as a beta-emitting radiopharmaceutical), which Fusion acquired in 2021, with actinium-225. Fusion continues to anticipate submitting an IND application for FPI-2059 in the second quarter of 2022.

Recent Updates

In April, Fusion entered into a loan and security agreement with Oxford Finance LLC, under which Oxford is providing term loans to Fusion in an aggregate principal amount of up to $75.0 million. The Company plans to use the proceeds of the term loans for working capital and general corporate purposes. The loan agreement provides a term loan commitment of $50.0 million in two potential tranches: (i) a $25.0 million Term A loan facility, with $10.0 million funded on the closing date and the remaining $15.0 million to be funded at the request of the Company on a one-time basis at any time prior to April 4, 2023; and (ii) a $25.0 million Term B loan facility to be funded at the request of the Company, no later than June 30, 2023. Both term loans have a maturity date of April 1, 2027. The loan agreement also provides access to an additional Term C loan facility in the amount of $25.0 million, funded at Oxford’s discretion. The debt facility strengthens Fusion’s balance sheet, provides additional financing flexibility and extends the Company’s cash runway into the first quarter of 2024.
First Quarter 2022 Financial Results

Cash and Investments: As of March 31, 2022, Fusion held cash, cash equivalents and investments of $206.7 million, compared to cash, cash equivalents and investments of $220.8 million as of December 31, 2021. Fusion expects its existing cash, cash equivalents and investments as of March 31, 2022, together with the proceeds available under the first tranche of the loan and security agreement with Oxford Finance LLC executed in April 2022, will be sufficient to fund operations into the first quarter of 2024.
Collaboration Revenue: For the first quarter of 2022, Fusion recorded $0.6 million of revenue under the AstraZeneca collaboration agreement.
R&D Expenses: Research and development expenses for the first quarter of 2022 were $12.7 million, compared to $10.7 million for the same period in 2021. The increase was primarily due to an increase in direct costs related to our FPI-1434 and FPI-1966 product candidates, specifically continued expenditures related to our Phase 1 clinical trials as well as preclinical research and manufacturing costs.
G&A Expenses: General and administrative expenses for the first quarter of 2022 were $8.4 million, compared to $7.0 million for the same period in 2021. The increase was primarily due to an increase in personnel-related and corporate expenses, partially offset by a decrease in professional fees.
Net Loss: For the first quarter of 2022, Fusion reported a net loss of $19.9 million, or $0.46 per share, compared with a net loss of $17.5 million, or $0.42 per share, for the same period in 2021.
Upcoming Events

Fusion will participate in a fireside chat and panel presentation at the Guggenheim Securities Radiopharmaceutical Day on May 17, 2022 in New York. The fireside chat will be available via webcast on Fusion’s website at View Source
Fusion will present at the Jefferies Healthcare Conference on Friday, June 10, 2022 at 10:30am ET in New York.
Fusion plans to present imaging data from the "cold antibody sub study" evaluating pre-administration of cold antibody (naked antibody without the isotope) prior to administration of the hot antibody (antibody with the isotope) in the Phase 1 study of FPI-1434 at the upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2022 Annual Meeting taking place in Vancouver, British Columbia. The presentation titled, "Impact of Pre-Administration of Anti-IGF-1R Antibody FPI-1175 on the Dosimetry, Tumor Uptake, and Pharmacokinetics of the IGF-1R Targeted Theranostic Imaging Agent [111In]-FPI-1547 in Patients with Solid Tumors" will be presented on June 14, 2022.
Impact of COVID-19

Fusion is experiencing material delays in patient recruitment, enrollment and study site initiations as a result of continued resourcing issues related to COVID-19 at trial sites.

There also remains uncertainty relating to the trajectory of the pandemic, hospital staffing and resource issues, and whether they may cause further delays in patient study recruitment. The impact of related responses and disruptions caused by the COVID-19 pandemic may result in further difficulties or delays in initiating, enrolling, conducting or completing the planned and ongoing trials and the incurrence of unforeseen costs as a result of disruptions in clinical supply or preclinical study or clinical trial delays. The continued impact of COVID-19 on results will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence.

On May 10, 2022 Theratechnologies Inc. ("Theratechnologies" or "the Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that initiated enrollment of patients in the basket portion of the first-in-human study of TH1902, Theratechnologies’ investigational lead peptide drug conjugate (PDC) for the treatment of sortilin-expressing cancers (Press release, Theratechnologies, MAY 10, 2022, View Source [SID1234614053]).

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Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, Theratechnologies, noted, "We are pleased to move forward to the next stage of development of TH1902, the basket portion of the first-in-human study. We firmly believe that the unique mechanism of entry of TH1902 in cancer cells is a key advantage to improve the therapeutic window of docetaxel. TH1902’s targeted delivery and rapid internationalization in cancer cells via the Sortilin receptor enables the potential to accumulate 7.5 to 10 times more docetaxel in cancer cells — as compared to the administration of docetaxel alone. Based on the pre-clinical results obtained so far, we are optimistic in the development of a first-in-class and promising treatment for patients with Sortilin positive solid tumors. Additionally, we continue to advance the development of our SORT1+ TechnologyTM platform by conjugating our proprietary peptide with other effective anti-cancer agents."

Based on the data of the dose escalation part of the study, the dose of TH1902 for the expansion study was established at 300 mg/m2 or 1.5 times the therapeutic dose of docetaxel alone. No dose limiting toxicities were observed following the completion of the first cycle in the last 6 patients treated at 300 mg/m2. The basket portion of the first-in-human study is an expansion study designed to assess TH1902 as monotherapy treatment of advanced refractory or resistant solid tumor types expressing high levels of Sortilin, including Hormone Receptor-positive (HR+) Breast Cancer, Triple Negative Breast Cancer, Ovarian Cancer, Endometrial Cancer, and Melanoma with approximately 10 patients per tumor type. One arm will include a mix of tumor types including Thyroid, Small Cell Lung, Prostate and potential other high Sortilin expressing cancers with approximately 15 patients in total. In addition to evaluating the anti-tumor activity of TH1902, the study will continue to evaluate the safety and pharmacokinetics of TH1902. Exploratory pharmacodynamic and biomarker analyses will also be conducted.

About TH1902
TH1902 is Theratechnologies’ proprietary peptide drug conjugate (PDC) linked to docetaxel, a well-established and well-characterized cytotoxic agent. TH1902 is being developed as a single agent for the treatment of all advanced solid tumors expressing sortilin that are refractory to standard therapy. TH1902 is the Company’s lead PDC drug candidate stemming from Theratechnologies’ SORT1+ Technology in oncology.

About SORT1+ TechnologyTM
Theratechnologies has developed a peptide which specifically targets sortilin (SORT1) receptors. SORT1 is expressed in ovarian, triple negative breast, skin, lung, colorectal and pancreatic cancers, among others. SORT1 plays a significant role in protein internalization, sorting and trafficking, making it an attractive target for drug development.

Commercially available anticancer drugs, like docetaxel, doxorubicin or tyrosine kinase inhibitors are conjugated to Theratechnologies’ investigational novel peptides to specifically target sortilin receptors with the aim of improving the efficacy and safety of those agents.

What is a basket trial?
A type of clinical trial that tests how well a new drug or other substance works in patients who have different types of cancer that all have the same mutation or biomarker. In basket trials, patients all receive the same treatment that targets the specific mutation or biomarker found in their cancer. Basket trials may allow new drugs to be tested and approved more quickly than traditional clinical trials. Basket trials may also be useful for studying rare cancers and cancers with rare genetic changes.

On May 10, 2022 Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), an immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, reported financial results for the first quarter ended March 31, 2022, and provided recent corporate updates (Press release, Sensei Biotherapeutics, MAY 10, 2022, View Source [SID1234614052]).

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"We continue to make significant progress in the development of our TMAb platform, which is designed to address the challenge of resistance to checkpoint blockade. New preclinical data show that SNS-101, our anti-VISTA antibody, binds selectively in low-pH environments to inhibit tumor growth, offering high potential for therapeutic benefit while avoiding the pharmacokinetic sinks and on-target, off-tumor toxicities that have made multiple immune targets difficult to drug," said John Celebi, president and chief executive officer of Sensei Biotherapeutics. "Importantly, we have extended our cash runway into the first quarter of 2025 by prioritizing near-term milestones for SNS-101 and other TMAb programs, while also continuing to optimize our ImmunoPhage platform."

Highlights and Milestones

TMAb (Tumor Microenvironment Activated Biologics) Platform

SNS-101

Sensei continues preclinical studies to evaluate SNS-101, a monoclonal antibody targeting the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation), which is implicated in resistance to PD-1/PD-L1 and correlates with poor survival across numerous cancers. Recent updates for SNS-101 include:

In April 2022 Sensei presented preclinical data demonstrating that SNS-101 had a favorable pharmacokinetic profile in a single-dose mouse model. Notably, pH-selective SNS-101 demonstrated a long mean residence time in the blood, indicating a lack of significant target-mediated drug disposition and clearance in non-malignant tissues.
SNS-101 demonstrated synergistic anti-tumor activity in vivo in combination with anti-PD-1 in a MC38 syngeneic tumor model in human VISTA knock-in mice.
SNS-101 has demonstrated great manufacturing productivity to date and Sensei anticipates reviewing pharmacokinetic and toxicology data from its single dose non-human primate studies in mid-2022.
Sensei has initiated GMP manufacturing for SNS-101 and remains on track to submit an IND in the first half of 2023.
SNS-102

Sensei intends to select a product candidate and initiate IND-enabling studies in 2023 for SNS-102, a monoclonal antibody targeting VSIG4 (V-Set and Immunoglobulin Domain Containing 4), a B7-family related protein that is frequently overexpressed on tumor-associated macrophages.
VSIG4 is a potent inhibitor of T-cell activity and potential driver of immunosuppressive macrophage polarization. Given its expression within normal tissues and the resulting potential safety challenges, Sensei believes that VSIG4 is an ideal candidate for development through its TMAb platform.
Sensei has generated the first set of parental tumor-selective antibodies targeting VSIG4 aimed at developing an inhibitory antibody with high selectivity for VSIG4 in the tumor microenvironment versus normal tissue environments.
SNS-103

Sensei remains on track to select a product candidate in 2023 for SNS-103, a monoclonal antibody targeting ENTPDase1 (ecto-nucleoside triphosphate diphosphohydrolase-1, also known as CD39), the upstream, rate-limiting enzyme leading to the breakdown of extracellular ATP.
ImmunoPhage Platform and SNS-401-NG

Sensei is optimizing its ImmunoPhage platform to offer a potentially transformative approach to generating new T cells to fight cancer, with potential to address multiple tumor types. Current work in this platform area extending into 2023 is focused on SNS-401-NG, a potential first-in-class, multi-antigenic bacteriophage designed to deliver anti-tumor antigens to the immune system. Sensei believes that a measured approach to development will position the company to advance the most potent ImmunoPhage product candidate when ready.

Corporate

In April 2022, Robert Pierce, M.D., Chief R&D Officer, presented an update on SNS-101 at the World Vaccine Congress, held April 18-21, 2022, in Washington DC.
In March 2022, Sensei announced the appointment of William Ringo as Chair of the Board of Directors.
In January 2022, Sensei announced the promotions of Erin Colgan to Chief Financial Officer and Robert Pierce, M.D., to Chief R&D Officer.
First Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $136.2 million as of March 31, 2022, as compared to $147.6 as of December 31, 2021. Sensei expects the current cash balance to fund operations into the first quarter of 2025.

Research and Development (R&D) Expenses: R&D expenses were $7.5 million for the quarter ended March 31, 2022, compared to $3.4 million for the quarter ended March 31, 2021. The increase in R&D expenses was primarily attributable to increased headcount to support Sensei’s research, development, and manufacturing activities.

General and Administrative (G&A) Expenses: G&A expenses were $5.0 million for the quarter ended March 31, 2022, compared to $4.6 million for the quarter ended March 31, 2021, with the increase mainly driven by franchise tax increases. The company is focused on carefully managing the growth of G&A expenses in the near term.

Net Loss: Net loss was $12.4 million, for the quarter ended March 31, 2022, compared to $8.0 million for the quarter ended March 31, 2021.

On May 10, 2022 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported a corporate and financial update for the first quarter ended March 31, 2022 (Press release, Athenex, MAY 10, 2022, View Source [SID1234614051]).

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"Our focus for 2022 continues to be on transforming Athenex into a robust, well-positioned cell therapy company with a solid balance sheet. We are proud of the progress we have made since announcing our strategic pivot and remain committed to delivering on cutting operating expenses and executing on additional monetization of noncore assets," said Johnson Lau, Chief Executive Officer of Athenex. "Our cell therapy programs continue to generate exciting data, which we are looking forward to presenting throughout the year. We believe our NKT cell therapy platform will be the main driver of future growth and will position us to be a differentiated leader in cell therapy space. Our corporate initiatives continue to set us up for successful value creation and allow us to further execute on our ultimate mission of bringing innovative treatments to cancer patients."

Corporate Developments

Business Updates

Lowered operating expenses in the first quarter of 2022 by 34% versus the prior year period, with additional cost-cutting underway
APD/APS division delivered four new product launches and generated 42% growth in product revenues during the first quarter of 2022 versus the prior year period
Plan to monetize non-core assets to support development of cell therapy pipeline
Key Anticipated Milestones

Oral presentation of interim analysis of Phase 1 GINAKIT2 study of KUR-501, our autologous GD2 CAR NKT program in pediatric relapsed/refractory high-risk neuroblastoma, at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual meeting on May 16, 2022 at 2:30 p.m. ET
Online presentation of KUR-503 preclinical data, our allogeneic GPC3 CAR-NKT cell program in liver cancer, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) on June 3-7, 2022
Multi-center expansion of CD19 CAR-NKT ANCHOR study of KUR-502 permitted under the newly allowed IND
Data update from ANCHOR study evaluating allogeneic CD19 CAR NKT therapy KUR-502 at American Society of Hematology (ASH) (Free ASH Whitepaper) expected in December 2022
Regulatory interactions with MHRA for Oral Paclitaxel in advanced breast cancer in UK
Phase 2 data from I-SPY 2 trial of Oral Paclitaxel in combination with dostarlimab in neoadjuvant breast cancer expected in 2H 2022
IND filing for KUR-503, our allogeneic CAR-NKT program in liver cancer planned in 2023
First Quarter 2022 and Recent Business Highlights

Clinical Programs

Cell Therapy

Presented interim analysis from ANCHOR study of KUR-502 at the American Society of Transplantation and Cellular Therapy (ASTCT). Reported 60% ORR and 6-month CR rate of 40% in five patients of the NHL cohort, including 1 ongoing CR at 34 weeks. Allogeneic CD19 CAR-NKT cells well tolerated with no cases of cytokine release syndrome (CRS) in the NHL cohort, no immune effector cell-associated neurotoxicity syndrome (ICANS) and no graft versus host disease (GvHD)
Upcoming presentation of abstract from interim analysis of Phase 1 GINAKIT2 study of KUR-501, an autologous GD2 CAR-NKT cell therapy for relapsed/refractory high risk neuroblastoma at ASGCT (Free ASGCT Whitepaper). Data presented shows dose response at low doses of 1×108 cells/m2, including a durable complete response persisting 12 months. Analysis of results found that response correlates with CD62L+ NKT frequency as well as CAR-NKT area under the curve (AUC). Treatment remains well-tolerated with no dose-limiting toxicity, no ICANS, and one case of grade 2 CRS.
Commercial Update

Klisyri (tirbanibulin)

Commercial partner Almirall reported 3.6% market share in the U.S.
Klisyri was granted Medicare coverage and now has 40% coverage
Uptake remains strong in German market, and pre-launch activities in place to support the continued rollout in Europe
American Academy of Dermatology guidelines for the management of actinic keratosis included Klisyri receiving the strongest recommendation
Specialty Pharmaceutical Business

Athenex Pharmaceutical Division (APD) currently markets a total of 29 products with 54 SKUs.
Athenex Pharma Solutions (APS) currently markets 6 products with 16 SKUs
First Quarter 2022 Financial Highlights

Revenues from product sales increased to $29.0 million for the three months ended March 31, 2022, from $20.4 million for the three months ended March 31, 2021, an increase of $8.6 million or 42%. This increase was primarily attributable to an increase in APD specialty product sales, which increased by $9.5 million as the result of increases in shortage product sales and product launches during 2022.

License fees and other revenue for three months ended March 31, 2022 was $0.8 million, compared to $20.7 million for the same period in 2021, a decrease of $19.9 million. This decrease was primarily due to the recognition of $20.0 million of license revenue pursuant to the 2017 Almirall License Agreement upon the launch of Klisyri in the U.S. during the three months ended March 31, 2021.

Cost of sales for the three months ended March 31, 2022 totaled $23.3 million, an increase of $6.9 million, or 42%, as compared to $16.4 million for the three months ended March 31, 2021. The increase in our cost of specialty product sales was primarily due to an increase in cost of APD and 503B product sales, of $5.7 million and $2.5 million, respectively. These were partially offset by a $1.3 million decrease in cost of API product sales.

R&D expenses totaled $14.0 million for the three months ended March 31, 2022, a decrease of $9.1 million, or 39%, as compared to $23.1 million for the three months ended March 31, 2021. This decrease was primarily due to a decrease in Oral Paclitaxel product development and medical affairs costs, costs of clinical and regulatory operations, and costs of preclinical operations.

SG&A expenses totaled $14.9 million for the three months ended March 31, 2022, a decrease of 28% as compared to $20.7 million for the three months ended March 31, 2021. The decrease was primarily due to a $6.7 million decrease of costs for preparing to commercialize Oral Paclitaxel as significant pre-launch activities occurred in 2020, partially offset by a $1.3 million increase in operating costs.

Interest income and interest expense totaled $0.1 million and $4.5 million, respectively, for the three months ended March 31, 2022. Interest income and interest expense for three months ended March 31, 2021 totaled less than $0.1 million and $4.9 million, respectively. Interest expense in both periods was incurred from the Senior Credit Agreement with Oaktree.

Income tax expense for the three months ended March 31, 2022 amounted to less than $0.1 million, compared to $0.2 million for the same period in 2021. We did not record a provision for U.S. federal income taxes for the three months ended March 31, 2022, because we expect to generate a loss for the year ending December 31, 2022.

Net loss attributable to Athenex for the three months ended March 31, 2022 was $17.4 million, or ($0.16) per diluted share, as compared to a net loss of $25.1 million, or ($0.27) per diluted share, for the same period in 2021.

For further details on the Company’s financial results, including the results for the three months ended March 31, 2022, refer to the Form 10Q filed with the SEC.

2022 Financial Guidance

Athenex now expects product sales growth to be in the range of 20-25% over the prior year period, versus the prior range of 15-20% growth, year-over-year, due to the strong performance of Athenex’s APD/APS division, earlier than expected NY State license, and the robust pipeline of launches planned for the remainder of 2022.

Cash Conservation Update

As of March 31, 2022, the Company had cash and cash equivalents of $27.2 million, restricted cash of $13.8 million, and short-term investments of $10.2 million, for a total of $51.2 million. The Company is implementing cost savings programs and monetizing non-core assets, and as the Company completes such activities, the Company plans to extend its cash runway into next year.

Conference Call and Webcast Information

Athenex will host a conference call and live audio webcast today, Tuesday, May 10, 2022, at 8:00 a.m. Eastern Time to discuss the financial results and provide a business update.

To participate in the call, dial either the domestic or international number fifteen minutes before the conference call begins:

The live conference call and replay can also be accessed via audio webcast here and on the Investor Relations section of the Company’s website under "Events and Presentations", located at View Source