On May 5, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported financial results for the first quarter of 2022 (Press release, Oncternal Therapeutics, MAY 5, 2022, View Source [SID1234613650]).

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"In the first quarter, we continued to advance our robust pipeline towards important inflection points, including the planned initiation of our zilovertamab registrational Phase 3 study in patients with MCL in Q3 2022, the submission of an IND for our ROR1-targeting CAR-T cell therapy candidate ONCT-808 in mid-2022, and the execution of IND-enabling studies for ONCT-534, our DAARI product candidate that may address key resistance mechanisms in metastatic prostate cancer," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "Substantial progress of our pipeline has been supported by solid collaborations with our partners and execution by our team, and is being carried out with a focus on prudent cash management. Very importantly, we narrowed our focus on hematological malignancies and prostate cancer, and deprioritized our ONCT-216 program, which helped extend our cash runway well into Q3 2023. We will continue to explore and evaluate all potential sources of capital to enable us to reach our milestones."

Recent Highlights

In January 2022, we announced that we reached consensus with the FDA on the design and major study details of the Phase 3 Study, ZILO-301, to treat patients with relapsed or refractory mantle cell lymphoma (MCL) with zilovertamab, an investigational anti-ROR1 monoclonal antibody, in combination with ibrutinib. The agency also provided positive feedback on the proposed key clinical and regulatory requirements of our development program for zilovertamab in patients with MCL.
In April 2022, we established a clinical manufacturing agreement with the Dana-Farber Cancer Institute to conduct cGMP cell preparation and manufacturing activities for use in first-in-human studies of our ROR1-targeting CAR-T cell therapy candidate ONCT-808.
In April 2022, we announced the deprioritization of further development of ONCT-216 and the discontinuation of enrollment in the Phase 1/2 study evaluating ONCT-216 in patients with relapsed or refractory Ewing sarcoma.
Expected Upcoming Milestones

Zilovertamab, our ROR1 antibody program
Initiation of global registrational Phase 3 Study, ZILO-301, in the third quarter of 2022
Interim clinical data update for patients with MCL and CLL treated with zilovertamab plus ibrutinib in ongoing Phase 1/2 clinical study will be presented at the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting
Initiation of Phase 1b investigator sponsored trial of zilovertamab plus docetaxel for patients with metastatic castration-resistant prostate cancer (mCRPC) in mid-2022
ONCT-808, lead candidate in our autologous ROR1-targeted CAR-T cell therapy program
Investigational New Drug (IND) application submission in mid-2022
ONCT-534, lead candidate in our DAARI program
IND-enabling GLP toxicology studies and GMP manufacturing initiated in the second quarter of 2022
First Quarter 2022 Financial Results
Our grant revenue was $0.7 million for the first quarter ended March 31, 2022. Our grant revenue is derived from a subaward under a grant from the California Institute for Regenerative Medicine (CIRM) to the University of California, San Diego and two research and development grant awards from the National Institutes of Health (NIH).

Our total operating expenses for the first quarter ended March 31, 2022 were $10.7 million, including $2.0 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $7.0 million, and general and administrative expenses for the quarter totaled $3.7 million. Net loss for the first quarter was $9.9 million, or a loss of $0.20 per share, basic and diluted.

As of March 31, 2022, we had approximately 49.4 million shares of common stock outstanding, $82.2 million in cash and cash equivalents and no debt. We believe these funds will be sufficient to fund our operations well into Q3 2023. Our cash guidance is subject to a number of assumptions, including those related to the severity and duration of the COVID-19 pandemic, and the pace of our research and clinical development programs, among other aspects of our business and the geopolitical environment.

On May 5, 2022 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported financial results for the quarter ended March 31, 2022 and recent business highlights (Press release, Coherus Biosciences, MAY 5, 2022, View Source [SID1234613649]):

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RECENT BUSINESS HIGHLIGHTS

After receiving a complete response letter ("CRL") for the Biologics License Application ("BLA") for toripalimab, Coherus and partner Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences") plan to resubmit the toripalimab BLA by mid-summer with an expected six month review by the United States Food and Drug Administration ("FDA"). The CRL requests a quality process change that Coherus and Junshi Biosciences believe is readily addressable.
The FDA review of the BLA for CIMERLI (ranibizumab-ranq), a Lucentis biosimilar, is advancing toward the target action date of August 2, 2022.
The FDA granted Orphan Drug Designation for toripalimab for the treatment of small cell lung cancer.
Two proprietary immuno-oncology research programs have advanced to preclinical development: CHS-1000, an ILT4-targeted antibody, and CHS-3318, a CCR8-targeted antibody. Coherus expects to file an investigational new drug application ("IND") for CHS-1000 in 2023.
Positive toripalimab clinical data were presented and published:
Final progression-free survival ("PFS") and interim overall survival ("OS") data from the JUPITER-02 trial evaluating toripalimab plus chemotherapy for advanced nasopharyngeal carcinoma were presented at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April.
Final PFS and interim OS data from the CHOICE-01 trial evaluating toripalimab plus chemotherapy for non-small cell lung cancer were presented at the March ASCO (Free ASCO Whitepaper) Plenary Series.
Final PFS and interim OS data from the JUPITER-06 trial evaluating toripalimab plus chemotherapy for first-line treatment of esophageal squamous cell carcinoma were published in the March issue of Cancer Cell.
Coherus has discontinued development of CHS-305 ("IBI-305"), an Avastin biosimilar candidate, and is returning IBI-305 rights to Innovent Biologics (Suzhou) Co., Ltd.
Coherus is lowering by $20 million the projected range for combined full year 2022 R&D and SG&A expenses. See "2022 R&D and SG&A Expense Guidance" section below.
"As we prepare for as many as four new product launches in 2022 and 2023, we continue to make strong progress transforming Coherus into an innovative immuno-oncology company supported by revenues generated by our diversified commercial portfolio of FDA-approved products," said Denny Lanfear, Coherus’ CEO. "Following the recent late-cycle review meeting with the FDA, we are finalizing our preparations to launch CIMERLI later this year, if approved, into the $7 billion anti-VEGF ophthalmology market in the United States. We expect to resubmit the toripalimab BLA by mid-summer and are preparing for the commercial launch directly upon approval. We continue to invest significantly in YUSIMRY ahead of the planned launch in July 2023, as robust supply availability is a key part of our market strategy. Our UDENYCA business continues to provide strong funding for our operations, and we look forward to the potential launch next year of our on-body injector presentation which, if approved, would allow us to compete directly with Neulasta Onpro, a greater than $1 billion market opportunity."

FIRST QUARTER 2022 FINANCIAL RESULTS

Net revenue, consisting of net sales of UDENYCA, was $60.1 million and $83.0 million during the three months ended March 31, 2022 and 2021, respectively. The decline was primarily due to a decrease in the number of units of UDENYCA sold as well as a lower net realized price due to increased competition.

Cost of goods sold (COGS) was $9.4 million and $7.5 million during the three months ended March 31, 2022 and 2021, respectively. Until the first quarter of 2021, Coherus sold inventory that was manufactured and expensed prior to the approval of UDENYCA in late 2018. This inventory was depleted in the first quarter of 2021, and since then, COGS fully reflects per unit acquisition cost. UDENYCA COGS also includes a mid-single digit royalty on net sales payable through the first half of 2024.

Research and development (R&D) expense for the three months ended March 31, 2022 was $82.9 million and included a $35 million option exercise fee to Junshi Biosciences to license CHS-006, a clinical stage TIGIT-targeted antibody, as well as development and manufacturing costs for clinical and preclinical pipeline programs. For the same period in 2021, R&D expense was $203.5 million and included a $145 million upfront fee paid to Junshi Biosciences for the license to rights to toripalimab for the United States and Canada, $11.5 million in costs related to the discontinuation of the CHS-2020 (Eylea biosimilar) program, as well as development costs for clinical and preclinical pipeline programs.

Selling, general and administrative (SG&A) expense for the three months ended March 31, 2022 was $48.8 million compared to $39.4 million for the same period in 2021. The increase was primarily driven by higher commercialization expenses to support current UDENYCA sales and in preparation for multiple anticipated new product launches in 2022 and 2023, including CIMERLI, toripalimab, YUSIMRY, and the on-body injector presentation of UDENYCA.

Net loss for the first quarter of 2022 was $96.1 million, or $(1.24) per share on a diluted basis, compared to a net loss of $172.9 million, or $(2.37) per share on a diluted basis for the same period in 2021.

Non-GAAP net loss for the first quarter of 2022 was $77.0 million, or $(1.00) per share on a diluted basis, compared to non-GAAP net loss of $144.6 million, or $(1.98) per share on a diluted basis for the same period in 2021. Beginning in the first quarter of 2022, the Company no longer regularly excludes upfront and milestone based license fee payments from its non-GAAP financial information. To conform to this change, the prior period non-GAAP financial information has been recast to include upfront and milestone based license fee payments. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and investments in marketable securities were $325.7 million as of March 31, 2022, compared to $417.2 million at December 31, 2021.

2022 R&D and SG&A Expense Guidance

As a result of the discontinuation of the CHS-305 development program and the delay of the toripalimab commercial launch, Coherus is lowering the projected range for combined full year 2022 R&D and SG&A expenses by $20 million to $395 million to $430 million. This range includes $55 million to $60 million of stock-based compensation expense and excludes the $35 million license fee paid in the first quarter of 2022 for CHS-006 as well as a potential $25 million milestone payable upon FDA approval of the toripalimab BLA for nasopharyngeal carcinoma. This financial guidance also excludes the effects of any potential future strategic acquisitions, collaborations or investments, the exercise of rights or options related to collaboration programs, and any other transactions or circumstances not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below.

On May 5, 2022 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported financial results for the first quarter ended March 31, 2022 and provided a review of recent business and clinical highlights (Press release, Xencor, MAY 5, 2022, View Source [SID1234613648]).

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"Our XmAb Fc domains and protein engineering expertise have enabled a broad portfolio of clinical-stage drug candidates, which we and our partners are investigating across many therapeutic areas. Internally we are focused on efficiently using our resources to advance the most promising clinical-stage programs, as well as the next wave of Xencor innovations to enter the clinic – more reduced-potency XmAb cytokines, CD28 T cell engagers and 2+1 CD3 T cell engagers," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Today we are pleased to announce we have dosed the first patient in a potentially registration-enabling study for plamotamab to evaluate the chemotherapy-free, triple combination with tafasitamab and lenalidomide for patients with an aggressive form of non-Hodgkin’s lymphoma."

Dr. Dahiyat continued, "As we progress through the year, we remain on track to present additional clinical data from our vudalimab and plamotamab programs and initial data from our IL2-Fc autoimmune program, XmAb564, in healthy volunteers. In addition, we will present data from our XmAb104 program at the ASCO (Free ASCO Whitepaper) Annual Meeting. In 2022, we also expect to start Phase 1 studies for XmAb819, our ENPP3 x CD3 bispecific antibody for renal cell carcinoma engineered with our multivalent 2+1 format for greater tumor selectivity, and for XmAb808, our B7-H3 x CD28 bispecific antibody. This broad development pipeline is supported by the recent strong revenue from our marketed partnered programs and our robust financial position."

Recent Portfolio Highlights

Plamotamab (CD20 x CD3): Xencor has dosed the first patient in a potentially registration-enabling Phase 2 study, evaluating plamotamab in combination with tafasitamab plus lenalidomide, in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study consists of two parts, a safety run-in intended to establish the safety of the triple combination (Part 1) and a two-arm, open-label cohort where patients will be randomized to receive either the triple combination or tafasitamab plus lenalidomide (Part 2). Xencor is conducting the clinical study in collaboration with MorphoSys AG and Incyte Corporation. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the United States and is marketed by Incyte under the brand name Minjuvi in the European Union. Incyte has exclusive commercialization rights to tafasitamab outside the U.S.

Expansion cohorts in the Phase 1 study of plamotamab are actively recruiting patients with DLBCL and follicular lymphoma (FL) and are dosing using the recommended Phase 2 regimen to further evaluate the safety and efficacy of plamotamab as a monotherapy. Subcutaneous administration of plamotamab will be introduced this year, and the Company plans to present data from the expansion cohorts in the second half of 2022.
Vudalimab (PD-1 x CTLA-4): Xencor is supporting two newly initiated investigator-sponsored studies of vudalimab, in patients with advanced biliary tract cancers and in patients with advanced rare cancers.

The Company is currently enrolling a Phase 2 study in patients with metastatic castration-resistant prostate cancer (mCRPC), in which vudalimab is being evaluated as a monotherapy or in combination with chemotherapy or a PARP inhibitor depending on the tumor’s molecular subtype. The Company plans to present initial data from the study in the second half of 2022 and is currently initiating a Phase 2 study evaluating vudalimab monotherapy in patients with advanced pelvic tumors, including clinically defined high-risk mCRPC and certain gynecologic malignancies.
XmAb306 (IL15/IL15Rα-Fc): Xencor’s co-development partner Genentech, a member of the Roche Group, has initiated a Phase 1 study to evaluate the combination of XmAb306 (RO7310729) and daratumumab, an anti-CD38 monoclonal antibody, in patients with relapsed/refractory multiple myeloma.

XmAb306 is a potency-reduced IL15/IL15Rα-Fc fusion protein targeting NK and T cells for the treatment of patients with cancer. In an ongoing Phase 1 dose-escalation study of XmAb306 in patients with advanced solid tumors, XmAb306 has promoted high levels of sustained NK cell expansion and evidence of peripheral effector T cell proliferation. Additional studies of XmAb306 in combination with other therapeutic agents are also being planned.
XmAb104 (PD-1 x ICOS): An abstract with initial dose-escalation data from the Phase 1 study of XmAb104 in patients with advanced solid tumors was accepted for a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2022.
Preclinical Data Presentations: New data from two preclinical-stage XmAb cytokine programs, an IL18-Fc (XmAb143) and a LAG-3 targeted IL15/IL15Rα-Fc, were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2022.
Tidutamab (SSTR2 x CD3) and XmAb841 (CTLA-4 x LAG-3): The Company will stop internal development of the tidutamab and XmAb841 programs. Neither program demonstrated a competitive clinical profile in recent trials, and the Company has decided to focus resources on new clinical programs. The Company will continue to support patients currently enrolled and being treated.
Progress Across Partnered Programs

Vir Biotechnology, Inc.: In the first quarter of 2022, Xencor recognized $70.3 million in royalty revenue under the Company’s agreement with Vir. Sotrovimab, an antibody that targets the SARS-CoV-2 virus and incorporates Xencor’s Xtend Fc domain for longer duration of action, has been made available by Vir and its partner Glaxo Wellcome UK Limited and GlaxoSmithKline Biologicals S.A. Due to the rapid emergence of the sotrovimab-resistant Omicron BA.2 subvariant in the first quarter, sotrovimab’s authorization was ended in all U.S. regions.
Alexion Pharmaceuticals, Inc.: In April 2022, Ultomiris (ravulizumab-cwvz), which incorporates an Xtend Fc domain, was approved by the U.S. Food and Drug Administration for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. In the first quarter of 2022, Xencor earned $6.1 million from Alexion on net sales of Ultomiris.
Astellas Pharma, Inc.: Astellas has advanced ASP2138, a CLDN18.2 x CD3 XmAb bispecific antibody, into Phase 1 clinical development for the treatment of patients with gastric, gastroesophageal, and pancreatic cancers. Under the Astellas agreement, Xencor applied XmAb bispecific Fc technology to an antigen pair provided by Astellas.
Ultomiris is a registered trademark of Alexion Pharmaceuticals, Inc. Monjuvi and Minjuvi are registered trademark of MorphoSys AG.

Financial Results for the First Quarter Ended March 31, 2022

Cash, cash equivalents, receivables and marketable debt securities totaled $683.6 million as of March 31, 2022, compared to $664.1 million on December 31, 2021. During the first quarter of 2022, the Company received milestone payments and royalties from partners of $83.7 million, which offset spending on operations and resulted in a higher cash balance relative to the 2021 year-end amount.

Revenues for the first quarter ended March 31, 2022 were $85.5 million, compared to $34.0 million for the same period in 2021. Total revenues earned in the first quarter of 2022 included revenues earned from Xencor’s Janssen collaboration, milestone revenue from Astellas, and royalties from the Alexion, MorphoSys and Vir agreements, compared to revenue earned from the Janssen collaboration and royalties and milestones from the Alexion and MorphoSys agreements in the first quarter of 2021.

Research and development expenses for the first quarter ended March 31, 2022 were $47.8 million, compared to $41.4 million for the same period in 2021. Increased research and development spending for first quarter of 2022 compared to 2021 reflects increased spending on the Company’s new development programs including XmAb808 (B7-H3 x CD28) and XmAb662 (IL-12).

General and administrative expenses for the first quarter ended March 31, 2022 were $11.3 million, compared to $8.2 million in the same period in 2021. Increased general and administrative spending for the first quarter of 2022 compared to 2021 reflects increased staffing and additional lease expenses.

Non-cash, stock-based compensation expense for the first quarter ended March 31, 2022 was $10.8 million, compared to $8.3 million for the same period in 2021.

Net income for the first quarter ended March 31, 2022 was $23.6 million, or $0.39 on a fully diluted per share basis, compared to a net loss of $2.5 million, or $(0.04) on a fully diluted per share basis, for the same period in 2021. Net income reported for the first quarter of 2022 compared to net loss for the same period in 2021 is primarily due to increased royalties from partners in 2022.

The total shares outstanding were 59,529,192 as of March 31, 2022, compared to 58,221,953 as of March 31, 2021.

Financial Guidance

Based on current operating plans, Xencor expects to have cash to fund research and development programs and operations through the end of 2025. While future royalty revenues are uncertain, based on recent guidance from GSK, Xencor expects the amount of royalty revenue that it receives from sales of sotrovimab to substantially decline in future reporting periods. The Company expects to end 2022 with between $500 million and $550 million in cash, cash equivalents, receivables and marketable debt securities.

Conference Call and Webcast

Xencor will host a conference call today at 4:30 p.m. ET (1:30 p.m. PT) to discuss the first quarter 2022 financial results and provide a corporate update.

The live call may be accessed by dialing (877) 359-9508 for domestic callers or +1 (224) 357-2393 for international callers and referencing conference ID number 2583486. A live webcast of the conference call will be available online from the Investors section of the Company’s website at www.xencor.com. The webcast will be archived on the company’s website for 30 days.

On May 5, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the first quarter ended March 31, 2022 and provided business updates (Press release, Curis, MAY 5, 2022, View Source [SID1234613647]).

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"During the first quarter of 2022, we continued to advance the clinical trials of emavusertib, previously referred to as CA-4948, our first-in-class, small molecule IRAK4 inhibitor in nine distinct patient populations across AML, MDS and B cell cancers. In January, we provided additional preliminary data showing early anti-cancer activity of emavusertib in AML/MDS patients with spliceosome or FLT3 mutation. In addition, we presented initial data from the dose escalation study of CI-8993, a monoclonal antibody targeting VISTA, in patients with relapsed/refractory solid tumors. We also would highlight that we have cleared the 0.3mg/kg dose level, which we believe is an important initial safety hurdle," said James Dentzer, President and Chief Executive Officer of Curis.

"Shortly after the close of the first quarter, our two TakeAim studies were put on partial clinical hold by the U.S. Food and Drug Administration ("FDA") as the agency is seeking additional data relating to emavusertib, including data related to rhabdomyolysis and our determination of the Recommended Phase 2 Dose. We are working collaboratively with the FDA and hope to resolve the partial hold on our studies quickly," continued Mr. Dentzer. "As we gain clarity on the timing of this resolution, we will provide updated guidance on our plan to discuss the potential for a rapid registrational path for emavusertib with the FDA."

First Quarter 2022 and Recent Operational Highlights

Precision oncology, emavusertib (IRAK4 Inhibitor; Aurigene collaboration):

In January, the company hosted a conference call detailing updated data from the TakeAim Leukemia study.
The TakeAim Leukemia study is a Phase 1/2 dose escalation, dose expansion study examining emavusertib use as both monotherapy and in combination with azacitidine or venetoclax in patients with relapsed or refractory ("R/R") acute myeloid leukemia ("AML") or R/R high risk myelodysplastic syndrome ("MDS").
In patients with spliceosome-mutated R/R AML, key findings included:
CR/CRh rate of 40% (2 out of 5 patients)
Both patients who achieved CR/CRh have been on study > 6 months and achieved negative MRD (minimal residual disease) status
Consistent tumor burden reduction observed, 3 out of 5 patients with elevated blast counts achieving ≥ 50% reduction in blast counts
In patients with spliceosome-mutated R/R MDS, key findings included:
Objective response rate of 57% (4 out of 7 patients)
One of the patients who achieved a marrow CR ("mCR") proceeded to stem cell transplant after 1 cycle
Consistent tumor burden reduction observed, with 4 out of 6 patients with elevated baseline blast counts achieving ≥ 50% reduction in blast counts
In patients with a FLT3 mutated R/R AML, key findings included:
CR rate of 33% (1 out of 3 patients; this patient’s AML also had a spliceosome mutation)
2 out of 3 patients showed eradication of FLT3 mutation following treatment, indicating potential for disease modification with emavusertib
Consistent tumor burden reduction observed; with 2 out of 3 patients with elevated blast counts achieving ≥ 50% reduction in blast counts
Curis collaborators at the Washington University School of Medicine in St. Louis, published research suggesting the potential use of emavusertib in solid tumors, such as pancreatic cancer, a setting with very limited therapeutic options.
The manuscript titled "IRAK4 signaling drives resistance to checkpoint immunotherapy in pancreatic ductal adenocarcinoma" concluded that tumor IRAK4 drives T-cell exhaustion in pancreatic nonclinical ductal adenocarcinoma models and is a promising therapeutic target when combined with checkpoint immunotherapy.
The manuscript is available online at View Source(22)00201-3/pdf.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext collaboration):

Also discussed during the January update call were data from the Phase 1 study of CI-8993, Curis’s first-in-class monoclonal anti-VISTA antibody, in patients with R/R solid tumors.
Dose escalation has proceeded to the 0.6mg/kg dose level, past the 0.15mg/kg dose level where toxicities were seen previously, namely cytokine release syndrome, or CRS. Dose escalation will continue until the Recommended Phase 2 Dose ("RP2D") has been determined
Pharmacodynamic data suggest CI-8993 has multiple anticancer mechanisms that may position it for combination with existing checkpoint inhibitors, in addition to monotherapy
Presentations at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Curis Presentations

TakeAim Lymphoma
Abstract Number: 7575
Abstract Title: Open-label, dose-escalation, and expansion trial of CA-4948 in combination with ibrutinib in patients with relapsed or refractory hematologic malignancies.
Session Type/Title: Poster Session/ Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Session Date and Time: Saturday, June 4, 2022, 8:00 AM-11:00 AM CDT
TakeAim Leukemia
Abstract Number: 7016
Abstract Title: Phase 1/2a study of the IRAK4 inhibitor CA-4948 as monotherapy or in combination with azacitidine or venetoclax in patients with relapsed/refractory (R/R) acute myeloid leukemia or myelodysplastic syndrome.
Session Type/Title: Poster Discussion Session/ Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Session Date and Time: Saturday, June 4, 2022, 1:15 PM-2:45 PM; 8:00 AM-11:00 AM CDT
Collaborator Presentations

Gastric and Esophageal Cancer
Abstract Number: TPS4168
Abstract Title: Phase I trial of CA-4948, an IRAK4 inhibitor, in combination with FOLFOX/PD-1 inhibitor +/- trastuzumab for untreated unresectable gastric and esophageal cancer
Session Type/Title: Poster Session/Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date and Time: Saturday, June 4, 2022, 8:00 AM-11:00 AM CDT
Melanoma Brain Metastases
Abstract Number: 2011
Abstract Title: CA-4948 for the treatment of melanoma brain metastasis.
Session Type/Title: Poster Discussion Session/ Central Nervous System Tumors
Session Date and Time: Sunday, June 5, 2022, 11:30 AM-1:00 PM; 8:00 AM-11:00 AM CDT
Upcoming Planned Milestones for 2022

Report data from the TakeAim Lymphoma study
In the first half of 2022, we plan to present new data for approximately 12 patients who have received treatment with the combination of emavusertib and ibrutinib at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") and European Hematology Association (EHA) (Free EHA Whitepaper) ("EHA") meetings in June 2022
Report data from the TakeAim Leukemia study
In the first half of 2022, we plan to present the monotherapy data released on our January update call in a peer-reviewed setting at the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) conferences
In the second half of 2022, we plan to present an update with additional monotherapy data
In the second half of 2022, we plan to present initial data for the study of emavusertib in combination with azacitadine or venetoclax
Report data from the CI-8993 (VISTA checkpoint inhibitor) study
In the second half of 2022, we plan to present an update with additional monotherapy data
First Quarter 2022 Financial Results

For the first quarter of 2022, Curis reported a net loss of $16.1 million or $0.18 per share on both a basic and diluted basis, as compared to a net loss of $9.9 million, or $0.11 per share on both a basic and diluted basis for the same period in 2021.

Revenues for the first quarter of 2022 and 2021 were $2.1 million and $2.2 million, respectively. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses for the first quarter of 2022 were $17.2 million, as compared to $11.0 million for the same period in 2021, and comprised the following:

Cost of Royalty Revenues. Cost of royalty revenues, represents amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.1 million for the first quarter of 2022 and 2021.

Research and Development Expenses. Research and development expenses were $11.4 million for the first quarter of 2022 as compared to $6.8 million for the same period in 2021. The increase in direct research and development expenses for the quarter is primarily attributable to increased manufacturing costs for our programs and increased consulting services. Additionally, personnel related costs increased by $2.4 million and stock compensation increased $0.4 million, primarily as a result of additional headcount.

General and Administrative Expenses. General and administrative expenses were $5.7 million for the first quarter of 2022, as compared to $4.1 million for the same period in 2021. The increase in general and administrative expense was driven primarily by higher costs for personnel, stock-based compensation, and insurance costs.

Other Expense, Net. For the third quarter of 2022 and 2021, net other expense was $1.0 million and $1.1 million, respectively. Net other expense primarily consisted of imputed interest expense related to future royalty payments.

As of March 31, 2022, Curis’s cash, cash equivalents and investments totaled $120.7 million, and there were approximately 91.6 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations into 2024.

Conference Call Information

Curis management will host a conference call today, May 5, 2022, at 4:30 p.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.

On May 5, 2022 MannKind Corporation (Nasdaq: MNKD) reported financial results for the quarter ended March 31, 2022 (Press release, Mannkind, MAY 5, 2022, View Source [SID1234613646]).

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"As we approach the FDA action date for Tyvaso DPI, our company is focused on supporting United Therapeutics in their planned commercial launch," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "Our endocrine business unit execution has resulted in Afrezza net revenue growth of 21% vs. the first quarter 2021 and we continue to add sites and patients into our Afrezza pediatric trial, INHALE-1."

Total revenues were $12.0 million for the first quarter of 2022, reflecting Afrezza net revenue of $9.8 million and collaborations and services revenue of $2.2 million. Afrezza net revenue increased 21% compared to $8.1 million in the first quarter of 2021 as a result of wholesaler inventory ordering patterns for the first quarter of 2021, which was adversely impacted as wholesalers decreased inventory levels, plus price, which included more favorable gross-to-net deductions. Collaborations and services revenue decreased $7.2 million compared to the first quarter of 2021 primarily due to the completion of the R&D Services associated with our collaboration with United Therapeutics ("UT"). In August 2021, we entered into a commercial supply agreement ("CSA") with UT. Revenue associated with the CSA is deferred as of March 31, 2022 and will be recognized over the period when commercial product is sold to UT. The deferred revenue balance associated with the CSA increased by $7.1 million in the first quarter to $25.7 million as of March 31, 2022.

Afrezza gross profit for the first quarter of 2022 was $7.5 million compared to $3.8 million in the same period of 2021, an increase of $3.8 million, or 99%, which was driven by an increase in Afrezza sales and a decrease in cost of goods sold. The Afrezza cost of goods sold decreased by $2.0 million, or 47%, compared to the same period in 2021, primarily as a result of the absorption of manufacturing-related costs due to the manufacturing of a second product. Afrezza gross margin in the first quarter of 2022 was 77% compared to 47% for the same period in 2021.

Cost of revenue – collaborations and services increased by $5.4 million in the first quarter of 2022 compared to the same period in 2021 primarily due to an increase in costs of manufacturing activities in preparation for supplying commercial product to UT.

Research and development expenses for the first quarter of 2022 were $3.5 million compared to $2.4 million for the first quarter of 2021. This $1.1 million increase was mainly related to costs incurred for research and development activities for our product pipeline, including a phase 1 clinical trial for inhaled clofazimine.

Selling, general and administrative expenses for the first quarter of 2022 were $20.7 million compared to $17.4 million for the first quarter of 2021. This $3.3 million increase was primarily attributable to an enhanced primary care physician-focused promotional campaign that began in the fourth quarter of 2021, Afrezza territory restructuring costs, as well as promotional and patient support services expenses to support Afrezza sales growth.

For the first quarter of 2022, the gain on foreign currency translation (for insulin purchase commitments denominated in Euros) was $2.0 million compared to $3.8 million for the first quarter of 2021. The fluctuation was due to a change in the U.S. dollar to Euro foreign currency exchange rate.

Interest expense on financing liability was $2.4 million for the first quarter of 2022 and represented interest incurred on the sale lease-back transaction for our manufacturing facility in Danbury, CT.

Interest expense on debt for the first quarter of 2022 was $2.7 million compared to $6.5 million for the first quarter of 2021. This decrease of $3.7 million was primarily due to a milestone payment obligation that was achieved during the first quarter of 2021, partially offset by an increase in interest expense related to our senior convertible notes.

The net loss for the first quarter of 2022 was $26.0 million, or $0.10 per share, compared to $12.9 million in the first quarter of 2021, or $0.05 per share. The $13.1 million increase in the net loss was primarily due to a decrease in revenues from collaboration and services and an increase in the cost of revenue for collaborations and services. Revenue associated with the CSA is deferred as of March 31, 2022 and will be recognized over the period when commercial product is sold to UT. The increase in cost of revenue for collaborations and services was primarily due to an increase in costs of manufacturing activities in preparation for supplying commercial product to UT.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at mannkindcorp.com under Events & Presentations. A replay will be available on MannKind’s website for 14 days.