On May 5, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, reported first quarter 2022 financial results and provided a business update (Press release, CytomX Therapeutics, MAY 5, 2022, View Source [SID1234613662]).

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"The CytomX team continued to execute across our portfolio during the first quarter of 2022, including significant progress with patient enrollment in our most advanced clinical studies. Initial data readouts for both Arms A and B for praluzatamab ravtansine and a data update for CX-2029 remain on track for the second half of this year. Beyond these important milestones, we are also advancing many new experimental therapeutics, including our conditionally activated version of interferon alpha-2b, which was detailed in a presentation at the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The breadth of our clinical and preclinical pipeline continues to demonstrate the multi-modality potential of our technology platform to deliver important new treatments for cancer," said Sean McCarthy, D.Phil., chief executive officer and chairman at CytomX Therapeutics.

First Quarter Business Highlights and Recent Developments

Praluzatamab ravtansine – Praluzatamab ravtansine is a CD166-directed conditionally activated antibody-drug conjugate (ADC) wholly-owned by CytomX. The three-arm Phase 2 study is evaluating praluzatamab ravtansine as monotherapy in patients with hormone receptor-positive, human epidermal growth factor receptor 2-non-amplified breast cancer (Arm A) and in patients with triple-negative breast cancer (TNBC, Arm B), and in combination with pacmilimab, our PD-L1 directed Probody therapeutic, in patients with TNBC (Arm C). Enrollment to Arm A is complete.
CX-2029 – CX-2029 is a CD71-directed conditionally activated ADC being co-developed by CytomX and AbbVie. In addition to head and neck squamous cell carcinoma, the Phase 2 expansion study has now also completed patient enrollment in the squamous non-small cell lung cancer cohort. The study remained open for enrollment in the esophageal and gastro-esophageal junction cancers cohort, and the diffuse large B-cell lymphoma cohort.
CX-904 – CX-904 is a conditionally activated T-cell-engaging bispecific antibody targeting the epidermal growth factor receptor (EGFR) on tumor cells and the CD3 receptor on T cells, and is partnered with Amgen. The investigational new drug application for a first-in-human Phase 1 study of CX-904 in patients with advanced solid tumors was allowed to proceed by the U.S. Food and Drug Administration and study start-up activities were initiated.
Ipilimumab Probody Program – BMS-986249 and BMS-986288 are Probody versions of the anti-CTLA4 antibody, ipilimumab and non-fucosylated ipilimumab, respectively. BMS-986249 is currently being evaluated by CytomX’s collaboration partner, Bristol Myers Squibb, in a randomized Phase 2 study in combination with nivolumab, the anti-PD-1 antibody, versus ipilimumab plus nivolumab in patients newly diagnosed with advanced melanoma. This novel combination is also being studied in advanced hepatocellular carcinoma, castration-resistant prostate cancer, and TNBC. Bristol Myers Squibb also continued to evaluate BMS-986288, as monotherapy and in combination with nivolumab, in a Phase 1 study in advanced solid tumors.
Preclinical Programs – CytomX continued to work on broadening the potential application of its multi-modality Probody platform to other product candidates, including a broad initiative towards enhancing the therapeutic window of cytokines. At the 2022 AACR (Free AACR Whitepaper) Annual Meeting, CytomX presented encouraging preclinical data that highlighted a conditionally activated interferon alpha-2b therapeutic candidate as a promising addition to current immunotherapy regimens, potentially expanding benefit to patients with typically unresponsive tumors.
Priorities for 2022

Continue enrolling patients with TNBC in Arms B and C in the Phase 2 study of praluzatamab ravtansine and report initial data from Arms A and B in the second half of 2022
Continue advancing the expansion phase of the Phase 2 study of CX-2029 in collaboration with our partner AbbVie and provide a data update in the second half of 2022
Advance the Phase 1 study of CX-904 in solid tumors
First Quarter 2022 Financial Results
Cash, cash equivalents and investments totaled $263 million as of March 31, 2022, compared to $305 million as of December 31, 2021.

Total revenue was $17.1 million for the three months ended March 31, 2022 compared to $16.0 million for the corresponding period in 2021. The increase in total revenue was largely related to the CD71 collaboration with AbbVie.

Research and development expenses increased by $8.2 million during the three months ended March 31, 2022 to $30.6 million compared to $22.4 million for the first quarter of 2021. The increase was primarily driven by contract and service expenses in manufacturing and development activities in support of our pre-clinical and clinical portfolio.

General and administrative expenses increased by $1.3 million during the first quarter of 2022 to $10.5 million compared to $9.2 million in the same period in 2021. The increase was mainly in personnel and professional expenses.

Conference Call & Webcast Information
CytomX management will host a conference call and a simultaneous webcast today at 5:00 p.m. ET (2:00 p.m. PT) to discuss the financial results and provide a business update. To join the conference call, please dial (877) 809-6037 (domestic) or (615) 247-0221 (international) and reference the conference ID 5241057. A live webcast of the call can be accessed on the Events and Presentations page of CytomX’s website at View Source An archived replay of the webcast will be available on the Company’s website until May 12, 2022.

On May 5, 2022 Idera Pharmaceuticals, Inc. ("Idera," the "Company," "we," "us," or "our") (Nasdaq: IDRA) reported its financial and operational results for the first quarter ended March 31, 2022 (Press release, Idera Pharmaceuticals, MAY 5, 2022, View Source [SID1234613661]).

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"We continue to preserve cash while actively pursuing new development or commercial-stage assets for Idera’s portfolio," stated Vincent Milano, Idera’s Chief Executive Officer. "We also continue to work with JMP Securities, a Citizens Company, our current partner and advisor on business development activities, to explore additional strategic alternatives for the Company."

First Quarter Financial Results
Our cash position as of March 31, 2022 was $28.0 million. Based on our current operating plan, we anticipate that our current cash and cash equivalents will fund our operations through the one-year period subsequent to the May 5, 2022 filing date of the Quarterly Report Form 10-Q.

Research and development expenses for the three months ended March 31, 2022 totaled $1.8 million, compared to $6.9 million for the same period in 2021. General and administrative expense for the three months ended March 31, 2022 totaled $2.4 million, compared to $3.2 million for the same period in 2021.

Additionally, during the three months ended March 31, 2021, we recorded $7.0 million and $118.8 million non-cash warrant revaluation gain and non-cash future tranche right revaluation gain, respectively, related to the change in fair value of securities issued in connection with our December 2019 private placement transaction. No such non-cash gains were recognized in the three months ended March 31, 2022, as the warrants and future tranche rights were terminated in the first quarter of 2021.

As a result of the factors above, net loss applicable to common stockholders for the three months ended March 31, 2022 was $4.2 million or $0.08 per basic and diluted share compared to net income applicable to common stockholders of $109.6 million or $2.66 per basic share for 2021. On a diluted basis, net loss applicable to common stockholders for the three months ended March 31, 2021 was $10.0 million or $0.14 per diluted share.

Excluding the non-cash gain of approximately $125.8 million for the three months ended March 31, 2021 related to the termination of securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders was $10.0 million, or $0.24 per basic and diluted share (calculated based upon the basic weighted-average number of common shares, due to the antidilutive effect of net loss).

On May 5, 2022 Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called "cytokine storm" with its lead drug candidate, lenzilumab (LENZ), reported financial results for the first quarter ended March 31, 2022 (Press release, Humanigen, MAY 5, 2022, View Source [SID1234613660]).

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"A key highlight of the first quarter was the completion of enrollment in the ACTIV-5/BET-B study. We also held a productive Type B pre-EUA meeting with FDA where we gained alignment on the data and statistical analysis plan to be included as part of the amendment to our EUA for LENZ in COVID-19 patients. In concert with the NIH, we anticipate top-line data in the primary analysis population to be reported in the second quarter, with an amendment to our EUA submission planned to follow," stated Cameron Durrant, Chairman and Chief Executive Officer, Humanigen. "We anticipate hospitalizations from COVID-19 will continue for years to come. Published data on LENZ, confirmed by key opinion leaders and national guideline committees, including NIH, supports treatment guidance based on CRP levels and first-line utilization in hypoxic patients."

"Hospitalizations from COVID-19 in the US continue to remain steady with a 7-day average of 2,072 new daily hospitalizations. While there have been more than 900,000 people already hospitalized in the U.S. this year to date,1 synergizing results from multiple forecasting models prepared by leading experts in epidemiology in four different scenarios forecast additional COVID-19 hospitalizations in the United States, to range from approximately 500,000 to 1,200,000 for the remainder of 2022.2 Variant agnostic treatments for hospitalized patients are still desperately needed," commented Edward Jordan, Chief Commercial Officer, Humanigen.

"As well as its clinical benefit in reducing invasive mechanical ventilation and death, LENZ could deliver significant economic savings to health care systems. LENZ can be used in combination with remdesivir, which is currently used in 50% of hospitalized COVID-19 patients in the U.S.3 Sales of the top two hospital treatments for COVID-19 exceeded $7 billion in global revenue in 2021.4,5 We believe LENZ is well positioned to participate in this sizable and sustainable market," he added.

Lenzilumab is an investigational product and is not currently authorized or approved in any country.

First Quarter and Recent Highlights:

Lenzilumab in COVID-19 patients

Completed enrollment of the Phase 2/3 ACTIV-5/BET-B study, sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and enrolled over 400 patients in the primary analysis population (patients with a C-reactive protein level at baseline of less than 150mg/L).
Gained alignment with the FDA during a Type B pre-EUA meeting on the data and statistical analysis plan to be included in the amendment to the EUA.
Announced a peer-reviewed publication in ClinicoEconomics and Outcomes Research outlining the potential clinical and health economic benefits of lenzilumab, if authorized or approved for use in the United Kingdom.
First subject dosed in the PK study in Korea.
Lenzilumab in Development in Other Therapeutic Areas

Gained alignment with the FDA on the protocol for the planned registrational Phase 3 SHIELD study of lenzilumab for the prevention of CAR-T therapy related toxicities including Immune Effector Cell-Associated Neurotoxicity ("ICANS"), in which Humanigen intends to enroll the first patient in the second quarter.
Announced a peer-reviewed publication in Leukemia, a leading oncology and hematology journal, entitled "GM-CSF disruption in CART cells modulates T cell activation and enhances CART cell anti-tumor activity."
Notified by the University of Birmingham, UK, that the amended Investigational Medicinal Product Dossier has been accepted by Medicines & Healthcare products Regulatory Agency for the "RATinG" study. Humanigen believes the first patient will be enrolled in this Phase 2/3 potentially registrational trial for lenzilumab to treat patients who have undergone allogeneic hematopoietic stem cell therapy, who are at high and intermediate risk for acute Graft versus Host Disease ("aGvHD") in the second quarter.
Continued enrollment in the PREACH-M study of lenzilumab in chronic myelomonocytic leukemia. Study sponsor planning for expansion of clinical sites.
First Quarter Ended March 31, 2022 Financial Results

Net loss for the quarter ended March 31, 2022 was $21.3 million, or $0.32 per share, as compared to $65.6 million, or $1.25 per share, for the quarter ended March 31, 2021. The decrease in net loss was due to a decrease in total expenses, mainly Research and Development ("R&D") expense. R&D expense decreased $42.7 million from $59.9 million for the three months ended March 31, 2021, to $17.2 million for the three months ended March 31, 2022. The decrease is primarily due to a decrease of $35.7 million in lenzilumab manufacturing costs.

Cash and Cash Equivalents

Net cash used in operating activities, net of balance sheet changes, was $19.4 million for the quarter ended March 31, 2022. During the first quarter of 2022, the company sold shares of its common stock under its At-the-Market or "ATM" facility, raising net proceeds of approximately $18 million. As of March 31, 2022, the company had cash and cash equivalents of approximately $69 million.

A summary of key financial highlights as of and for the three months ended March 31, 2022 and 2021 is as follows ($ in thousands):

About Lenzilumab

Lenzilumab is a proprietary Humaneered first-in-class monoclonal antibody that has been proven to neutralize GM-CSF, a cytokine of critical importance in the hyperinflammatory cascade, sometimes referred to as cytokine release syndrome, or cytokine storm, associated with COVID-19 and other indications. Lenzilumab binds to and neutralizes GM-CSF, potentially improving outcomes for patients hospitalized with COVID-19. Humanigen believes that GM-CSF neutralization with lenzilumab also has the potential to reduce the hyper-inflammatory cascade known as cytokine release syndrome common to chimeric antigen receptor T-cell (CAR-T) therapy and acute Graft versus Host Disease (aGvHD).

In CAR-T, lenzilumab successfully achieved the pre-specified primary endpoint at the recommended dose in a Phase 1b study with Yescarta in which the overall response rate was 100% and no patient experienced severe cytokine release syndrome or severe neurotoxicity. Based on these results, Humanigen plans to test lenzilumab in a randomized, multicenter, potentially registrational, Phase 3 SHIELD study to evaluate its efficacy and safety when combined with Yescarta and Tecartus CAR-T therapies in non-Hodgkin lymphoma. Lenzilumab will also be tested to assess its ability to prevent and/or treat aGvHD in patients undergoing allogeneic hematopoietic stem cell transplantation.

A study of lenzilumab is also underway for patients with chronic myelomonocytic leukemia exhibiting RAS pathway mutations. This study builds on evidence from a Phase 1 study, conducted by Humanigen, that showed RAS mutations are associated with hyper-proliferative features, which may be sensitive to GM-CSF neutralization.

On May 5, 2022 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported financial results for the first quarter 2022, recent business highlights and key upcoming catalysts (Press release, Atara Biotherapeutics, MAY 5, 2022, View Source [SID1234613659]).

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"Atara is off to a strong start in 2022, and we look forward to the upcoming interim analysis of our ATA188 Phase 2 study. With compelling Phase 1 data, two Fast Track designations, and validated groundbreaking science, ATA188 has the potential to transform treatment in progressive forms of MS with high unmet need and limited options," said Pascal Touchon, President and Chief Executive Officer of Atara. "We have also commenced our strategic manufacturing partnership with FUJIFILM Diosynth Biotechnologies, continue to progress tab-cel with EMA’s review in Europe and further engagement with FDA, and anticipate IND filings for our innovative CAR T programs later this year."

ATA188 for Progressive Multiple Sclerosis (MS)

Atara is on track to conduct a formal interim analysis (IA) of the Phase 2 EMBOLD study, planned for June 2022, to include efficacy, safety, and biomarker data to further inform our development strategy
A key data point at the time of IA will be expanded disability status scale (EDSS) improvement at six months, for applicable patients which, based on Phase 1 data, is >85% predictive of achieving confirmed EDSS improvement at 12 months, the FDA-validated primary endpoint of EMBOLD
This IA will also include EDSS improvement beyond six months for patients with longer treatment duration, other clinical endpoints, imaging biomarkers like magnetization transfer ratio (MTR) and biologic biomarkers
Results of the IA will determine whether any sample size adjustments are needed to optimize the likelihood of success in Phase 2 and best inform Phase 3 design and planning
After the IA is conducted, Atara plans to communicate next steps for the program in July 2022, including rationale, while still maintaining the integrity of the study
With the recent granting of Fast Track designation to ATA188 for non-active primary progressive multiple sclerosis (PPMS) and non-active secondary progressive multiple sclerosis (SPMS) by the FDA, we also then plan to meet with the FDA following the IA to share the data and to discuss next steps for the development pathway
Atara continues to advance enrollment in the Phase 2 EMBOLD study, with target enrollment of 80 patients expected soon after conducting the IA
Landmark studies in Nature and Science continue to drive significant interest and awareness of EBV as the trigger of MS
Momentum around ATA188 continues to build, marked by Atara’s successful EBV and MS Day where updated Phase 1 and open-label extension (OLE) data demonstrated that 20 out of 24 patients have had either EDSS improvement or EDSS stability throughout their observation in the study with up to 42 months follow-up. Overall, 33% of patients in the high-dose cohorts achieved confirmed EDSS improvement at the 12-month timepoint
Tabelecleucel (tab-cel) for Post-Transplant Lymphoproliferative Disease (PTLD)

The European Medicines Agency (EMA) review of tab-cel is progressing well and Atara anticipates European Commission (EC) approval in Q4 2022
The EMA has transitioned tab-cel to a standard assessment as Atara was informed that additional time was needed to adequately review the Company’s responses to EMA questions. Atara does not expect an impact to the anticipated EC approval timeframe
Atara remains in active dialogue with the FDA and has made further progress on discussing proposals to enable potential filing of the BLA that do not require a new Phase 3 clinical study
Proposals reflect tab-cel clinical and commercial product data generated to date, its status as a Breakthrough Therapy Designation product that addresses an urgent medical need, and its potential to save the lives of patients with an ultra-rare, often fatal disease with no approved therapeutic options
Tab-cel for Potential Additional Indications

The multi-cohort Phase 2 study evaluating tab-cel in six additional patient populations for EBV+ immunodeficiency-associated lymphoproliferative diseases (IA-LPDs) and other EBV-driven diseases continues to enroll in the U.S. and EU
First data from the multi-cohort study is on track for presentation in 2023
CAR T Programs

ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)

The global strategic collaboration for autologous ATA2271 and allogeneic ATA3271 with Bayer continues to progress
In February 2022, Memorial Sloan Kettering Cancer Center (MSK) notified the FDA of a fatal serious adverse event (SAE) in a patient treated in the third, higher dose cohort in the ongoing Phase 1, MSK-conducted and investigator led dose-escalation clinical study of autologous mesothelin CAR T, ATA2271
Per protocol, MSK voluntarily paused enrollment of new patients in the study on a temporary basis while additional information regarding the case is gathered and reviewed
Autopsy and additional data are still being analyzed by MSK
As is typical, we expect MSK will share autopsy and other results with FDA when ready, in addition to any intended informed consent and/or study protocol amendments
Atara and MSK expect to provide a Phase 1 data update for ATA2271 in H2 2022
IND-enabling work for ATA3271, our off-the-shelf, allogeneic CAR-T therapy targeting mesothelin using next-generation PD-1 DNR and 1XX CAR technologies for patients with advanced mesothelioma, is advancing, with the IND filing anticipated in Q4 2022
ATA3219 (B-cell Malignancies)

Atara continues to progress ATA3219, a potential best-in-class, allogeneic CAR T for B cell malignancies expressing CD19
Atara is on track to submit an IND in Q4 2022
ATA3219 is an optimized approach to address high unmet medical need, leveraging our next-generation 1XX CAR co-stimulatory signaling domain and allogeneic EBV T-cell platform and does not require TCR or human leukocyte antigen (HLA) gene editing
Allogeneic T-Cell Platform Manufacturing and Operations

In April 2022, Atara announced the appointment of Charlene Banard as Chief Technical Officer, who will oversee process science and development, quality, manufacturing and supply, further validating Atara’s advanced technology and its potential to transform the lives of patients with serious diseases
In April 2022, Atara announced the completion of the sale of its cell therapy manufacturing facility for USD 100 million upfront and the commencement of a long-term strategic manufacturing partnership with FUJIFILM Diosynth Biotechnologies (FDB)
With the closing of the transaction, FDB provides Atara with access to the flexible capacity and specific capability needed to manufacture clinical and commercial-stage allogeneic cell therapies for its maturing and promising pipeline, including tab-cel, ATA188 for multiple sclerosis, and allogeneic CAR T therapies, ATA3271 and ATA3219
The agreement is expected to reduce Atara’s planned operating expenses over the multi-year partnership period
Atara has retained a talented Technical Operations team who will continue to manage external manufacturing partnerships, manufacturing process science & development, quality assurance, supply chain, and logistics. Atara’s Thousand Oaks-based Atara Research Center (ARC) now houses Atara’s pre-clinical, translational sciences, manufacturing process sciences, and analytical development teams to further drive innovation by leveraging our unique and differentiated allogeneic cell therapy platform
First Quarter 2022 Financial Results

Cash, cash equivalents and short-term investments as of March 31, 2022, totaled $301.8 million, as compared to $371.1 million as of December 31, 2021; the amount as of March 31, 2022, excludes the $100.0 million upfront received from FDB in April
The March 31, 2022, cash balance includes $20.5 million of net proceeds from the sale of 1,319,878 shares of common stock through the Company’s ATM facilities in the first quarter
Atara believes that its cash as of March 31, 2022, together with the $100.0 million received from FDB on April 4, 2022, will be sufficient to fund the Company’s planned operations into the fourth quarter of 2023
Net cash used in operating activities was $84.5 million for the first quarter 2022, as compared to $65.7 million for the same period in 2021
Atara reported net losses of $88.1 million, or $0.87 per share for the first quarter 2022, as compared to $78.3 million, or $0.86 per share for the same period in 2021
Total operating expenses include non-cash expenses of $15.9 million for the first quarter 2022, as compared to $14.5 million for the same period in 2021
Research and development expenses were $75.0 million for the first quarter 2022, as compared to $64.1 million for the same period in 2021
The increases in the first quarter 2022 were primarily due to higher employee-related and overhead costs from increased headcount in support of continuing expansion of research and development activities and increased spending on research, development, and clinical trial costs related to the ATA188 program
Research and development expenses include $8.5 million of non-cash stock-based compensation expenses for the first quarter 2022 as compared to $7.5 million for the same period in 2021
General and administrative expenses were $20.6 million for the first quarter 2022, as compared to $17.7 million for the same period in 2021
The increases in the first quarter 2022 were primarily due to higher compensation-related costs from increased headcount
General and administrative expenses include $5.8 million of non-cash stock-based compensation expenses for the first quarter 2022, as compared to $4.7 million for the same period in 2021
Conference Call and Webcast Details
Atara will host a live conference call and webcast today, Thursday, May 5, 2022, at 4:30 p.m. EDT to discuss the Company’s financial results and recent operational highlights. Analysts and investors can participate in the conference call by dialing 877-407-8291 for domestic callers and 201-689-8345 for international callers, using the conference ID 13728000. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of atarabio.com. An archived replay will be available on the Company’s website for 30 days following the live webcast.

On May 5, 2022 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, metabolic, oncologic and neurological disorders by modulating the effects of the hormone cortisol, reported its results for the quarter ended March 31, 2022 (Press release, Corcept Therapeutics, MAY 5, 2022, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-first-quarter-financial-results [SID1234613658]).

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Financial Results

Revenue of $93.7 million, compared to $79.4 million in first quarter 2021
Reiterated 2022 revenue guidance of $400 – $430 million
Diluted net income per share of $0.20, compared to $0.18 in first quarter 2021
Cash and investments of $368.1 million, compared to $335.8 million at December 31, 2021
"As pandemic restrictions and fears recede, we expect our growth to continue and are reiterating our 2022 revenue guidance of $400 – $430 million," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "Korlym is an excellent treatment for patients with Cushing’s syndrome and there are many eligible patients who have yet to receive it."

Corcept’s first quarter 2022 revenue was $93.7 million, compared to $79.4 million in the first quarter of 2021. First quarter operating expenses were $66.9 million, compared to $59.8 million in the first quarter of 2021, due to increased expenses to support the expansion of our clinical development and commercial teams and legal fees. Diluted net income per share was $0.20 in the first quarter of 2022, compared to $0.18 in the first quarter of 2021.

Cash and investments increased $32.3 million in the first quarter, to $368.1 million at March 31, 2022.

Clinical Development

"Corcept was founded on the premise that cortisol modulation has the potential to help treat many serious diseases," said Dr. Belanoff. "Our clinical development programs have produced increasing amounts of evidence validating this hypothesis and our programs in castration-resistant prostate cancer, antipsychotic-induced weight gain and non-alcoholic steatohepatitis will produce important data this year. We are especially excited about our advancing platinum-resistant ovarian cancer program. Based on the statistically significant and clinically meaningful results of our large, controlled Phase 2 study, we will soon initiate a pivotal trial."

Solid Tumors

Phase 3 trial in patients with recurrent platinum-resistant ovarian cancer planned
to start this quarter; Oral presentation of Phase 2 trial results at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting on June 6 in Chicago
Selection of the optimum dose of exicorilant or relacorilant plus enzalutamide in patients
with castration-resistant prostate cancer (CRPC) expected this quarter
Enrollment continues in 20-patient, open-label, Phase 1b trial of relacorilant plus
PD-1 checkpoint inhibitor pembrolizumab in patients with adrenal cancer with cortisol excess
"We are excited to start our Phase 3 trial of relacorilant in patients with recurrent platinum-resistant ovarian cancer," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "Our goal is to replicate the positive findings of our 178-patient Phase 2 trial, in which women who received relacorilant in addition to nab-paclitaxel exhibited meaningful improvements in progression-free survival, duration of response and overall survival, without increased side effects, when compared to women who received nab-paclitaxel alone. The 20,000 women in the United States and an equal number in Europe with platinum-resistant ovarian cancer have few good treatment options. If our Phase 3 trial is successful, relacorilant plus nab-paclitaxel could become the new standard of care for these patients. We plan to meet with the FDA in June regarding our proposed path forward."

Metabolic Diseases

Enrollment completed in GRATITUDE and GRATITUDE II – two double-blind, placebo-controlled Phase 2 trials of miricorilant to reverse recent and long-standing antipsychotic-induced weight gain (AIWG); data from both trials expected in fourth quarter 2022
Enrollment continues in Phase 1b dose-finding trial of miricorilant in patients
with presumed NASH
"We look forward to the results of GRATITUDE and GRATITUDE II," said Dr. Guyer. "Weight gain and other metabolic adverse effects caused by antipsychotic medications pose serious risks to the health of millions of patients, who have few treatment options. We initiated these double-blind, placebo-controlled trials to build on the positive data from our studies of both miricorilant and mifepristone in healthy volunteers."

Cushing’s Syndrome

Enrollment continues in Phase 3 GRACE trial of relacorilant as a treatment for patients with all etiologies of Cushing’s syndrome; new drug application (NDA) submission now expected
in second half 2023
Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients
with Cushing’s syndrome caused by adrenal adenomas
"We advanced relacorilant to Phase 3 in Cushing’s syndrome based on its extremely promising Phase 2 efficacy and safety data. We expect our GRACE trial, which is accruing patients and generating data, to serve as the basis for relacorilant’s NDA in Cushing’s syndrome. The timing for the completion of this trial has been impacted by the pandemic, as clinical trial sites have experienced challenges in recruiting and managing patients. We are currently planning to submit this relacorilant NDA in the second half of 2023," said Dr. Guyer. "The Phase 3 GRADIENT trial will produce valuable data about an etiology of Cushing’s syndrome that has not been subject to rigorous, controlled study, but affects many patients."

Conference Call

We will hold a conference call on May 5, 2022, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, click this link (listen-only mode) or dial 1-833-693-0540 from the United States or 1-661-407-1581 internationally approximately 15 minutes before the start of the call. A replay will be available through May 12, 2022 at 1-855-859-2056 from the United States and 1-404-537-3406 internationally. The passcode will be 6942208. A replay will also be available on the Investors / Past Events tab of our website.

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively. Corcept holds patents directed to the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism.