On August 8, 2023 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported a corporate update and reported financial results for the fiscal third quarter ended June 30, 2023 (Press release, ESSA, AUG 8, 2023, View Source [SID1234634011]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"Over the past months we have ramped up preparations to initiate the randomized Phase 2 combination study of EPI-7386 and Astellas and Pfizer’s antiandrogen Xtandi (enzalutamide), and we expect to complete the Phase 1 part of the study in the coming quarter," stated David Parkinson, MD, President and CEO of ESSA. "In the past quarter, we finalized our clinical collaboration with Janssen to evaluate EPI-7386 in combination with Janssen’s antiandrogens Erleada (apalutamide) and Zytiga (abiraterone acetate) in two Phase 1 cohorts, building on initial Phase 1 clinical data demonstrating promising prostate-specific antigen ("PSA") declines following combination treatment. ESSA is in a strong cash position as we advance our EPI-7386 studies, with our cash runway expected to fund operations and programs through 2025."

Clinical and Corporate Highlights for the Third Quarter Ended June 30, 2023
EPI-7386 Clinical Collaborations

The Company is preparing to initiate the open-label, randomized Phase 2 study of EPI-7386 and Astellas and Pfizer’s antiandrogen Xtandi (enzalutamide) in patients with metastatic castration-resistant prostate cancer ("mCRPC") naïve to second-generation antiandrogens. The Phase 2 study will assess the anti-tumor activity of EPI-7386 in combination with enzalutamide at the recommended Phase 2 doses versus single agent enzalutamide at the standard-of-care dose. The study is expected to enroll approximately 120 patients. The Company expects to complete the Phase 1 part of the study and establish the recommended Phase 2 combination doses (for both EPI-7386 and enzalutamide when used in combination) in the third calendar quarter of 2023, followed by initiation of the Phase 2 part of the study.

In April 2023, the Company entered into a clinical trial support agreement with Janssen Research & Development, LLC ("Janssen") under which Janssen will supply apalutamide and abiraterone acetate for a Phase 1 clinical study sponsored and conducted by ESSA evaluating EPI-7386 combination therapies in two cohorts. The two cohorts will be evaluated as additional cohorts in the Company’s ongoing Phase 1 study of EPI-7386 (Clinical Trials Identifier: NCT04421222). Cohort 1 will assess EPI-7386 in combination with abiraterone acetate plus prednisone in patients with mCRPC and high-risk metastatic castration-sensitive prostate cancer. Cohort 2 is a Window of Opportunity study in which patients with non-metastatic castration-resistant prostate cancer ("nmCRPC") will receive up to 12 weeks of single agent EPI-7386 before adding standard-of-care apalutamide. ESSA will retain all rights to EPI-7386. The Company expects enrollment to begin in the second half of calendar 2023.
EPI-7386 Monotherapy

The Phase 1b EPI-7386 monotherapy dose expansion study is ongoing and is evaluating two doses/schedules of single agent EPI-7386 in mCRPC patients with less than three prior lines of therapy, no visceral disease and no prior chemotherapy who have progressed on at least one second-generation antiandrogen. The Company is also enrolling nmCRPC patients in the Window of Opportunity cohort of the study, in which patients will receive 12 weeks of EPI-7386 monotherapy treatment before starting standard-of-care therapy.
Corporate Updates

In June 2023, the Company announced the appointment of Lauren Merendino, M.B.A., to its Board of Directors. Ms. Merendino is a leading biopharmaceutical executive who brings over 25 years of commercial experience spanning 20+ disease states, including 15 years of leadership for oncology-specific portfolios.
Summary Financial Results

Net Loss. ESSA recorded a comprehensive loss of $7.3 million for the third quarter ended June 30, 2023, compared to a comprehensive loss of $8.8 million for the third quarter ended June 30, 2022. For the third quarter ended June 30, 2023, this included non-cash share-based payments of $1.2 million compared to $1.6 million for the prior year, recognized for stock options granted and vesting. The decrease in the third quarter was primarily attributed to decreases in research and development expenditures and general and administration expenditures in addition to an increase of $1.2 in interest and other income.

Research and Development ("R&D") expenditures. R&D expenditures for the third quarter ended June 30, 2023 were $6.3 million compared to $6.4 million for the third quarter ended June 30, 2022 and include non-cash costs related to share-based payments ($599,621 for the third quarter ended 2023 compared to $872,531 for the third quarter ended 2022). The decrease in R&D expenditures for the year ended June 30, 2023 is the result of decreased non-cash share-based payments, legal patents and license fees and manufacturing costs related to the Phase 1 clinical trial of EPI-7386.

General and administration ("G&A") expenditures. G&A expenditures for the third quarter ended June 30, 2023 were $2.6 million compared to $2.9 million for the third quarter ended June 30, 2022 and include non-cash costs related to share-based payments of $561,452 for the third quarter ended 2023 compared to $718,469 for the third quarter ended 2022. The decrease in the third quarter is the result of decreased non-cash share-based payments, salaries and benefits and consulting and subcontractor fees.
Liquidity and Outstanding Share Capital
At June 30, 2023, the Company had available cash reserves and short-term investments of $152.5 million reflecting the gross proceeds of the February 2021 financing of approximately $150.0 million, less operating expenses in the intervening period. The Company’s cash position is expected to be sufficient to fund current and planned operations through 2025.

As of June 30, 2023, the Company had 44,092,374 common shares issued and outstanding.

In addition, as of June 30, 2023 there were 2,927,477 common shares issuable upon the exercise of warrants and broker warrants. This includes 2,920,000 prefunded warrants at an exercise price of $0.0001, and 7,477 warrants at a weighted average exercise price of $42.80. There were 8,150,274 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $5.05 per common share.

On August 8, 2023 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, reported significantly improved financial results and a favorable overall company performance for the second quarter of 2023 (Press release, Cumberland Pharmaceuticals, AUG 8, 2023, View Source [SID1234634010]).

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Highlights include:

$10.9 million in revenue during the second quarter, an increase of 6% over the prior year period, and an increase of 18% sequentially from the first quarter of this year.
Positive earnings for the second consecutive quarter, with $1.1 million in net income for the first half of the year.
Adjusted earnings for the first half of 2023 of $4.0 million, or $0.27 a share, which is up significantly from the same period last year.
$89.4 million in total assets, $52.5 million in total liabilities, and $36.8 million of shareholders’ equity at the end of June 2023.
Cumberland will report its full second quarter 2023 financial results and provide a company update via a conference call today at 4:30 p.m. Eastern Time.

"We have had an overall successful first half of the year, with several key developments, including FDA approval for the use of our Caldolor product for treating infants," said Cumberland’s CEO, A.J. Kazimi. "We look forward to building on this success throughout the remainder of the year, as we continue to provide innovative products to improve patients’ lives."

Recent Company developments include:

Caldolor for Treating Infants & Supporting Study Publication

In May 2023, Cumberland announced that the FDA approved expanded labeling for its Caldolor product, an intravenously delivered formulation of ibuprofen, to now include use in infants. The non-narcotic agent may now be administered for the treatment of pain and fever in patients 3 to 6 months of age. With this newly approved labeling, Caldolor is the only non-opioid product approved to treat pain in infants that is delivered through injection.

In June 2023, the Company shared the positive results from a clinical study investigating the safety and pharmacokinetics of Caldolor in newborn infants. The clinical study evaluated the safety and drug exposure profile of Caldolor in 24 hospitalized infants between the ages of 1 and 6 months who required treatment for pain or fever. The results of the study support the growing body of evidence that demonstrates Caldolor is a safe therapeutic option available to practitioners for the treatment of fever and pain in infants and children.

Clinical Development Programs

Cumberland has been evaluating its ifetroban product candidate, a selective thromboxane-prostanoid receptor antagonist, in a series of clinical studies. It has been dosed in nearly 1,400 subjects and has been found to be safe and well tolerated in healthy volunteers and various patient populations.

Patient enrollment is well underway in two of the company’s sponsored Phase II clinical programs to evaluate ifetroban in Systemic Sclerosis, or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs; and the cardiomyopathy associated with Duchenne Muscular Dystrophy ("DMD"), a rare and fatal genetic neuromuscular disease that results in deterioration of the skeletal, heart and lung muscles.

In June 2023, Cumberland presented results from an interim analysis for the FIGHT DMDTM trial at the 29th annual Parent Project Muscular Dystrophy Conference in Dallas. The interim analysis was conducted on data from 25 patients with DMD who completed six of the 12 total months of treatment and assessments. Both doses of ifetroban were reported well tolerated in DMD participants ages 7 years of age or older. The FDA Orphan Product Division previously awarded Cumberland $1.0 million in funding under its Orphan Products Grants Program to support this trial. This was the first DMD trial awarded such funding.

In May 2023, Cumberland announced that the FDA had cleared the Investigational New Drug Application for a Phase II study in patients with Idiopathic Pulmonary Fibrosis ("IPF"), the most common form of progressive fibrosing interstitial lung disease. As a result, the company will launch its FIGHTING FIBROSIS trial designed to enroll 128 patients in over 20 medical centers of excellence across the U.S. This Phase II clinical trial will study the safety, tolerability and efficacy of oral ifetroban in patients with IPF. Recent studies have shown ifetroban can both prevent and enhance resolution of lung fibrosis in multiple preclinical models.

Cumberland has also completed Phase II clinical programs with ifetroban in patients with Hepatorenal Syndrome, Portal Hypertension and Aspirin Exasperated Respiratory Disease. Additional preclinical and pilot clinical studies of ifetroban are underway, including several investigator-initiated trials.

The company plans to complete each of its company-sponsored studies, analyze their final data and announce top-line results before deciding on the best development path for the registration of ifetroban.

FDA Fee Waivers

During the second quarter of 2023, the FDA informed Cumberland that it had granted two barrier-to-innovation waivers that would result in refunds totaling approximately $2.8 million that the company previously paid for prescription drug program fees.

The FDA granted each waiver after concluding that Cumberland met the statutory criteria based on the innovation associated with its ifetroban clinical development programs, as the funds could be better used to advance those studies, which are designed to address a series of unmet medical needs. Cumberland received both refunds in June 2023.

Sancuso Acquisition and Approval of New Manufacturing Plant

In early 2022, Cumberland announced its acquisition of the U.S. rights to oncology-supportive drug Sancuso from the U.S. subsidiary of Kyowa Kirin, Inc., a Japan-based specialty pharmaceutical company. Sancuso is the first and only FDA-approved prescription patch for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment. The active drug in Sancuso, granisetron, slowly dissolves in the thin layer of adhesive that sticks to the patient’s skin and is released into their bloodstream over several days, working continuously to prevent chemotherapy-induced nausea and vomiting ("CINV"). It is applied 24 to 48 hours before receiving chemotherapy and can prevent CINV for up to five consecutive days. Alternative oral treatments must be taken several times (day and night) to deliver the same therapeutic doses.

Cumberland assumed commercial responsibility for the product in the U.S. – including its marketing, promotion, distribution, manufacturing and medical support activities – early last year and largely completed the transition of Sancuso to Cumberland throughout the remainder of the year. In late 2022, the FDA approved moving the product’s manufacture to a new facility, which will be source of future product supplies. In June 2023, Cumberland launched an expanded oncology sales division to feature the product, which continues to be a significant contributor to Cumberland’s business.

Nordic Pharma RediTrex Agreement Restructured

In 2022, Cumberland restructured its agreement with Nordic Pharma, who previously provided Cumberland with the license for the U.S. rights associated with the RediTrex product line. Nordic has assumed responsibility for the product in the U.S. as of July 1, 2023.

FINANCIAL RESULTS:

Net Revenue: For the three months ended June 30, 2023, net revenues were $10.9 million. Net revenue by product for the second quarter of 2023, included $4.1 million for Kristalose, $2.1 million for Vibativ, $1.9 million for Sancuso and $1.2 million for Caldolor.

Year-to-date 2023 net revenues were $20.1 million. Year-to-date net revenues by product were $8.4 million for Kristalose, $4.0 million for Vibativ, $3.8 million for Sancuso and $2.2 million for Caldolor.

Operating Expenses: Total operating expenses were $10.9 million for the second quarter of 2023 and $21.6 million for the first half of the year.

Net Income: The Net Income for the second quarter of 2023 was $0.9 million, or $0.06 a share, and $1.1 million year to date, or $0.07 a share.

Adjusted earnings: Adjusted earnings for the second quarter of 2023 were $2.3 million, or $0.16 a share and $4.0 million year to date, or $0.27 a share. The adjusted earnings calculation does not include the benefit of the $0.2 million of Vibativ cost of goods, which were received with the product acquisition. It also does not include the benefit of the $0.3 million of Sancuso cost of goods, which were received with that product’s acquisition.

Balance Sheet: At June 30, 2023, Cumberland had $89.4 million in total assets, including $18.2 million in cash and cash equivalents.

Total liabilities were $52.5 million, including $13.1 million outstanding on the Company’s revolving line of credit. Total shareholders’ equity was $36.8 million.

EARNINGS REPORT CALL:

A conference call will be held on August 8 at 4:30 p.m. Eastern Time, to discuss the results. To participate in the call, please register at: https://register.vevent.com/register/BIeb03c2e461914b7d94f99de2f7535170.

Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference.

A replay of the call will be available for one year and can be accessed via Cumberland’s website or by visiting View Source

On August 8, 2023 Bio-Techne Corporation (NASDAQ: TECH) reported its financial results for the fourth quarter ended June 30, 2023 (Press release, Bio-Techne, AUG 8, 2023, View Source [SID1234634009]).

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Fourth Quarter FY2023 Highlights

Fourth quarter organic revenue increased by 5% (5% reported) to $301.3 million. Full year organic revenue increased 5% (3% reported) to $1.1 billion.
GAAP earnings per share1) (EPS) was $0.47 versus $0.38 one year ago. Delivered adjusted EPS1) of $0.55 compared to $0.51 one year ago. Full year GAAP EPS was $1.76 versus $1.66 one year ago. Full year adjusted EPS was $1.99 versus $1.97 one year ago.
Strong commercial execution in Diagnostics and Genomics led to 10% organic segment growth (10% reported) in the fourth quarter and 8% organic segment growth (6% reported) for fiscal year 2023.
Our ExoDx prostate test and GMP proteins strategic growth platforms continued to deliver record performance with fourth quarter revenue growth of 68% and 58% and fiscal year 2023 revenue growth of 92% and 30%, respectively.
Enhanced Bio-Techne’s leading spatial biology franchise with the acquisition of Lunaphore whose fully automated, high-throughput COMET instrument enables the identification of spatial biomarkers in tumors and other tissues at single-cell and subcellular resolution.
1)On November 29, 2022, the company executed a four-for-one split of Bio-Techne’s common stock in the form of a stock dividend to all shareholders of record on November 14, 2022. All references made to share or per share amounts in this press release have been retroactively adjusted to reflect the effects of the stock split.

The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). Adjusted diluted EPS, adjusted net earnings, adjusted gross margin, adjusted operating income, adjusted tax rate, organic growth, adjusted operating margin, earnings before interest, taxes, depreciation, and amortization (EBITDA), and adjusted EBITDA are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of non-GAAP Adjusted Financial Measures." A reconciliation of GAAP to non-GAAP financial measures is included in this press release.

"We finished fiscal 2023 largely in-line with our expectations, as the Bio-Techne team continued to successfully grow on top of high year-over-year comparisons and navigate dynamic end market conditions that included a lower biotech funding environment and soft macro-economic conditions in China," said Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "We delivered these results with a continued focus on operational efficiencies, leading to an adjusted operating margin of 37.1%."

Kummeth continued, "We finalized the acquisition of Lunaphore, which closed on July 7, adding the fully automated, high throughput COMET instrument to our portfolio of spatial biology solutions. The combination of Lunaphore and Bio-Techne will enable the first fully automated spatial multiomic solution capable of same-slide detection of protein and RNA biomarkers. This novel solution positions Bio-Techne to further its leadership position in the nascent and high growth spatial biology market."

Kummeth concluded, "In fiscal 2023, we demonstrated the strength of our portfolio to grow in even the most challenging of times, which this year included very high comps from the prior year, lower biotech funding, customer de-stocking, and unprecedented China economic malaise… all largely due to the "COVID hangover". Our differentiated platforms in Cell & Gene Therapy, Liquid Biopsy, Spatial Biology, and Analytical Instruments finished the year with double-digit growth and it will be these platforms that carry our company back to overall double-digit growth as the markets normalize."

Fourth Quarter Fiscal 2023

Revenue

Net sales for the fourth quarter increased 5% to $301.3 million. Organic growth was 5% compared to the prior year with foreign currency exchange and acquisitions having an immaterial impact.

GAAP Earnings Results

GAAP EPS was $0.47 per diluted share, versus $0.38 in the same quarter last year. GAAP operating income for the fourth quarter of fiscal 2023 increased 17% to $94.5 million, compared to $80.6 million in the fourth quarter of fiscal 2022. GAAP operating margin was 31.4%, compared to 28.0% in the fourth quarter of fiscal 2022. Current year GAAP operating margin was favorably impacted by changes in the fair value of performance-based stock compensation awards.

Non-GAAP Earnings Results

Adjusted EPS increased to $0.55 per diluted share compared to $0.51 in the same quarter last year. Adjusted operating income for the fourth quarter of fiscal 2023 increased 5% compared to the fourth quarter of fiscal 2022. Adjusted operating income growth was driven by organic revenue growth. Adjusted operating margin was 37.1%, compared to 37.4% in the fourth quarter of fiscal 2022. Adjusted operating margin decreased from the prior year primarily due to the acquisition of Namocell this year.

Full Year Fiscal 2023

Revenue

Net sales for the full year fiscal 2023 increased 3% to $1,136.7 million. Organic growth was 5% with foreign currency exchange having an unfavorable impact of 2% and acquisitions having an immaterial impact.

GAAP Earnings Results

GAAP EPS was $1.76 per diluted share compared to $1.66 last fiscal year. Current year GAAP EPS was favorably impacted by gains on the sale of our ChemoCentryx investment and our investment in Eminence. GAAP operating income for full year fiscal 2023 increased 1% to $298.9 million, compared with $296.6 million in the full year fiscal 2022. GAAP operating margin was 26.3%, compared to 26.8% in the full year fiscal 2022. GAAP operating margin was unfavorably impacted by foreign currency exchange and strategic growth investments including the Namocell acquisition.

Non-GAAP Earnings Results

Adjusted EPS increased to $1.99 per diluted share compared to $1.97 last year. Adjusted operating margin for full fiscal year 2023 decreased to 36.1%, compared with 38.3% in full year fiscal 2022. Adjusted operating margin compared to the prior year was unfavorably impacted by foreign currency exchange and strategic growth investments including the Namocell acquisition.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the Company’s business segments, as highlighted below.

Protein Sciences Segment

The Company’s Protein Sciences segment is one of the world’s leading suppliers of specialized proteins such as cytokines and growth factors, immunoassays, antibodies and reagents, to the biotechnology and academic research communities. Additionally, the segment provides an array of platforms useful in various areas of protein analysis. Protein Sciences segment’s fourth quarter fiscal 2023 net sales were $223.0 million, an increase of 3% from $217.0 million for the fourth quarter of fiscal 2022. Organic growth for the segment was 4%, with foreign currency exchange having an unfavorable impact of 1% and acquisitions having an immaterial impact. Protein Sciences segment’s operating margin was 44.7% in the fourth quarter of fiscal 2023 compared to 44.9% in the fourth quarter of fiscal 2022. The segment’s operating margin compared to the prior year was negatively impacted by acquisitions.

Protein Sciences segment’s full year fiscal 2023 net sales were $845.7 million, an increase of 2% from $832.3 million for fiscal 2022. Organic growth for the segment was 4% for the fiscal year, with foreign currency exchange having an unfavorable 2% impact on revenue and acquisitions having an immaterial impact.

Protein Sciences segment’s operating margin was 44.2% in fiscal 2023 compared to 45.4% in fiscal 2022. Segment operating margin compared to the prior year was unfavorably impacted by foreign currency exchange and strategic growth investments including the Namocell acquisition.

Diagnostics and Genomics Segment

The Company’s Diagnostics and Genomics segment provides blood chemistry and blood gas quality controls, hematology instrument controls, immunoassays and other bulk and custom reagents for the in vitro diagnostic market. The Diagnostics and Genomics segment also develops and provides spatial biology products as well as exosome-based diagnostics for various pathologies, including prostate cancer. The Diagnostics and Genomics segment’s fourth quarter fiscal 2023 net sales were $79.0 million, an increase of 10% from $71.7 million for the fourth quarter of fiscal 2022. Organic revenue for the segment increased by 10% from the prior year, with foreign exchange having an immaterial impact. The Diagnostics and Genomics segment’s operating margin was 18.5% in the fourth quarter of fiscal 2023 compared to 15.7% in the fourth quarter of fiscal 2022. The segment’s operating margin increased primarily due to volume leverage.

The Diagnostics and Genomics segment’s full year fiscal 2023 net sales were $292.6 million, an increase of 6% from $274.8 million for fiscal 2022. Organic growth for the segment was 8% with foreign currency exchange having an unfavorable impact of 2% on revenue growth. The Diagnostics and Genomics segment’s operating margin was 14.7% in fiscal 2023 compared to 17.8% in fiscal 2022. Fiscal 2023 operating margin was unfavorably impacted due to the prior year revenue related to the ExoTru kidney transplant rejection agreement as well as strategic investments to drive future revenue growth, which was partially offset by volume leverage.

Conference Call

Bio-Techne will host an earnings conference call today, August 8, 2023 at 8:00 a.m. CDT. To listen, please dial 1-877-300-8521 or 1-412-317-6026 for international callers, and reference conference ID 10180893. The earnings call can also be accessed via webcast through the following link View Source

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512- 2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 10180893. The replay will be available from 11:00 a.m. CDT on Tuesday, August 8, 2023, until 11:00 p.m. CDT on Friday, September 8, 2023.

On August 8, 2023 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer, reported an update from its currently enrolling multi-center open-label Phase 1b clinical trial of camsirubicin in patients with advanced soft tissue sarcoma (ASTS) (Press release, Monopar Therapeutics, AUG 8, 2023, View Source [SID1234634008]). Both patients treated to date at the 650 mg/m2 dose level have experienced tumor size reductions – of 18% and 20% respectively – after the first two cycles of camsirubicin treatment. Both patients are set to receive additional cycles of camsirubicin treatment, as well, which may result in further tumor size reduction.

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The Phase 1b clinical trial data is continuing to support Monopar’s dose-response hypothesis with camsirubicin. The best response seen prior to the current 650 mg/m2 dose level was at the immediately prior dose level (520 mg/m2), which was a 21% reduction in tumor size in a patient after receiving six cycles of camsirubicin treatment. This patient’s cancer was unresectable at study entry, but after the tumor size reduction, became eligible and the patient underwent successful surgical removal of their cancer with clear margins. Furthermore, all three patients at the 520 mg/m2 dose level achieved stable disease and had either a net reduction or no overall change in tumor size per RECIST 1.1 while on study drug.

Additionally, no drug­related cardiotoxicity has been observed in the trial to date as evaluated by the industry standard left ventricular ejection fraction (LVEF), and no toxicities have been experienced by any patient that have required expanding the size of a dose cohort. Further, 71% of camsirubicin patients have experienced no hair loss, and only approximately 14% have experienced >50% hair loss, with the remainder having low grade hair loss. This compares favorably to the approximately 50% of doxorubicin treated patients in recent ASTS clinical trials reporting some amount of hair loss, with the majority of these patients experiencing >50% hair loss. Only 14% of camsirubicin patients in the Phase 1b trial have experienced mild-to-severe oral mucositis. This compares favorably to the roughly 35-40% of doxorubicin-treated patients in recent ASTS clinical trials that experienced mild-to-severe oral mucositis.

ASTS is a deadly cancer with inadequate treatment options. Doxorubicin is currently the first-line standard of care treatment for most types of ASTS, and the average life expectancy from time of diagnosis for these patients is only about 12 to 15 months. Because of the risk of irreversible heart damage, patients discontinue doxorubicin treatment after just 6 to 8 cycles. Camsirubicin has been designed to retain the anti-cancer activity while avoiding the irreversible heart damage that is seen with doxorubicin. The value-driving hypothesis for camsirubicin is straightforward: modifying doxorubicin in order to reduce cardiac damage could enable higher and longer dosing, resulting in better efficacy and patient outcomes.

Camsirubicin Clinical Trial Design and GEIS Collaboration

The purpose of this dose escalation Phase 1b trial is to determine the maximum tolerated dose (MTD) of camsirubicin. Once the MTD is reached, Monopar has a clinical collaboration agreement in place with the Spanish Sarcoma Group (Grupo Español de Investigación en Sarcomas, or GEIS) to conduct a multi-country randomized Phase 2 clinical trial. The Phase 2 plan is to evaluate camsirubicin head-to-head against doxorubicin in patients with ASTS, with GEIS as the study sponsor with support from Monopar.

Further information about this actively enrolling, open-label, dose-escalation Phase 1b clinical trial is available at www.ClinicalTrials.gov under study identifier NCT 05043649.

On August 8, 2023 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, reported financial results for the second quarter ended June 30, 2023 and provided a business update (Press release, iTeos Therapeutics, AUG 8, 2023, View Source [SID1234634007]).

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"Our team continues to bring forward innovation in immunotherapy through our differentiated development pipeline, which is expected to make significant progress in the second half of 2023," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "To start, with GSK’s anti-PD-1 mAb, dostarlimab, as the backbone for our ambitious TIGIT-based clinical development plans, we remain confident that its combination with belrestotug has the potential to become a best-in-class program. Furthermore, we are continuing to build our position as a leader unlocking the adenosine pathway with the announcement of enrolling patients in the Phase 1 trial of EOS-984. This program will deepen our understanding of the mechanisms of adenosine-mediated immunosuppression and potentially reinforce the unique, insurmountable profile of inupadenant. Based on the progression of our 9 ongoing clinical trials and solid cash position with runway into 2026, we believe we are poised for an abundance of opportunity in 2024, including the presentation of TIGIT data from the Phase 2 clinical trials treating patients with NSCLC and HNSCC."

Program Highlights:

Belrestotug (EOS-448/GSK4428859A): IgG1 anti-TIGIT monoclonal antibody designed to
engage the Fc gamma receptor (FcγR) and enhance the anti-tumor response through multifaceted mechanisms.

In collaboration with GSK, late-stage development of belrestotug as a potential next-generation immuno-oncology (IO) agent through multiple combination studies are progressing as expected. We plan to present related datasets in 2024. Preparation is underway for Phase 3 registrational studies evaluating belrestotug and dostarlimab combination.
The ongoing trials include:
Randomized Phase 2 trial assessing the doublet of dostarlimab with belrestotug in previously untreated advanced / metastatic non-small cell lung cancer (NSCLC).
Phase 2 expansion study assessing the doublet of dostarlimab with belrestotug in first line advanced or metastatic head and neck squamous cell carcinoma (HNSCC).
Phase 1b trials exploring the addition of chemotherapy and two novel triplets in selected advanced solid tumors: belrestotug with dostarlimab and GSK’s investigational anti-CD96 antibody, and belrestotug with dostarlimab and GSK’s investigational anti-PVRIG antibody.
Additional studies include the continued advancement of the monotherapy dose escalation part of a Phase 1/2 trial evaluating belrestotug as both a monotherapy and in combination with Bristol Myers Squibb’s iberdomide in multiple myeloma.
Adenosine Pathway

Inupadenant (EOS-850): Designed as an insurmountable and highly selective small molecule antagonist of the adenosine A2A receptor, the only high-affinity adenosine receptor expressed on multiple immune cells found in the tumor microenvironment. Highlights include:

Progression of the ongoing two-part Phase 2 trial in post-IO metastatic non-squamous NSCLC to evaluate the combination of inupadenant with platinum-doublet chemotherapy compared to standard platinum-doublet chemotherapy.
EOS-984: First-in-class small molecule program targeting a novel mechanism in the adenosine pathway.

The company has initiated enrolling patients in its Phase 1 trial of EOS-984.
This complementary clinical development program has the potential to fully reverse the profound immunosuppressive action of adenosine on T and B cells. EOS-984’s effects have been shown preclinically to be enhanced by combining with inupadenant and other standards of care.
Second Quarter 2023 Financial Results

Cash and Investment Position: The company’s cash, cash equivalents, and investments position was $677.5 million as of June 30, 2023, as compared to $791.9 million as of June 30, 2022. The company continues to expect its cash balance to provide runway into 2026.
Research and Development (R&D) Expenses: R&D expenses were $29.2 million and $54.9 million for the quarter and six months ended June 30, 2023, respectively, as compared to $26.9 and $48.0 million for the same quarter and six months of 2022, respectively. The increases in each comparative period were primarily due to increases in activities related to the belrestotug, inupadenant, and EOS-984 programs.
General and Administrative (G&A) Expenses: G&A expenses were $13.4 million and $25.4 million for the quarter and six months ended June 30, 2023, respectively, as compared to $11.5 million and $22.1 million for the same quarter and six months of 2022, respectively. The increases were primarily due to increases in headcount and related costs compared to the same quarter and six months last year.
Net Income/Loss: Net loss attributable to common shareholders was $34.3 million, or net loss of $0.96 per basic and diluted share for the quarter ended June 30, 2023, as compared to a net income of $5.6 million, or a net income of $0.16 per basic share and $0.15 per diluted share for the same quarter of 2022. Net loss attributable to common shareholders was $49.9 million, or net loss of $1.39 per basic and diluted share for the six months ended June 30, 2023, as compared to a net income of $75.2 million, or a net income of $2.12 per basic share and $1.98 per diluted share for the same six months of 2022.