On August 12, 2022 ASLAN Pharmaceuticals (Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, reported financial results for the second quarter ended June 30, 2022, and provided an update on recent corporate activities (Press release, ASLAN Pharmaceuticals, AUG 12, 2022, View Source [SID1234618255]).

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"This quarter, we advanced our understanding of eblasakimab’s differentiated profile and its role in reducing pruritic neuronal responses – which remains one of the most burdensome symptoms for AD patients – with late-breaking data presented at the Society for Investigative Dermatology meeting," stated Dr Carl Firth, CEO, ASLAN Pharmaceuticals. "These insights, and those that we are building with the initiation of new research collaborations related to eblasakimab’s unique mechanism of action, contribute key data on the distinct biological effects of eblasakimab’s selective targeting of the Type 2 receptor and its differentiation from current standard-of-care therapies. We look forward to sharing new insights on eblasakimab at the upcoming EADV Annual Congress in September as we continue to progress the TREK-AD trial of eblasakimab in moderate-severe AD and remain on track for a topline data readout from the trial in the first half of 2023."

Second quarter 2022 and recent business highlights

Eblasakimab

In May, the Company presented new, late-breaking data on insights related to neuronal itch mechanisms through eblasakimab’s targeting of IL-13Rα1 at the Society for Investigative Dermatology (SID) Annual Meeting. The findings demonstrated that eblasakimab significantly reduced cytokine-enhanced neuronal responses to IL-4 and IL-13-driven itch by more than 40% versus control conditions (p=0.0001), and suggest eblasakimab’s unique mechanism of blocking IL-13Rα1 could provide a molecular basis for the significant reduction of pruritus scores observed in eblasakimab-treated moderate-to-severe AD patients in the Phase 1b clinical trial. Further data from the translational studies will be shared in the second half of 2022.
In June, the Company initiated a scientific collaboration with Dr Shawn Kwatra from Johns Hopkins University School of Medicine and Dr Madan Kwatra from Duke University Medical Center to explore the distinct role of IL-13 receptor signaling in AD. The collaboration is evaluating how IL-13Rα1-mediated allergic, inflammatory and regulatory pathways are affected by eblasakimab’s selective targeting of the Type 2 receptor. Research findings will be disclosed for presentation during the second half of 2022.
In June, the Company hosted the third episode in its series of Key Opinion Leader (KOL) webinars, the "A4 (Aspects of Atopic Dermatitis and ASLAN004/eblasakimab) Series: ‘Dialogues with International Thought Leaders in Dermatology’". Peter Lio MD, Clinical Assistant Professor of Dermatology and Pediatrics at Northwestern University, discussed the limitations of the current treatment landscape in AD and the resulting unmet medical needs in patients who do not respond optimally to current standards of care. All three webinar episodes from the A4 series are available for replay here.
Farudodstat (ASLAN003)

In June, based on emerging clinical data for DHODH inhibitors in inflammatory bowel disease, the Company decided to prioritize the further development of farudodstat in autoimmune skin diseases. A clinical development plan is being finalized and a Phase 2 trial is expected to commence in the first half of 2023.
Anticipated upcoming milestones

Three abstracts with new data on biomarkers and patient reported outcome measures from the Phase 1b proof-of-concept trial of eblasakimab have been accepted for e-poster presentation at the 31st EADV Annual Congress held in person and virtually, from September 7 to 10, 2022, in Milan, Italy.
The Company will host a Research and Development (R&D) Day on September 15, 2022, with a hybrid in-person and virtual format. More information will be announced in the weeks ahead.
Topline data from the Phase 2b TREK-AD trial of eblasakimab is expected in the first half of 2023.
Second quarter 2022 financial highlights

Cash used in operating activities for the second quarter of 2022 was US$9.7 million compared to US$6.9 million in the same period in 2021.
Cash, cash equivalents and short-term investments as of June 30, 2022, were US$78.1 million.
Research and development expenses were US$10.0 million in the second quarter of 2022 compared to US$4.0 million in the second quarter of 2021. The increase was due to clinical development expenses and manufacturing costs related to eblasakimab TREK-AD Phase 2b trial.
General and administrative expenses were US$2.3 million in the second quarter of 2022 compared to US$3.8 million in the second quarter of 2021.
Net loss attributable to stockholders for the second quarter of 2022 was US$13.0 million compared to a net loss of US$5.4 million for the second quarter of 2021.
The weighted average number of American Depositary Shares (ADS) outstanding in the computation of basic loss per share for the second quarter of 2022 was 69.7 million (representing 348.7 million ordinary shares) compared to 69.6 million (representing 347.8 million ordinary shares) for the second quarter of 2021. One ADS is the equivalent of five ordinary shares.

On August 12, 2022 Imago BioSciences, Inc. ("Imago" or the "Company") (Nasdaq: IMGO), a clinical-stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported financial results for the second quarter ended June 30, 2022 and provided business updates (Press release, Imago BioSciences, AUG 12, 2022, View Source [SID1234618253]).

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"We were delighted to present updated positive data on our Phase 2 trial of bomedemstat in essential thrombocythemia (ET) at EHA (Free EHA Whitepaper) in June. In our updated dataset, bomedemstat demonstrated hematologic and symptomatic improvement in ET patients and, importantly, demonstrated the durability of these hematologic responses. These data will support our ongoing discussions with the FDA, as we target an End of Phase 2 meeting with the FDA later this year, and move towards initiating the pivotal trial," said Hugh Young Rienhoff, Jr., M.D, Chief Executive Officer of Imago. "At EHA (Free EHA Whitepaper), we also presented positive data from our advanced myelofibrosis (MF) Phase 2 trial where bomedemstat demonstrated improvements in total symptom scores, fibrosis grades, spleen volumes and anemia, as well as reductions in mutant allele frequencies. Looking ahead, we plan to evaluate bomedemstat in combination with ruxolitinib in MF patients in a trial starting in the Fall 2022. Lastly, in addition to our long-held plans to study bomedemstat in other myeloproliferative neoplasms, such as polycythemia vera, we were pleased to see initiation of the first solid tumor clinical study of bomedemstat, an investigator-sponsored study of bomedemstat in combination with atezolizumab for small cell lung cancer."

Second Quarter 2022 and Subsequent Highlights

Presented Positive Data from the Ongoing Phase 2 Study of Bomedemstat in Essential Thrombocythemia at EHA (Free EHA Whitepaper) 2022. In June 2022, Imago presented updated positive data from its ongoing global Phase 2 clinical study evaluating bomedemstat in patients with ET. As of the data cutoff date of 29 April 2022: bomedemstat demonstrated normalization of platelets in the absence of new thromboembolic events (the primary efficacy endpoint of this study) in 94% of patients; as well as durability of hematologic response with 81% of patients achieving normalized platelet counts for at least 12 weeks (ELN criteria defining a durable response in ET); 58% of patients treated with bomedemstat experienced symptomatic improvement (defined as a decrease in Total Symptom Score) at 24 weeks; and both JAK2 and CALR mutation burdens were decreased during treatment with bomedemstat. As of the data cutoff date, the most common adverse events (AEs) were dysgeusia, fatigue, constipation, and arthralgia. Twelve patients reported a total of 19 serious adverse events (SAEs) with six deemed related to bomedemstat by the investigator. There have been no dose limiting toxicities (DLTs) or deaths related to drug. The EHA (Free EHA Whitepaper) data cut represented the last presentation before the End-of-Phase 2 meeting with FDA expected later this year.
Presented Positive Data from the Ongoing Phase 2 Study of Bomedemstat in Advanced Myelofibrosis at EHA (Free EHA Whitepaper) 2022. In June 2022, the Company presented updated positive data from its ongoing global Phase 2 clinical study evaluating bomedemstat in patients with MF. As of the data cutoff date of 29 April 2022, in addition to improvements in the standard metrics of spleen volume reduction and symptom scores, long term treatment with bomedemstat showed: 52% of evaluable patients had reductions in mutant allele frequencies, including ASXL1; 85% of evaluable patients demonstrated improved or stable fibrosis scores; and 90% of patients who were transfusion independent at baseline had stable or improved hemoglobin. The most common non-hematologic AE was dysgeusia. Of 14 drug related SAEs, 5 were Grade 2, 8 Grade 3 and 1 Grade 4 (thrombocytopenia). There have been no DLTs or deaths related to drug. Eligible MF patients completing this Phase 2 study have rolled into an extension study to evaluate the longer-term safety and impact of bomedemstat on the natural history of MF. Imago plans to commence an investigator-sponsored evaluation of bomedemstat in combination with ruxolitinib in patients with MF who have a sub-optimal response to JAK inhibition or are treatment naïve in the Fall 2022.
Announced First Participant Dosed in Investigator-Sponsored Study of Bomedemstat in Combination with Atezolizumab in Small Cell Lung Cancer, the first clinical study of Bomedemstat in patients with Solid Tumors. In May 2022, Imago announced that the first participant had been treated in an investigator-sponsored Phase 1/2 study of bomedemstat in combination with atezolizumab (Tecentriq) during the maintenance phase of treatment in people newly diagnosed with extensive stage small cell lung cancer (ES-SCLC). The Phase 1/2 open-label study will enroll approximately 30 participants diagnosed with ES-SCLC to establish the safety and tolerability of a combination treatment with bomedemstat and atezolizumab. The study is being conducted in Seattle and led by Rafael Santana-Davila, M.D., associate professor at the University of Washington School of Medicine and Joseph Hiatt, M.D., Ph.D., of Fred Hutchinson Cancer Center ("Fred Hutch"), and in collaboration with the National Cancer Institute (NCI) funded Fred Hutch Lung Specialized Project of Research Excellence.
Completed Enrollment in Phase 2 Study of Bomedemstat in Essential Thrombocythemia. In May 2022, Imago announced the completion of enrollment for the Phase 2 clinical study of bomedemstat for the treatment of ET with 73 patients enrolled, exceeding the initial target enrollment of 60 patients. This study is designed to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of bomedemstat, an oral lysine-specific demethylase 1 (LSD1) inhibitor, in patients with ET who have failed at least one standard therapy.
Obtained Advice from FDA Clinical Outcomes Assessment (COA) Group with Regard to Patient Reported Outcome (PRO) Endpoints for the Company’s Planned Phase 3 Trial of Bomedemstat in ET Patients. In June 2022, Imago discussed with FDA the proposed instruments to assess patient-reported symptoms and outcomes for key secondary endpoints.
Anticipated Upcoming Milestones

End-of-Phase 2 meeting with FDA for bomedemstat in ET expected this year
Anticipate initiating investigator-sponsored Phase 2 combination study of bomedemstat with ruxolitinib in MF in the Fall 2022
Expect data updates for the bomedemstat Phase 2 trials in ET and MF at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2022
Second Quarter 2022 Financial Results

Cash, Cash Equivalents and Short-term Investments: As of June 30, 2022, Imago had cash, cash equivalents and short-term investments of $190.0 million, compared to $217.4 million as of December 31, 2021. Based on current operating plans, management believes cash runway extends into 2025.
Research & Development (R&D) Expenses: R&D expenses for the quarter ended June 30, 2022 were $9.7 million (including stock-based compensation expense of $0.7 million), compared to $7.1 million for the same period in 2021. The overall increase in R&D expenses was primarily related to the commencement of a Phase 2 extension study started in the second half of 2021 for the long-term follow-up of patients from MF and ET clinical trials, and salaries and non-cash stock-based compensation expense for R&D employees as we ramped up our operations.
General and Administrative (G&A) Expenses: G&A expenses for the quarter ended June 30, 2022 were $4.3 million (including stock-based compensation expense of $1.0 million), compared to $1.7 million for the same period in 2021. The increase was primarily due to increases in professional fees attributable to accounting, legal, audit, and insurance expenses associated with public company operations and compensation and personnel-related costs, including stock-based compensation expense, as a result of increased headcount.
Net Loss: Net loss for the quarter ended June 30, 2022 was $13.7 million, compared to $8.8 million for the same period in 2021.

On August 12, 2022 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported financial results for the second quarter of 2022 (Press release, CASI Pharmaceuticals, AUG 12, 2022, View Source [SID1234618251]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "We are pleased to report $8.6 million in EVOMELA sales revenue for the second quarter of 2022. This is an increase of 19% compared to the same period last year. Our sales and marketing team is proven to be resilient, rapidly adapting strategies to address COVID-19 related challenges to ensure that our priories remain on track."

Dr. He continued, "Equipped with experience from EVOMELA and the ability to adapt to a changing environment, I believe our commercial and medical marketing team can efficiently execute the anticipated launch of CNCT19 in China. In addition, we continue to progress on the development and regulatory framework for BI-1206 in China. The BI-1206 trial in China has been initiated, and we expect to dose the first patient in the second half of this year."

Second Quarter 2022 Financial Highlights
Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, can be found at www.casipharmaceuticals.com.

Revenues consist primarily of product sales of EVOMELA. Revenue was $8.6 million for the three months ended June 30, 2022, compared to $7.2 million for the three months ended June 30, 2021.
Costs of revenues were $3.6 million for the three months ended June 30, 2022, compared to $3.0 million for the three months ended June 30, 2021, which included royalty payment of $1.7 million and $1.4 million, respectively.
Research and development expenses for the three months ended June 30, 2022, were $3.9 million, compared with $2.3 million for the three months ended June 30, 2021. The increase of research and development expenses for the three months periods was mainly due to expense incurred for CID-103.
General and administrative expenses for the three months ended June 30, 2022, were $5.5 million, compared with $5.5 million for the three months ended June 30, 2021.
Selling and marketing expenses for the three months ended June 30, 2022, were $3.4 million, compared with $3.4 million for the three months ended June 30, 2021.
Acquired in-process R&D expenses for the three months ended June 30, 2022, were $0, compared with $1.06 million for the three months ended June 30, 2021.
As of June 30, 2022, CASI had cash and cash equivalents of $18.9 million.
Conference Call

The conference call can be accessed by dialing 1-866-218-2402 (U.S.) or 1-412-902-6605 (International) and ask to be joined into the CASI Pharmaceuticals call to listen to the live conference call. Confirmation #10169302.

This call will be recorded and available for replay by dialing 1-877-344-7529 (U.S.) or 1-412-317-0088 (International) and enter 9173539 to access the replay.

On August 12, 2022 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the second quarter ended June 30, 2022, and recent corporate highlights (Press release, Checkpoint Therapeutics, AUG 12, 2022, View Source [SID1234618250]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "Over the past few months, we have made substantial progress towards the regulatory submission for, and potential approval of, cosibelimab for the treatment of cutaneous squamous cell carcinoma ("cSCC"). Simultaneously, we continue to generate compelling clinical data with cosibelimab, most recently announcing positive interim results from our registration-enabling trial in locally advanced cSCC, with over half of the patients achieving a confirmed objective response. These impressive data follow the positive results reported in metastatic cSCC earlier this year. Importantly, we successfully completed our pre-BLA meetings with the FDA in July, reaching agreement on all key aspects discussed with regard to the upcoming BLA submission, including the inclusion of both the locally advanced and metastatic indications. We remain on target to submit the cosibelimab BLA in late 2022."

Mr. Oliviero, continued, "Also during the quarter, we continued to advance our commercial planning to enable a successful launch upon possible approval next year, and believe our price disruptive strategy could generate substantial market share for cosibelimab in the U.S. In parallel, we continue to engage in active discussions with multiple pharmaceutical companies with the goal of expanding access to cosibelimab to patients outside of the U.S."

Recent Corporate Highlights:

In May 2022, Checkpoint announced that it received Pediatric Investigation Plan product-specific waivers from the European Medicines Agency and the U.K. Medicines & Healthcare products Regulatory Agency for cosibelimab in cSCC. The waivers remove the requirement to conduct pediatric clinical studies to support cosibelimab marketing authorization applications in Europe.
In June 2022, the top-line results of the pivotal trial of cosibelimab in metastatic cSCC were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Data highlights presented include a confirmed objective response rate ("ORR") by independent central review in the modified intent to treat population of 48.7% (95% CI, 37.0-60.4) and 13.2% of patients achieved a complete response in target lesions. Cosibelimab was generally well tolerated with no unexpected safety signals.
Also in June 2022, Checkpoint announced positive interim results from its pivotal trial of cosibelimab in locally advanced cSCC. As of the March 2022 data cutoff, the confirmed ORR by independent central review in 31 patients was 54.8% (95% CI: 36.0, 72.7), substantially exceeding a clinically meaningful lower bound of the 95% two-sided confidence interval.
In July 2022, Checkpoint successfully completed two pre-BLA meetings with the FDA (chemistry, manufacturing and controls [CMC] and clinical/non-clinical). Based upon favorable interactions with the agency, the planned BLA submission will include both the metastatic and locally advanced indications. Checkpoint also reached agreement with the FDA on all key aspects discussed with regard to the content of the upcoming BLA submission.
Checkpoint is discontinuing its CONTERNO study, a global, randomized Phase 3 trial of cosibelimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with non-squamous non-small cell lung cancer, due to the substantially longer enrollment period expected as a result of the ongoing conflict in Ukraine. The Company expects that the study will be wound down and closed over the coming months and all costs associated with the study to cease by the end of the fourth quarter.
Financial Results:

Cash Position: As of June 30, 2022, Checkpoint’s cash and cash equivalents totaled $30.9 million, compared to $41.5 million at March 31, 2022 and $54.7 million at December 31, 2021, a decrease of $10.6 million for the quarter and a decrease of $23.8 million for the first half of 2022.
R&D Expenses: Research and development expenses for the second quarter of 2022 were $12.1 million, compared to $7.2 million for the second quarter of 2021, an increase of $4.9 million. Research and development expenses for the second quarters of 2022 and 2021 each included $0.2 million of non-cash stock expenses.
G&A Expenses: General and administrative expenses for the second quarters of 2022 and 2021 each were $2.1 million. General and administrative expenses for the second quarter of 2022 included $0.5 million of non-cash stock expenses, compared to $0.9 million for the second quarter of 2021.
Net Loss: Net loss attributable to common stockholders for the second quarter of 2022 was $14.1 million, or $0.16 per share, compared to a net loss of $9.1 million, or $0.12 per share, in the second quarter of 2021. Net loss for the second quarter of 2022 included $0.7 million of non-cash stock expenses, compared to $1.0 million for the second quarter of 2021.

On August 12, 2022 Privo Technologies, Inc. ("Privo") reported that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to Privo’s PRV platform delivery of cisplatin for the treatment of carcinoma in situ (CIS) of the anterior 2/3 of the oral cavity (Press release, Privo Technologies, AUG 12, 2022, View Source;utm_medium=rss&utm_campaign=privo-technologies-inc-receives-us-fda-orphan-drug-designation [SID1234618249]). This represents Privo’s third ODD for a rare disease following their approval in oral cavity cancers and anal cancers. Privo Technologies is a clinical stage biopharmaceutical company that has designed and developed a nanoengineered drug delivery platform to safely deliver highly potent and toxic APIs locoregionally, led by founder and CEO Manijeh Goldberg, PhD.

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"Achieving this important regulatory milestone means we are one step closer to bringing new treatment options to patients diagnosed with oral CIS. The standard of care currently is surgery, resulting in severe disfigurement and poor quality of life. Our novel transmucosal delivery system with embedded cisplatin loaded nanoparticles, PRV111, allows for patients to be treated with topical chemotherapy providing an alternative to surgery that effectively treats cancer while maintaining the form and function of the oral cavity," said Dr. Goldberg.

FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug status provides benefits to drug developers that includes assistance in the drug development process, tax credits for clinical costs, exemption from FDA PDUFA fees, and seven years of post-approval exclusivity.