On August 12, 2022 Applied Therapeutics, Inc. (NASDAQ: APLT) (the "Company"), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, reported financial results for the second quarter ended June 30, 2022 (Press release, Applied Therapeutics, AUG 12, 2022, View Source [SID1234618257]).

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"In the second quarter we continued our progress across our three registrational Phase 3 trials in Galactosemia, SORD Deficiency and Diabetic Cardiomyopathy," said Shoshana Shendelman, PhD, Founder, CEO and Chair of the Board of Applied Therapeutics. "As we look towards the second half of this year, we are excited about the milestones ahead. We expect to complete our 12 month analysis in the pediatric Galactosemia study in September, and plan to announce full enrollment in both SORD Deficiency and DbCM soon. We expect these catalysts to bring us closer to our goal of delivering meaningful new treatments to patients in need."

Recent Highlights

Completed underwritten public offering of equity. In June 2022, the Company closed a public offering of its common stock and warrants with gross proceeds of $30 million, before deducting the underwriting discounts and commissions and offering expenses payable by the Company.

Granted Orphan Medicinal Product Designation by the EMA for AT-007 for Galactosemia. In June 2022, the European Medicines Agency (EMA) designated orphan medicinal product for AT-007 (gavorestat) for the treatment of Galactosemia. Applied Therapeutics plans to meet with the EMA to discuss a potential Marketing Authorization Application (MAA) submission in Europe for conditional approval based on available biomarker data or for full approval based on expected clinical outcomes data.
Financial Results

Cash and cash equivalents and short-term investments totaled $67.7 million as of June 30, 2022, compared with $80.8 million at December 31, 2021.

Research and development expenses for the three months ended June 30, 2022 were $15.4 million, compared to $14.8 million for the three months ended June 30, 2021. The $0.6 million increase was due to an increase in clinical and pre-clinical expense of $2.2 million, primarily related to the progression of the SORD pivotal trial, progression of the AT-007 ACTION-Galactosemia long-term extension adult study, and progression of the AT-007 ACTION-Galactosemia Kids pediatric registrational study; an increase in personnel expenses of $0.3 million due to the increase in headcount in support of our clinical program pipeline; an increase in stock-based compensation of $0.3 million due to new stock option and restricted stock grants; offset by a decrease in drug manufacturing and formulation costs of $2.2 million and a decrease in regulatory and other expenses of $19,000.

General and administrative expenses were $6.1 million for the three months ended June 30, 2022, compared to $11.1 million for the three months ended June 30, 2021. The decrease of $4.9 million was due to a decrease in legal and professional fees of $0.5 million due to lower external legal fees; a decrease in commercial expenses of $2.5 million related to a decrease in spend for commercial operations; a decrease in personnel expenses of $0.4 million related to a decrease in headcount; a decrease in stock-based compensation of $0.7 million relating to options being forfeited during the current period as well as decrease in headcount; a decrease in insurance expenses of $0.1 million related to decreased insurance costs; and a decrease in other expenses of $0.7 million relating to decreased costs of other office expenses.

Net loss for the second quarter of 2022 was $25.9 million, or $0.96 per basic and diluted common share, compared to a net loss of $25.8 million, or $0.99 per basic and diluted common share, for the second quarter 2021. The net loss for the second quarter of 2022 included $4.4 million in a non-cash expense due to a mark-to-market adjustment on warrant liabilities issued as part of the June 2022 public offering.

On August 12, 2022 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported its second quarter 2022 financial results and provided a corporate update (Press release, Instil Bio, AUG 12, 2022, View Source [SID1234618256]).

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Second Quarter 2022 Highlights and Anticipated Milestones:

Enrollment ongoing in DELTA-1, a Phase 2 trial of ITIL-168 in advanced melanoma with registrational intent: Instil is targeting completion of enrollment in 1H 2023 for the registrational cohort and expects top-line safety and efficacy data in early 2024, which could potentially support a biologics license application (BLA) submission and a European Medicines Agency marketing authorization application (MAA) filing.
Cash runway expected to extend from 2024 into 2025 with anticipated sale-leaseback of Tarzana, CA manufacturing site: Instil expects its current cash reserves along with expected proceeds from a potential sale-leaseback of its Tarzana, CA, manufacturing site to fund Company operations into 2025.
Enrolling Phase 1 study of ITIL-306, Instil’s first CoStAR-TIL: Instil has initiated a Phase 1 study of ITIL-306, its first CoStAR-TIL product candidate. CoStAR is a genetic modification designed to enhance the activity of TILs within the tumor microenvironment. The Phase 1 study of ITIL-306 features a TIL treatment regimen free of IL-2 and will enroll patients with non-small cell lung cancer (NSCLC), ovarian cancer (OC), and renal cell carcinoma (RCC).
Initiated DELTA-2, a Phase 1 study of ITIL-168 in combination with pembrolizumab: Instil has initiated DELTA-2, a Phase 1 study of ITIL-168 in combination with pembrolizumab, which will enroll patients with NSCLC, cervical cancer, and squamous cell carcinoma of the head and neck.
Tarzana, CA manufacturing facility operational: Instil was cleared by the US Food and Drug Administration (FDA) for manufacturing of both ITIL-168 and ITIL-306 at its Tarzana, CA manufacturing facility, which will support DELTA-1, DELTA-2, and ITIL-306 clinical trials.
Presented Preclinical Data on CoStAR T cells at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting: Instil presented findings from preclinical studies evaluating anti-FOLR1 CoStAR T cells in vitro as well as a murine solid tumor model in vivo demonstrating enhanced T cell function and tumor control by CoStAR-modified T cells.

Title: Antitumor activity of T cells expressing a novel anti-folate receptor alpha (FOLR1) costimulatory antigen receptor (CoStAR) in a human xenograft murine solid tumor model and implications for in-human studies.
Presented Product Characterization Data from Unmodified TILs in Cutaneous Melanoma at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper): Instil presented advanced correlative analyses from a cohort of melanoma patients enrolled in a compassionate use program that were treated with TIL products made by Instil at the 25th Annual ASGCT (Free ASGCT Whitepaper) meeting.

Title: Characterization of the Transcriptomic and TCR Clonal Heterogeneity of TIL Therapy Infusion Products by Single-Cell Sequencing and Correlative Analyses With Clinical Efficacy in Patients with Advanced Cutaneous Melanoma.
Second Quarter 2022 Financial and Operating Results:

As of June 30, 2022, we had $354.6 million in total cash and cash equivalents and marketable securities, comprised of $42.5 million in cash and cash equivalents and $312.1 million in marketable securities compared to $454.1 million in total cash and cash equivalents and marketable securities, comprised of $37.6 million in cash and cash equivalents and $416.5 million in marketable securities as of December 31, 2021. The Company expects that its cash, cash equivalents and marketable securities as of June 30, 2022 will enable it to fund its operating plan into 2025 upon completion of the anticipated sale-leaseback of its Tarzana, CA manufacturing site.

Research and development expenses were $41.5 million and $80.7 million for the three and six months ended June 30, 2022, respectively, compared to $21.2 million and $35.6 million for the three and six months ended June 30, 2021, respectively.

General and administrative expenses were $17.2 million and $32.3 million for the three and six months ended June 30, 2022, respectively, compared to $14.2 million and $23.2 million for the three and six months ended June 30, 2021, respectively.

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.