On November 14, 2022 Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the third quarter ended September 30, 2022 (Press release, Leap Therapeutics, NOV 14, 2022, View Source [SID1234624001]).

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Leap Highlights :
Presented clinical data from Part A of the DisTinGuish study of DKN-01 plus BeiGene’s tislelizumab in gastroesophageal adenocarcinoma (GEA) cancer patients, and the Phase 2 WAKING study of DKN-01 plus Tecentriq in oesophagogastric adenocarcinoma (OGA), at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress

Presented clinical data from Part B of the DisTinGuish study of DKN-01 plus tislelizumab in GEA cancer patients whose tumors express high levels of DKK1 (DKK1-high), and preclinical data supporting further evaluation of DNK-01 in colorectal cancer (CRC), at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting

Enrolled first patient into Part C of the DisTinGuish study, the randomized controlled trial of DKN-01 plus tislelizumab and chemotherapy in first-line G/GEJ patients

Enrolled first patient into the Phase 2 DeFianCe study of DKN-01 in second-line CRC patients
"This past quarter saw incredible progress across our DKN-01 program as we continue to focus on execution in our clinical, preclinical, biomarker, and manufacturing activities, and advance into the next stages of development," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "Results from Parts A and B of the DisTinGuish trial have been compelling with updated data presented at both ESMO (Free ESMO Whitepaper) and SITC (Free SITC Whitepaper). We were also delighted to announce the enrollment of the first patients into both Part C of the DisTinGuish gastric cancer study and the newly-initiated DeFianCe colorectal cancer trial, as we explore the broad therapeutic potential of DKN-01."

DKN-01 Development Update
DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein. DKK1 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways, which play an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating natural killer (NK) cell ligands on tumor cells.

Updated Clinical Data from Part A of DisTinGuish Study of DKN-01 Plus Tislelizumab in First-Line Patients with Advanced GEA at the ESMO (Free ESMO Whitepaper) Congress. The DisTinGuish study (NCT04363801) is a Phase 2 study of DKN-01 in combination with tislelizumab and standard of care (SOC) chemotherapy in patients with inoperable, locally advanced GEA.
Overall median progression-free survival (PFS) was 11.3 months, exceeding benchmark results in unselected patients and in all four important biomarker-directed subgroups (DKK1-high, DKK1-low, PD-L1-low, and PD-L-1-high).
Median overall survival was not yet reached.
Overall response rate (ORR) was high and durable in unselected and aggressive subgroups (DKK1-high and PD-L1-low); 68% ORR in modified intent-to-treat (mITT) population overall (1 complete response, 14 partial responses).
DKN-01 and tislelizumab plus CAPOX was well tolerated in first-line treatment for advanced GEA patients, with a safety profile consistent with previous reports.

New Clinical Data from WAKING Study of DKN-01 Plus Tecentriq at the ESMO (Free ESMO Whitepaper) Congress. The WaKING study (NCT04166721) is an investigator-sponsored study of DKN-01 in combination with atezolizumab, Roche’s anti-PD-L1 antibody, in patients with microsatellite stable esophago gastric cancer who have progressed following chemotherapy. This study is being sponsored by The Royal Marsden Hospital in the United Kingdom and being funded by Roche as part of its imCORE network.

Updated Data from Part B of DisTinGuish Study of DKN-01 Plus Tislelizumab in Second-Line Patients with Advanced GEA Cancer Whose Tumors Exress High Levels of DKK1-High at the SITC (Free SITC Whitepaper) Annual Meeting.
DKN-01 and tislelizumab were well tolerated at both 300mg and 600mg DKN-01 doses with no Grade 5 treatment-emergent AEs (TEAE) and no TEAEs leading to study drug discontinuation or dose reduction
In evaluable anti-PD-1/PD-L1 naïve mITT population (n=43), 27% ORR and 43% disease control rate (DCR), exceeding the benchmark studies for anti-PD-1 monotherapy
In DKK1-high/PD-L1-high CPS ≥ 10 patients: 55% ORR, 73% DCR, and 7.7 months PFS
In DKK1-high/PD-L1-negative CPS < 1 patients: 27% ORR

New Preclinical Data in Colorectal Cancer (CRC) Models at the SITC (Free SITC Whitepaper) Annual Meeting.
DKN-01 additive activity with 5-fluorouracil (5FU) and can overcome 5FU-resistance in two xenograft models, resulting in tumor regressions. 5FU-resistant models are reflective of a second-line CRC population currently being recruited in the DeFianCe study.
Treatment with DKN-01 as monotherapy or in combination with anti-PD-1 resulted in tumor regression in a CT26 synergenic CRC model.

Leap Announced First Patient Enrolled in Part C of Phase 2 DisTinGuish Study of DKN-01 in Combination with Tislelizumab and Chemotherapy Compared to a Tislelizumab and Chemotherapy Control Arm, in Patients with G/GEJ. The DisTinGuish study (NCT04363801) is a Phase 2 study of DKN-01 in combination with tislelizumab and standard of care (SOC) chemotherapy in patients with inoperable, locally advanced, G/GEJ adenocarcinoma. Part C of the DisTinGuish study will enroll approximately 160 first-line, HER2-negative patients who have had no prior therapy for unresectable locally advanced or metastatic G/GEJ adenocarcinoma.

Leap Announced First Patient Enrolled in DeFianCe Study of DKN-01 in Combination with Standard of Care Bevacizumab and in Chemotherapy in Second-Line Patients for the Treatment of CRC. The DeFianCe study (NCT05480306) is a Phase 2 study of DKN-01 in combination with bevacizumab and SOC chemotherapy in patients with advanced CRC who have received one prior systemic therapy. The study is designed with an initial 20 patient cohort and to then expand into a 130 patient randomized controlled trial against bevacizumab and SOC chemotherapy.
Selected Third Quarter 2022 Financial Results
Net Loss was $15.1 million for the third quarter 2022, compared to $11.1 million for the three months ended September 30, 2021.

Research and development expenses were $12.1 million for the three months ended September 30, 2022, compared to $10.1 million for the three months ended September 30, 2021. The increase of $2.0 million in research and development expenses was due to an increase of $1.4 million in clinical trial costs due to patient enrollment and the duration of patients on study, an increase of $0.4 million in payroll and other related expenses due to increased headcount, and an increase of $0.2 million in stock-based compensation expense.

General and administrative expenses were $3.2 million for the three months ended September 30, 2022, compared to $2.4 million for the three months ended September 30, 2021. The increase of $0.8 million in general and administrative expenses were due to an increase of $0.5 million in professional fees due to higher recruiting costs and an increase of $0.2 million in payroll and other related expenses due to an increase in headcount.

Cash and cash equivalents totaled $78.3 million at September 30, 2022. Additionally, short-term research and development incentive receivable totaled $1.3 million.

On November 14, 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 third quarter 2022 financial results and provided a corporate update (Press release, Instil Bio, NOV 14, 2022, View Source [SID1234623999]).

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Third Quarter 2022 Highlights and Anticipated Milestones:

DELTA-1 manufacturing and regulatory update: As previously announced, enrollment in DELTA-1 was voluntarily paused following the observation of decreased rates of successful manufacturing of ITIL-168. Our ongoing investigation of the manufacturing failures identified a central source of contamination in the cell media. In conjunction with this pause, we are also evaluating opportunities to increase the robustness of our manufacturing process. In addition, in October 2022, we notified the FDA and other regulatory agencies that an unplanned review of the data for the initial patients that had been dosed with ITIL-168 in the DELTA-1 trial was conducted in order to review risk-benefit. This review was inconclusive because the response data were not mature. Subsequently, the Data Safety Monitoring Board’s prespecified review found no safety concerns. We plan to discuss next steps for the DELTA-1 trial with the FDA and other regulatory agencies, and after such discussions, or as a result of our ongoing investigation of our manufacturing process, we may be required to modify, delay or restart our ITIL-168 clinical development program. We plan to provide an update on our ITIL-168 clinical development program in the first quarter of 2023.

DELTA-2 clinical update: The Company is deferring enrollment in the DELTA-2 study to focus resources toward higher-priority clinical programs.

First patient dosed in Phase 1 dose escalation study of ITIL-306, Instil’s first CoStAR-TIL: Instil recently announced dosing of the first patient with non-small cell lung cancer in the Phase 1 dose escalation study of ITIL-306 for the treatment of multiple solid tumors. The ITIL-306 product contained the target dose of approximately 1 billion CoStAR-TILs in addition to unmodified TILs. The CoStAR platform introduces a genetic modification which is designed to enhance the activity of TILs within the tumor microenvironment. The Phase 1 trial of ITIL-306 excludes the high-dose interleukin-2 regimen after ITIL-306 infusion. The Company remains committed to the CoStAR platform and expects to report initial clinical data from the trial in 2023.

Appointment of Head of Research and Development: Instil announced the appointment of Robert Hawkins, M.B.B.S., Ph.D., as Head of Research and Development. Dr. Hawkins is a world-renowned oncologist and biotechnology innovator, with a focus on development of novel cell and gene therapies. Dr. Hawkins was the founder and CEO of Immetacyte Ltd., a cell therapy company spun out of the University of Manchester where Dr. Hawkins served as Professor of Medical Oncology. Immetacyte Ltd. generated the foundational TIL technology and clinical data on which Instil was founded.

Resignation of Chief Medical Officer: Instil announced that, pursuant to a separation agreement, Zachary Roberts, M.D., Ph.D., Chief Medical Officer of the Company, has resigned effective November 11, 2022 to pursue other opportunities. The company appreciates Dr. Roberts’ contributions and wishes him the best in his future endeavors.

Company confirms cash-runway into 2025 with anticipated sale-leaseback transaction of its Tarzana manufacturing facility
Third Quarter 2022 Financial and Operating Results:

As of September 30, 2022, we had $303.3 million in total cash and cash equivalents and marketable securities, comprised of $41.1 million in cash and cash equivalents and $262.2 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 September 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 $39.7 million and $120.3 million for the three and nine months ended September 30, 2022, respectively, compared to $29.1 million and $64.7 million for the three and nine months ended September 30, 2021, respectively.

General and administrative expenses were $17.0 million and $49.3 million for the three and nine months ended September 30, 2022, respectively, compared to $14.0 million and $37.1 million for the three and nine months ended September 30, 2021, respectively.

On November 14, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its revenues and cash position for the first nine months of 2022 (Press release, Innate Pharma, NOV 14, 2022, View Source [SID1234623998]).

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"Innate’s strong financial position, innovative science and strategic collaborations enable us to progress a focused pipeline of antibodies, including several potentially first-in-class clinical and preclinical candidates, in cancers with high unmet medical need." said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "We are pleased to see that lacutamab continues to show clinical activity in mycosis fungoides. We look forward to sharing data from the Phase 2 TELLOMAK trial for lacutamab in Sézary syndrome at ASH (Free ASH Whitepaper), as well as shining the spotlight on our proprietary ANKET platform, which demonstrates an important role in activating an anti-tumor response. Our third strategic pillar continues to advance, as part of our collaboration with AstraZeneca the PACIFIC-9 Phase 3 study of monalizumab in the early non-small cell lung cancer setting."

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Webcast and conference call will be held today at 2:00pm CET (8:00am ET).
The live webcast will be available at the following link:
View Source

Participants may also join via telephone by registering in advance of the event at: View Source Upon registration, participants will be provided with dial-in numbers, a direct event passcode and a unique registrant ID that they may use 10 minutes prior to the event start to access the call.

This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com. A replay of the webcast will be available on the Company website for 90 days following the event.

Click here to download the Presentation.

Pipeline highlights:
Lacutamab (anti-KIR3DL2 antibody):
Preliminary results from the Phase 2 TELLOMAK study were presented at the EORTC-CLTG (European Organisation for Research and Treatment of Cancer – Cutaneous Lymphoma Tumours Group) 2022 meeting on 23 September, confirming clinical activity and favorable safety profile of lacutamab in patients with mycosis fungoides who express KIR3DL2 and who were previously treated with at least two lines of systemic therapy. Results showed that lacutamab produced a global objective response rate (ORR) of 28.6% (95% confidence interval [CI], 13.8-50.0) in the KIR3DL2-expressing MF patients (n=21), including 2 complete responses and 4 partial responses.
The Company announced that it will report preliminary data from the Phase 2 TELLOMAK study in Sézary syndrome at the ASH (Free ASH Whitepaper) (American Society of Hematology) 2022 Annual Congress on 10 December. The ASH (Free ASH Whitepaper) abstract states that the preliminary data demonstrate that lacutamab showed clinical activity and a favorable safety profile. In the heavily pre-treated post-mogamulizumab patient population with an average of six prior lines of therapy, in the Intention to treat population (ITT) population, the global confirmed ORR was 21.6% (8/37). Confirmed ORR in the skin was 35.1% (13/37) and confirmed ORR in the blood was 37.8% (14/37). Additional data will be presented at the ASH (Free ASH Whitepaper) 2022 Annual Congress.
On 11 September, at the ESMO (Free ESMO Whitepaper) 2022 conference, the Company presented a poster on the ongoing lacutamab Phase 1b trial design in monotherapy in peripheral T-cell lymphoma (PTCL).
Two clinical trials are underway evaluating lacutamab in patients with KIR3DL2-expressing, relapsed/refractory PTCL:
Phase 1b trial: a Company-sponsored Phase 1b clinical trial to evaluate lacutamab as a monotherapy in patients with KIR3DL2-expressing relapsed PTCL.
Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial: The Lymphoma Study Association (LYSA) investigator-sponsored, randomized trial to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL.
ANKET (Antibody-based NK cell Engager Therapeutics):
An 18 October edition of Cell Reports Medicine described the development of Innate’s fit-for-purpose ANKETTM antibody-based tetra-specific molecule to harness the antitumor functions of NK cells, boosting their capacity to proliferate, to accumulate at the tumor site and to kill tumor cells.
Progress continues toward investigational new drug (IND) filing in 2023 for the CD20 targeted tetra-specific ANKETTM, IPH6501.
Sanofi will present two posters on SAR’579/IPH6101 and SAR’514/IPH6401 at the ASH (Free ASH Whitepaper) 2022 Annual Congress on the 11 and 12 December:
An open-label, first-in-human, dose-escalation study of SAR443579 administered as single agent by intravenous infusion in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high-risk myelodysplasia (HR-MDS)
The Novel Trifunctional Anti-BCMA NK Cell Engager SAR’514 Has Potent in-Vitro and in-Vivo Anti-Myeloma Effect through Dual NK Cell Engagement
The Phase 1/2 clinical trial by Sanofi continues, evaluating IPH6101/SAR’579, the first NKp46/CD16-based CD123-targeted ANKETTM NK cell engager, in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high-risk myelodysplastic syndrome (HR-MDS).
It was previously announced that Sanofi had made the decision to progress IPH6401/SAR’514 into investigational new drug (IND)-enabling studies. IPH6401/SAR’514 is a BCMA-targeting NK cell engager using Sanofi’s proprietary CROSSODILE multi-functional platform, which comprises the Cross-Over-Dual-Variable-Domain (CODV) format. It induces a dual targeting of the NK activating receptors, NKp46 and CD16, for an optimized NK cell activation, based on Innate’s ANKETTM proprietary platform.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:
Innate continues to see progress for monalizumab in the early non-small cell lung cancer setting, with the ongoing Phase 3 PACIFIC-9 study run by AstraZeneca.
On 12 September at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2022 congress, AstraZeneca presented an oral presentation on the Phase 2 NeoCOAST study assessing the safety and efficacy of neoadjuvant durvalumab in combination with chemotherapy and oleclumab (AstraZeneca’s anti-CD73) or monalizumab and adjuvant treatment in patients with resectable, early-stage NSCLC.
On 1 August, Innate announced that a planned futility interim analysis of the Phase 3 INTERLINK-1 study sponsored by AstraZeneca did not meet a pre-defined threshold for efficacy. The company announced that, based on the result and the recommendation of an Independent Data Monitoring Committee, the study was to be discontinued. There were no new safety findings. AstraZeneca plan to share the data in due course. The INTERLINK-1 study, evaluated monalizumab in combination with cetuximab vs. cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors.
IPH5201 (anti-CD39), partnered with AstraZeneca:
The previously announced Phase 2 clinical trial conducted by Innate in lung cancer for IPH5201, an anti-CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca, is in planning. The Company will present a poster of preclinical data supporting the rationale for the clinical trial at the 2022 ESMO (Free ESMO Whitepaper) Immuno-Oncology (IO) Annual Congress in December.
AstraZeneca will present a poster entitled "IPH5201 as Monotherapy or in Combination with Durvalumab in Advanced Solid Tumours" at the 2022 ESMO (Free ESMO Whitepaper) IO Annual Congress in December.
IPH5301 (anti-CD73):
The investigator-sponsored Phase 1 trial of IPH5301 (CHANCES), in collaboration with Institut Paoli-Calmettes is ongoing. The trial will be conducted in two parts, Part 1, the dose escalation, followed by a Part 2 safety expansion study cohort. Part 2 will evaluate IPH5301 in combination with chemotherapy and trastuzumab in HER2+ cancer patients. The design of the Phase 1 study will be highlighted at the ESMO (Free ESMO Whitepaper) IO congress in December.
Corporate Update:
On May 03, Innate announced the commencement of an At-The-Market (ATM) program, pursuant to which it may, from time to time, offer and sell to eligible investors a total gross amount of up to $75 million American Depositary Shares ("ADS"). Each ADS representing one ordinary share of Innate. As of September 30, 2022, the balance available under our May 2022 sales agreement remains at $75 million.
Financial Results:
Cash, cash equivalents and financial assets of the Company amounted to €151.4 million as of September 30, 2022. At the same date, financial liabilities amounted to €43.1 million.
Revenues for the first nine months of 2022 amounted to €44.3 million (€10.3 million for the same period in 2021). For the nine-month period, ended September 30, 2022, revenue from collaboration and licensing agreements mainly results from the spreading of the payments received under our agreements with AstraZeneca and Sanofi.

On November 14, 2022 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease ("PD"), Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, reported financial results for the third quarter ended September 30, 2022 and highlighted recent developments (Press release, Inhibikase Therapeutics, NOV 14, 2022, View Source [SID1234623997]).

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Inhibikase Therapeutics, Inc. Logo (PRNewsfoto/Inhibikase Therapeutics, Inc.)

"While the FDA clinical hold on our IkT-148009 programs for Parkinson’s disease and Multiple System Atrophy was unexpected, we are actively working with the agency to understand their concerns and resolve them as soon as possible. To date we have not seen any serious adverse events in our Phase 2a ‘201’ trial and believe the recently presented results from our Phase 1/1b ‘101’ trial continues to support the safety, tolerability and pharmacokinetics of IkT-148009," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "As we work to resolve the clinical hold, we remain on track to initiate the ‘501’ bioequivalence study to evaluate IkT-001Pro for the treatment of stable phase Chronic Myelogenous Leukemia in the fourth quarter. In addition, we will continue to gather preclinical data for IkT-148009 in MSA and expect to advance a second animal model study in the fourth quarter. We remain committed to our mission to improve the lives of patients suffering from devastating neurodegenerative diseases and look forward to providing updates as appropriate."

Recent Developments and Upcoming Milestones:

Phase 2a ‘201’ Clinical Trial of IkT-148009 for the Treatment of Parkinson’s Disease: In August 2022, Inhibikase announced dosing of the first patient in its ‘201 trial’ evaluating IkT-148009 for the treatment of Parkinson’s disease. The 201 trial is a 1:1:1:1 randomized, double-blind, twelve-week dosing trial evaluating three-dose levels of IkT-148009. The primary endpoints will assess the safety, tolerability and steady-state pharmacokinetics of IkT-148009. The trial will also measure a hierarchy of fifteen Parkinson’s-related disease assessments in the brain and gut as secondary or exploratory endpoints. On November 7, 2022, Inhibikase announced that the U.S. Food and Drug Administration ("FDA") had issued a clinical hold on the IkT-148009 development programs. The FDA indicated it will provide an official clinical hold letter to Inhibikase within 30 days to explain the reason for this action. To date, the Company has dosed eleven patients in the trial and will conduct a blinded safety assessment, but there have been no serious adverse events seen in the trial to date and only two mild adverse events have been recorded. Since none of the initial eleven patients completed the study, once the clinical hold is lifted, the study will need to be restarted.
Presented data supporting c-Abl inhibitor therapy and the patient experience with IKT-148009 at two expert industry and academic conferences. In September 2022, Inhibikase presented data at two scientific conferences highlighting five animal model studies of acute, inherited and sporadic disease demonstrating the functional benefit of IkT-148009 in Parkinson’s disease. At the annual Movement Disorder Society Congress in Madrid Spain, Inhibikase presented data detailing the dosing experience of healthy subjects and Parkinson’s patients from multiple doses of IkT-148009 therapy between 12.5 mg and 325 mg for up to 7 days. In addition, an assessment of Parkinson’s-related disease measures demonstrated that IkT-148009 did not worsen disease.

At the Van Andel Institute’s Grand Challenges in Parkinson’s Disease conference, the Company elaborated on the fundamental studies of five distinct animal models of either acute, inherited or idiopathic disease that forms the basis of the Company’s understanding of Parkinson’s disease initiation and the critical role of c-Abl in the disease process. Data presented also demonstrated that treatment with IkT-148009 in animals led to functional recovery correlating with clearance of pathological alpha-synuclein protein. Clinical data presented at both conferences from the Phase 1/1b ‘101’ trial demonstrated a favorable safety and tolerability profile up to a dose of 325 mg with no clinically significant adverse events observed.
Received FDA Clearance for Investigational New Drug (IND) Application for IkT-001Pro for Chronic Myelogenous Leukemia (CML): In August 2022, Inhibikase received clearance by the FDA for its IND application for IkT-001Pro, the Company’s prodrug formulation of imatinib mesylate designed to enhance the safety and efficacy of imatinib (marketed as Gleevac). The Company is advancing IkT-001Pro into a single, ascending dose bioequivalence study for safety and efficacy evaluation of IkT-001Pro. The study will enroll approximately 56 male and female healthy volunteers between the ages of 25 and 55 who will be administered IkT-001Pro at one of three doses. In addition to safety and efficacy evaluations, the study will be designed to identify a dose that mimics the systemic exposure and pharmacokinetics of 400 mg imatinib mesylate, the standard-of-care dose for Stable-Phase CML. The Company expects to dose the first patient in its ‘501’ bioequivalence study in the fourth quarter of 2022.
Appointed Gisele Dion to Board of Directors: In September 2022, Inhibikase appointed Gisele Dion to the Board of Directors. Ms. Dion serves as chair of the Audit Committee, as well as a member of the Compensation Committee. Ms. Dion brings extensive experience in the public company space and has previously spearheaded financial, accounting and M&A strategies across large pharma.
Third Quarter 2022 Financial Results

Net Loss: Net loss for the three months ended September 30, 2022 was $4.49 million, or $0.18 per share, compared to a net loss of $4.47 million, or $0.18 per share for the comparable quarter in 2021.

Net loss for the nine months ended September 30, 2022, was $13.78 million or $0.55 per share, compared to a net loss of $9.74 million, or $0.61 per share in the comparable period in 2021.

R&D Expenses: Research and development expenses were $2.98 million for the three months ended September 30, 2022, compared to $3.15 million in the comparable quarter in 2021. The $0.17 million decrease in research and development expenses for the third quarter 2022 was due to a $0.77 million decrease in stock compensation partially offset by a net increase of $0.60 million of all other normal R&D expenses expenditures as the Company continued to focus on and progress its PD clinical trial activities.

Research and development expenses were $8.98 million for the nine months ended September 30, 2022 compared to $7.97 million in comparable period in 2021. The $1.01 million increase was driven by a $0.49 million decrease in non-cash stock compensation expenses offset by a $0.48 million increase in compensation and related costs, a $0.90 million increase in external R&D services and consultants, a $0.08 million increase in legal and a net increase of $0.04 million in all other normal R&D expensed.

SG&A Expenses: Selling, general and administrative expenses for the three months ended September 30, 2022 were $1.54 million compared to $1.64 million for the comparable quarter in 2021. The decrease was primarily driven by a $0.36 million decrease in stock compensation expense partially offset by increases of $0.13 million and $0.08 million of legal fees and compensation and related costs, respectively, and a $0.04 million net increase in all other normal selling, general and administrative expenses.

Selling, general and administrative expenses for the nine months ended September 30, 2022 were $4.87 million compared to $4.85 million for comparable period in 2021. The major drivers were a $1.07 million decrease in non-cash stock compensation expense for the nine months ended September 30, 2022 compared to the nine months ended September 30, 2021. The stock compensation decrease was offset by increased compensation and related costs of $0.38 million, increased legal fees of $0.35 million, increased compliance, regulatory and consultants of $0.30 million and a net increase all other normal selling, general and administrative expenses of $0.02 million.

Cash Position: Cash, cash equivalents and marketable securities were $26.5 million as of September 30, 2022.

Conference Call Information

The conference call is scheduled to begin at 8:00am ET on November 15, 2022. Participants should dial 1-844-825-9789 (United States) or 1-412-317-5180 (International) with the conference code 10172407. A live webcast may be accessed using the link here, or by visiting the investors section of the Company’s website at www.inhibikase.com. After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.

On November 14, 2022 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) ("Infinity" or the "Company"), a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported its third quarter 2022 financial results, provided a business update, and in a separate press release provided more mature data from the Phase 2 MARIO-3 1L TNBC clinical trial (Press release, Infinity Pharmaceuticals, NOV 14, 2022, View Source [SID1234623996]).

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"Our top priority is entering into a strategic partnership to advance eganelisib development and pave the way to eventual approval. Current business development discussions are directed towards an initial, focused development plan in a randomized controlled setting. It is our goal to announce a partnership, and the focus of the next clinical study for eganelisib, in the first quarter of 2023," said Adelene Perkins, Chief Executive Officer and Chair of Infinity. "We are encouraged by the long-term benefit seen in front-line TNBC patients reported earlier today from MARIO-3. These data are consistent with the long-term benefit seen in other indications in which eganelisib has been studied, giving us multiple potential paths forward to be prioritized with a prospective partner."

MARIO-3 Clinical Update:

The Company reported today an update from its MARIO-3 study of eganelisib in combination with atezolizumab and nab-paclitaxel in front-line metastatic triple negative breast cancer (TNBC) patients: (Press release here)

Encouraging one-year progression free survival rates in MARIO-3 1L TNBC study regardless of PD-L1 status
52% increase in one-year progression free survival rate in ITT patient population compared to IMpassion130 benchmark
No new safety signals were observed during the extended period on treatment, and the MARIO-3 safety profile continued to be consistent with expectations for the three component drugs.
Third Quarter 2022 Financial Results:

At September 30, 2022, Infinity had total cash and cash equivalents of $47.2 million, compared to $80.7 million at December 31, 2021.
Research and development expenses for the third quarter of 2022 were $7.7 million, compared to $7.1 million in the same period in 2021. The increase is primarily related to higher compensation expense due to additional staff to support the future development of eganelisib.
General and administrative expenses were $3.5 million for the third quarter of 2022, compared to $3.8 million in the same period in 2021. The decrease is primarily related to a decrease in professional services.
Net loss for the third quarter of 2022 was $10.7 million, or a basic and diluted loss per common share of $0.12, compared to a net loss of $10.7 million, or a basic and diluted loss per common share of $0.12 in the same period in 2021.
2022 Financial Outlook:

Infinity’s 2022 financial guidance remains as follows:

Net Loss: Infinity continues to expect net loss for 2022 to range from $40 million to $50 million.
Cash and Investments: Infinity continues to expect to end 2022 with a cash and cash equivalents balance ranging from $35 million to $45 million, which provides a cash runway into 2024. Infinity’s financial guidance does not include additional funding or business development activities even as we move toward a strategic partnership on eganelisib which is our goal to announce in the first quarter of 2023.
Conference Call Information

Infinity will host a conference call today, November 14, 2022, at 8:30 AM ET to discuss these financial results and business updates. To access the conference call, please register at https://register.vevent.com/register/BId44f86e6a2af42faadbb2844131346a8. Upon registering, each participant will be provided with call details and access codes. All participants are encouraged to join 10 minutes prior to the start time. A live webcast of the conference call can be accessed from the Events & Presentations page in the Investors/Media section of Infinity’s website at www.infi.com. An archived version of the webcast will be available on Infinity’s website for 30 days following the event.