On May 15, 2023 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 first quarter ended March 31, 2023 and highlighted recent developments (Press release, Inhibikase Therapeutics, MAY 15, 2023, View Source [SID1234631724]).

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"With a clear clinical path ahead, we are focused on executing across our pipeline portfolio in 2023," said Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase. "Our recent industry presentations and publications have highlighted the exciting promise of our lead IkT-148009 program in neurodegenerative disease. We began screening patients in April at 7 sites for our Phase 2 ‘201’ trial for Parkinson’s disease and anticipate up to fourteen sites to be screening patients by the end of May. In addition, we are rapidly advancing our ‘501’ bioequivalence study for IkT-001Pro for Stable-Phase CML and anticipate commencing the confirmatory analysis portion of the study in June 2023. We look forward to providing updates on both our clinical and preclinical efforts later this year."

Recent Developments and Upcoming Milestones:

Actively screening patients across multiple sites in the Phase 2 ‘201’ Clinical Trial of 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 intended to assess the safety, tolerability and steady-state pharmacokinetics of IkT-148009 as primary endpoints. Inhibikase plans to enroll 120 patients with untreated Parkinson’s Disease (Hoehn & Yahr < 3.0) who have yet to require symptomatic therapy. The study will evaluate three doses of IkT-148009 on a staggered schedule with 50 and 100 mg doses preceding 200 mg enrollment. The trial will also measure a hierarchy of fifteen Parkinson’s-related disease assessments in the brain and gut as secondary or exploratory endpoints. Thirty-six clinical sites have now been selected with 27 fully contracted. Up to 14 sites could be actively screening patients by the end of May 2023.

In March 2023, Inhibikase completed an evaluation of safety and steady-state pharmacokinetic (PK) profile of the 200 mg dose of IkT-148009 in six healthy volunteers and submitted the data to the FDA in April 2023. The Company is completing an ethics committee review at all sites to add this dose into the ‘201’ trial.

Completed Dose escalation portion of the ‘501’ bioequivalence study of IkT-001Pro: IkT-001Pro is the Company’s prodrug formulation of imatinib mesylate intended to enhance the safety and efficacy of imatinib (marketed as Gleevec) in patients with Chronic Myelogenous Leukemia (CML). In May 2023, Inhibikase completed dosing of the four dose escalation cohorts evaluating 300, 400 and 500 and 600 mg IkT-001Pro. As the Company completes the pharmacokinetic analysis of these four cohorts, Inhibikase anticipates identifying the dose of IkT-001Pro that delivers the equivalent dose of commercial 400 mg imatinib mesylate. IkT-001Pro has shown a favorable safety profile, with fewer adverse events observed relative to 400 mg imatinib mesylate and none of clinical significance. Inhibikase anticipates commencing the confirmatory analysis of the bioequivalent dose of IkT-001Pro in thirty-two additional healthy volunteers using a two-period crossover design in June 2023. The Company expects to complete this confirmatory analysis by the end of the second quarter 2023. Inhibikase is also considering the addition of a cohort that will measure bioequivalence for high-dose imatinib delivered by prodrug that is equivalent to 600 mg imatinib mesylate to further explore the safety benefit of IkT-001Pro over standard-of-care, subject to agreement with the FDA.

Advancing preclinical development of IkT-148009 in MSA: In March 2023, Inhibikase announced that the Investigational New Drug (IND) application for the Phase 2 trial of IkT-148009 in MSA was opened. An ongoing MSA animal model study has shown that pre-exposure prophylaxis of IkT-148009 precludes loss of function in a transgenic model of MSA; an independent model is running concurrently with the transgenic model to confirm the apparent functional benefit of IkT-148009 treatment. These studies will form the basis for determining the timing for initiation of a planned Phase 2 clinical study of IkT-148009 in MSA.
First Quarter Financial Results

Net Loss: Net loss for the quarter ended March 31, 2023 was $4.5 million, or $0.16 per share, compared to a net loss of $4.6 million, or $0.18 per share in the quarter ended March 31, 2022.

R&D Expenses: Research and development expenses were $2.9 million for the quarter ended March 31, 2023 compared to $3.0 million in the quarter ended March 31, 2022. The decrease was primarily due to the company restarting its Phase 2 ‘201’ clinical trial.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended March 31, 2023 were $1.9 million compared to $1.7 million for the quarter ended March 31, 2022. The increase was primarily the result of legal, consulting fees and promotional related costs.

Cash Position: Cash and cash equivalents and marketable securities were $25.7 million as of March 31, 2023. This includes the net proceeds from the Company’s $10 million January 2023 concurrent registered direct offering and private placement. The Company expects that existing cash and cash equivalents will be sufficient to fund operations into the fourth quarter of 2024.

Conference Call Information
The conference call is scheduled to begin at 8:00am ET on May 16, 2023. Participants should dial 1-844-825-9789 (United States) or 1-412-317-5180 (International) with the conference code 8552474. 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 May 15, 2023 Immedica’s partner Actinium Pharmaceuticals, Inc. reported that an abstract on the Iomab-B SIERRA trial results has been accepted for an oral presentation at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) 2023 Congress (EHA) (Free EHA Whitepaper) which will be held in Frankfurt, Germany, June 8-11, 2023 (Press release, Immedica Pharma, MAY 15, 2023, View Source [SID1234631723]).

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The abstract includes data from Actinium’s controlled phase 3 study, SIERRA , comparing the efficacy of Iomab-B based conditioning, a first-in-class targeted radiotherapy, versus physician’s choice of conventional care in patients ≥55 years of age with relapsed/refractory acute myeloid leukemia (AML). This latest acceptance of the SIERRA trial results at EHA (Free EHA Whitepaper), a major medical conference, is helping spread awareness about the potential of Iomab-B in facilitating allogeneic hematopoietic stem cell transplantations (HSCT) for patients with relapsed/refractory AML.

In April 2022 Immedica entered into a license and supply agreement with Actinium Pharmaceuticals, Inc. for Iomab-B in Europe, the Middle East and North Africa.

Details of the EHA (Free EHA Whitepaper) presentation are as follows:

Presentation Title: SIERRA trial results with a targeted radiotherapy, Iomab-B, a myeloablative conditioning with reduced intensity tolerability yields high CR, long term survival in HSCT ineligible active r/r AML

Session Type/Title: Oral / SCT Clinical

Date and Time: June 10, 11:30am – 12:45pm CEST

On May 15, 2023 Ikena oncology presented its corporate presentation (Presentation, Ikena Oncology, 15 15, 2023, View Source [SID1234631722]).

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On May 15, 2023 Ikena Oncology, Inc. (Nasdaq: IKNA, "Ikena", "Company"), a targeted oncology company forging new territory in patient-directed cancer treatment, reported financial results for the first quarter ended March 31, 2023 (Press release, Ikena Oncology, MAY 15, 2023, View Source [SID1234631721]). The Company also provided an update across the organization and pipeline.

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"The start to 2023 has been full of exciting developments, including external clinical validation of the Hippo pathway and targeting TEAD. In addition to this de-risking event, we have been able to highlight our own differentiation in the space with IK-930’s unique selectivity profile, optimized therapeutic index, and broad applicability as both a monotherapy and in combination across several patient populations. As we continue to advance in the clinic, our ability to continuously dose patients will allow us to fully explore IK-930’s therapeutic potential," commented Mark Manfredi, Ph.D., Chief Executive Officer of Ikena. "The first quarter also was the first time we shared the novel profile of IK-595, our MEK-RAF complex inhibitor. We designed IK-595 to optimize the potential therapeutic window and durably bind the RAFs, focusing on preventing multiple CRAF mechanisms that can cause tumorigenesis. Both of these programs are aiming to serve patient populations in which current approved and experimental therapies are insufficient or failing. That need is driving our entire team to continue delivering on development in the clinic, including the IK-595 IND filing and the initial IK-930 clinical data expected later this year."

Summary of Recent Pipeline Progress and Corporate Update

IK-930: TEAD1-Selective Hippo Pathway Inhibitor

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IK-930 revealed as a TEAD1 selective inhibitor with significant advantages in therapeutic index at American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023

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Multiple preclinical datasets comparing IK-930 to panTEAD inhibition presented, including nonhuman primate tolerability and comparable efficacy in multiple models

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Data presented demonstrated that the combination of IK-930 and several targeted agents, including EGFR, KRAS G12C, and MEK inhibitors, showed a decrease in the development of drug-resistant persister cells, suggesting the potential of IK-930 to expand the number of patients who could benefit from these targeted therapies

LOGO

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Initial clinical data from the monotherapy portion of the ongoing Phase 1 clinical trial of IK-930, including patients from the dose escalation cohorts and backfilling, is planned for the fourth quarter of 2023

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The study continues to progress as planned through dose escalation with no reported dose-limiting toxicities to date

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The protocol includes backfilling of cohorts at efficacious exposures in patients with NF2-deficient mesothelioma and epithelioid hemangioendothelioma (EHE)

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The expansion cohorts of the trial will evaluate IK-930 as a monotherapy in these indications, as well as in other patients with solid tumors with detectable alterations in the Hippo pathway, including NF2 deficiency and YAP/TAZ alterations

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Combination cohorts in the IK-930 clinical program are planned based on emerging pharmacokinetic and pharmacodynamic data from monotherapy dose escalation; osimertinib is the first combination partner through a clinical collaboration with AstraZeneca

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Preclinical data exemplified the potential of IK-930 in combination with osimertinib in EGFR mutant cancers, both in first line as a resistance-preventative combination and in later lines, post-resistance emergence

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Additional combinations of IK-930 with MEK inhibitors and KRAS inhibitors have the potential to address resistance to and durability of targeted treatments in RAS mutant cancers

IK-595: MEK-RAF Complex Inhibitor

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Data presented at the AACR (Free AACR Whitepaper) Special Conference on Targeting RAS demonstrated key differentiation characteristics of IK-595 from first and second generation MEK inhibitors including:

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IK-595 traps MEK and RAF in an inactive complex to overcome CRAF bypass mechanism and block its kinase-independent activity, more durably and completely inhibiting RAS-MAPK signaling than existing inhibitors

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The optimization of the half-life of IK-595 can enable dosing schedules to achieve plasma exposure above IC90 to drive tumor cell killing, while allowing a break from target engagement for normal tissues to recover

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Investigational new drug (IND) application submission for IK-595 planned for the second half of 2023

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Potential indications for the clinical program are being explored based on IK-595 sensitivity and unmet clinical need; indication models that have shown high sensitivity for IK-595 to date include:

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NRAS mutant cancers, including melanoma, colorectal cancer, and acute myeloid leukemia

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KRAS mutant cancers, including non-small cell lung, colorectal and pancreatic cancers, and

LOGO

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CRAF altered cancers, which represent an orphan population with a high unmet need and a unique potential to benefit from IK-595’s mechanism

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Additionally, IK-595 has been shown to be active as a monotherapy in many RAF models, including BRAF mutant cancers, and synergistic in combination with other targeted agents, including KRAS G12C, SHP2, SOS1, TEAD, EGFR, PI3K and mTOR inhibitors in various RAS mutant cancer cell lines

IK-175: AHR Inhibitor in Collaboration with Bristol Myers Squibb

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In March 2023, the FDA granted Fast Track designation for IK-175, the Company’s novel aryl hydrocarbon receptor (AHR) antagonist, in combination with immune checkpoint inhibitors, in patients with advanced urothelial carcinoma who have progressed on or within three months of receiving the last dose of checkpoint inhibitors

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The Phase 1 clinical trial in urothelial carcinoma has completed enrollment; treatment is ongoing and the program is eligible for opt-in from Bristol Myers Squibb through early 2024

Corporate Update

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Today the Company announced the pricing of an underwritten offering for estimated gross proceeds of approximately $40 million

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Together with its existing cash, cash equivalents, and investments, the Company believes that cash at hand will be sufficient to meet its operating requirements into 2026 and will fund additional data events for both IK-930 and IK-595 beyond the initial read outs

Financial Results for the Quarter Ended March 31, 2023

As of March 31, 2023, Ikena had $137.8 million in cash, cash equivalents and marketable securities, which does not include proceeds from the recent underwritten offering that priced today.

Collaboration revenue was $5.3 million and $3.4 million for the three months ended March 31, 2023 and 2022, respectively. The increase in collaboration revenue was primarily due to the Company’s decision to stop the IK-175 head and neck study.

Research and development expenses were $15.6 million and $14.3 million for the three months ended March 31, 2023 and 2022, respectively. The increase in research and development expenses of $1.2 million was primarily related to personnel and overhead costs due to an increase in headcount, partially offset by a decrease in other discovery stage programs, as a result of the Company prioritizing its focus on advancing its clinical stage programs.

General and administrative expenses were $5.3 million and $6.0 million for the three months ended March 31, 2023 and 2022, respectively. The decrease in general and administrative expenses of $0.7 million was primarily attributable to a decrease in legal, consulting, and insurance expenses.

On May 15, 2023 Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results and provided a business update for the three months ended March 31, 2023 (Press release, Galectin Therapeutics, MAY 15, 2023, View Source [SID1234631720]). These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said:
"Our entire team is actively engaged in oversight and management of our adaptively designed Phase 2b/3 NAVIGATE trial for the prevention of esophageal varices in patients with NASH cirrhosis, which completed randomization of 357 patients in February 2023. Our stated target remains obtaining interim analysis results from the Phase 2b portion in the fourth quarter of 2024. The Company’s results will be the first, and as of now, the only late-stage trial in compensated cirrhosis that has advanced to include portal hypertension caused by NASH. Currently, this patient population has no therapeutic option, other than liver transplantation.

Additionally, we are continuing to evaluate options and develop plans for a potential Phase 2 clinical trial of belapectin in combination with Keytruda in patients with advanced head and neck cancers. Our team is fully committed to maximizing the value of our company for the stockholders by advancing our programs for patients."

Dr. Pol Boudes, Chief Medical Officer stated: "Joel and I were pleased to discuss our innovative NAVIGATE trial for the prevention of esophageal varices with Ed Arce, managing director of equity research at H.C. Wainwright on May 2, 2023. A replay of that discussion is available in the Investor Relations section of our website, www.galectintherapeutics.com. As we reiterated in that discussion, as compared to NASH pre-cirrhotic stages, cirrhosis of the liver is characterized by a distinct pathophysiology, with activated macrophages, the target of belapectin, playing a central role in the progression to portal hypertension and, ultimately, liver failure. We continue to be encouraged by the apparent high level of safety and tolerance of belapectin in the NAVIGATE patient population, and we remain optimistic that the NAVIGATE results can one day bring a therapy to patients with NASH cirrhosis that currently can only contemplate liver transplantation as a therapeutic option."

Financial Results

For the three months ended March 31, 2023, the Company reported a net loss applicable to common stockholders of $11.5 million, or ($0.19) per share, compared to a net loss applicable to common stockholders of $9.9 million, or ($0.17) per share for the three months ended March 31, 2022. The increase is largely due to an increase in 2023 research and development expenses related to the Company’s NAVIGATE trial.

Research and development expenses for the three months ended March 31, 2023, was $8.8 million compared with $8.1 million for the three months ended March 31, 2022. The increase was primarily due to costs related to our NAVIGATE clinical trial and other supportive activities. General and administrative expenses for the three months ended March 31, 2023, were $1.5 million, compared to $1.9 million for the three months ended March 31, 2022. The decrease was primarily due to non-cash stock-based compensation expense.

As of March 31, 2023, the Company had $17.8 million of cash and cash equivalents. Additionally, the Company has $40 million remaining available under a $60 million line of credit provided by its chairman to fund operations. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through at least December 31, 2024.

The Company expects that it will require more cash to fund operations after December 31, 2024, and believes it will be able to obtain additional financing as needed. However, there can be no assurance that we will be successful in obtaining such new financing or, if available, that such financing will be on terms favorable to us.

About Belapectin

Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs, including fibrotic disorders of the liver, lung, kidney, heart, and vascular system. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. A Phase 2 study showed belapectin may prevent the development of esophageal varices in NASH cirrhosis, and these results provide the basis for the conduct of the NAVIGATE trial. The NAVIGATE trial (www.NAVIGATEnash.com), titled "A Seamless Adaptive Phase 2b/3, Double-Blind, Randomized, Placebo-controlled Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis," completed randomization of 357 patients in February 2023 with top-line data expected from the Phase 2b portion in the fourth quarter of 2024, and is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3 has a significant role in cancer, and the Company has supported a Phase 1b study in combined immunotherapy of belapectin and Keytruda in advanced melanoma and in head and neck cancer. This trial provided a strong rationale for moving forward into a Company-sponsored Phase 2 development program, which the company is exploring.

About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis

Non-alcoholic steatohepatitis (NASH), also known as fatty liver disease, has become a common disease of the liver with the rise in obesity and other metabolic diseases. NASH is estimated to affect up to 28 million people in the U.S. It is characterized by the presence of excess fat in the liver along with inflammation and hepatocyte damage (ballooning) in people who consume little or no alcohol. Over time, patients with NASH can develop excessive fibrosis, or scarring of the liver, and ultimately liver cirrhosis. It is estimated that as many as 1 to 2 million individuals in the U.S. will develop cirrhosis as a result of NASH, for which liver transplantation is the only curative treatment available. Approximately 9,000 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis or cirrhosis.