On August 15, 2024 TriSalus Life Sciences Inc., (Nasdaq: TLSI), an oncology company integrating novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, reported its financial results for the second quarter ended June 30, 2024, and provided a business update (Press release, TriSalus Life Sciences, AUG 15, 2024, View Source [SID1234645953]).

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Mary Szela, President and Chief Executive Officer of TriSalus Life Sciences, stated, "We concluded the second quarter with robust revenue growth and effective execution across our operations. Our sustained revenue growth underscores the critical demand for our Pressure Enabled Drug Delivery technology (PEDD ). We are excited to launch the DELIVER program, which will showcase the advantages of our TriNav system in treating a diverse array of complex patients."

"Additionally, we have successfully advanced development of nelitolimod, having treated 100 patients in four indications and three clinical trials using our PEDD technology. Our progress to date indicates that nelitolimod can be delivered to the liver and pancreas with minimal systemic exposure and shows early promise of benefit in heavily pretreated patients with advanced disease," added Ms. Szela. "We anticipate further growth of our PEDD technology and TriNav system and look forward to presenting our final Phase 1 data for uveal melanoma liver metastases and locally advanced pancreatic cancer in the fourth quarter."

Second Quarter Business Update

DELIVER Program

TriSalus is excited to unveil the DELIVER program, a series of clinical trials designed to significantly expand the addressable market by evaluating the use of the TriNav system across a diverse range of complex patient populations, with the intent to further validate prior clinical studies that demonstrated the favorable clinical effects of the PEDD technology. This initiative aims to generate comprehensive data and solidify the evidence supporting TriNav’s application in patients who might not be suitable candidates for traditional transarterial chemotherapy and radioembolization treatments. A key focus of the DELIVER program is to investigate the potential of combining use of the TriNav system with these therapies to enhance effectiveness and address resistance mechanisms in challenging cancers.
The Company expects to launch the program with its first clinical study, named "PROTECT" (Pressure Enabled Retrograde Occlusive Therapy with Embolization for Control of Thyroid Disease). The goal of the trial is to highlight the advantages of this novel approach compared to conventional surgical methods.
Nelitolimod Clinical Studies in Uveal Melanoma Liver Metastases, Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, and Locally Advanced Pancreatic Cancer via the Pressure-Enabled Regional Immuno-Oncology (PERIO) Clinical Program

In November 2023, TriSalus presented initial Phase 1 results for the PERIO-01 and PERIO-03 studies at the Society of Immunotherapy for Cancer annual meeting, and in June 2024, it presented top-line results for PERIO-02 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.
PERIO-01 is a Phase 1 trial evaluating hepatic arterial delivery of nelitolimod via the PEDD technology in patients with uveal melanoma liver metastases. The trial includes dose-escalation cohorts with monotherapy and in combination with checkpoint inhibitors. The preliminary data show a tolerable safety profile, evidence of liver metastases myeloid-derived suppressor cells (MDSC) depletion with T cell infiltration, and promising indications of activity, including ctDNA responses, disease control, and survival beyond historical benchmarks in predominantly pre-treated patients. The final results for the PERIO-01 Phase 1 trial are expected in Q4 2024.
PERIO-02 focuses on the hepatic arterial delivery of nelitolimod via the PEDD technology for patients with hepatocellular carcinoma or intrahepatic cholangiocarcinoma. The study has been completed, and recent findings presented by investigators from MD Anderson Cancer Center at ASCO (Free ASCO Whitepaper) demonstrated consistent safety and immunologic effects, along with encouraging survival times in a subset of patients treated with a systemic checkpoint inhibitor doublet. The Company expects further investigation into these indications to continue only through investigator-initiated studies.
PERIO-03 is a Phase 1 dose-escalation study of nelitolimod in locally advanced pancreatic cancer. Nelitolimod is administered through outpatient interventional radiology procedures using the Pancreatic TriSalus Infusion System PEDD device. Phase 1 results for this study are anticipated in Q4 2024.
Closed up to $50 million of Debt Financing with OrbiMed to support TriNav Growth Initiatives

In April, TriSalus announced the closing of a debt financing facility with OrbiMed, a healthcare investment firm. Under the terms of the credit agreement with OrbiMed, the Company borrowed $25 million at closing. In addition, an aggregate of up to an additional $25 million is available in two tranches at the Company’s option, subject to the Company’s achievement of certain revenue thresholds.

Cash and cash equivalents on hand totaled $16.5 million on June 30, 2024. Including the Company’s Standby Equity Purchase Agreement (SEPA) and other existing sources of liquidity and assuming it achieves the revenue targets and borrow the remaining $25 million of the debt financing, the Company expects to have sufficient cash runway to fund operations through the end of 2025.

Completion of Warrant Exchange Offer

On May 24, 2024, TriSalus announced an exchange offer of 0.30 shares of Common Stock for each publicly traded and private warrant tendered.
The offer’s purpose was to simplify the Company’s capital structure and reduce the potential dilutive impact of the warrants, thereby providing the Company with more flexibility for financing its operations in the future.
On July 1st, the Company issued 2,110,366 shares of common stock in exchange for 6,529,954 (or 79%) of its publicly traded warrants and 504,685 (or 10%) of its private warrants.
Financial Results for Q2 2024

Revenue, all of which is from the sale of the TriNav system, was $7.4 million and $13.8 million, respectively, for the three and six months ended June 30, 2024, up 60% and 82%, respectively, compared to the same periods in 2023. Revenue growth was driven primarily by increased selling resources and continued market share increases.

Gross margins were 88% and 86% for the three and six months ended June 30, 2024, respectively, compared to 83% and 81%, respectively, for the same periods in 2023. The improvement in the quarter and year-to-date is due to increased factory volumes and improved operational efficiency.

Operating losses were $8.2 million and $19.9 million, respectively, for the three and six months ended June 30, 2024, respectively, compared to losses of $11.4 million and $21.6 million, respectively, for the same periods in 2023. Current year reductions in operating losses are due to increased sales, improved gross margins, and reduced research and development spending associated with the timing of clinical trial spending.

Net losses available to common stockholders were $4.3 million and $17.6 million, respectively, for the three and six months ended June 30, 2024, compared to losses of $14.0 million and $22.2 million, respectively, for the same periods in 2023. Net losses in 2024 include non-cash related losses on change in fair value of the Company’s SEPA, warrant and revenue base redemption liabilities of $9.0 million and $6.5 million, respectively for the three and six months ended June 30, 2024, compared to gains of $1.1 million and $3.5 million, respectively, for the same periods in 2023. Net losses in 2023 also include the impact of non-cash related losses on equity issuance of $4.2 million in the three and six months ended June 30, 2023. These amounts are partially offset in 2024 by the impact of non-cash related gains on the change in fair value of contingent earnout liabilities of $13.7 million and $9.7 million, respectively, for the three and six months ended June 30, 2024.

The basic and diluted loss per share for the three and six months ended June 30, 2024, were $0.21 and $0.81, respectively, compared to $35.84 and $59.79 for the three and six months ended June 30, 2023, respectively.

Conference Call

TriSalus will host a webcast to discuss its second quarter 2024 financial results and business highlights on August 15, 2024 at 9:00 a.m. EDT. The webcast can be accessed on the investor relations section of TriSalus’ website at View Source Following the conclusion of the event, a webcast replay will be available on the website for approximately 90 days. Interested parties participating by phone will need to register using this online form. After registering for the webcast, dial-in details will be provided in an auto-generated e-mail containing a link to the conference phone number and a personal pin.

On August 15, 2024 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended June 30, 2024, as well as key recent clinical and corporate developments (Press release, Cel-Sci, AUG 15, 2024, View Source [SID1234645952]).

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Clinical and Corporate Developments include:

In July 2024, following the end of the third fiscal quarter, CEL-SCI reported the results of a bias analysis. The bias analysis, a standard process to ensure a trial’s findings are reliable, was conducted in preparation for CEL-SCI’s upcoming confirmatory Registration Study. This study will enroll 212 patients representing the target population for which Multikine had a 5-year survival of 73% vs. 45% in the control group. Detailed data on parameters including patient age, sex, race, tumor locations, and staging demonstrated balance between the treatment and control arms. No bias helping Multikine was found, supporting confidence that Multikine is the reason for the large increase in patient survival.
CEL-SCI received the go-ahead from the FDA for its confirmatory Registration Study of Multikine in the treatment of head and neck cancer based on strong safety and efficacy data from the completed Phase 3 study which enrolled 928 patients. The FDA agreed with the pre-surgical selection of patients most likely to benefit from Multikine—those with newly diagnosed advanced primary head and neck cancer with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy). In this target population in the Phase 3 study, Multikine demonstrated a 5-year survival of 73% vs a 45% survival in the control patients as well as a hazard ratio of 0.35.
Dr. Eyal Talor, CEL-SCI’s Chief Scientific Officer, delivered a presentation titled "Neoadjuvant Immunotherapy for Head and Neck Cancer: Low Tumor PD-L1 Expression – IT-MATTERS – RCT" at the International Drug Discovery Science & Technology (IDDST) 20th Annual Congress in Budapest, Hungary. Highlights of the presentation include:
Multikine significantly increases overall survival in patients with low levels of tumor cell PD-L1 expression in contrast to approved checkpoint inhibitors
73% survival for Multikine vs 45% in the control arm at 5 years
Statistically significant log rank p = 0.0015
5-year risk of death cut in half from 55% to 27%
Hazard ratio = 0.35 (95% CIs [0.19, 0.66])
The presentation may be accessed on CEL-SCI’s website at the following LINK
CEL-SCI strengthened its Board of Directors with the addition of Mario Gobbo and the appointment of Robert Watson as Chairperson of the Board. Mr. Gobbo has nearly 40 years of banking and corporate finance experience in healthcare and energy. Mr. Watson brings extensive expertise in capital formation strategies and partnerships, having negotiated over a half dozen exits and more than $750 million in capital transactions including IPOs, secondary offerings, and debt instruments.
Key opinion leader, Dr. Giovanni Selvaggi, joined CEL-SCI as a Clinical Advisor. Dr. Selvaggi, who has brought several oncology drugs to market, is a US-based drug developer, cancer researcher, and strategic advisor to big pharma and early-to-late-stage biotech companies. He joins several other top-tier physician consultants and head and neck cancer key opinion leaders who are advisors to CEL-SCI.
"We achieved significant and critical milestones in the third fiscal quarter including receiving the FDA’s green light on our confirmatory Registration Study of Multikine to address a vast unmet need in treating newly diagnosed head and neck cancer. Our data is so strong, and now further validated by the bias analysis, that the FDA has agreed to a 212-person study," stated CEL-SCI CEO, Geert Kersten. "We believe, as do independent statisticians, that the Registration Study is highly likely to succeed because it aims to confirm prior findings which showed excellent survival benefit."

Financial Results

Research and development expenses were $4.7 million during the three months ended June 30, 2024, compared to $5.7 million for the three months ended June 30, 2023. General and administrative expenses in the three months ended June 30, 2024 were $2.0 million compared to $2.5 million in the three months ended June 30, 2023. Following the end of the third quarter of fiscal 2024, on July 29, 2024, CEL-SCI closed on an equity fundraise of $10.85 million.

On August 15, 2024 DermBiont, a clinical-stage biotechnology company that is advancing first-in-class topical therapeutics to address patient needs in rare disease oncology and aesthetic dermatology, reported positive initial data from its ongoing open label, multi-center Phase 2a study for the treatment of basal cell carcinoma (BCC) (Press release, DermBiont, AUG 15, 2024, View Source [SID1234645951]). As a result, DermBiont has reprioritized SM-020, a first-in-class, patient-applied, and topical kinase inhibitor, for the development of two lead orphan disease oncology indications: treatment of locally advanced basal cell carcinoma (laBCC) and prevention of BCC in Gorlin Syndrome patients.

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DermBiont’s Phase 2a open-label trial is actively enrolling and treating up to 30 subjects with one to five superficial, nodular, or infiltrating primary BCCs. Lesions are being treated with SM-020 1% gel BID (twice daily) for 28 days, with the primary endpoint based on percent change from baseline in greatest tumor diameter at week 6. The safety of the drug product is being evaluated based on frequency of adverse events (AEs) and application site reactions (ASRs).

At the time of this release, seven subjects with a total of nine BCCs (1 superficial, 4 nodular, and 4 infiltrating) have been treated and show a prompt (within days of starting treatment) and robust clinical response to the application of SM-020 1% gel, clearly demonstrating the disease modifying potential of SM-020. All nine tumors have also demonstrated a partial or total reduction in clinically visible tumor.

Dr. Karl Beutner, M.D., Ph.D., and CEO of DermBiont said: "We are excited about these early results in BCC and the potential for a topical product for the treatment of laBCC and the prevention of BCCs in Gorlin Syndrome. An effective topical treatment would be welcomed by patients with laBCC given the limitations and side effects of the currently approved oral hedgehog inhibitors, while also providing patients with Gorlin Syndrome with an alternative to expensive and painful surgical procedures to remove chronic BCCs that result in significant scarring, require post-operative wound care, and lead to significant down time."

SM-020 has been well tolerated to date with no drug-related adverse events and only rare and transient primarily mild-to-moderate severity application site reactions. The same drug product has also been shown to be extremely well tolerated by subjects with seborrheic keratoses (SK), having been administered by over 100 subjects with SKs twice daily for at least 28 days in prior clinical trials.

Emma Taylor, M.D. and Chief Medical Officer at DermBiont, added: "SM-020 in vitro is highly potent at killing BCC cells and has a well-defined mechanism of action that hits established tumorigenesis pathways known to be the cause of BCCs, so the robust response that we are seeing in the clinic is not surprising."

Basal Cell Carcinoma is the most common cancer with over three million cases annually in the United States alone. A BCC that is at least 10mm in diameter and that has either failed or is not appropriate for conventional treatment is considered a laBCC. In the United States, over 10,000 individuals suffer from laBCC annually, at least 10,000 individuals suffer from Gorlin Syndrome, and more than 30,000 people suffer from high frequency sporadic BCC, with tens of thousands of individuals being diagnosed with multiple basal cell carcinomas annually.

In parallel to ongoing pivotal trial-enabling nonclinical and CMC scale-up work, DermBiont plans to seek Orphan Drug and Fast Track Designations for the treatment of laBCC and the prevention of BCC in patients with Gorlin Syndrome, to be followed by pivotal trials in two orphan indications for the approval of SM-020 for treatment of laBCC and prevention of BCC in Gorlin Syndrome patients. Following the reprioritization of SM-020 for laBCC and Gorlin Syndrome, Dermbiont is evaluating options for its SK program.

On August 15, 2024 Incyte (Nasdaq: INCY) reported positive topline results from the pivotal Phase 3 inMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, or placebo in combination with lenalidomide and rituximab compared to lenalidomide and rituximab alone in patients with relapsed or refractory follicular lymphoma (FL) (Press release, Incyte, AUG 15, 2024, View Source [SID1234645950]).

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The trial met its primary endpoint of progression free survival (PFS) by investigator assessment in FL. It also met key secondary endpoints of PFS in the overall population by investigator assessment as well as the positron-emission tomography-complete response rate in the FDG-avid FL population. In addition, the secondary endpoint of PFS results by blinded independent review are consistent with investigator based PFS results. No new safety signals with tafasitamab were observed.

"While many patients with follicular lymphoma initially benefit from first-line treatment, relapse of the disease is common, underscoring the need for additional therapies," said Steven Stein, M.D., Chief Medical Officer, Incyte. "These results demonstrate the potential of tafasitamab added to the standard of care to be a meaningful new treatment option for patients with FL whose disease has progressed after at least one prior therapy."

FL is the most common indolent, or slow growing, form of B-cell non-Hodgkin lymphoma (NHL) and accounts for approximately 13-26% of overall NHL cases.1,2,3,4,5 There are limited treatment options for the more than 17,000 new cases of relapsed or refractory FL treated every year in the United States, Europe and Japan.6

Based on these positive results, Incyte expects to file a supplemental Biologics License Application for tafasitamab for the treatment of patients with FL who have failed at least one prior systemic anti-CD20 immunotherapy or chemo-immunotherapy by the end of the year.

The full inMIND data will also be submitted for presentation at an upcoming scientific meeting.

Tafasitamab was approved in combination with lenalidomide by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2020 and 2021 respectively, for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant. Tafasitamab is marketed as Monjuvi (tafasitamab-cxix) in the United States and Minjuvi (tafasitamab) in Europe and Canada.

About inMIND

A global, double-blind, randomized, controlled Phase 3 study, inMIND (NCT04680052) evaluated the clinical benefit of tafasitamab and lenalidomide as an add-on to rituximab compared with lenalidomide alone as an add-on to rituximab in patients with relapsed or refractory follicular lymphoma (FL) Grade 1 to 3a or relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL). The study enrolled a total of 654 adults (age ≥18 years).

The primary endpoint of the study is progression-free survival (PFS) by investigator assessment in the FL population, and the key secondary endpoints are PFS in the overall population as well as positron emission tomography complete response (PET-CR) and overall survival (OS) in the FL population.

For more information about the study, please visit View Source

About Tafasitamab

Tafasitamab (Monjuvi) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally.

In the United States, Monjuvi (tafasitamab-cxix) received accelerated approval by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, Minjuvi (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT.

XmAb is a registered trademark of Xencor, Inc.

Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the "triangle" design are registered trademarks of Incyte.

IMPORTANT SAFETY INFORMATION

What are the possible side effects of MONJUVI?

MONJUVI may cause serious side effects, including:

Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.
Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding.
Infections. Serious infections, including infections that can cause death, have happened in people during treatment with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs and symptoms of an infection.
The most common side effects of MONJUVI include:

Feeling tired or weak
Diarrhea
Cough
Fever
Swelling of lower legs or hands
Respiratory tract infection
Decreased appetite
These are not all the possible side effects of MONJUVI. Your healthcare provider will give you medicines before each infusion to decrease your chance of infusion reactions. If you do not have any reactions, your healthcare provider may decide that you do not need these medicines with later infusions. Your healthcare provider may need to delay or completely stop treatment with MONJUVI if you have severe side effects.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all of your medical conditions, including if you:

Have an active infection or have had one recently.
Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.
You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.

On August 15, 2024 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, reported that it has entered into a Master Services Agreement with Aronnax, Inc. for its HT-KIT cancer therapeutic (Press release, Hoth Therapeutics, AUG 15, 2024, View Source [SID1234645949]).

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HT-KIT research, which was conducted at NC State University to evaluate the efficacy of HT-KIT in cancerous and non-cancerous cells, has demonstrated that HT-KIT effectively kills human mast cells that rely on signaling through the KIT receptor to survive. The effect of a single dose lasted for about two weeks, while reduced KIT expression lasted for 7 days. This result also demonstrated HT-KIT’s potential to reduce KIT expression using GIST cells and kill within 48 and 72 hours along with lower KIT expression in AML cells over 72 hours.

HT-KIT is an antisense oligonucleotide that targets the proto-oncogene cKIT being developed for the treatment of mast cell-derived cancers and anaphylaxis and previously received Orphan Drug Designation from FDA.

Aronnax will oversee the third-party provider, ITR Laboratories, conducting intravenous injection using increasing/decreasing doses for each subsequent group. A timeframe of forty-eight hours will be allowed between each dose group. This study will provide Hoth key metrics in both max dose and range finding elements which will help formulate its proposed clinical trial.

"We continue to make quick progress in moving HT-KIT from the lab to patients. This further analysis will help us with that process, finalizing the protocols in our upcoming IND-enabling study," stated Robb Knie, Chief Executive Officer. "We are pleased to further engage Aronnax and ITR Laboratories on these key studies given their reputation for IND-enabling studies."