On March 27, 2024 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported the expansion of the inclusion criteria in the open label 15- patient REM-001 study in cutaneous metastatic breast cancer (CMBC) to include patients receiving pembrolizumab (KEYTRUDA) for at least three months at screening (Press release, Kintara Therapeutics, MAR 27, 2024, View Source [SID1234641505]).

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CMBC patients are being screened and dosed in the 15-patient study which is evaluating REM-001, a second-generation photodynamic therapy (PDT) photosensitizer agent, and is designed to test the 0.8 mg dose as well as optimize the study design in advance of a Phase 3 trial initiation. The primary endpoint in the study is Best Overall Objective Response Rate (bORR) (complete response or partial response) of the target treatment fields at any time from treatment up to, and including, week 24. The majority of the costs to run this study will be covered by the $2.0 million Small Business Innovation Research (SBIR) grant Kintara was awarded from the National Institutes of Health (NIH).

"Expanding the inclusion criteria to include CMBC patients on pembrolizumab for at least three months at screening is expected to significantly increase enrollment in our REM-001 study" commented Robert E. Hoffman, Kintara’s President and Chief Executive Officer. "With a strengthened balance sheet, we continue to evaluate strategic options with the goal of maximizing shareholder value."

On March 27, 2024 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 fourth quarter and full year ended December 31, 2023 and highlighted recent developments (Press release, Inhibikase Therapeutics, MAR 27, 2024, View Source [SID1234641504]).

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"2023 was a year of clinical execution across our pipeline, culminating in the recent pre-NDA meeting with the FDA for IkT-001Pro and robust enrollment of untreated Parkinson’s patients in our 201 Trial evaluating Risvodetinib ("Risvo")," said Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase. "As we look ahead, we believe that FDA feedback from our pre-NDA meeting was constructive as we work on the requirements for NDA submission for IkT-001Pro. In addition, enrollment of patients into the 201 Trial supports our belief that topline data from the three-month, double-blind phase of the study may be available in the second half of this year. Our recent publication of Phase 1 safety, tolerability and pharmacokinetic clinical data for Risvo in the Journal of Parkinson’s Disease reinforces our belief that Risvo is well tolerated and reaches therapeutic exposures in patients with Parkinson’s disease and related disorders. We look forward to taking advantage of the recent momentum we have experienced as we continue to build value for our shareholders and bring new medicines to patients in need."

Recent Developments and Upcoming Milestones:

Completed Pre-NDA Meeting with the FDA for IkT-001Pro: On January 19, 2024, Inhibikase met with the FDA Review Team ("Review Team") from the Division of Hematologic Malignancies to discuss requirements for a 505(b)(2) NDA submission for IkT-001Pro in up to 11 blood and stomach cancer indications. Final Meeting Minutes were provided by the FDA on February 12, 2024. The Meeting Minutes confirmed that the 505(b)(2) pathway appears to be appropriate for approval of IkT-001Pro. The Review Team removed the requirement to perform a formal use-related risk assessment but expects the NDA package to justify how medication errors will be avoided for physicians, pharmacists and patients who are prescribed IkT-001Pro. The Company plans to manufacture dosage forms at 150 mg and 300 mg to discriminate IkT-001Pro from the 100 mg and 400 mg dosage forms of imatinib mesylate. These alternative dosage forms do not require any manufacturing process development. In terms of bioequivalence, clinical studies completed to date indicate that imatinib delivered by 600 mg and 800 mg IkT-001Pro provide similar exposures to imatinib delivered by 400 mg and 600 mg imatinib mesylate, respectively. Imatinib mesylate is approved for use between 300 mg and 800 mg once daily for 11 blood or stomach cancers. To cover the range of approved doses of imatinib mesylate, the Company plans to study the 1200 mg dose of IkT-001Pro that is expected to lead to exposures equivalent to 800 mg imatinib. The Review Team also suggested the Company analyze how IkT-001Pro and imatinib mesylate behave with respect to certain gut transporters that regulate absorption from the gastrointestinal tract. Inhibikase is in alignment with the FDA on this point and is initiating the necessary pre-clinical test to compare IkT-001Pro and imatinib mesylate. The Review Team and Company also agreed on the size of drug substance and drug product batches needed to meet the quality control requirements for approval. The Company will request milestone-based meetings as it completes the manufacturing and quality control processes to ensure the Company and the Review Team remain aligned throughout the process. The Company also continues to evaluate the market potential of IkT-001Pro in non-oncology indications to which imatinib has already been shown to have clinical benefit.

Actively enrolling patients in the Phase 2 201 Trial of Risvodetinib (IkT-148009) in untreated Parkinson’s disease: As of March 22, 2024, 73 participants have been enrolled, 20 prospective participants are in medical screening and 48 potential participants are being evaluated for suitability to initiate medical screening. Additionally, 34 participants have completed the 12-week dosing period. 15 mild and 2 moderate adverse events that may have been related to Risvo have been reported thus far in the trial. As the trial remains blinded, it is unknown whether any or how many of these mild or moderate adverse events are actually related to Risvo itself. Depending on the enrollment of the last participant, the Company may report topline results from the 201 Trial in the second half of 2024, including measurement of novel biomarker data as it relates to alpha-synuclein aggregates.

Published Phase 1 Results of Risvodetinib in the Journal of Parkinson’s Disease: In January 2024, Inhibikase published the results of its Phase 1 clinical studies with Risvo entitled "A Phase I, Randomized, SAD, MAD, and PK Study of Risvodetinib in Older Adults and Parkinson’s Disease," online in the peer reviewed Journal of Parkinson’s Disease. The publication highlighted data demonstrating that Risvo was well tolerated up to 7 days of daily dosing with no clinically meaningful events in healthy volunteers or worsening of symptoms in participants taking anti-PD medications. Of note, voluntary lumbar puncture was used to measure the concentration of Risvo in cerebrospinal fluid (CSF) in six participants with or without PD. Measures of the CSF concentration of Risvo indicate that it crossed the blood-brain barrier and was persistently present in the central nervous system.
Full Year 2023 Financial Results

Net Loss: Net loss for the year ended December 31, 2023, was $19.0 million, or $3.57 per share, compared to a net loss of $18.1 million, or $4.28 per share for the year ended December 31, 2022.

R&D Expenses: Research and development expenses for the year ended December 31, 2023 were $13.6 million compared to $12.0 million for the full year 2022. The $1.6 million increase was primarily due to a $1.5 million increase in CML expenditures, a decrease of $0.6 million in PD expenses and a net increase of $0.7 million in all other research and development activities.

SG&A Expenses: Selling, general and administrative expenses for the year ended December 31, 2023 were $6.7 million compared to $6.2 million for the year ended December 31, 2022. The $0.5 million increase was primarily the result of an increase in investor relations costs of $1.0 million and an increase in employee costs of $0.3 million that were partly offset by a decrease in D&O insurance of $0.6 million, a decrease in legal and consulting fees of $0.4 million and a net increase of $0.2 million in all other selling, general and administrative expenses.

Cash Position: Cash, cash equivalents and marketable securities were $13.3 million as of December 31, 2023. The Company expects that existing cash and cash equivalents will be sufficient to fund operations into the first quarter of 2025.

Conference Call Information
Inhibikase will host a conference call and webcast to discuss its full-year 2023 financial results and business highlights tomorrow, March 28, 2024, at 8:00am ET. The conference call can be accessed by dialing 1-877-407-0789 (United States) or 1-201-689-8562 (International) and referencing Inhibikase Therapeutics. 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 March 27, 2024 Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), reported that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the treatment of multiple myeloma to its lead candidate HDP-101 (Press release, Heidelberg Pharma, MAR 27, 2024, View Source [SID1234641496]). Heidelberg Pharma is investigating the candidate in a clinical Phase I/IIa study for the treatment of relapsed/refractory multiple myeloma (RRMM).

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HDP-101 is an antibody-drug conjugate, that consists of an anti-BCMA antibody, a specific linker and the Amanitin toxin. BCMA (B-cell maturation antigen) is a surface protein that is highly expressed in multiple myeloma cells and to which BCMA antibodies specifically bind.

Prof. Dr. Andreas Pahl, Chief Executive Officer at Heidelberg Pharma, commented: "We are delighted that our proprietary ATAC candidate, HDP-101, has been granted Orphan Drug Designation by the FDA, providing further validation of its potential benefit as a therapeutic for patients with multiple myeloma. This indication represents a major unmet medical need where new, more effective therapies are urgently required. Orphan Drug Designation will provide us with several important benefits, including a potential seven-year marketing exclusivity upon HDP-101 receiving approval from the FDA."

Orphan Drug Designation is granted for a drug or biological product that is intended for the prevention, diagnosis, or treatment of rare diseases or disorders that affect fewer than 200,000 people in the US. The designation provides significant incentives to promote the development of the drug including tax credits for qualified clinical trials, prescription drug user-fee exemptions, and potential seven-year marketing exclusivity upon FDA approval.

The team at Heidelberg Pharma will be presenting early safety and preliminary efficacy data at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held in San Diego, California on the 5 – 10 April 2024.

HDP-101 is an investigational product that has not yet been approved by any regulatory authority, including the FDA. The safety and efficacy of this investigational compound is being evaluated and is not yet established.

On March 27, 2024 GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, reported its financial results and highlights for the quarter and year ended December 31, 2023. Cash and cash equivalents as of December 31, 2023, were $41.8 million (Press release, GlycoMimetics, MAR 27, 2024, View Source [SID1234641495]).

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"With the time-based analysis imminent for our pivotal Phase 3 study of uproleselan in R/R AML, we are laser-focused on delivering the topline results in Q2 and excited about the possibility of submitting an NDA before year-end. This large, randomized, global trial now has a median follow-up of more than three years, which is remarkable in R/R AML, and could demonstrate the potential of uproleselan to become a new standard of care for a disease with limited treatment options and high unmet need," said Harout Semerjian, Chief Executive Officer of GlycoMimetics. "We are also pleased to announce our agreement with the ASH (Free ASH Whitepaper) RC for GMI-1687, further validating the potential of this highly potent E-selectin antagonist for the treatment of sickle cell disease. We remain deeply committed to bringing life-changing treatments to patients and look forward to sharing more important updates in the coming months."

Operational Highlights

Uproleselan

In June 2023, GlycoMimetics announced FDA clearance of a protocol amendment to the company’s pivotal Phase 3 study of uproleselan for R/R AML. This amendment provides for a time-based analysis of the primary endpoint of overall survival after a defined cutoff date, if the 295 survival events of the originally planned event-driven analysis have not been observed by that date. With adoption of the time-based analysis, the company expects to report topline results in Q2 2024.
A total of 388 patients across 70 sites in nine countries were enrolled and randomized in the pivotal Phase 3 trial, which has a primary endpoint of overall survival. The time-based analysis dataset will reflect a median follow-up in patients remaining on study of more than three years, underscoring the potential utility of uproleselan in R/R AML.
The National Cancer Institute (NCI) Alliance for Clinical Trials in Oncology will conduct an analysis of event-free survival in 267 patients enrolled and randomized in its Phase 2/3 clinical trial (NCI protocol A041701) evaluating uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy. Enrollment of the Phase 2 portion of the study was completed in December 2021. The company reiterates that when available, it will share these results.
GMI-1687

In August 2023, GlycoMimetics initiated a Phase 1a single-center, double-blind, randomized, placebo-controlled, sequential, single ascending dose trial in healthy adult volunteers. The study enrolled 40 subjects. Eligible subjects received a single dose of GMI-1687 or placebo (6:2 ratio) via subcutaneous injection. In January 2024, the company announced that the study met its primary and secondary endpoints of safety/tolerability and pharmacokinetics. There were no dose-limiting toxicities or other safety signals. Potentially therapeutic plasma levels that may alleviate vaso-occlusive events (VOE) were achieved at multiple dose levels after a single injection. Full study results of this Phase 1a first-in-human trial of GMI-1687 will be presented at an upcoming medical meeting.
GlycoMimetics announced today that it has entered into a research agreement with the ASH (Free ASH Whitepaper) RC and its Sickle Cell Disease Research Network. This collaboration will obtain feedback on the GMI-1687 clinical development plan from people living with sickle cell disease and therapeutic area experts. ASH (Free ASH Whitepaper) RC fosters partnerships to accelerate progress and improve outcomes for people living with SCD by expediting therapeutics development and generating high-quality evidence to support clinical decision-making.
Corporate Update

GlycoMimetics strengthened its leadership team by appointing Shantha Tyavanagimatt, Ph.D., as Senior Vice President of Technical Operations.
Fourth Quarter and Full Year 2023 Financial Results

Cash position: As of December 31, 2023, GlycoMimetics had cash and cash equivalents of $41.8 million, compared to $47.9 million as of December 31, 2022.
R&D Expenses: The company’s research and development expenses decreased to $5.3 million for the quarter ended December 31, 2023, compared to $5.9 million for the fourth quarter of 2022. Research and development expenses for the year ended December 31, 2023, decreased to $20.1 million, compared to $28.4 million in the prior year. These decreases were due to lower clinical development expenses for the global Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML, and decreased manufacturing costs due to the completion of engineering and validation batches for uproleselan, partially offset by the Phase 1 clinical trial of GMI-1687.
G&A Expenses: The company’s general and administrative expenses decreased to $4.3 million for the quarter ended December 31, 2023, compared to $4.7 million for the fourth quarter of 2022. General and administrative expenses for the year ended December 31, 2023, increased slightly to $19.2 million, compared to $19.1 million in the prior year. The overall increase was due to higher personnel-related expenses, offset in part by a decrease in external consulting expenses.
Shares Outstanding: Shares of common stock outstanding as of December 31, 2023, were 64,393,744.
Conference Call Information

The company will host a conference call and webcast today at 8:30 a.m. ET. To access the call by phone, please go to this registration link and you will be provided with dial in details. Participants are encouraged to connect 15 minutes in advance of the scheduled start time.

A live webcast of the call will be available on the "Investors" tab on the GlycoMimetics website. A webcast replay will be available for 30 days following the call.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class E-selectin antagonist. Uproleselan (yoo’ pro le’se lan) is currently being evaluated in a broad development program, including a late-stage Phase 3 trial in acute myeloid leukemia (AML), GlycoMimetics has received Breakthrough Therapy and Fast Track designations from the FDA and Breakthrough Therapy designation from the Chinese National Medical Products Administration for uproleselan as a potential treatment for adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin binding and stimulation of myeloid cells. E-selectin is expressed on the surface of blood vessels, and its binding to myeloid cells is believed to confer a pro-survival effect. Uproleselan is intended to enable a novel approach to disrupting established mechanisms of leukemic cell resistance.

About GMI-1687

Discovered and developed by GlycoMimetics, GMI-1687 is a highly potent E-selectin antagonist that is bioavailable after subcutaneous administration. This second-generation compound has potential application in inflammatory diseases, and the company’s initial clinical development will focus on SCD. E-selectin is believed to play a major role in vaso-occlusive events (VOEs), a group of acute complications that are associated with SCD and include vaso-occlusive pain crises, acute chest syndrome (ACS), stroke, and splenic sequestration. Administration of GMI-1687 by subcutaneous injection, if successfully developed in the clinic, may enable this study drug to be approved as a patient-controlled, point-of-care treatment option.

On March 27, 2024 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported a business update and announces full year 2023 financial results (Press release, Evaxion Biotech, MAR 27, 2024, View Source [SID1234641494]).

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Christian Kanstrup, Chief Executive Officer at Evaxion, commented: "We have made significant progress in our business and our financing strategies in recent months, notably the successful closing of our bridge financing round towards the end of 2023 and a subsequent public offering in early February 2024. We are very pleased with the MSD GHI participation in both financing rounds, following which we now have cash at hand into Q1 2025."

Christian continues: "With our refined strategy centered around AI-Immunology focusing on value realization via Targets, Pipeline and Responders based upon a muti-partner approach, we are enthusiastic about the prospects this brings for 2024. Further, we are executing to progress our ambition to fund our projected $14 million operational cash burn for 2024 through revenue generated from our business development activities."

Business Updates Since Last Quarterly Update

In January 2024, Evaxion announced it had commenced developing tailored novel cancer vaccines using the AI-Immunology platform. The initiative involves a new category of AI-identified tumor vaccine targets, ERVs, and aims to obtain preclinical Proof-of-Concept by the second half of 2024. With the AI-Immunology discovered novel cancer targets, designing personalized and precision vaccines may become feasible. This approach holds the potential to provide treatment solutions for cancer patients who typically do not respond to cancer immunotherapy.

In February 2024, the initial phases of an ongoing vaccine collaboration with MSD were successfully completed. The collaboration was initiated in September 2023, and in February 2024 MSD was revealed as the pharma partner for the EVX-B3 vaccine collaboration in connection with the collaboration update. The project aims to develop a vaccine against a bacterial pathogen responsible for a pressing global medical issue, lacking preventive or curative options.

Evaxion hosted an R&D Day on March 19, 2024, providing deeper insights into the validated and differentiated AI-Immunology platform. Key takeaway messages from the day were:

The proprietary AI-Immunology platform brings the potential for a new era in vaccine discovery, design and development using advanced AI and machine learning technologies.
AI-Immunology outcompetes standard vaccine target discovery approaches and holds the promise of addressing serious unmet needs.
With a unique modular architecture, AI-Immunology is scalable and adaptable towards partner needs.
The potential of AI-Immunology is validated by established partnerships, including the ongoing vaccine collaboration with MSD.
In the initial months of 2024, we showcased our differentiated AI-Immunology platform for vaccine target discovery, design and development, alongside our refined strategy for value generation, at the following conferences:

January 8-11: CEO Christian Kanstrup attended the 42nd annual J.P. Morgan Healthcare Conference.
February 27: Chief AI Officer, Andreas Holm Mattsson, participated in a panel discussion at the Sachs Associates 5th Annual European HealthTech CEO Forum.
February 28: CEO Christian Kanstrup presented the Sachs Associates 17th Annual European Life Sciences CEO Forum.
March 7: VP of AI & Innovation, Jens Kringelum, presented the 5th Biologics World Nordics 2024 Conference.
March 7: CEO Christian Kanstrup and CSO Birgitte Rønø participated in a fireside chat at the H.C. Wainwright 1st Annual Artificial Intelligence Based Drug Discovery & Development Virtual Conference.
March 7-8: Senior Project Manager, Immuno-oncology, Daniela Kleine-Kohlbrecher, presented at the 8th Annual MarketsandMarkets Next-Gen Immuno-Oncology Conference.

Anticipated 2024 Milestones
Milestones Target
EVX-B1 Conclusion of final MTA study with potential partner Q1 2024
AI-Immunology Launch of EDEN model version 5.0 Mid 2024
EVX-B2-mRNA EVX-B2-mRNA preclinical Proof-of-Concept obtained Q3 2024
EVX-01 Phase 2 one-year readout Q3 2024
EVX-B3 Conclusion of target discovery and validation work in collaboration with MSD (tradename of Merck & Co., Inc., Rahway, NJ, USA) H2 2024
Precision ERV cancer vaccines Preclinical Proof-of-Concept obtained H2 2024
Funding Ambition for full year 2024 is to generate business development income equal to 2024 cash burn (excluding financing activities) of $14 million*
* No assurances can be made that we will generate such business development income
Full Year 2023 Financial Results

Cash position: As of December 31, 2023, cash and cash equivalents were $5.6 million compared to $13.2 as of December 31, 2022. Cash position was strengthened by a private placement with gross proceeds of $5.3 million, which closed on December 21, 2023. The private placement included participation from existing and new shareholders, with the largest new shareholder being MSD Global Health Innovation Fund (MSD GHI), a corporate venture capital arm of Merck & Co., Inc., Rahway, NJ, USA, accounting for some 25% of the total aggregate offering amount. Further, the Private Placement included significant participation by all members of the Company’s management and the Company’s board of directors. After a public offering in February 2024, resulting in net proceeds of $12.7 million, we expect that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements into February 2025. If all pre-funded warrants included in the public offering are exercised, we expect necessary funding will be in place into April 2025.
Research and Development expenses were $11.9 million for the year ended December 31, 2023, as compared to $17.1 million for the year ended December 31, 2022. The decrease was primarily due to a reduction in external costs.
General and Administrative expenses were $10.4 million for the year ended December 31, 2023, as compared to $8.2 million for the year ended December 31, 2022. The increase was primarily due to an increase in external costs in connection with funding activities.
Net loss was $22.1 million for the year ended December 31, 2023, or ($0.81) per basic and diluted share, as compared to a net loss of $23.2 million, or ($0.98) per basic and diluted share for the year ended December 31, 2022.
Based on the Company’s current cash position, with an estimated cash runway into February 2025 and the need for further funding, it is the assessment of management that there exists substantial doubt about the Company’s ability to continue as a going concern.

Webcast

Evaxion will host a Business Update and Full Year 2023 Financial Results webcast on Tuesday, April 2, at 15:00 CEST / 9:00 a.m. EDT. To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique pin code. The call can be accessed 15 minutes prior to the start of the live event. To join the webcast, please click on this link. The webcast recording will be available shortly after the event.

Evaxion Biotech A/S
Consolidated Statement of Financial Position Data (Audited)
(USD in thousands)
Dec 31,
2023 Dec 31,
2022

Cash and cash equivalents $ 5,583 $ 13,184
Total assets 12,889 22,025
Total liabilities 17,618 13,722
Share capital 5,899 3,886
Other reserves 97,342 90,262
Accumulated deficit (107,970) (85,845)
Total equity (4,729) 8,303
Total liabilities and equity $ 12,889 $ 22,025

Evaxion Biotech A/S
Consolidated Statement of Comprehensive Loss Data (Audited)
(USD in thousands, except per share data)

Three Months Ended
December 31,
Twelve Months Ended
December 31,
2023 2022 2023 2022


Revenue $ 73 $ — $ 73 $ —
Research and development (2,298) (4,073) (11,916) $ (17,056)
General and administrative (2,138) (2,452) (10,354) (8,208)

Operating loss (4,363) (6,525) (22,197) (25,264)
Finance income 559 70 963 2,831
Finance expenses (895) (590) (1,681) (1,508)

Net loss before tax $ (4,699) $ (7,045) $ (22,915) $ (23,941)

Income tax benefiT 177 173 790 772

Net loss for the period $ (4,522) $ (6,872) $ (22,125) $ (23,169)

Net loss attributable to shareholders of Evaxion Biotech A/S $ (4,522) $ (6,872) $ (22,125) $ (23,169)

Loss per share – basic and diluted $ (0.16) $ (0.29) $ (0.81) $ (0.98)
Number of shares used for calculation (basic and diluted) 29,061,036 24,082,247 27,335,829 23,638,685