On March 27, 2024 OSE Immunotherapeutics reported its consolidated annual financial results for 2023 and provided an update on key proprietary clinical and preclinical achievements, on ongoing collaboration and licensing agreements, as well as on the 2024 Company’s outlook (Press release, OSE Immunotherapeutics, MAR 27, 2024, View Source [SID1234646995]).

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Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, commented: "The Company has built today a broad and independent portfolio of five clinical assets, three pharmaceutical partnerships and three research platforms, all with potential key milestones expected in 2024. We have achieved significant steps in 2023 and all of which put in place during this year will help advance our key priorities on our clinical and preclinical stage products in immuno-oncology and inflammation in the coming months. We started 2024 with a major achievement for the Company’s growth as we also reinforced our financial resources with a new license and collaboration agreement with AbbVie valued up to $713 million, including a $48 million upfront payment, in line with our business-model of recurrent and strategic pharmaceutical partnerships. We will advance the Company’s clinical programs and continue investing in our R&D drug discovery engine to identify novel therapeutics for patients with high medical need in inflammation, autoimmune diseases and immuno-oncology.

The conduct of our Tedopi new pivotal Phase 3 clinical program in second-line non-small cell lung cancer, in patients with secondary/acquired resistance, is on track. Two dossiers were filed to the Food & Drug Administration (FDA) end of 2023: a companion test to identify HLA-A2 positive cancer patients eligible (collaboration with the company GenDx) and a clinical protocol. Both dossiers were approved mid-January 2024 and will be filed in Europe in the coming weeks.

Completion of patient enrollment in the Phase 2 trial evaluating Lusvertikimab in ulcerative colitis was recently announced, and we are now eagerly looking forward to the top-line efficacy results after the induction phase and first early assessment after 6 months of therapy expected mid-2024.

The ongoing Phase 1/2 trial with proprietary anti-PD1 OSE-279 in solid tumors has confirmed positive clinical efficacy results with a high anti-tumor response rate in difficult-to-treat patients. These results encourage further clinical development in the future, used in monotherapy in already identified cancer niche indications and to explore combinations with OSE drug candidates, in particular with our neoepitope cancer vaccine.

The positive interim data analysis from the FIRsT Phase 1/2 study evaluation of anti-CD28 FR104/VEL101 in renal transplant marks a key advancement in the clinical development towards a Phase 2 trial under preparation by our partner Veloxis Pharmaceuticals.

Two clinical drug-candidates, BI 765063 and BI 770371, from our selective SIRPa myeloid checkpoint technology are being evaluated by Boehringer Ingelheim in combination in cancer patients, in particular in metastatic or recurrent head and neck squamous cell carcinoma (HNSCC) and hepatocellular carcinoma (HCC). Promising results from the first Phase 1 study, with early clinical efficacy data and biomarkers predictive of response and survival, were presented at the 2023 AACR (Free AACR Whitepaper) and ESMO (Free ESMO Whitepaper) conferences.

We also look forward to generating additive value in immunology with our novel ‘pro-resolutive monoclonal antibody’ platform with additional identified GPCR targets, as well as our ‘myeloid checkpoint’ and ‘cytokine’ drug discovery platforms of which the latest updates are steadily selected for presentation at international scientific congresses. In parallel, at early research level, we keep strengthening our first-in-kind platform built at the intersection of Antibody Engineering, Data Science, Artificial Intelligence (AI) and novel RNA Therapeutics technologies to develop next-generation immunotherapy medicines modulating immune cell responses in the field of immuno-inflammation and immuno-oncology. Looking ahead to 2024, we are excited by several key clinical, preclinical and partnership milestones to advance the Company’s growth path with the involvement of our teams, experts and partners, all fully committed to innovation in service of patients".

On March 27, 2024 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) reported its consolidated annual financial results for 2023 and provided an update on key proprietary clinical and preclinical achievements, on ongoing collaboration and licensing agreements, as well as on the 2024 Company’s outlook (Press release, OSE Immunotherapeutics, MAR 27, 2024, View Source [SID1234641520]).

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Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, commented: "The Company has built today a broad and independent portfolio of five clinical assets, three pharmaceutical partnerships and three research platforms, all with potential key milestones expected in 2024. We have achieved significant steps in 2023 and all of which put in place during this year will help advance our key priorities on our clinical and preclinical stage products in immuno-oncology and inflammation in the coming months. We started 2024 with a major achievement for the Company’s growth as we also reinforced our financial resources with a new license and collaboration agreement with AbbVie valued up to $713 million, including a $48 million upfront payment, in line with our business-model of recurrent and strategic pharmaceutical partnerships. We will advance the Company’s clinical programs and continue investing in our R&D drug discovery engine to identify novel therapeutics for patients with high medical need in inflammation, autoimmune diseases and immuno-oncology.

The conduct of our Tedopi new pivotal Phase 3 clinical program in second-line non-small cell lung cancer, in patients with secondary/acquired resistance, is on track. Two dossiers were filed to the Food & Drug Administration (FDA) end of 2023: a companion test to identify HLA-A2 positive cancer patients eligible (collaboration with the company GenDx) and a clinical protocol. Both dossiers were approved mid-January 2024 and will be filed in Europe in the coming weeks.

Completion of patient enrollment in the Phase 2 trial evaluating Lusvertikimab in ulcerative colitis was recently announced, and we are now eagerly looking forward to the top-line efficacy results after the induction phase and first early assessment after 6 months of therapy expected mid-2024.

The ongoing Phase 1/2 trial with proprietary anti-PD1 OSE-279 in solid tumors has confirmed positive clinical efficacy results with a high anti-tumor response rate in difficult-to-treat patients. These results encourage further clinical development in the future, used in monotherapy in already identified cancer niche indications and to explore combinations with OSE drug candidates, in particular with our neo-epitope cancer vaccine.

The positive interim data analysis from the FIRsT Phase 1/2 study evaluation of anti-CD28 FR104/VEL-101 in renal transplant marks a key advancement in the clinical development towards a Phase 2 trial under preparation by our partner Veloxis Pharmaceuticals.

Two clinical drug-candidates, BI 765063 and BI 770371, from our selective SIRPa myeloid checkpoint technology are being evaluated by Boehringer Ingelheim in combination in cancer patients, in particular in metastatic or recurrent head and neck squamous cell carcinoma (HNSCC) and hepatocellular carcinoma (HCC). Promising results from the first Phase 1 study, with early clinical efficacy data and biomarkers predictive of response and survival, were presented at the 2023 AACR (Free AACR Whitepaper) and ESMO (Free ESMO Whitepaper) conferences.

We also look forward to generating additive value in immunology with our novel ‘pro-resolutive monoclonal antibody’ platform with additional identified GPCR targets, as well as our ‘myeloid checkpoint’ and ‘cytokine’ drug discovery platforms of which the latest updates are steadily selected for presentation at international scientific congresses. In parallel, at early research level, we keep strengthening our first-in-kind platform built at the intersection of Antibody Engineering, Data Science, Artificial Intelligence (AI) and novel RNA Therapeutics technologies to develop next-generation immunotherapy medicines modulating immune cell responses in the field of immuno-inflammation and immuno-oncology.

Looking ahead to 2024, we are excited by several key clinical, preclinical and partnership milestones to advance the Company’s growth path with the involvement of our teams, experts and partners, all fully committed to innovation in service of patients".

Anne-Laure Autret-Cornet, Chief Financial Officer of OSE Immunotherapeutics, adds: "Our business-model is mostly based on recurrent and strategic partnerships with pharmaceutical companies. Thanks to the collaboration and license agreement signed with AbbVie, we strongly reinforced our financial visibility, which will allow us to pursue our investments in our proprietary clinical programs and our innovative R&D engine to increase their intrinsic value and to prepare the next wave of Company’s growth".

2023 FINANCIAL RESULTS

A meeting of the Board of Directors of OSE Immunotherapeutics was held on March 27, 2024. Following the Audit Committee opinion, the Board approved the annual and consolidated financial statements prepared under IFRS on 31 December 2023.

The key figures of the 2023 consolidated annual results are reported below (and presented in the attached tables):

In K€

December 31, 2023

December 31, 2022

Current operating result

(22,980)

(18,392)

Operating result

(22,986)

(18,476)

Net result

(23,221)

(17,760)

Available cash*

18,672

25,620

Consolidated balance sheet

82,054

91,781

As of December 31, 2023, the Company’s available cash totaled €18.7 million, versus €25.6 million as of December 31, 2022.

In 2024, the Company will reinforce its financial position with a $48 million upfront payment as part of the global and exclusive license and collaboration on OSE-230 signed with AbbVie in February 2024 giving a financial visibility until 2026.

In 2023, OSE Immunotherapeutics secured:

– An equity financing line with Vester Finance, set up on April 27, 2023. This financing has triggered at the end of September a capital increase of €11.6 million (without any discount on the share price at the date of signature). To supplement its financial resources and in order to extend its financial visibility until the fourth quarter of 2024, OSE Immunotherapeutics signed on 27 September 2023, an extension to this equity financing line agreement with Vester Finance, at the same conditions2.

This extension, approved by the Board of Directors of September 27, 2023, acting on delegation from the general assembly meeting of shareholders of June 22, 20233, relates to a maximum of 900,000 shares of the Company, representing a maximum of 4,16% of the share capital, that Vester committed to subscribe on its own initiative, over a maximum period of 24 months, subject to certain usual contractual conditions.

Assuming that the totality of this additional line of financing is used in full, a shareholder holding 1.00% of the capital of OSE Immunotherapeutics before its establishment, would see his stake increase to 0.96% of the capital on an undiluted basis4 and 0.96% of the share capital on a diluted basis5.

This transaction does not give rise to the preparation of a prospectus subject to the approval of the "Autorité des Marchés Financiers", based on Article 1 of the Prospectus Regulation granting an exemption when a transaction relates to a dilution less than 20% of the Company’s share capital.

The number of shares issued under this agreement and admitted to trading are communicated monthly on the Company’s website.

– Loans and "PGE Resilience"

The Company obtained the formal agreement on loans for a total amount of €5.3 million with the collective support of "La Région Pays de la Loire", Bpifrance and its banking pool composed by banks CIC, Crédit Mutuel and BNP to finance its strategic R&D programs. Favorable conditions were granted for these loans, with an interest range of 2-4% and reimbursement timelines within 3 to 5 years. Part of these loans is composed by a "PGE Resilience" ("Prêt Garanti par l’État") loan guaranteed by the French State, implemented in the context of the Ukrainian crisis.

2023 Financial results

The audit procedures on the consolidated accounts have been performed. The certification report will be issued after finalization of the procedures required for the purposes of filing the registration document.

The Company recorded a consolidated operating loss of €-23.0 million. Current operating expenses were €25.2 million (versus €36.6 million in 2022) of which 74% related to R&D. R&D expenses amounted to €17.1 million versus €26.9 million in 2022.

APPENDICES

CONSOLIDATED PROFIT & LOSS

P&L IN K€

December 31, 2023

December 31, 2022

Turnover

2,227

18,302

Total Revenues

2,227

18,302

Research and development expenses

(17,158)

(26,893)

Overhead expenses

(6,015)

(6,672)

Expenses related to shares payments

(2,034)

(3,130)

OPERATING PROFIT/LOSS – CURRENT

(22,980)

(18,392)

Other operating expenses

(6)

(84)

OPERATING PROFIT/LOSS

(22,986)

(18,476)

Financial products

2,177

2,079

Financial expenses

(2,412)

(1,624)

PROFIT/LOSS BEFORE TAX

(23,221)

(18,022)

Income Tax

219

263

NET PROFIT/LOSS

(23,003)

(17,760)

Of which consolidated net result attributable to shareholders

(23,003)

(17,760)

Net earnings attributable to shareholders

Weighted average number of shares outstanding

19,562,147

18,527,401

Basic earnings per share

(1.18)

(0.96)

Diluted earnings per share

(1.18)

(0.96)

IN K€

2023

2022

NET RESULT

(23,003)

(17,760)

Amounts to be recycled in the income statement:

Currency conversion difference

(77)

(61)

Amounts not to be recycled in the income statement:

(9)

122

Other comprehensive income in the period

(86)

(61)

GLOBAL PROFIT/LOSS

(23,089)

(17,699)

CONSOLIDATED BALANCE SHEET

ASSETS IN K€

December 31, 2023

December 31, 2022

Acquired R&D costs

46,401

48,784

Tangible assets

464

743

Right-of-use assets

3,606

4,236

Financial assets

910

635

Differed tax assets

195

182

TOTAL NON-CURRENT ASSETS

51 ,576

54,581

Trade receivables

982

403

Other current assets

10,824

11,177

Cash and cash equivalents

18,672

25,620

TOTAL CURRENT ASSETS

30,478

37,200

TOTAL ASSETS

82,054

91,781

EQUITY & LIABILITIES IN K€

December 31, 2023

December 31, 2022

SHAREHOLDERS’ EQUITY

Stated capital

4,330

3,705

Share premium

49,816

38,784

Merger premium

26,827

26,827

Treasury stock

(408)

(549)

Reserves and retained earnings

(34,587)

(18,349)

Consolidated result

(23,003)

(17,760)

TOTAL SHAREHOLDERS’ EQUITY

22,975

32,658

NON-CURRENT DEBTS

Non-current financial liabilities

35,508

37,231

Non-current lease liabilities

3,032

3,586

Non-current deferred tax liabilities

1,311

1,514

Non-current provisions

429

524

TOTAL NON-CURRENT DEBTS

40,280

42,856

CURRENT DEBTS

Current financial liabilities

6,403

3,093

Current lease liabilities

858

883

Trade payables

9,299

8,539

Corporate income tax liabilities

20

21

Social and tax payables

1,867

2,916

Other debts and accruals

351

816

TOTAL CURRENT DEBTS

18,799

16,268

TOTAL LIABILITIES

82,054

91,781

CONSOLIDATED CASH FLOW STATEMENTS

In K€

December 31, 2023

December 31, 2022

CONSOLIDATED RESULT

(23,003)

(17,760)

+/-

Depreciation, amortization and provision expenses

2,574

2,744

+

Amortization on "right-of-use"

846

742

+/-

Shares based payments (1)

1,746

2,728

CASH FLOW BEFORE TAX

(17,838)

(11,545)

+

Financial charges

(657)

(3,066)

–

Income tax expenses

(219)

(263)

–

Tax paid

(216)

(236)

+/-

Working capital variation (2)

(835)

(3,142)

CASH FLOW FROM OPERATING ACTIVITIES (A)

(19,764)

(18,252)

–

Tangible assets increase

(16)

(274)

+/-

Financial assets variation

0

0

+/-

Net variation in rights-of-use

(216)

0

+/-

Loans and advances variation

(275)

300

CASH FLOW FROM INVESTING ACTIVITIES (B)

(507)

26

+

Capital increase (including share premium)

11,357

+/-

Own shares transactions

0

+

Warrant subscription

300

+

Loan subscription

5,023

12,056

–

Loan repayment

(2,719)

(1,010)

–

Lease debt repayment (3)

(637)

(785)

–

Financial charges

CASH FLOW FROM FINANCING ACTIVITIES (C)

13,324

10,267

+/-

Currency translation transactions (D)

CASH VARIATION E = (A + B + C + D)

(6,948)

(7,959)

CASH OPENING BALANCE (F)

25,620

33,579

CASH CLOSING BALANCE (G)

18,672

25,620

DIFFERENCE: E (G-F)

0

(1) Warrants and free shares awards granted in 2023 and valuated for 1,746 K€
(2) Mainly explained by:
– Increase in trade receivable for 578 K€
Decrease in other current assets for 353 K€
– Increase in trade accounts payable for 759K€
– Decrease in social and tax payable for 1,048 K€
– Decrease in other debts for 464 K€
(3) Explained by IFRS16 application, which corresponds to reimbursement of lease debt for 637 K€

On March 27, 2024 Iambic Therapeutics, a biotechnology company developing novel therapeutics using its unique AI-driven discovery platform, reported that the first patient has been dosed in its Phase 1 clinical study evaluating IAM1363, a selective and brain-penetrant inhibitor of HER2 signaling for the treatment of HER2-driven cancers (Press release, Iambic Therapeutics, MAR 27, 2024, View Source [SID1234641521]).

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"Using Iambic’s AI platform, we have been able to rapidly discover and advance a candidate that is highly selective for inhibiting HER2 compared to effects on EGFR and other tyrosine kinase receptors that contribute to toxicity in patients. Along with its demonstrated CNS penetrance and potential to inhibit both wild-type HER2 and common HER2 mutants, we believe IAM1363 can be a highly differentiated, best-in-class small molecule for the treatment of HER2-altered cancers," said Iambic’s Chief Medical Officer, Neil Josephson, M.D.

The Phase 1/1b trial, NCT06253871, is an open-label, multi-center, dose escalation and dose optimization study, designed to evaluate tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of IAM1363 as monotherapy and in combination with trastuzumab in patients with advanced HER2 cancers.

IAM1363 is a selective and brain-penetrant small molecule inhibitor of wild-type and oncogenic mutant HER2 proteins, designed to expand the therapeutic index compared to available HER2 inhibitors and to avoid toxicities from off-target inhibition of EGFR, a related receptor tyrosine kinase. In preclinical studies, IAM1363 has demonstrated over 1000-fold selectivity for HER2 compared to EGFR, a promising pharmacokinetic and safety profile, preferential tumor enrichment, and penetrance of the central nervous system. In HER2 tumor models, including intracranial tumor models, IAM1363 has demonstrated favorable efficacy and tolerability compared to benchmark tyrosine kinase inhibitors and HER2-targeted antibody-drug conjugates. IAM1363 was identified using Iambic’s AI-driven discovery platform, which unifies physics-informed machine learning and experimental automation to identify therapeutic candidates with differentiated drug profiles.

"For the patients I see in clinic there remains a significant need to improve therapies for HER2-driven cancers. Even with recent advances in the field we still lack treatments that can provide long-term disease control in multiple tumor types and for disease that has metastasized to the brain. IAM1363 is a promising agent because of its potency and selectivity for HER2, and its ability to readily cross the blood brain barrier. Because of its selective targeting, I see great potential for it to be developed across the entire spectrum of HER2 altered cancers, both as a single agent and in combination with other standard of care therapies," said Dr. Alexander Spira at Virginia Cancer Specialists in Fairfax, Virginia and principal investigator on the Phase 1 study of IAM1363.

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 Novocure (NASDAQ: NVCR) reported the phase 3 METIS clinical trial met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression for adult patients treated with Tumor Treating Fields (TTFields) therapy and supportive care compared to supportive care alone in the treatment of patients with 1-10 brain metastases from non-small cell lung cancer (NSCLC) following stereotactic radiosurgery (SRS) (Press release, NovoCure, MAR 27, 2024, View Source [SID1234641522]). Patients treated with TTFields therapy and supportive care exhibited a median time to intracranial progression of 21.9 months compared to 11.3 months in patients treated with supportive care alone for brain metastasis (n=298; hazard ratio=0.67; P=0.016). Median TTFields therapy treatment duration was 16 weeks and median usage was 67%. Consistent with previous studies, TTFields therapy was well-tolerated with sustained quality of life and neurocognitive function. Baseline characteristics were well balanced between arms.

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"Patients with brain metastases from non-small cell lung cancer are frequently treated with radiosurgery but face a high likelihood of rapid brain relapse," said Minesh Mehta, MD, Chief of Radiation Oncology and Deputy Director at Miami Cancer Institute, part of Baptist Health South Florida. "In this international, multicenter, phase 3 trial, the use of TTFields therapy significantly delayed time to brain relapse, with associated improvement in quality of life and stable cognition. This is a major benefit and is potentially practice changing."

Preliminary analyses of key secondary endpoints (time to neurocognitive failure, overall survival, and radiological response rate) did not demonstrate statistical significance. Certain secondary endpoints showed positive trends in favor of treatment with TTFields therapy, including time to distant progression and quality of life. Full analysis of secondary endpoints is ongoing.

"Novocure’s willingness to pursue areas of considerable unmet need, like the patient population studied in METIS, is a point of pride for our company," said Asaf Danziger, Novocure’s Chief Executive Officer. "We are so pleased with the positive outcome of this trial and encouraged by TTFields’ performance. I would like to thank everyone involved with METIS, especially our courageous patients and dedicated investigators, for their contributions to the trial and for meaningfully contributing to the evolution of treatment of brain metastases from NSCLC."

Novocure intends to submit these data to regulatory authorities. Novocure also intends to publish these findings in a peer-reviewed scientific journal and share them at an upcoming scientific congress.

Conference Call Details

Novocure will host a conference call and webcast to discuss the METIS topline results at 8:00 a.m. EST today, March 27th. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link.

The webcast and slides presented during the webcast can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

About METIS

METIS [NCT02831959] is a phase 3 trial of stereotactic radiosurgery with or without TTFields therapy for patients with 1-10 brain metastases from NSCLC. 298 adult patients were enrolled in the trial and randomized to receive either TTFields therapy with supportive care or supportive care alone following SRS. Supportive care consisted of, but was not limited to, treatment with steroids, anti-epileptic drugs, anticoagulants, pain control or nausea control medications. Patients in both arms of the study were eligible to receive systemic therapy for their NSCLC at the discretion of their treating physician. Patients with known tumor mutations for which targeted agents are available were excluded from the trial.

The primary endpoint of the METIS trial is time to first intracranial progression, as measured from the date of first SRS treatment to intracranial progression or neurological death (per RANO-BM criteria), whichever occurs first. Time to intracranial progression was calculated according to the cumulative incident function. Patient scans were evaluated by a blinded, independent radiologic review committee. Secondary endpoints include, but are not limited to, time to distant progression, time to neurocognitive failure, overall survival, time to second intracranial progression, quality of life and adverse events. Key secondary endpoints (time to neurocognitive failure, overall survival, and radiological response rate) were planned to be used in labeling claims, if successful. Patients were stratified by the number of brain metastases (1-4 or 5-10 metastases), prior systemic therapy, and tumor histology. Patients were allowed to crossover to the experimental TTFields therapy arm following confirmation of second intracranial progression.

About Brain Metastases

Brain metastases are a secondary tumor formed when cancer cells break away from the primary tumor and travel through the blood or lymph system to form new tumors (or metastases) in the brain. Brain metastasis are a negative prognostic factor in NSCLC and adversely impact neurocognitive function and quality of life. Approximately 25% of patients with NSCLC have brain metastasis at diagnosis, and lifetime risk among patients with NSCLC is approximately 50%. Neurologic symptoms are present in approximately 60-75% of patients with brain metastasis, and seizures, focal neurologic deficits, headaches, and altered mental status are common. Treatment options for patients with brain metastasis from NSCLC are limited to neurosurgery, SRS, whole brain radiation therapy, or combinations of these options. However, given the neurotoxicity and significant decline in cognitive functioning, whole brain radiation therapy (WBRT) is an unfavorable treatment option. New therapeutic options are needed for greater intracranial control while minimizing the risk of neurocognitive adverse events.

About Tumor Treating Fields Therapy

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.