On May 15, 2024 Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors, reported corporate updates and financial results for the first quarter ended March 31, 2024 (Press release, Marker Therapeutics, MAY 15, 2024, View Source [SID1234643326]).

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"We are pleased to report a strong start to the first quarter of 2024, marked by continued advances in our clinical programs," said Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. "Building on our positive results, we continue to observe objective responses in our Phase 1 APOLLO study investigating MT-601 in patients with lymphoma who have relapsed or are ineligible for CAR T therapy. We recently announced that our first patient treated in this study achieved a complete response, which was maintained nine months after initial treatment with MT-601. This patient relapsed within 90 days of CAR T therapy, indicating that MT-601 has superior durability in this study participant. In April, our Principal Investigator at City of Hope National Medical Center was invited to share his findings from the APOLLO trial at a medical conference, where he presented data from two additional study participants and that three out of three subjects treated at City of Hope demonstrated objective responses. While we plan to provide a more comprehensive clinical update on the APOLLO study in the second half of this year, we are encouraged by these preliminary results, which underscore the potential benefit of MT-601 in patients with lymphoma."

"Another significant milestone this quarter was to receive approval from the United States Adopted Name (USAN) council and International Nonproprietary Names (INN) expert committee for "neldaleucel" as nonproprietary drug name for MT-601. Having made these steady advances, we are confident that we are well positioned to achieve our near- and long-term goals related to MT-601 in patients with lymphoma," concluded Dr. Vera.

PROGRAM UPDATES & EXPECTED MILESTONES

MT-601 (Lymphoma)

- Phase 1 multicenter APOLLO trial (clinicaltrials.gov identifier: NCT05798897), investigating MT-601 in patients with lymphoma who relapsed or are ineligible for anti-CD19 CAR T cell therapies, was

selected as lead program based on promising preliminary clinical results and non-clinical proof-of-concept data (Press Release, January 8, 2024).

- Three patients were treated at City of Hope National Medical Center as part of the APOLLO study:

· First study participant treated with MT-601 had diffuse large B cell lymphoma (DLBCL) and failed four prior lines of therapy, including a relapse within 90 days of anti-CD19 CAR T cell therapy (Breyanzi) (Press Release, June 12, 2023). Without prior lymphodepletion, this participant achieved a complete response eight weeks after the second infusion of MT-601 and remains in complete response nine months after initial treatment with MT-601 (Press Release, April 8, 2024).

· Another study participant had transformed follicular Non-Hodgkin’s Lymphoma (NHL) and failed 12 lines of therapy, including bispecific T cell engager therapy (mosunetuzumab) for follicular NHL, and anti-CD19 CAR T cells (Yescarta) after transformation into DLBCL. At the time of MT-601 infusion, only follicular NHL persisted in this patient. Eight weeks after initial infusion with MT-601 without prior lymphodepletion, the study participant achieved a complete response, which remains three months following treatment with MT-601(Press Release, April 8, 2024).

· The third study participant treated had DLBCL with cutaneous involvement and was not eligible for CAR T cell therapy. This participant achieved a partial response eight weeks after MT-601 treatment without prior lymphodepletion with all lesions decreasing in size including one that has completely resolved (Press Release, April 8, 2024).

· Treatment was well tolerated among all patients with no significant treatment-related adverse events including cytokine release syndrome or neurotoxicity.

· All patients continue to be observed for durability of response.

- The Company is enrolling additional patients in the Phase 1 APOLLO trial and expects to report further data in the second half of 2024.

- MT-601 designated non-proprietary name "neldaleucel" by United States Adopted Name (USAN) Counsel and International Nonproprietary Names (INN) Expert Committee.

MT-601 (Pancreatic)

- Investigational New Drug (IND) application cleared by U.S. Food and Drug Administration (FDA) for multicenter Phase 1 trial of MT-601 in patients with metastatic pancreatic cancer in combination with front-line chemotherapy.

- Clinical advancement will be pending additional financial support from non-dilutive grant activities.

MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic Syndrome)

- To streamline resources and to reduce time to treatment, Marker decided to discontinue the patient-specific part of the Acute Myeloid Leukemia (AML) program and to focus on a ready for use "Off-the-Shelf" product (Press Release, January 8, 2024).

- U.S. FDA has granted an Investigational New Drug (IND) to investigate MT-401 as an "Off-the-Shelf" (MT-401-OTS) product in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). MT-401-OTS is manufactured from healthy donors, and Marker has established a cellular inventory with ongoing efforts of expanding it further.

- Granted Orphan Drug Designation from the European Medicines Agency (EMA) and U.S. FDA.

- Marker has non-clinical proof-of-concept data supporting the clinical benefits of MT-401-OTS in AML and secured $2M in non-dilutive funding from the NIH Small Business Innovation Research (SBIR) program to support the clinical investigation of MT-401-OTS in patients with AML.

- Clinical program initiation of MT-401-OTS anticipated for the second half of 2024.

FIRST QUARTER 2024 FINANCIAL HIGHLIGHTS

Cash Position and Guidance: At March 31, 2024, Marker had cash and cash equivalents of $11.3 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses into the fourth quarter of 2025, inclusive of available drawdowns from grant funds.

R&D Expenses: Research and development expenses were $2.6 million for the quarter ended March 31, 2024, compared to $3.4 million for the quarter ended March 31, 2023.

G&A Expenses: General and administrative expenses were $1.2 million for the quarter ended March 31, 2024, compared to $2.2 million for the quarter ended March 31, 2023.

Net Loss: Marker reported a net loss of $2.4 million for the quarter ended March 31, 2024, compared to a net loss of $4.9 million for the quarter ended March 31, 2023.

About multiTAA-specific T cells

The multi-tumor associated antigen (multiTAA)-specific T cell platform is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient’s/donor’s blood capable of recognizing a broad range of tumor antigens. Since multiTAA-specific T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefits. As a result, Marker believes that its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

On May 15 2024 MaaT Pharma, a clinical-stage biotech company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported the successful completion of its offering of 18.2 million euros, comprising a reserved offering of 2,161,250 new ordinary shares to institutional investors and a public offering of 112,454 new ordinary shares to retail investors via the PrimaryBid platform (the "Primary Offering"), at a price of €8 per share (the "Offering Price") (Press release, MaaT Pharma, MAY 15, 2024, View Source [SID1234643325]).

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The net proceeds from the Primary Offering, which are estimated to be approximately €17.3 million, will be used to fund the company’s R&D activities, covering completion of the Phase 3 trial for MaaT013 in Europe, including top-line results/primary endpoint in mid Q4 2024, continuing the pipeline development, including the initiation of Phase 3 trial activities for MaaT013 in the US and the broadening of the Phase 2b trial with MaaT033 across Europe and for working capital and other general corporate purposes, including repayment of current debts.

The Company estimates that, the total cash and cash equivalents as of March 31, 2024 of €18.2 million (unaudited), and the funds raised, will be able to finance its operations into early Q1 2025.

Concurrently with the Primary Offering, certain funds managed by Seventure Partners (together, the "Selling Shareholder"), have sold 125,000 existing shares, at the Offering Price, i.e. an amount of €1 million (the "Secondary Offering" and together with the Primary Offering, the "Global Offering"). These funds are currently in a divestment period and are progressively selling the shares they hold in the Company, but Seventure Partners will continue to support the development and growth of the Company and has committed to participate to the Reserved Offering through other funds.

Hervé Affagard, CEO and co-founder of MaaT Pharma, commented: "I extend my gratitude to both our institutional and retail investors, as well as the financial commitment from the management team. 70% of new retail investors were previously non-shareholders, showcasing a strong influx of new support, with a total investment of €0.9 million. Since our IPO in late 2021, MaaT Pharma, leader in Microbiome/Oncology, has consistently met its objectives across various fronts. Today’s investment propels us further toward in harnessing the full potential of microbiome innovations. This raise will secure our upcoming completion of Phase 3, including primary endpoint results, for MaaT013 in treating refractory acute graft-versus-host disease and contribute to positioning us to further advance our therapeutic pipeline."

Main characteristics of the Global Offering

The Global Offering, for a total amount of 19.2 million euros, was carried out by the issue of 2,273,704 new ordinary shares, in the context of the Primary Offering through (i) a reserved offering, without pre-emptive subscription rights, for the benefit of specific categories of investors of 2,161,250 new ordinary shares were subscribed for by investors in the Reserved Offering for a total amount of approximately 17.3 million euros, in accordance with the 25th resolution of the annual general meeting of June 19, 2023 (the "AGM") and pursuant to article L. 225-138 of the French Commercial Code (the "Reserved Offering"), (ii) a public offering aimed at retail investors, via the PrimaryBid platform, of 112,454 new ordinary shares were subscribed for by investors in the Reserved Offering for a total amount of approximately 0.9 million euros, in accordance with the 23rd resolution of the AGM and pursuant to article L. 225-136 of the French Commercial Code and article L. 411-2-1 1° of the French Monetary and Financial Code (the "PrimaryBid Offering") and (iii) the sale of 125,000 existing ordinary shares representing 1 Million euros held by the Selling Shareholder to the same specific categories of investors defined in the Reserved Offering.

Upon completion of the Global Offering, the share capital of the Company will be composed of 13,897,143 ordinary shares with a par value of €0.10 each. The 2,273,704 newly issued ordinary shares, represent approximately 19.6% of the Company’s share capital, on a non-diluted basis, before completion of the Global Offering and 16.3% of the Company’s share capital, on a non-diluted basis, after completion of the Global Offering. By way of illustration, a shareholder holding 1% of the share capital prior to the Global Offering and which did not participate in the Global Offering will hold 0.84% after completion of the Global Offering.

The issue price of the new ordinary shares has been set at €8 per share, representing a discount of 14.3% to the closing price of the Company’s shares on the Euronext Paris regulated market at the time of the last trading session preceding its setting (i.e. May 14, 2024) in accordance with the decisions of the Company’s Chief Executive Officer pursuant to the sub-delegations of authority granted by the Company’s Board of Directors on May 14, 2024, in accordance with the 25th, 23rd and 27th resolutions of the AGM.

To the best of the Company’s knowledge, the breakdown of shareholders before and after completion of the Global Offering is as follows:

Shareholder Pre-offer
(non-diluted basis) Post-Offer
(non-diluted basis)
Number of Ordinary Shares held Percentage of Existing Share Capital Number of Ordinary Shares held Percentage of Enlarged Share Capital
Karim Dabbagh 1 960 0,02% 1 960 0,01%
Hervé Affagard 230 776 1,99% 235 151 1,69%
Total of individual corporate officers 232 736 2,00% 237 111 1,71%
Seventure Funds 2 593 068 22,31% 2 630 568 18,93%
Crédit Mutuel Innovation SAS 1 412 364 12,15% 1 412 364 10,16%
Biocodex SAS 1 234 185 10,62% 1 859 185 13,38%
Symbiosis LLC 2 027 702 17,44% 2 027 702 14,59%
FPCI Fonds PSIM 1 802 439 15,51% 2 802 439 20,17%
Other Shareholders 1 004 141 8,64% 1 306 641 9,40%
Total Historical shareholders 10 073 899 86,67% 12 038 899 86,63%
Employees and consultants 166 471 1,43% 174 596 1,26%
Public Float 1 150 333 9,90% 1 446 537 10,41%
Total 11 623 439 100,0% 13 897 143 100,0%

Current shareholders Bpifrance Investissement, Biocodex and Seventure Partners which respectively held 15,51%, 10,62% and 22,31% of the Company’s share capital on a non-diluted basis, prior to the Global Offering, had pledged to subscribe €8 million, €5 million, and €1.3 million respectively in the Reserved Offering, subject to the Reserved Offering representing at least €17 million. The management of the Company has pledged to subscribe €100,000 in the Reserved Offering.

Members of the Company’s Board of Directors Mr. Hervé Affagard, Mr. Jean-Marie Lefèvre for Biocodex and Mrs Isabelle de Crémoux for Seventure Partners subscribed to the Global Offering for a total amount of €6.3 million. It should be noted that none of the members of the Board of Directors having subscribed to the Global Offering took part in the vote on the decision setting its terms. These investors represent approximately 32% of the Global Offering.

Admission of new ordinary shares

Settlement-delivery of the new ordinary shares and their admission to trading on the regulated market of Euronext Paris are expected to occur on May 17, 2024. The new shares will be of the same class and fungible with the existing shares, will carry all rights attached to the shares, and will be admitted to trading on the Euronext Paris market under the same ISIN code FR0012634822 – MAAT.

Undertakings to retain shares and refrain from issuing shares

In connection with the Reserved Offering, participating Directors and certain existing shareholders namely, Bpifrance Investissement, Biocodex and Seventure Partners have respectively entered into a lock-up agreement with the Placement Agents for a period of 90 days from the settlement-delivery date of the Global Offering, subject to customary exceptions.

In connection with the Reserved Offering, the Company has undertaken to refrain from issuing shares for a period of 90 days from the settlement-delivery date of the Global Offering, subject to customary exceptions.

Financial Intermediaries

Stifel Europe AG ("Stifel") is acting as Global Coordinator and Joint Bookrunner in connection with the Reserved Offering. Gilbert Dupont SNC, Groupe Société Générale, is acting as Joint Bookrunner in connection with the Reserved Offering. (together, the "Placement Agents"). The Reserved Offering is subject to a placement agreement entered into between the Company and the Placement Agents dated May 14, 2024.

Within the framework of the PrimaryBid Offering, investors subscribed via the PrimaryBid partners mentioned on the PrimaryBid website (www.PrimaryBid.fr). The PrimaryBid Offering is subject to an engagement letter entered into between the Company and PrimaryBid and is not subject to a placement agreement.

Prospectus

Since the new ordinary shares issued over a period of 12 months, including in the context of the Reserved Offering represent less than 20 % of the number of securities already admitted to trading on the same regulated market, no listing prospectus would be subject to the approval of the French Financial Markets Authority (Autorité des Marchés Financiers or the "AMF") pursuant to the Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 (as amended, the "Prospectus Regulation").

This press release does not constitute a prospectus under Prospectus Regulation, or a public offering.

Risk factors

The public’s attention is drawn to the risk factors relating to the Company and its business, presented in chapter 3 of the universal registration document 2024 approved by the Autorité des marchés financiers on April 02, 2024, which is available free of charge on the Company’s website (www.maatpharma.com) and the website of the Autorité des marchés financiers (www.amf-france.org). The occurrence of any or all of these risks could have an adverse effect on the Company’s business, financial situation, results, development or prospects.

In addition, investors are invited to consider the following risks specific to the issue: (i) the market price of the Company’s shares could fluctuate and fall below the subscription price of the shares issued under the Global Offering, (ii) the volatility and liquidity of the Company’s shares could fluctuate significantly, (iii) sales of the Company’s shares could occur on the market and have an unfavorable impact on the Company’s share price, and (iv) the Company’s shareholders could suffer potentially significant dilution as a result of any future capital increases made necessary by the Company’s search for financing.

On May 14, 2024 Lumos Pharma, Inc., a clinical stage biopharmaceutical company focused on therapeutics for rare diseases, reported the outcome from its End-of-Phase 2 meeting with the FDA, provided a clinical programs update, and reported financial results for the quarter ended March 31, 2024 (Press release, Lumos Pharma, MAY 15, 2024, View Source [SID1234643324]).

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"We are pleased to announce that, earlier this quarter, we had a very productive End-of-Phase 2 meeting with the FDA," said Rick Hawkins, Chairman and CEO of Lumos Pharma. "In this review, the FDA recognized LUM-201’s unique mechanism as a growth hormone secretagogue and acknowledged the use of a placebo-controlled clinical trial design as an appropriate option for a LUM-201 Phase 3 trial. Based on the FDA’s feedback, we plan to move forward with a proposal for a single Phase 3 study that will be a double-blinded, placebo-controlled clinical trial with a 2:1 randomization in approximately 150 patients. We expect to finalize design details with the FDA in the third quarter and to be in position to initiate this trial before the end of this year."

"In addition to our encouraging engagement with the FDA, we are also very pleased to share updated data from our Phase 2 OraGrowtH trials. These data continue to show that LUM-201 produces a significant increase in growth from baseline in annualized height velocity (AHV) at 6 and 12 months in per protocol analysis. Combined data also suggest durable benefit out to 24 months."

"We believe these developments have positioned us to advance LUM-201 toward both a Phase 3 registrational trial and potential approval of LUM-201 as the first oral therapeutic for moderate pediatric growth hormone deficiency," Rick Hawkins concluded.

Recent Highlights

•End of Phase 2 Meeting Held with FDA
◦FDA indicated that a placebo-controlled trial design is an appropriate option for a Phase 3 trial for LUM-201. We believe this reflects FDA’s recognition of unique qualities of LUM-201’s mechanism of action as a growth hormone secretagogue.
◦Proposal for a Phase 3 trial to include a 12-month double-blinded, placebo-controlled design with 2:1 randomization, ~150 patients with the placebo-controlled portion of the study lasting six months, which we believe will improve the likelihood of success when compared to a non-inferiority study.
◦Planning is ongoing, and the Company expects to initiate a Phase 3 trial of LUM-201 in Q4 2024, subject to FDA approval.
•Updated LUM-201 Data from Combined OraGrowtH210 and OraGrowtH212 Trials

Exhibit 99.1

◦Additional data continue to show durable LUM-201 treatment effect to 12 and 24 months.
◦Full 12-month data from OraGrowtH210 demonstrated LUM-201 produces significant increase in growth from baseline with AHVs of 8.2 cm/yr (N=22) and 7.6 cm/yr (N=21) at 6 and 12 months, respectively, at the 1.6 mg/kg dose vs. 4.7 cm/yr baseline growth (N=13).*
◦Full 12-month data from OraGrowtH210 continued to show durable effect to 12 months for all LUM-201 cohorts and 1.6 mg/kg/day as optimal dose to advance to Phase 3.
◦Updated combined data from OraGrowtH210 and OraGrowtH212 trials continued to demonstrate LUM-201 AHV durable to 24 months with per protocol-24M (N=12) AHV of 8.1 cm/yr and 7.3 cm/yr at 12 and 24 months, respectively .
◦More moderate year-2 decline in AHV of 9.9% for LUM-201 compared to year-2 decline in AHV of 19.7% observed in historical rhGH benchmarks likely due to LUM-201 restoration of GH and IGF-1 to normal levels via amplification of physiologic pulsatile secretion of growth hormone within the natural endocrine feedback loop.
◦Investigational safety profile continues to be favorable.
•Data from Phase 2 OraGrowtH210 and OraGrowtH212 Trials Presented at Medical Meetings in US and Europe
◦Pediatric Endocrinology Society (PES)
◦10th International Congress of the Growth Hormone Research Society (GRS)
◦European Congress of Endocrinology (ECE)
◦Data presented at these medical conferences demonstrate that by augmenting the natural pulsatile secretion of growth hormone LUM-201 produces comparable growth to injectable rhGH with significantly less exposure to circulating growth hormone.
•Additional Data from Phase 2 OraGrowtH Trials to be Presented in Q2 2024
◦Full 12-Month OraGrowtH212 data, additional analyses of OraGrowtH210 data, and updated combined 24-month data to be presented in Q2 2024
◦Two abstracts accepted for poster presentation at the Endocrine Society (ENDO) Annual Meeting

*Baseline AHV data were not required for enrollment; baseline data available for N=13 subjects.

Financial Results for Quarter Ended March 31, 2024

Cash Position – Lumos Pharma ended the quarter on March 31, 2024, with cash, cash equivalents, and short-term investments totaling $23.2 million, as compared to $36.1 million on December 31, 2023. Cash on hand is expected to support operations through Q3 2024, which is inclusive of Phase 3 planning and preparatory activities.

R&D Expenses – Research and development expenses for the quarter ended March 31, 2024 were $7.2 million, an increase of $2.9 million compared to the same period in 2023, primarily due to increases of $2.0 million in licensing expense, $0.8 million in clinical trial expenses and $0.2 million in consulting expenses, offset by a decrease of $0.1 million in personnel-related expenses.

G&A Expenses – General and administrative expenses for the quarter ended March 31, 2024 were $3.8 million, a decrease of $0.6 million compared to the same period in 2023, primarily due to decreases of $0.4 million in licensing expenses, $0.1 million in travel expenses, $0.1 million in consulting expenses and $0.1 million in other expenses, offset by an increase of $0.1 million in personnel-related expenses.

Net Loss – The net loss for the quarter ended March 31, 2024, was $10.4 million compared to a net loss of $7.3 million for the same period in 2023.

On May 15, 2024 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company with a mission to develop next-generation immunotherapies in oncology that address cancer immune resistance, reported financial results for the three months ended March 31, 2024 and provided a corporate update (Press release, Kineta, MAY 15, 2024, View Source;utm_medium=rss&utm_campaign=kineta-reports-first-quarter-2024-financial-results-and-provides-update-on-its-ongoing-phase-1-2-vista-101-clinical-trial-and-corporate-activities [SID1234643323]).

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In February 2024, the Company announced a significant corporate restructuring to substantially reduce expenses and preserve cash. The restructuring included a significant workforce reduction and the suspension of enrollment of new patients in its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123 in patients with advanced solid tumors. Patients currently enrolled in the trial will be permitted to continue to participate. The Company announced the restructuring as a result of certain investors indicating that they would not fulfill their April 2024 funding obligation in the previously disclosed private placement financing. In connection with the restructuring, the Company announced that it is exploring strategic alternatives to maximize stockholder value.

"The Company announced additional clinical updates on the progress of the KVA12123 monotherapy and combination therapy results during the first quarter of 2024. We continue to be pleased with these early clinical results as well as the accompanying biomarkers and immune cell data sets. We look forward to sharing additional clinical updates in the second quarter and we will continue to explore strategic alternatives," said Craig Philips, President of Kineta.

RECENT CORPORATE HIGHLIGHTS

Phase 1/2 VISTA-101 Trial of KVA12123 in Patients with Solid Cancer Tumors (clinical data was announced in March 2024)

Efficacy

Announced positive KVA12123 monotherapy safety data from its ongoing Phase 1/2 VISTA-101 clinical trial in patients with advanced solid tumors.
Monotherapy Dose Escalation (3 – 300 mg KVA12123 Q2W)
Of 21 patients enrolled, 12 received at least one baseline and one follow up scan.
Best overall response (BOR) in nine of 12 patients is currently stable disease among patients with at least one follow-up scan with a mean duration of 15 weeks.
One patient with non-small cell lung cancer that failed six prior lines of therapy, including checkpoint inhibitor (CPI) therapy, has experienced a stable disease lasting 28 weeks.
Nine participants remain on-treatment.
Combination Therapy Dose Escalation (30-100 mg KVA12123 Q2W, 400 mg pembrolizumab Q6W).
Of nine patients enrolled, three received at least one baseline and one follow-up scan.
BOR in 2 of 3 patients with at least one follow up scan is:
Stable disease in one CPI-failure renal cell carcinoma patient with a 24% reduction in target lesions.
Partial response in one patient with a PD-L1 negative mucoepidermoid carcinoma and a 54% reduction in target lesions and a complete response in non-target lesions.
Eight patients remain on treatment.
Biomarkers

Dose-dependent induction of on-target pro-inflammatory cytokines and chemokines.
Dose-dependent increases in non-classical monocytes, CD4+ and CD8+ T cells, and NK cells.
Safety

No dose limiting toxicities (DLTs) observed in any patient at any dose level.
No evidence of cytokine release syndrome in any patient at any dose level.
Conference Presentations

Co-organized the 3rd Annual VISTA Symposium, with Hummingbird Bioscience and Dartmouth Giesel School of Medicine, held virtually on March 27, 2024.
Presented clinical and preclinical data on VISTA blocking KVA12123 at the Keystone Symposia of Cancer Immunotherapy: Beyond Immune Checkpoint Blockade and Overcoming Resistance.
Presented new preclinical data on KVA12123 in acute myeloid leukemia (AML) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Blood Cancer Discovery Symposium.
ANTICIPATED FUTURE MILESTONES

Additional KVA12123 monotherapy safety and efficacy data in Q2 2024.
Additional KVA12123 and pembrolizumab combination therapy data in Q2 2024.
FIRST QUARTER 2024 FINANCIAL HIGHLIGHTS

Cash position: As of March 31, 2024, cash was $1.8 million, compared to $5.8 million as of December 31, 2023. The decrease was primarily due to cash used for clinical trial development of KVA12123 as well as general corporate purposes. As of March 31, 2024, we had $1.8 million in cash, and there is substantial doubt about our ability to continue as a going concern. In April 2024, we received a cash investment of $500,000 from an existing investor in connection with settlement of claims relating to the prior failure to fund by certain investors in the private placement. We are pursuing litigation against the other two larger investors who did not fund. Based on our current operating plans, we do not have sufficient cash and cash equivalents to fund our operating expenses and capital expenditures for at least the next 12 months from the filing date of our Quarterly Report on Form 10-Q for the three months ended March 31, 2024, which we expect to file on May 15, 2024, and there is substantial doubt about our ability to continue as a going concern.
Revenues: Total revenues were zero for the three months ended March 31, 2024 and $281,000 for the three months ended March 31, 2023. Revenues in 2023 were primarily due to providing research services provided under the Merck Neuromuscular License Agreement, which we completed in June 2023.
Research and development (R&D) expense: R&D expenses were $2.7 million for the three months ended March 31, 2024 and $2.8 million for the three months ended March 31, 2023. The decrease in R&D expenses was primarily due to lower facilities allocations expense as we transitioned to clinical trials in 2023 and ceased using our laboratory space, partially offset by higher activities for KVA12123, our lead product candidate, and CD27 licensing expense.
General and administrative expense: General and administrative expenses were $3.7 million for the three months ended March 31, 2024 and $3.9 million for the three months ended March 31, 2023. The decrease was primarily due to a decrease in personnel costs of $538,000 and other administrative expenses of $328,000, partially offset by an increase in professional services of $441,000 and higher facilities allocation of $181,000.
Net loss: Net loss was $10.2 million, or $0.89 per basic and diluted share, for the three months ended March 31, 2024 compared to a net loss of $6.5 million, or $0.77 per basic and diluted share, for the three months ended March 31, 2023.

On May 15, 2024 IMUNON, a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, reported that an abstract describing a Phase 2 study with IMNN-001 plus bevacizumab (Avastin) and neoadjuvant chemotherapy in advanced epithelial ovarian cancer patients has been accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, to be held in Chicago from May 31st to June 4th (Press release, IMUNON, MAY 15, 2024, View Source [SID1234643322]).

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The abstract, titled "A phase II study evaluating the effect of IMNN-001 on second-look laparoscopy when administered in combination with bevacizumab and neoadjuvant chemotherapy in patients newly diagnosed with advanced epithelial ovarian cancer," will be presented on June 3rd at the Gynecologic Cancer session between 9:00 a.m. and 12:00 p.m. CT by lead investigator Amir A Jazaeri, M.D., Professor of Gynecological Oncology & Reproductive Medicine at The University of Texas MD Anderson Cancer Center. The study is actively recruiting patients in the U.S.

Abstract #: TPS5633
Poster Board #: 498a
Session Title: Gynecologic Cancer
Location: Hall A

"This study, substantially funded by Break Through Cancer, and with MD Anderson as the leading clinical site, is a pivotal part of IMUNON’s IL-12 gene therapy development for women with ovarian cancer. The combination with bevacizumab makes a lot of sense as we have observed synergies in pre-clinical experiments. We hope to complete enrollment of this study quickly to answer this important clinical question," said Dr. Sebastien Hazard, IMUNON’ chief medical officer.