On May 14, 2024 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, reported financial results for the first quarter ended March 31, 2024, and provided a business update (Press release, Aprea, MAY 14, 2024, View Source [SID1234643208]).

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"During the first quarter of 2024, Aprea had a number of noteworthy achievements across clinical, regulatory and corporate fronts," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "FDA clearance of the IND for APR-1051, our next-generation inhibitor of WEE1 kinase, was an important milestone and allows us to commence clinical trials with this exciting, differentiated and potentially best in class molecule. We look forward to evaluating its therapeutic activity in patients, focusing on Cyclin E overexpressing cancers, including ovarian and breast cancers amongst others. Enrollment continues in the dose escalation portion of our ABOYA-119 clinical trial evaluating ATRN-119 in patients with advanced solid tumors having mutations in defined DDR-related genes. We are encouraged by correlations of the preliminary signs of clinical benefit and genetic mutations. Importantly, Aprea has a strong balance sheet, and the closing of our successful private placement in March of this year provides us with the capital to fund both our lead programs through meaningful clinical milestones. As we progress, we are committed to leveraging our expertise in synthetic lethality in order to provide hope and new treatment options to cancer patients who urgently need them. We believe that our strategic initiatives and pipeline expansion have the potential to drive substantial value for shareholders."

Key Business Updates and Potential Upcoming Key Milestones

ABOYA-119: ATR inhibitor, ATRN-119, on track to complete monotherapy dose escalation end of the year

ATRN-119 is a potent and highly selective first-in-class macrocyclic ATR inhibitor, designed to be used in patients with mutations in DDR-related genes. Cancers with mutation in DDR-related genes represent a high unmet medical need. Patients with DDR-related gene mutations have poor prognosis and, currently, have no effective therapies.
Enrollment continues in the open-label Phase 1/2a clinical trial of ABOYA-119 (study AR-276-01) as monotherapy in patients with advanced solid tumors having at least one mutation in a defined panel of DDR-related genes.
An update on the ongoing trial was featured in a poster at the AACR (Free AACR Whitepaper) Annual Meeting this past April. As of March 12, 2024, 16 patients were enrolled in the first five cohorts of the dose escalation stage (50 mg/day, 100 mg/daily, 200 mg/daily, 350 mg/daily, and 550 mg/daily). Based on data to date, ATRN-119 has been found to be safe and well tolerated. PK studies show ATRN-119 serum concentrations are entering the expected therapeutic range at the current highest dose level (550 mg). We have clearance up to 800 mg/daily and, on March 12, submitted an amendment to the FDA for the additional cohorts. Preliminary signs of clinical benefit have been observed with two patients achieving stable disease (SD) – one in the 50 mg/day cohort and a second patient who showed longer duration when treated at 200 mg/day. The latter patient at 200 mg/day had SD at Days 55, 112, and 168. For further details, including the status of all 16 patients enrolled to date, refer to the AACR (Free AACR Whitepaper) poster here.
Initial efficacy data from Part 1 of the study may potentially be announced in 2H 2024. At completion of Part 1, the company anticipates identification of a recommended Phase 2 dose (RP2D) that will be used in a Phase 2a cohort expansion (Part 2) to test the tolerability and potential efficacy of ATRN-119 monotherapy in approximately 30 additional patients. The Phase 1 dose escalation is expected to be completed in 4Q 2024, and RP2D is to be determined in 1Q 2025. Enrollment in the Phase 2a cohort is expected to begin in 1Q 2025 with additional efficacy data expected in 3Q 2025.
For more information, please refer to clinicaltrials.gov NCT04905914.
ACESOT-1051: Oral WEE1 inhibitor, APR-1051, expected to enter Phase 1 clinical trial in June, 2024

APR-1051 is a potent and selective small molecule that has been designed to potentially solve liabilities and achieve greater clinical activity than other WEE1 programs currently in development. Aprea is advancing APR-1051 as monotherapy in ovarian and breast cancers with Cyclin E over expression, amongst others. Cancers over expressing Cyclin E represent a high unmet medical need. Patients with Cyclin E over expression have poor prognosis and, currently, have no effective therapies.
In March 2024, the U.S. FDA cleared the Investigational New Drug (IND) application (IND 169359) for APR-1051. Clearance of this IND is allowing Aprea to initiate the Phase 1 ACESOT-1051 trial. This dose escalation trial will evaluate the safety, tolerability, and preliminary efficacy of APR-1051. Enrollment of the first patient is expected in 2Q 2024 with an update expected in 4Q 2024.
APR-1051 was featured in two posters at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting which took place in April 2024 in San Diego, which summarized the pre-clinical data supporting APR-1051 and the trial design for ASECOT-1051.
Pipeline – lead candidate for a third synthetic lethality program to be selected in 2024

Aprea’s research and development team has identified a new target in synthetic lethality. Our chemists and discovery team are developing a series of molecules that are selective and potent against it.
A lead molecule is expected to be declared in 3Q 2024. This program may provide clinically meaningful differences for cancer patients that currently have limited therapies.
An additional poster at AACR (Free AACR Whitepaper) described a combination approach using Aprea’s next-generation macrocyclic ATR inhibitor, ATRN-333, to sensitize glioblastoma (GBM) tumors to lomustine, an oral DNA alkylating agent. The results support further investigation and potential clinical implementation of ATRN-333 and other macrocyclic ATR inhibitors as chemosensitizers for glioblastoma.
Corporate

In March 2024, Aprea announced a securities purchase agreement with new and existing healthcare institutional investors and certain Company insiders to raise up to $34.0 million in gross proceeds, including initial upfront gross funding of $16.0 million and up to an additional $18.0 million upon cash exercise of accompanying warrants at the election of the investors. The financing was led by Sphera Healthcare with participation from new and existing healthcare focused investors including Nantahala Capital, DAFNA Capital Management, Exome Asset Management and Stonepine Capital Management, among others, as well as certain Company insiders. The capital is being deployed for general working capital purposes and to fund the Phase 1 ACESOT-1051 clinical trial, as well as, continuation of patient enrollment in the dose expansion portion of the ABOYA-119 clinical trial evaluating ATRN-119.
Appointed Nadeem Q. Mirza, M.D., M.P.H. as Chief Medical Officer (CMO), effective May 1, 2024. Dr. Mirza had been a consultant to Aprea since February, 2023 and has now assumed a more central role in leading the Company’s development of its expanding clinical pipeline.
Select Financial Results for the First Quarter ended March 31, 2024

As of March 31, 2024, the Company reported cash and cash equivalents of $32.4 million, compared to $21.6 million at December 31, 2023. The Company believes its cash and cash equivalents as of March 31, 2024 will be sufficient to meet its currently projected operating expenses and capital expenditure requirements into the third quarter of 2025.
For the quarter ended March 31, 2024, the Company reported an operating loss of $3.1 million, compared to an operating loss of $4.6 million in the comparable period in 2023.
Research and Development (R&D) expenses were $1.6 million for the quarter ended March 31, 2024, compared to $1.3 million for the comparable period in 2023. The increase in R&D expense was primarily related to IND enabling studies for APR-1051, the Company’s small molecule WEE1 inhibitor, in preparation for enrollment of first patient into Phase 1 dose-escalation in the second quarter of 2024.
General and Administrative (G&A) expenses were $1.9 million for the quarter ended March 31, 2024, compared to $3.4 million for the comparable period in 2023. The decrease in G&A expenses was primarily due to a decrease in personnel costs.
The Company reported a net loss of $2.8 million ($0.67 per basic share) on approximately 4.2 million weighted-average common shares outstanding for the quarter ended March 31, 2024, compared to a net loss of $4.4 million ($1.34 per basic share) on approximately 3.3 million weighted average common shares outstanding for the comparable period in 2023.

On May 14, 2024 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the initiation of an investigator initiated Phase 1 clinical study (NCT06205849) evaluating the safety and efficacy of the company’s lead asset mitazalimab (CD40 mAb agonist) injected intratumorally at the time of surgical irreversible electroporation (IRE) in patients with locally advanced pancreatic cancer (LAPC) (Press release, Alligator Bioscience, MAY 14, 2024, View Source [SID1234643206]).

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The NCI-funded Phase 1a/1b single-center study will enroll up to 18 patients, who will receive a single intratumoral injection of mitazalimab immediately after the surgical IRE, a form of non-thermal ablation that is currently in clinical use for selected patients with LAPC. The study is being conducted by researchers at Moores Cancer Center at UC San Diego. Alligator will supply mitazalimab for the study.

"The preclinical data generated in our lab shows that the combination of IRE with an antibody that stimulates the CD40 receptor improves the response to IRE and inhibits metastatic tumor growth," said Rebekah White, MD, principal investigator of Phase 1 of the study and associate professor of Surgery at UC San Diego School of Medicine. "While IRE is widely used in patients with LAPC, most will ultimately develop distant metastases. We believe that local delivery of mitazalimab at the time of IRE in patients with LAPC will be safe, augment the immune effects of IRE and decrease the risk of recurrence."

"Intratumoral delivery of immunotherapy is gaining increased importance, and in the setting of localized disease provides an opportunity to efficiently activate the immune cells in the tumor microenvironment. In this investigator-initiated study, we are looking forward to evaluating the combination of mitazalimab administered directly into the tumor alongside IRE," said Sumeet Ambarkhane, CMO of Alligator Bioscience. "The strong clinical data generated by mitazalimab over the last 12 months have received a great amount of interest from the scientific and medical communities. We are very pleased that an accomplished center of clinical excellence, such as Moores Cancer Center, is conducting this study, which could broaden the clinical applicability of mitazalimab in pancreatic cancer patients."

In January 2024, Alligator announced positive top-line results from the OPTIMIZE-1 Phase 2 study evaluating mitazalimab in combination with mFOLFIRINOX in 1st line metastatic pancreatic cancer. The study met its primary endpoint and also demonstrated a median Overall Survival (mOS) of 14.3 months, compared to 11.1 months for standard of care, along with an unprecedented Duration of Response of 12.5 months, compared to 5.9 months with FOLFIRINOX alone.

On May 14, 2024 ADC Therapeutics presented its corporate presentation (Presentation, ADC Therapeutics, MAY 14, 2024, View Source [SID1234643205]).

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On May 14, 2024 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, reported that results from the Phase 3 SIERRA trial of Iomab-B have been accepted for an oral presentation and poster presentation at the 2024 European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Congress being held June 13 – 16, 2024, in Madrid, Spain (Press release, Actinium Pharmaceuticals, MAY 14, 2024, View Source [SID1234643204]). The Phase 3 SIERRA trial enrolled 153 patients ages 55 and above with active relapsed or refractory acute myeloid leukemia (r/r AML) and compared outcomes of patients receiving an Iomab-B led bone marrow transplant (BMT) to those of patients receiving physician’s choice of care in the control arm. Across all patients in SIERRA study, only patients receiving an Iomab-B led BMT achieved the trial’s primary endpoint of durable complete remission with these patients having 92% 1-year survival and 69% 2-year survival with statistically significant higher event free survival. The SIERRA trial enrolled high-risk patients including those with one or more of the following: a TP53 mutation, advanced age up to 77 years old, complex cytogenetics and prior therapy including venetoclax and other targeted agents.

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In total, 24% (37/153) of the patients enrolled on SIERRA had a TP53 mutation, which is usually associated with limited treatment options and poor outcomes. Median Overall Survival of 5.49 months observed in patients with a TP53 mutation receiving an Iomab-B led allogeneic bone marrow transplant compared to 1.66 months in patients that did not receive Iomab-B (hazard ratio=0.23, p=0.0002).

Iomab-B EHA (Free EHA Whitepaper) presentations titles are as follows:

Oral Presentation

131I-APAMISTAMAB-LED ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANT RESULTS IN IMPROVED SURVIVAL OUTCOMES IN R/R AML PATIENTS WITH HIGH-RISK TP53 MUTATIONS IN THE RANDOMIZED PHASE III SIERRA TRIAL

Poster Presentation

LONG TERM EFFICACY RESULTS OF THE SIERRA TRIAL: A PHASE 3 STUDY OF 131I-APAMISTAMAB-LED ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION VERSUS CONVENTIONAL CARE IN OLDER PATIENTS WITH ACTIVE, R/R AML

On May 14, 2024 MaaT Pharma (EURONEXT: MAAT – the "Company"), 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 launch of an offering of approximately 18 million euros, comprising a reserved offering of new ordinary shares to categories of investors and a public offering of new ordinary shares to retail investors (via the PrimaryBid platform) (the "Primary Offering"), and a sale of existing shares for 1 million euros, at a price of €8 per share (the "Offering Price") (Press release, MaaT Pharma, MAY 14, 2024, View Source [SID1234643194]).

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MaaT Pharma will use the net proceeds of the Primary Offering to fund the continued development of its Microbiome Ecosystem TherapiesTM, including:

completion of the Phase 3 trial for MaaT013 in Europe, including top-line results/primary endpoint expected in mid-Q4 2024;
refining the pipeline development, encompassing 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
working capital and other general corporate purposes, including repayment of current debts.
In the context of the Global Offering, the Company benefits from the long-term support of its historical shareholders Bpifrance Investissement, Biocodex and Seventure Partners who have committed themselves to subscribe for a total amount of €14.3m in the Global Offering, subject to the Reserved Offering representing at least €17 million.

Excluding the proceeds of the Reserved Offering, on the basis of planned expenditure, total cash and cash equivalents as of March 31, 2024, of €18.2 million (unaudited), the Company estimates that it will be able to fund its operations until the end of September 2024. On the same basis, including the proceeds of the Reserved Offering representing more than €17 million, the Company estimates that it will be able to finance its operations into early Q1 2025. The Company is also engaged to seek further financing dilutive and/or non-dilutive financing solutions to finance operations beyond early Q1 2025 and remains confident in extending its cash runway to meet its financial obligations over the next 12 months. The Company reports in parallel revenues of EUR 0.8 million for the first quarter of 2024 compared with EUR 0.7 million for the same period of 2023, in relation to its Early Access Program for MaaT013 in Europe.

Concurrently with the Primary Offering, certain funds managed by Seventure Partners (together, the "Selling Shareholder") will sell a maximum of 125,000 shares, representing a maximum amount of 1 million euros (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: "We are pleased to announce a capital increase at a price of €8 per share with €14,4 million already committed by our longstanding investors and management. While anchored around our historical investors, this offering is strategically aimed at continuing expanding our shareholder base through retail investors, further increasing our market float. Thus, we have partnered with the PrimaryBid platform to offer them the opportunity to join us under the same conditions as institutional investors.

This transaction will enable us to finalize and present the primary endpoint of the Phase 3 trial of our lead product, MaaT013, in acute graft-versus-host disease, and to support the increase of maturity of our pipeline, including the expansion in the US.

Encouraged by the positive clinical data from our recent early access program, we are highly motivated to push forward in our development efforts. We are dedicated to a structured approach that aims to bring innovative therapeutic solutions to patients who are battling diseases with limited treatment options and challenging prognoses."

Terms and Conditions of the Global Offering

The Global Offering will be carried out in three concomitant components under the same pricing conditions:

a reserved offering (the "Reserved Offering") of new ordinary shares without pre-emptive subscription rights, to specific categories of investors, namely: (i) natural person(s) or legal entity(ies), including companies, trusts, investment funds or other investment vehicles, in any form, established under French or foreign law, that regularly invest in the pharmaceutical, biotechnological or medical technologies sectors, as the case may be, when an industrial, commercial, licensing, research or partnership agreement is entered into with the Company; and/or (ii) company(ies), institution(s) or entity(ies) in any form, French or foreign, which conduct a significant portion of their business in these sectors or in the field of cosmetics or chemicals or medical devices or research in these fields, or having entered into an industrial commercial, licensing, research or partnership agreement with the Company, 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
a public offering of new ordinary shares, aimed at retail investors via the PrimaryBid platform, which will be carried out via an allocation proportional to demand, limited to the amount allocated to this public offering, with allocations reduced should demand exceed this limit, 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
a sale of up to 125,000 existing ordinary shares representing a maximum amount of 1 Million euros held by the Selling Shareholder to the same specific categories of investors defined in the Reserved Offering.
The total amount of the Global Offering would be approximately 18 million euros, with a possibility to increase this total amount, subject to investor demand.

The amount of the Global Offering will depend exclusively on the orders received for each of the above-mentioned components, with no possibility of reallocating the amounts committed to the Reserved Offering and the Secondary Offering, to the PrimaryBid Offering. The PrimaryBid Offering to retail investors is incidental to the Reserved Offering and may not exceed 20% of the total amount of the Global Offering. In any event, the PrimaryBid Offering will not be carried out if the Reserved Offering does not occur.

The Offering Price of the new shares will be at a price of €8 per share, representing an approximate discount of 15% of the Company’s shares on the Euronext Paris regulated market at the time of the last trading session preceding announcement (i.e. May 13, 2024), in compliance with the 25th, 23rd and 27th resolutions of the Company. The Offering Price of the new ordinary shares issued under the PrimaryBid Offering and of the existing shares sold in the Secondary Offering will be equal to the price of the new ordinary shares issued under the Reserved Offering.

The Reserved Offering and the Secondary Offering will be carried out by "accelerated bookbuilding", at the end of which the number of new shares to be issued and the price per share will be determined by the Chief Executive Officer of the Company, pursuant to and within the limits of the sub-delegations of au thority granted by the Board of Directors of the Company as of the date of this press release and in accordance with the resolutions of the AGM.

The accelerated book-building process for the Reserved Offering and the Secondary Offering will be initiated immediately following the publication of this press release and is expected to close before markets open tomorrow, subject to early closing. The PrimaryBid Offering will also begin immediately and is expected to close at 10 p.m. today, subject to early closing. The Company will announce the results of the Global Offering by press release after the order book closes, tomorrow before the market opens.

The Reserved Offering will be available, within the categories of investors defined above, (i) to institutional investors in France, outside France with the exception of the United States, Canada, Australia and Japan and, solely within the categories of investors specifically provided for in the 25th resolution mentioned above, and (ii) to certain institutional investors in the United States.

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.

Shareholders’ subscription and lock-up agreements

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

The subscription commitments received by the Company, as detailed above, thus represent a total of €14.4 million.

The press release announcing the results of the Global Offering will set out the shareholding resulting from the transaction.

The independent directors of the Company were called upon to vote alone on the transaction, unanimously approved both the principle of the transaction and its terms. Mr. Hervé Affagard, Mrs Isabelle de Crémoux for Seventure Partners, and Mr. Jean-Marie Lefèvre for Biocodex, did not take part in the vote of this decision.

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

Financial Intermediaries

Stifel Europe AG ("Stifel") are 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. Stifel is also acting as Centralizing Agent (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 may only subscribe via the PrimaryBid Partners mentioned on the PrimaryBid website. 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

In connection with the Reserved Offering, a listing prospectus will be submitted to the Autorité des Marchés Financiers (the "AMF") prior to the settlement and delivery of the new ordinary shares (the "Prospectus"). The Prospectus will consist of (i) the Company’s universal registration document filed with the AMF on April 2, 2024, under number D.24-0225, with its amendment to be filed with the AMF, and (ii) a securities note including the summary of the Prospectus. This Prospectus will be available on the AMF’s website (www.amf-france.org) and on the Company’s website (www.maatpharma.com/) and may be obtained free of charge from the Company’s registered office.

This press release does not constitute a prospectus under Regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017, as amended, 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 Offering Price of the shares issued under the Offer, (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.