Regulatory News:

TME Pharma N.V. (Euronext Growth Paris: ALTME) (Paris:ALTME), a clinical-stage biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), announces today that it has successfully completed a capital raise for a total consideration of €2.35 million gross through a private placement with professional investors and a public offering to retail investors in France via the PrimaryBid platform.

“The last six months have been important for TME Pharma. Through strategic fundraising efforts we have not only eliminated dilutive convertible debt but also secured additional cash runway allowing us to deliver industry-leading clinical data for our lead asset NOX-A12 in glioblastoma. This successful capital increase we announce today allows us focus on achieving the next financial and strategic milestones including a collaboration with a pharma partner on drug supply of the anti-VEGF antibody which is to be combined with NOX-A12 in the Phase 2 clinical trial, monetization of the NOX-E36 asset (e.g. via a spinout) and additional transactions sufficient to secure financing of the upcoming Phase 2 NOX-A12 brain cancer trial via a combination of non-dilutive grant funding, a strategic alliance and/or investment from expert institutional investors. In summary, our goal for this financing is to allow a significant transformation of the company’s profile in the remainder of 2024," said Aram Mangasarian, CEO of TME Pharma. "This would not have been possible without the strong support of our existing shareholders and without the dedication of the TME Pharma team and our partners, all of whom I would like to warmly thank.”

The capital increase announced on June 17, 2024, for a total amount of €2.35 million gross was carried out through the issuance of 13,088,158 new ordinary shares at the price of €0.1798 per new share, representing 46% of the company's share capital prior to the transaction and a 10% discount to the closing share price prior to the capital increase announcement, and included:

  • a raise for an amount of €2.27 million gross via private placement with an accelerated book-building with professional investors in the European Union (the Reserved Offering) by issuance of 12,648,607 new shares, representing 96.64% of the transaction, and
  • a raise for an amount of €79,031 via public offering to retail investors in France only through the French PrimaryBid platform (the PrimaryBid Offering) by subscription for 439,551 new shares, representing 3.36% of the transaction.

The settlement-delivery of the new shares and their admission to Euronext Growth Paris under the same ISIN code NL0015000YE1 will take place on June 20, 2024.

Following the transaction, the company’s share capital will be composed of 41,541,531 ordinary shares.

Table: Dilution from the transaction

Description

Shares to be issued (max)

Total shares outstanding

Dilution (max)

Shareholder starting with 1% would then hold

Prior to announcement of capital increase

-

28,453,373

-

1%

€2.35 million capital increase at €0.1798 per share

13,088,158

41,541,531

31.51%

0.68%

The capital increase was advised and managed by ALLInvest acting as Lead Manager and Bookrunner for the Reserved Offering. The PrimaryBid Offering was advised and managed by PrimaryBid.

About TME Pharma

TME Pharma is a clinical-stage company focused on developing novel therapies for treatment of the most aggressive cancers. The company’s oncology-focused pipeline is designed to act on the tumor microenvironment (TME) and the cancer immunity cycle by breaking tumor protection barriers against the immune system and blocking tumor repair. By neutralizing chemokines in the TME, TME Pharma’s approach works in combination with other forms of treatment to weaken tumor defenses and enable greater therapeutic impact. In the GLORIA Phase 1/2 clinical trial, TME Pharma is studying its lead drug candidate NOX-A12 in newly diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy. TME Pharma has delivered top-line data from the NOX-A12 three dose-escalation cohorts combined with radiotherapy of the GLORIA clinical trial, observing consistent tumor reductions and objective tumor responses. Additionally, GLORIA expansion arms evaluate safety and efficacy of NOX-A12 in other combinations where the interim results from the triple combination of NOX-A12, radiotherapy and bevacizumab suggest even deeper and more durable responses, and improved survival. US FDA has approved the design of a randomized Phase 2 trial in glioblastoma and TME Pharma was awarded fast track designation by the FDA for NOX-A12 in combination with radiotherapy and bevacizumab for use in the treatment of the aggressive adult brain cancer, glioblastoma. NOX-A12 in combination with radiotherapy had also previously received orphan drug designation (ODD) for glioblastoma in the United States and glioma in Europe. TME Pharma has delivered final top-line data with encouraging overall survival and safety profile from its NOX-A12 combination trial with Keytruda® in metastatic colorectal and pancreatic cancer patients, which was published in the Journal for ImmunoTherapy of Cancer in October 2021. The company has entered in its second collaboration with MSD/Merck for its Phase 2 study, OPTIMUS, to further evaluate safety and efficacy of NOX-A12 in combination with Merck’s Keytruda® and two different chemotherapy regimens as second-line therapy in patients with metastatic pancreatic cancer. The design of the trial has been approved in France, Spain and the United States. The company’s second clinical-stage drug candidate, NOX-E36, is designed to target the innate immune system. TME Pharma is considering several solid tumors for further clinical development. Further information can be found at: www.tmepharma.com.

TME Pharma® and the TME Pharma logo are registered trademarks.

Keytruda® is a registered trademark of Merck Sharp & Dohme Corp.

Visit TME Pharma on LinkedIn and X.

About the GLORIA Study

GLORIA (NCT04121455) is TME Pharma’s dose-escalation, Phase 1/2 study of NOX-A12 in combination with radiotherapy in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy). GLORIA further evaluates safety and efficacy of NOX-A12 three additional arms combining NOX-A12 with: A. radiotherapy in patients with complete tumor resection; B. radiotherapy and bevacizumab; and C. radiotherapy and pembrolizumab.

About the OPTIMUS Study

OPTIMUS (NCT04901741) is TME Pharma’s planned open-label two-arm Phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients.

Disclaimer

Translations of any press release into languages other than English are intended solely as a convenience to the non-English-reading audience. The company has attempted to provide an accurate translation of the original text in English, but due to the nuances in translating into another language, slight differences may exist. This press release includes certain disclosures that contain "forward-looking statements.” Forward-looking statements are based on TME Pharma’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the risks inherent in oncology drug development, including clinical trials and the timing of and TME Pharma’s ability to obtain regulatory approvals for NOX-A12 as well as any other drug candidates. Forward-looking statements contained in this announcement are made as of this date, and TME Pharma undertakes no duty to update such information except as required under applicable law.