This information is not intended for residents of the United Kingdom, United States, Australia, Canada or Japan. See Annex for full disclaimer.

  • Guaranteed portion of the transaction will extend cash runway past regulatory milestones in Q1-2024
  • The financial visibility will allow TME Pharma to file and receive feedback from FDA on its IND and applications to expedited regulatory review pathways
  • Current shareholders to receive preferential rights to participate in capital raise issuing shares with warrants attached
  • Buyback of nearly half of outstanding convertible debt and lock-up of the remainder until April 1, 2024
  • New warrants issued with potential to raise an additional €2.2 million and extend cash runway into September 2024 if fully exercised

TME Pharma N.V. (Euronext Growth Paris: ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), announced on November 24, 2023, the launch of a 100% guaranteed capital increase through issuance of new shares for €2.7 million gross proceeds with associated warrants potentially raising up to €2.2 million of additional gross proceeds in order to secure financing to reach key regulatory milestones in 2024. The guaranteed amount is secured by a group of Dutch investors.

The capital increase is carried out with preferential subscription rights for the company’s shareholders. The preferential subscription rights are detached and their listing begins today, November 28, 2023 (ISIN code of PSR: FR001400M9E2).

The transaction is expected to extend the company’s cash runway from February 20241 into May 2024 with possibility to extend further into July 2024 if the associated warrants expiring in February 2024 are exercised in full, and to September 2024 if both sets of warrants are fully exercised by July 2024. This transaction will reduce the liquidity risk that the company has been facing in recent months. The operation offers current shareholders subscription rights to maintain their holding in the company without being diluted.

"This guaranteed capital injection provides TME Pharma with financing into May 2024, with the possibility of extending our cash runway even further should all the warrants be fully exercised while ensuring minimal dilution to existing shareholders who continue to support our venture," said Aram Mangasarian, CEO of TME Pharma. "This will allow us to achieve our next clinical and regulatory milestones with our lead asset NOX-A12 in newly diagnosed brain cancer patients, including further maturing of the survival data, an Investigational New Drug filing, and potential access to expedited regulatory pathways in the US, such as Fast-Track. We are also announcing the repurchase of almost half our existing outstanding convertible debt, with the remainder locked up until April next year. This is the latest step in our commitment to our shareholders to end the use of convertible bond financing so we can remain focused on our goal of developing novel therapies for cancer patients and bringing them to market.”

Key Preferential Rights Issue details2:

  • Preferential subscription right: 1 preferential subscription right (PSR) will be awarded for 1 ordinary share held on November 27, 2023
  • Subscription rate: Each 3 PSRs give right to subscribe for 5 ABSA Y (5 new shares with 5 Warrants Y attached)
  • Subscription price: €0.25 per ABSA Y, representing a 37.5% discount vs. the closing price of EUR 0.4005 of the company’s shares on November 24, 2023
  • Subscription period: From November 30 to December 11, 2023 (inclusive) 

ABSA are shares with warrants attached. There are two types of ABSA: ABSA Y, containing one new share and one Warrant Y, and ABSA Z, containing one new share and one Warrant Z.

Warrants Y:

  • Each series of 5 Warrants Y entitle a holder to subscribe for 2 ABSA Z (2 new shares with 2 Warrants Z attached)
  • Warrant Y will have an exercise price of €0.25
  • Warrant Y maturity: February 16, 2024, with two periods of exercise. Warrants Y that have not been exercised by the end of the exercise period will become null and void. See Warrants Terms & Conditions for further details. 

Warrants Z:

  • Each series of 4 Warrants Z entitle a holder to subscribe for 5 new shares
  • Warrant Z will have an exercise price of €0.20
  • Warrant Z maturity: June 30, 2025, with one period of exercise per quarter. Warrants Y that have not been exercised by the end of the exercise period at the latest will become null and void, without value. See Warrants Terms & Conditions for further details.

Illustrative example
A shareholder holding 300 shares of TME Pharma as of November 27, 2023, would be awarded 300 preferential subscription rights (PSRs). Having 300 PSRs entitles the shareholder to acquire 500 ABSA Y, composed of 500 new shares and 500 Warrant Y, for an amount of €125. The 500 Warrant Y entitle them to subscribe for 200 ABSA Z for €50. These 200 ABSA Z are composed of 200 new shares and 200 Warrant Z. The 200 Warrant Z can be exercised for €50 granting 250 new TME Pharma shares. Thus, if this shareholder participates fully in the transaction, they would hold 1250 shares, of which 900 newly acquired for €225.

1 As reported in the half-year financial results published in the press release on October 27, 2023.
Full details of the transaction can be found on TME Pharma’s website.

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. 

Über die TME Pharma AG

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 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. NOX-A12 in combination with radiotherapy has received orphan drug designation 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 and Spain and is in discussion with regulatory authorities in 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 Twitter.

Firmenkontakt und Herausgeber der Meldung:

TME Pharma AG
Max-Dohrn-Str. 8-10
10589 Berlin
Telefon: +49 (30) 7262470
Telefax: +49 (30) 726247-225
http://www.tmepharma.com

Ansprechpartner:
Ph.D. Aram Mangasarian
Telefon: +49 (30) 726247-0
E-Mail: investors@tmepharma.com
Für die oben stehende Story ist allein der jeweils angegebene Herausgeber (siehe Firmenkontakt oben) verantwortlich. Dieser ist in der Regel auch Urheber des Pressetextes, sowie der angehängten Bild-, Ton-, Video-, Medien- und Informationsmaterialien. Die United News Network GmbH übernimmt keine Haftung für die Korrektheit oder Vollständigkeit der dargestellten Meldung. Auch bei Übertragungsfehlern oder anderen Störungen haftet sie nur im Fall von Vorsatz oder grober Fahrlässigkeit. Die Nutzung von hier archivierten Informationen zur Eigeninformation und redaktionellen Weiterverarbeitung ist in der Regel kostenfrei. Bitte klären Sie vor einer Weiterverwendung urheberrechtliche Fragen mit dem angegebenen Herausgeber. Eine systematische Speicherung dieser Daten sowie die Verwendung auch von Teilen dieses Datenbankwerks sind nur mit schriftlicher Genehmigung durch die United News Network GmbH gestattet.

counterpixel