GEMoaB Announces Publication of Pre-Clinical Proof-of-Concept Data on UniCAR-modified Off-the-shelf Natural Killer Cells in ‘Nature Scientific Reports’

On March 17, 2020 GEMoaB, a biopharmaceutical company focused on the development of next-generation immunotherapies for hard-to-treat cancers, reported that "Nature Scientific Reports" has published pre-clinical proof-of-concept data on UniCAR-modified off-the-shelf Natural Killer (NK) cells targeting GD2-expressing tumors (Mitwasi et al. 2020, 10:2141) (Press release, GEMoaB, MAR 17, 2020, View Source [SID1234555659]). The data generated by researchers of the Helmholtz-Center Dresden-Rossendorf (HZDR) provide further evidence on the unique flexibility of GEMoaB´s proprietary UniCAR platform.

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CAR-T cell therapy holds great promise for treating a wide range of malignancies. Nevertheless, the CAR-T approach faces multiple challenges, including the risk of acute and long-term toxicities, a current lack of suitable targets, insufficient engraftment and persistence especially in solid tumors. In addition, currently commercially available CAR-T products can only be derived from individual patients, adding significant complexity and cost to the autologous manufacturing process.

GEMoaB’s rapidly switchable universal CAR platform UniCAR promises an improved therapeutic window and increased efficacy and safety over conventional CAR-T therapies in hematological malignancies and solid tumors. As soluble adaptors termed targeting modules (TMs) are used to provide the antigen-specificity to activate UniCAR gene-modified T-cells (UniCAR-T), the manufacturing process is significantly simplified by the ability to use the same UniCAR-T effector cell against multiple antigens and tumor types.

Natural killer (NK) cells genetically engineered to express a CAR (CAR-NK) have recently emerged as promising candidates for effective cancer treatment. Off-the-shelf CAR-NK cells from an allogeneic source, such as cord blood, can be safely administered without the need for full HLA matching, therefore eliminating the need to produce a unique CAR product for each patient. Furthermore, allogeneic CAR-NK cells have a proven track record of safety due to their lack of causing cytokine release syndrome (CRS).

In a recent publication in Nature Scientific Reports (Mitwasi et al. 2020, 10:2141), researchers of the HZDR combined the advantages of the UniCAR approach with the off-the shelf capabilities of NK cells. The publication provides proof-of-concept for a universal off-the-shelf cellular therapeutic based on UniCAR-modified NK-92 cells retargeted to GD2-expressing tumors by GD2-specific TMs. Redirected UniCAR-NK-92 cells induced specific and effective killing of GD2-expressing cells in vitro and in vivo, associated with enhanced interferon-γ production.

"We are very pleased that our co-founder Prof. Michael Bachmann and researchers of the HZDR could demonstrate that GEMoaB’s highly flexible UniCAR system can be readily applied to continuously expanding off-the-shelf NK cells, which in combination with GD2-specific TMs efficiently target and lyse GD2-expressing tumor cells such as neuroblastoma and melanoma," said Prof. Gerhard Ehninger, co-founder and CMO of GEMoaB. "UniCAR-NK cells could represent an additional universal and modular off-the-shelf platform that would allow the use of TMs against multiple antigen targets for an effective and safe therapy of cancer."

"As we are progressing with our clinical development plans for UniCAR-T-CD123 in hematological malignancies and UniCAR-T-PSMA in solid tumors, we are developing a deep pipeline of TMs directed against a wide variety of blood and solid tumor cancers," said Dr. Armin Ehninger, Chief Scientific Officer of GEMoaB. "We believe that UniCAR-NK cells could further enhance the unique flexibility of our platform by combining the advantages of UniCAR with the safety and off-the-shelf capabilities of NK cells."

Johnson & Johnson to Host Investor Conference Call on First-Quarter Results

On March 17, 2020 Johnson & Johnson (NYSE: JNJ) reported that it will host a conference call for investors at 8:30 a.m. (Eastern Time) on Tuesday, April 14th to review first-quarter results (Press release, Johnson & Johnson, MAR 17, 2020, View Source;johnson-to-host-investor-conference-call-on-first-quarter-results-301025768.html [SID1234555658]). Joseph J. Wolk, Executive Vice President, Chief Financial Officer and Christopher DelOrefice, Vice President, Investor Relations will host the call. The question and answer portion of the call will also include additional members of Johnson & Johnson’s executive team.

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Investors and other interested parties can access the webcast/conference call in the following ways:

The webcast and presentation material are accessible at Johnson & Johnson’s website www.investor.jnj.com. A replay of the webcast will be available approximately three hours after the conference call concludes.
By telephone: for both "listen-only" participants and those financial analysts who wish to take part in the question-and-answer portion of the call, the telephone dial-in number in the U.S. is 877-869-3847. For participants outside the U.S., the dial-in number is 201-689-8261.
A replay of the conference call will be available until approximately 12:00 a.m. on April 22, 2020. The replay dial-in number for U.S. participants is 877-660-6853. For participants outside the U.S., the replay dial-in number is 201-612-7415. The replay conference ID number for all callers is 13700136.
The press release will be available at approximately 6:45 a.m. (Eastern Time) the morning of the conference call.
Please refer to www.investor.jnj.com for a complete list of currently planned 2020 earnings webcast/conference calls. Please note the second-quarter date of Thursday, July 16th, 2020.

Cigna Corporation Announces Early Results of Tender Offers for up to $1.45 billion in Aggregate Principal Amount of Outstanding Notes

On March 17, 2020 Cigna Corporation (NYSE: CI) reported the results as of 5:00 p.m., New York City time, on March 17, 2020 (the "Early Tender Date") of its previously announced offers to purchase for cash (1) up to $500,000,000 of Cigna Holding Company’s 4.000% Senior Notes due 2022, Cigna Corporation’s 4.000% Senior Notes due 2022, Express Scripts Holding Company’s 3.900% Senior Notes due 2022 and Cigna Corporation’s 3.900% Senior Notes due 2022 (collectively, the "2022 Existing Notes," and such tender offer, the "2022 Notes Tender Offer") and (2) up to $950,000,000 of Cigna Holding Company’s 7.650% Senior Notes due 2023, Cigna Corporation’s 7.650% Senior Notes due 2023 and 3.750% Senior Notes due 2023, Express Scripts Holding Company’s 3.000% Senior Notes due 2023 and Cigna Corporation’s 3.000% Senior Notes due 2023 (collectively, the "2023 Existing Notes," and such tender offer, the "2023 Notes Tender Offer"), in each case, validly tendered and accepted by Cigna, upon the terms and subject to the conditions set forth in the Offer to Purchase dated March 4, 2020 and the related Letter of Transmittal (collectively, the "Offer to Purchase") (Press release, Cigna , MAR 17, 2020, View Source [SID1234555657]). The 2022 Existing Notes and the 2023 Existing Notes are referred to collectively as the "Securities" and the 2022 Notes Tender Offer and the 2023 Notes Tender Offer are referred to collectively as the "Tender Offers."

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The Company has been advised by the tender and information agent that, as of the Early Tender Date, the amounts set forth in the tables below of each series of Securities had been validly tendered and not validly withdrawn. The amount of each series of Securities that is to be accepted for purchase as of the Early Tender Date will be determined in accordance with the acceptance priority levels and the proration procedures described in the Offer to Purchase. As set forth in the tables below, in connection with the 2022 Notes Tender Offer, it is expected that all of Cigna Holding Company’s 4.000% Senior Notes due 2022 and Cigna Corporation’s 4.000% Senior Notes due 2022 validly tendered and not validly withdrawn will be accepted for purchase and will not be subject to proration, and Express Scripts Holding Company’s 3.900% Senior Notes due 2022 validly tendered and not validly withdrawn will be subject to a proration factor of approximately 50.0%. The Company does not expect to accept any of Cigna Corporation’s 3.900% Senior Notes due 2022 for purchase. As set forth in the tables below, in connection with the 2023 Notes Tender Offer, it is expected that all of Cigna Holding Company’s 7.650% Senior Notes due 2023 and Cigna Corporation’s 7.650% Senior Notes due 2023 validly tendered and not validly withdrawn will be accepted for purchase and will not be subject to proration, and Cigna Corporation’s 3.750% Senior Notes due 2023 validly tendered and not validly withdrawn will be subject to a proration factor of approximately 33.5%. The Company does not expect to accept any of Express Scripts Holding Company’s 3.000% Senior Notes due 2023 and Cigna Corporation’s 3.000% Senior Notes due 2023 for purchase. The Company has also elected not to exercise its Aggregate Maximum Principal Amount Allocation (as defined in the Offer to Purchase) in connection with the Tender Offers.

Denotes a series of Securities for which the calculation of the applicable Total Consideration (as defined in the Offer to Purchase) will be performed using the present value of such Securities as determined at the Price Determination Time (as defined in the Offer to Purchase) as if the principal amount of Securities had been due on the applicable par call date of such series rather than the maturity date.

Denotes a series of Securities for which the calculation of the applicable Total Consideration will be performed using the present value of such Securities as determined at the Price Determination Time as if the principal amount of Securities had been due on the applicable par call date of such series rather than the maturity date.

It is anticipated that payment for the Securities that were validly tendered and accepted for purchase as of the Early Tender Date will be made on March 19, 2020.

The Tender Offers will expire at 11:59 p.m., New York City Time, on March 31, 2020. Because the Tender Offers have been fully subscribed as of the Early Tender Date, the Company does not expect to accept for purchase any Securities tendered by holders after the Early Tender Date.

Additional Information

BofA Securities, Goldman Sachs & Co. LLC and Morgan Stanley & Co. LLC are the Dealer Managers for the Tender Offers. D.F. King & Co., Inc. has been appointed as the tender agent and information agent for the Tender Offers.

Persons with questions regarding the Tender Offers should contact BofA Securities at (980) 387-3907 (collect) or (888) 292-0070 (toll-free), Goldman Sachs & Co. LLC at (917) 343-9660 (collect) or (800) 828-3182 (toll-free) and Morgan Stanley & Co. LLC at (212) 761-1057 (collect) or (800) 624-1808 (toll-free). The Offer to Purchase will be distributed to holders of Securities promptly. Holders who would like additional copies of the Offer to Purchase may contact the information agent, D.F. King & Co., Inc. by calling toll-free at (800) 499-8541 (banks and brokers may call collect at (212) 269-5550) or email [email protected].

This press release is not an offer to sell or a solicitation of an offer to buy any security. The Tender Offers are being made solely pursuant to the Offer to Purchase.

The Tender Offers do not constitute, and the Offer to Purchase may not be used in connection with, an offer or solicitation by anyone in any jurisdiction in which such offer or solicitation is not permitted by law or in which the person making such offer or solicitation is not qualified to do so or to any person to whom it is unlawful to make such offer or solicitation.

Immatics Announces Business Combination with Arya Sciences Acquisition Corp., Creating a Publicly Listed Leader in TCR-based Immunotherapies

On March 17, 2020 Immatics Biotechnologies GmbH ("Immatics" or the "Company"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, reported it has entered into a definitive business combination agreement with Arya Sciences Acquisition Corp. (NASDAQ: ARYA) ("Arya"), a special purpose acquisition company, sponsored by Perceptive Advisors (Press release, Immatics Biotechnologies, MAR 17, 2020, View Source [SID1234555656]).

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In addition to the funds held in Arya’s trust account, a group of leading US healthcare investors has committed to participate in the transaction through a ~$104 million common stock PIPE. Investors in the PIPE include Perceptive Advisors, Redmile Group, Federated Hermes Kaufmann Funds, RTW Investments, Sphera Funds, and an additional healthcare focused investor, as well as current existing Company shareholders including dievini Hopp BioTech, AT Impf and Wellington Partners.

Immatics will receive gross proceeds of up to $252 million at the closing of the transaction and will continue to operate under the Immatics management team headed by Chief Executive Officer Harpreet Singh, Ph.D. The respective boards of directors of both Arya and Immatics have approved the proposed transaction. Completion of the transaction, which is expected in the second quarter of 2020, is subject to approval of Arya’s and Immatics’ shareholders and the satisfaction of certain other customary closing conditions.

Adam Stone, Chief Investment Officer of Perceptive Advisors and CEO of Arya, stated: "Immatics has established a leadership position in the rapidly evolving area of T cell receptor (TCR) based cell therapies. Immatics’ TCR-based drug candidates are designed to disrupt the current solid tumor treatment paradigm and open new avenues for cancer patients." Adam Stone further commented: "Our goal when we formed Arya was to identify a unique company with disruptive potential. Immatics’ expertise in identifying cancer targets and developing the right TCRs for immunotherapies, provided exactly that opportunity for this investment vehicle. We look forward to working closely with the Immatics’ team and are excited about the potential their technologies represent – to both patients and investors."

Harpreet Singh, Ph.D., Co-Founder and CEO of Immatics commented: "We greatly value the commitment from Perceptive Advisors and other top-tier investors who are participating in this transaction, as well as our existing investors who have supported the development of Immatics to date. We believe this business combination with Arya represents a unique opportunity to transition our company onto a global stage. Access to the US capital markets will be critical to our ability to fuel our development plans and to advance Immatics’ innovative immunotherapies through the clinic as part of our mission to improve treatment options for cancer patients."

Immatics leverages advanced technologies and biologic insight to identify otherwise inaccessible and intracellular drug targets as a basis for a broad range of cancer immunotherapies designed to overcome the current limitations in immuno-oncology. The company is actively using these targets to develop novel T cell receptors to enable a robust and specific T-cell response against cancer cells. The Company has two distinct product classes, Adoptive Cell Therapies (ACT) and TCR Bispecifics, and is advancing product candidates in both classes in the Company’s proprietary pipeline with several clinical-stage ACT lead products. Additionally, the Company has several large-scale collaborations with global leaders in the pharmaceutical industry.

Summary of Transaction
Arya raised $143.75 million in its IPO which is now (together with interest thereon) held in a trust account. Under the terms of the proposed transaction, Immatics´ equity value contribution into the proposed business combination will amount to approximately $350 million. Accordingly, Immatics´ shareholders will receive 35 million shares of the newly established Immatics N.V. in exchange for their existing Immatics shares, as contemplated by the terms of the business combination agreement. Current shareholders of Arya will also become shareholders of Immatics N.V. and will exchange their ordinary shares and warrants of Arya for ordinary shares and warrants of Immatics N.V. on a one for one basis. Existing Immatics shareholders and management are retaining 100% of their equity. Assuming that no Arya shareholders elect to redeem their shares and participation by all Immatics shareholders participate in the transaction, it is estimated that the current shareholders of Immatics will own approximately 61% of the issued and outstanding shares in the combined company at closing. Assuming that no Arya shareholders elect to redeem their shares and participation by all Immatics shareholders in the transaction, the combined company will have an initial market capitalization of approximately $634 million. Upon closing, it is expected that Immatics N.V. will be publicly traded on Nasdaq Capital Market under the ticker symbol IMTX.

Additional information about the transaction will be provided in a Current Report on Form 8-K that will contain an investor presentation to be filed with the Securities and Exchange Commission ("SEC") and will be available at www.sec.gov. In addition, Immatics N.V. intends to file a registration statement on Form F-4 with the SEC, which will include a proxy statement/prospectus of Arya, and will file other documents regarding the proposed transaction with the SEC.

Advisors
Goldman Sachs International is acting as lead financial advisor with BofA Securities, SVB Leerink and Kempen serving as financial advisors to Immatics. Jefferies LLC is acting as financial and capital markets advisor to Arya as well as sole private placement agent. Chardan Capital Markets LLC is also serving as advisor to Arya. Goodwin Procter LLP and CMS are acting as legal counsel to Immatics. Kirkland & Ellis LLP is serving as legal counsel to Arya.

NANOBIOTIX 2019 Annual Results

On March 17, 2020 NANOBIOTIX (Paris:NANO) (Euronext : NANO – ISIN: FR0011341205 – the ‘‘Company’’), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported its audited consolidated results for the fiscal year ending December 31, 2019 (Press release, Nanobiotix, MAR 17, 2020, View Source [SID1234555655]):

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Major milestones achieved during the year:
First ever radioenhancer to receive European market approval for the treatment of locally advanced soft tissue sarcoma
Launched clinical collaboration with the University of Texas MD Anderson Cancer Center for nine clinical trials
Positive pre-clinical data in immuno-oncology presented at major congresses
Phase I study data showing NBTXR3 may present as a valuable option for hepatocellular carcinoma or liver metastasis patients
Expenses in R&D proceeding as expected according to clinical development plan
Consolidated cash available of €35.1M as of December 31, 2019
"2019 was a major year for Nanobiotix. We made significant progress in our clinical development plan and are proud to have received our first market approval in Europe for NBTXR3, under the brand name Hensify, in soft tissue sarcoma of the extremity and trunk wall. R&D expenses reflect the strength of our development plan and some key positions have been hired to sustain the activity. In 2020, we are prioritizing the registration pathway for head and neck cancer in the US and Europe, while also continuing our Immuno-Oncology program and evaluating NBTXR3 in other indications with our partners." – Philippe Mauberna, Chief Financial Officer of Nanobiotix

The audited consolidated financial statements for the fiscal year ending December 31, 2019 have been approved by the Company’s executive board and reviewed by the supervisory board on March 17, 2020.

Consolidated Income Statement: 1

In K€


2019

2018

Total revenue and other income


2,541

3,479

Sales


68

116

Service


40

109

Other sales


28

7

Licenses


Other revenues


2,473

3,363

Research Tax Credit


2,437

3,251

Subsidies


20

90

Other


17

22

Research & Development (R&D) costs


(30,411)

(20,893)

Selling, General and Administrative (SG&A) costs


(18,909)

(12,653)

Operating loss


(46,779)

(30,067)

Financial loss


(4,133)

(277)

Income tax


(3)

Net loss for the period


(50,915)

(30,345)

Financial Review

Total Revenue in 2019 amounted to €2.5M vs. €3.5M in 2018, mainly due to:

Revenues related to services provided by the Company to its partner PharmaEngine, pursuant to a commercial agreement which amounted to €68K in 2019 (vs. €116K in 2018); and
Other revenues of €2,473K in 2019 (vs. €3,363K in 2018), mainly related to the Research Tax Credit (Crédit d’Impôt Recherche – CIR).
Total Operating expenses reached €49.3M in 2019 vs. €33.5M in 2018:

R&D expenses in 2019 amounted to €30.4M (vs. €20.9M in 2018), with the variance coming from an increase in operations (launch and extension of new studies) as well as the addition of highly qualified staff
SG&A costs in 2019 were €18.9M (vs. €12.7M in 2018)
Total consolidated headcount reached 110 as of December 31, 2019 vs. 102 as of December 31, 2018, in line with the Company’s growth.

Net loss after tax amounted to €50.9M for the year ending December 31, 2019 (vs. €30.3M loss in 2018).

Cash available as of December 31, 2019 amounted to €35.1M (excluding the amount related to the 2018 research tax credit, which was received in February 2020)

Nanobiotix activities and achievements in 2019

Clinical

First ever radioenhancer to receive European market approval

In April 2019, the Company announced that Hensify received European market approval enabling commercialization in 27 European Union countries for the treatment of locally advanced soft tissue sarcoma (STS). Hensify is the brand name for NBTXR3 as approved for the treatment of locally advanced STS.

In July 2019, results from the randomized Phase II/III trial evaluating NBTXR3 in patients with locally advanced STS were published in The Lancet Oncology. The data from the registration study (Act.In.Sarc) demonstrated a significant advantage in both pathological complete response (pCR) and rate of margin-negative resection (R0) for those treated with NBTXR3 activated by radiation therapy (RT) versus RT alone. Data showed that an increase in efficacy was achieved with the addition of NBTXR3, without a significant difference in the safety profile compared to RT alone.

NBTXR3 may present as a valuable option for patients with hepatocellular carcinoma or liver metastasis

During an oral presentation at the ASTRO 2019 annual meeting, Nanobiotix announced phase I results in liver cancer. The study showed promising signs of efficacy for hepatocellular carcinoma (HCC) patients, as every evaluable patient responded and over half (62.5%) reached complete response. Moreover, given that the safety profile was very good, a 5th dose escalation level has been added to the trial.

Clinical collaboration(s)

MD Anderson

In January 2019, the Company announced a clinical collaboration with MD Anderson. This agreement expanded the clinical development plan for NBTXR3, as the nine MD Anderson-led trials will evaluate the product in new indications and patient populations, and should involve around 340 patients.

Pre-clinical collaboration(s)

MD Anderson and Weill Cornell Medical College

At AACR (Free AACR Whitepaper) 2019, Nanobiotix presented pre-clinical data from studies currently being conducted through its collaborations with MD Anderson and the Weill Cornell Medical College, demonstrating the efficacy of treatment combinations including NBTXR3, radiotherapy, and anti-PD-1 immunotherapy in treating resistant pre-clinical in vivo lung cancer models.

In November during SITC (Free SITC Whitepaper) 2019, Nanobiotix announced new results from an in vivo pre-clinical study showing the generation of adaptive immune response (turning cold tumors into hot tumors), better local control, increased abscopal effect, and significantly increased survival for NBTXR3 activated by RT and anti-PD-1 in combination versus RT alone in combination with anti-PD-1. Additionally, an in vivo RadScopal model showed superior local control along with significant increases in abscopal effect and survival for treatments combining NBTXR3 activated by RT with anti-PD-1 and anti-CTLA-4 versus all other tested combinations.

Financial Events

Registered public offering in the United States

Nanobiotix announced that it planned to conduct a registered public offering of ordinary shares, including in the form of American Depositary Shares (ADSs) in the United States, and has confidentially submitted a draft registration statement on Form F-1 to the U.S. Securities and Exchange Commission.2

€14m through the second tranche disbursement of financing from the European Investment Bank

Nanobiotix received €14 million in March 2019 through the second tranche disbursement of a non-dilutive loan from the European Investment Bank (EIB), which was originally announced on July 26, 2018. The payment was triggered by the achievement of two key company milestones:

– The determination of the recommended dose at 22% of the tumor volume for head and neck cancers following the end of the phase I clinical trial with NBTXR3;
– Receipt of the positive evaluation of the clinical benefit/risk ratio of NBTXR3 in STS in phase II/III by the clinical expert mandated by the French medical device notified body, GMED.

€29.5m capital increase through placement of new shares

In April 2019, the Company raised approximately €29.5m through the placement of new shares to a specific class of investors.

Laurent Levy, CEO, increased stake in Nanobiotix’s capital

At the end of April 2019, Laurent Levy subscribed to 160,000 new shares of the Company through the exercise of 160,000 founder’s warrants (bons de souscription de parts de créateur d’entreprise or BSPCE) for a total amount of 960,000 euros, bringing his ownership in the Company to 731,560 shares.

Corporate

New organizational structure

Nanobiotix announced organizational changes to align with strategic priorities post European market approval for Hensify.

Launch of Curadigm

In May 2019, Nanobiotix announced the launch of Curadigm, a new nanotechnology platform for healthcare. The company is a wholly-owned subsidiary of Nanobiotix, operating in France and in the US with a dedicated team. Curadigm opens new growth pathways for Nanobiotix beyond oncology, built on the success and expertise established through the development of NBTXR3. Curadigm’s "Nanoprimer" technology aims to prime the body to receive various therapeutics and could reshape the balance between efficacy and toxicity for patients.

Prix Galien

In December 2019, Nanobiotix received the French 2019 Prix Galien Award for Most Innovative MedTech. The Prix Galien Award recognizes outstanding achievement in biomedical and medical technology that improves the human condition.

Expected 2020 Perspectives

– Q2 2020 – Launch of phase I in pancreatic cancer with MD Anderson
– Mid 2020 – EU phase I expansion in H&N cancer: First data on efficacy and safety
– Q2-Q3 2020 – Submission of protocols for additional MD Anderson trials to FDA (in combo with checkpoint inhibitors and in Head and Neck cancer with limited PD-L1 expression)
– Mid 2020 – Phase I IO Basket Trial: First data reported
– Q3 2020 – Phase I in esophageal cancer and lung cancer in need of reirradiation with MD Anderson: First patients treated
– H2 2020 – Phase III in STS: further follow up of patients
– H2 2020 – Post-approval trial in STS: trial authorization
– Additional news on other clinical trials and preclinical programs