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.

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

On March 17, 2020 McKesson Corporation (NYSE:MCK) reported it is updating its adjusted earnings outlook for the fiscal year ending March 31, 2020 to reflect the completion of the company’s exit of its investment in Change Healthcare, as announced on March 10, 2020 (Press release, McKesson, MAR 17, 2020, View Source [SID1234555654]).

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McKesson is updating its previous fiscal 2020 Adjusted Earnings per diluted share guidance range of $14.60 to $14.80 to a new range of $14.67 to $14.87. This updated outlook reflects weighted average shares outstanding used in the calculation of earnings per share of approximately 182 million for the year, updated from the previous assumption of approximately 183 million weighted average shares outstanding for the year. All other underlying key fiscal 2020 assumptions provided in McKesson’s press release on February 4, 2020 are unchanged.

McKesson will host a conference call today, March 17, at 4:30 PM Eastern Time to discuss the completion of the split-off and its financial impact to McKesson. A live audio webcast of the conference call will be available on McKesson’s Investor Relations website at View Source The conference call can also be accessed by dialing 786-815-8297. The password is ‘McKesson’.

On March 17, 2020 MedX Health Corp. ("MedX") (TSX-V: MDX) reported that it has received regulatory approval to market and sell its SIAscopy on DermSecure TM skin assessment platform in Brazil (Press release, MedX Health, MAR 17, 2020, View Source [SID1234555653]). "MedX has worked seamlessly with its Brazilian distribution partners, MedX Brasil and Oneway Diagnostica to ensure we were able to complete this important certification from ANVISA, Brazil’s regulatory authority," commented Scott Spearn, President & CEO of MedX. "We had the support of the Brazilian Dermatological community in this process, and we are very appreciative of the efforts and professionalism of our partners in achieving this milestone."

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"There is a significant opportunity for MedX’s rapid skin assessment technology in Brazil, as skin cancer is the most common type of cancer in Brazil," stated Fabio Candello, CEO of MedX Brasil. Over a hundred thousand new cases of skin cancer were recorded in Brazil between 2016 and 2017, according to the Brazilian Cancer Institute, and almost 6,000 were classified as melanoma, an aggressive form of the disease that can spread to other parts of the body. A recent study shows that Brazilian melanoma patients experienced a lower survival rate than the current worldwide average. The high prevalence of advanced cases reinforces the importance of local strategies to diagnose melanoma in the early stages, and to treat it definitively. "MedX’s SIAscopy on DermSecure TM telemedicine platform and advanced SIAscopy imaging technology is a perfect solution for early detection," further noted Mr. Candello.

"MedX Brasil has ordered 500 SIAscopes to meet their initial demand, and now that we have received regulatory approval and our distribution partners can begin active marketing, we are ramping up along with our partners to fulfill this order, and will begin to see the impact of the recurring revenue model going forward," noted Mr. Spearn.

On March 17, 2020 Eureka Therapeutics, Inc., a clinical stage biotechnology company developing novel T cell therapies for solid tumors, reported that it has closed a $45 million Series E financing (Press release, Eureka Therapeutics, MAR 17, 2020, View Source [SID1234555652]). The round was led by Lyell Immunopharma and joined by a syndicate of new and prior investors. In addition to the financing, Eureka and Lyell have entered into a strategic collaboration to develop therapies against several undisclosed solid tumor targets expressed across multiple cancer types.

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The Company will use proceeds from the Series E round to advance its proprietary TCR-mimic and antibody-TCR ARTEMIS programs, including Eureka’s anti-AFP ARTEMIS Phase I/II clinical trial in the United States for the treatment of hepatocellular carcinoma (HCC), the predominant type of liver cancer.

TCR-mimics represent a novel way to target solid tumors. Whereas the current generation of CAR-T therapies exclusively recognize cell-surface targets, most cancer-associated proteins are found intracellularly and are considered ‘undruggable’ with conventional small molecule or antibody drugs. TCR-mimic antibodies recognize the same tumor specific peptide/MHC complexes as TCRs but with better affinity and specificity.

"Eureka’s TCR-mimic and ARTEMIS technologies are very promising. We look forward to working with them to improve the efficacy of engineered T cells in solid tumors," said Dr. Rick Klausner, Founder and CEO of Lyell, who also co-founded Juno Therapeutics and GRAIL and served as the 11th Director of the U.S. National Cancer Institute.

"We are delighted by the vote of confidence from Lyell and other investors in our TCR-mimic and ARTEMIS platforms," said Dr. Cheng Liu, Founder and CEO of Eureka Therapeutics. "This financing and strategic collaboration with Lyell represents a strategic inflection point for Eureka and will enable us to accelerate the development of novel therapies for patients."