On March 11, 2020 Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to developing and commercializing new medicines for patients battling cancer, reported financial results for the three months and full-year ended December 31, 2019, and provided an overview of recent corporate highlights (Press release, Verastem, MAR 11, 2020, View Source [SID1234555428]).

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Brian Stuglik, Chief Executive Officer of Verastem Oncology, commented, "We are very excited to be executing on our new strategic direction. Our newly expanded development pipeline and priorities, combined with our recently strengthened balance sheet, leave us well positioned to deliver on our key corporate objectives in 2020 and beyond."

New Strategic Direction

CH5126766 (VS-6766) in Combination with Defactinib

Accelerating Development for KRAS Mutant Solid Tumors. In early 2020, Verastem Oncology licensed exclusive global development and commercialization rights to CH5126766 (VS-6766), a unique and promising inhibitor of the RAF/MEK signaling pathway. The combination of CH5126766 (VS-6766) and defactinib is currently being investigated in a Phase 1 clinical study and expansion cohorts in patients with KRAS mutant advanced solid tumors, including low grade serous ovarian cancer, non-small cell lung cancer and colorectal cancer. Verastem Oncology plans to initiate discussions with regulatory authorities during the first half of 2020, with the goal of commencing a registration-directed trial as soon as possible.

Data from the Phase 1 combination study were submitted for presentation to the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2020 Annual Meeting. The AACR (Free AACR Whitepaper) recently announced that it was terminating the April 2020 meeting due to the COVID-19 outbreak and is planning to reschedule the meeting for later this year. Verastem Oncology is actively working with the appropriate organizations and institutions to determine next steps.
Duvelisib (COPIKTRA)

Prioritizing the Advancement of Duvelisib in Relapsed/Refractory PTCL. At the American Society of Hematology (ASH) (Free ASH Whitepaper) 2019 Annual Meeting, Verastem Oncology presented positive data from the dose optimization portion of the Phase 2 PRIMO study evaluating duvelisib in patients with relapsed or refractory PTCL, an aggressive disease with a lack of effective therapeutic options. This initial phase of the trial demonstrated promising clinical activity including complete and durable responses, as assessed by independent central review, with a manageable safety profile. The expansion phase of this registration-directed study continues to accrue patients and Verastem Oncology expects to complete enrollment in 2020 and report top-line results from the expansion cohorts in early 2021. Verastem Oncology intends to build on the existing Fast Track and Orphan Drug Designations and submit a regulatory package to the U.S. Food and Drug Administration to expand the approved indications for COPIKTRA to include relapsed or refractory PTCL.
Focusing COPIKTRA Commercial Activities. Verastem Oncology will be reducing the resources directed to the promotion and sale of COPIKTRA in its current indications, including reducing the size of its salesforce and non-core clinical research. The Company plans to shift its COPIKTRA promotional resources toward large, community-based practices and academic institutions, which represent the majority of the appropriate third-line patients with chronic lymphocytic leukemia/small lymphocytic lymphoma and follicular lymphoma. The Company expects to reduce its overall headcount number to approximately 90 employees.
Corporate and Financial

Strengthened the Balance Sheet Through a Private Placement with Premier Life Science Investors. On March 3, 2020, Verastem Oncology completed a private placement offering of approximately 46.5 million shares of its common stock to certain institutional investors, including RA Capital Management, Vivo Capital, Venrock Healthcare Capital Partners, Farallon Capital Management, Acuta Capital, EcoR1 Capital LLC, Avidity Partners and Logos Capital at a price of $2.15 per share, a 12.6% premium to the February 27, 2020 closing price. The gross proceeds to Verastem Oncology were $100 million. After deducting the underwriting discounts and commissions and other estimated offering expenses, net proceeds to the Company were approximately $92.0 million.
Fourth Quarter 2019 Financial Results

Net product revenue for the three months ended December 31, 2019 (2019 Quarter) was $3.6 million, compared to $1.2 million for the three months ended December 31, 2018 (2018 Quarter), following the FDA’s approval of COPIKTRA on September 24, 2018. COPIKTRA demand units for the 2019 Quarter increased 20% compared to the third quarter of 2019. There was no license and collaboration revenue for the 2019 or 2018 Quarter.

Total operating expenses for the 2019 Quarter were $36.9 million, compared to $35.5 million for the 2018 Quarter. Excluding non-recurring charges of $2.2 million related to the Convertible Notes Exchange, the total operating expenses for the 2019 Quarter were $34.7 million.

Research and development (R&D) expense for the 2019 Quarter was $12.5 million, compared to $8.8 million for the 2018 Quarter. The increase of $3.7 million, or 42.0%, was primarily related to higher contract research organization costs to support the development of the Phase 2 TEMPO study for Intermittent Dosing, pre-clinical collaborations, and personnel costs related to the October 2019 rightsizing of the organization. This is partially offset by a decrease in investigator fees and CMC costs related to the FDA Approval of COPIKTRA in 2018.

Selling, general and administrative expense for the 2019 Quarter was $23.7 million, compared to $26.2 million for the 2018 Quarter. The decrease of $2.5 million, or 9.5%, was primarily due to lower personnel and external consulting costs.

Net loss for the 2019 Quarter was $38.8 million, or $0.51 per share (diluted), compared to $11.3 million, or $0.37 per share (diluted), for the 2018 Quarter. The 2019 Quarter includes $1.3M of non-cash interest expense related to conversions of Convertible Senior Notes into shares of common stock.

For the 2019 Quarter, non-GAAP adjusted net loss was $30.3 million, or $0.40 per share (diluted), compared to non-GAAP adjusted net loss of $33.1 million, or $0.36 per share (diluted), for the 2018 Quarter. Please refer to the GAAP to Non-GAAP Reconciliation attached to this press release.

Full-Year 2019 Financial Results

Total revenue for the year ended December 31, 2019 (2019 Period) was $17.5 million. Net product revenue for the 2019 Period was $12.3 million, compared to $1.7 million for the year ended December 31, 2018 (2018 Period), following the FDA’s approval of COPIKTRA on September 24, 2018. License and collaboration revenue for the 2019 Period was $5.1 million, compared to $25.0 million for the 2018 Period.

Total operating expenses for the 2019 Period were $149.8 million compared to $121.5 million for the 2018 Period.

R&D expense for the 2019 Period was $45.8 million, compared to $43.6 million for the 2018 Period. The increase of $2.2 million, or 5.0%, was primarily related to higher contract research organization and personnel costs to support the development of the Phase 2 TEMPO study for Intermittent Dosing and the Phase 2 PRIMO study for the treatment of PTCL.

Selling, general and administrative expense for the 2019 Period was $101.2 million, compared to $77.3 million for the 2018 Period. The increase of $23.9 million, or 30.9%, was primarily due to the hiring and staffing of the sales and commercial teams to support the launch of COPIKTRA.

Net loss for the 2019 Period was $149.2 million, or $2.00 per share (diluted), compared to $72.4 million, or $1.37 per share (diluted), for the 2018 Period.

For the 2019 Period, non-GAAP adjusted net loss was $126.0 million, or $1.69 per share (diluted), compared to non-GAAP adjusted net loss of $88.4 million, or $1.27 per share (diluted), for the 2018 Period. Please refer to the GAAP to Non-GAAP Reconciliation attached to this press release.

Verastem Oncology ended 2019 with cash, cash equivalents and short-term investments of $111.3 million.

Financial Guidance for Fiscal 2020

As a result of its new strategic direction, Verastem Oncology expects to reduce its operating expenses by approximately 40% for 2020 compared to 2019. Based on its current operating plans, Verastem Oncology expects its R&D and SG&A expenses for the full year 2020 to be in the range of $70 million to $85 million. In light of all these changes, the company is guiding that 2020 COPIKTRA revenues may be in the range of $12 million to $16 million. Verastem Oncology expects that its existing cash and cash equivalents, along with the revenue it expects to generate from COPIKTRA, will be sufficient to fund its planned operations into the fourth quarter of 2021.

On March 11, 2020 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Navidea Biopharmaceuticals, MAR 11, 2020, View Source [SID1234555427]).

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"During the fourth quarter, Navidea made great strides in its enrollment of the NAV 3-31 Phase 2B trial in patients with rheumatoid arthritis," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "The Company continued its dialogue with several key potential partners and we anticipate providing updates on those initiatives in the very near future. Furthermore, with the most recent financing, the Company put in place the steps necessary to launch the next critical trials."

Fourth Quarter 2019 Highlights and Subsequent Events

Continued with double-digit subject enrollment in the Company’s NAV3-31 Phase 2b study in rheumatoid arthritis ("RA") and completed enrollment of subjects in Arms 1 and 2.
Announced positive results of the first interim analysis of the NAV3-31 Phase 2b study, demonstrating that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active RA, and that this imaging is stable, reproducible, and can define joints with and without RA-involved inflammation.
Completed enrollment in NAV3-24, a Phase 1 Kaposi’s Sarcoma trial; All imaging has been completed and the Company is currently compiling results.
Continued enrollment in the Investigator Initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.
Entered into a collaboration agreement with IMV Inc., a clinical-stage immuno-oncology company, to explore the combinatory effect of Navidea’s and IMV’s proprietary immuno-oncology platforms.
Converted the Tilmanocept Uptake Value quantitative imaging analysis provisional patent to an A1 patent application, and filed an additional provisional patent relevant to both imaging and therapeutic applications.
Executed agreements with five investors, including an existing investor, to purchase approximately 2.1 million shares of the Company’s common stock in a private placement for aggregate gross proceeds to Navidea of approximately $1.9 million.
Won summary judgment in the Court of Common Pleas for Franklin County, Ohio (the "Ohio Court") related to the Company’s ongoing litigation with Capital Royalty Partners II, L.P., et al ("CRG"), in the amount of $4.3 million plus interest (the "Judgment"). The Ohio Court also found that there was no unjust enrichment or conversion by CRG. The decision is a final appealable order and terminated the case.
Executed a binding term sheet to sell the Judgment for $4.2 million of proceeds to Navidea.
Executed agreements with two existing investors to purchase approximately 4.0 million shares of the Company’s common stock for aggregate gross proceeds to Navidea of approximately $3.4 million.
Following the funding transactions described above, the Company regained compliance with the NYSE American’s continued listing standards with stockholders’ equity of $6.0 million.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The clinical research team has been working diligently to advance the technology in key disease areas, with an emphasis on our ongoing RA trials. We continue to advance our Phase 2B trial in RA, building upon last quarter’s announced interim analysis results, and with an eye towards the second interim analysis. We are also planning for the start of our second Phase 2B trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients as well as the Phase 3 trial."

Financial Results

Navidea’s consolidated balance sheets, statements of operations, and statements of stockholders’ equity have been restated, as required, for all periods presented to reflect the April 2019 reverse stock split as if it had occurred on January 1, 2018. The consolidated statements of cash flows were not impacted by the reverse stock split.

Total revenues for the fourth quarters of both 2018 and 2019 were $119,000. Total revenues for fiscal 2019 were $658,000, compared to $1.2 million in 2018. The year-to-year decrease was primarily due to a decrease in license revenue related to the sublicense of the Company’s NAV4694 technology, which included a non-refundable upfront payment in 2018, coupled with a reduction in grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development.
Research and development ("R&D") expenses for the fourth quarter of 2019 were $1.7 million, compared to $854,000 in the same period of 2018. R&D expenses in 2019 were $5.3 million, compared to $4.2 million in 2018. The increase was primarily due to net increases in drug project expenses, which includes Manocept diagnostic and Tc99m tilmanocept development costs, offset by decreased Manocept therapeutic and NAV4694 development costs.
Selling, general and administrative ("SG&A") expenses for the fourth quarter of 2019 were $1.2 million, compared to $1.4 million in the same period of 2018. SG&A expenses for 2019 were $6.3 million, compared to $7.7 million in 2018. The decrease was primarily related to the resignation of the Company’s former CEO in 2018, coupled with net decreases in salaries and bonuses, investor relations, general office expenses and taxes, offset by increased legal and professional services, primarily related to litigation with the Company’s former CEO.
Navidea’s net loss attributable to common stockholders for the fourth quarter of 2019 was $2.8 million, or $0.15 per share, compared to a net loss attributable to common stockholders of $3.2 million, or $0.33 per share, for the same period in 2018. Navidea’s net loss attributable to common stockholders for 2019 was $10.9 million, or $0.76 per share, compared to a net loss attributable to common stockholders of $16.1 million, or $1.89 per share, for 2018.
Navidea ended the fourth quarter of 2019 with $1.0 million in cash and investments. Per Navidea’s recent filings with the SEC, the Company executed funding transactions totaling $7.6 million in proceeds during the first quarter of 2020.
Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.

Event:

Q4 2019 Earnings and Business Update Conference Call

Date:

Wednesday, March 11, 2020

Time:

5:00 p.m. (EDT)

U.S. & Canada Dial-in:

877-407-0312

International Dial-in:

+1 201-389-0899

Conference ID:

13699935

Webcast Link: View Source

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On March 11, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported it will release its fourth quarter and full year 2019 financial results after the market closes on Wednesday, March 25, 2020 (Press release, Personalis, MAR 11, 2020, View Source [SID1234555426]). In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

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Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 3623198. The live webinar of the call may be accessed by visiting the Events section of the company’s website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On March 11, 2020 Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its financial results for 2019 and provides an update on its product portfolio (Press release, Transgene, MAR 11, 2020, View Source [SID1234555425]).

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Philippe Archinard, Chairman and Chief Executive Officer of Transgene, commented:

"We achieved multiple important advances with our novel myvac and Invir.IO platforms during the course of 2019. We completed all the regulatory steps required to start the US and European clinical trials of TG4050, the first individualized therapeutic vaccine based on the myvac platform in January 2020. The clinical development is being co-funded by our partner NEC.

Our collaboration with AstraZeneca, based on our Invir.IO platform, is progressing well with the first multifunctional oncolytic viruses already being delivered to them. This platform has also generated a number of exciting new oncolytic candidates, including BT-001, which is being co-developed with BioInvent. The preclinical results generated with BT-001 have been remarkable and we are working hard to make sure we can take our first multifunctional Invir.IO oncolytic into the clinic before the end of 2020.

On the clinical front, we had a year of contrasts with on the one hand, the very encouraging initial results of TG4001, which were presented at ESMO (Free ESMO Whitepaper) 2019, and on the other hand, the disappointing outcome of the Phase 2 trial of TG4010 and the decision to stop Pexa-Vec trials in HCC.

We remain confident in the potential of our four clinical assets TG4001, TG4050, TG6002 and BT-001 as well as in our highly innovative technologies and platforms myvac and Invir.IO.

We also have sufficient financial visibility to pursue our developments with determination and confidence."

2020: multiple clinical milestones expected

Transgene’s portfolio currently consists of four immunotherapy drug candidates in clinical development:

Two therapeutic vaccines: TG4001 currently being evaluated in a Phase 2 trial and TG4050, the first individualized treatment based on the myvac platform, assessed in two Phase 1 trials.
Two oncolytic viruses: TG6002, which is being assessed in two Phase 1/2a trials, and BT-001, the first oncolytic virus based on the Invir.IO platform, and which is expected to enter the clinic before the end of 2020.
Clinical results for TG4001 and TG6002 are expected in the second quarter of 2020:

The Phase 2 trial of TG4001 in combination with avelumab in HPV-positive cancers is ongoing. Patient recruitment is in line with projections and interim results are expected in the second quarter of 2020.
The Phase 1 trial of TG6002 administered intravenously in patients with gastrointestinal cancers is ongoing. First data are also expected in the second quarter of 2020.
With myvac and Invir.IO, Transgene has two next-generation platforms whose potential has been validated by collaboration deals with NEC and AstraZeneca respectively:

myvac platform

Transgene is developing the therapeutic vaccine TG4050, together with NEC. This is the first individualized vaccine based on the myvac platform. It integrates NEC’s Artificial Intelligence technologies. These technologies are used to select the most relevant mutations (neoantigens) that are integrated into the TG4050 vaccine. These AI technologies will also contribute to the in-depth analysis of the patient’s immune characteristics, in order to determine the profiles of those who responded to the vaccine.
Data validating the vaccine design principle behind TG4050 are being actively promoted and will be presented at several specialized international congresses.
The first clinical trials assessing TG4050 are ongoing in Europe and in the United States. They are including patients with ovarian cancers and head and neck cancers. NEC is financing 50% of their cost.
The clinical trials are a central part of a broad program of translational research in collaboration with expert centers both in the US and Europe. This program will generate a significant body of data evaluating the activity of TG4050 from these initial clinical trials. The first data are expected in 1H 2021.
The Company has set up an in-house good manufacturing practice (GMP) unit dedicated to the manufacturing of the individualized batches of TG4050 needed for the current Phase 1 trials.
The myvac project is supported by Bpifrance, within the NEOVIVA program. The NEOVIVA project aims to strengthen the development of this highly innovative technology together with three partners: HalioDx, Traaser and Institut Curie. €2.6 million have been allocated to Transgene over five years. The NEOVIVA project is complimentary to the collaboration between Transgene and NEC.
Invir.IO platform

BT-001 is the first oncolytic virus from the Invir.IO platform. It is based on Transgene’s patented viral vector VVcopTK-RR- which has been designed to encode BioInvent’s anti-CTLA4 antibody (an immune checkpoint inhibitor) as well as the cytokine GM-CSF.
Preclinical results with BT-001 have been extremely promising, with treatment leading to the eradication of tumors in several murine models known for their low sensitivity to immune checkpoint inhibitors. These data will be presented at scientific congresses in the coming months. A first-in-human trial is being prepared and BT-001 is expected to enter the clinic before the end of 2020.
The collaboration with AstraZeneca is highly productive with Transgene already delivering the first multi-armed oncolytic viruses to its partner. As a result, Transgene has received $10 million at the time the collaboration was signed and booked €1.3 million related to the achievement of certain preclinical milestones. In 2020, Transgene will continue to design further oncolytic viruses for this collaboration. AstraZeneca can exercise an option to further develop each of these novel drug candidates.
Transgene’s patented viral vector, which underpins the Invir.IO platform, allows the development of a wide range of multifunctional oncolytic viruses. Transgene has already designed a number of proprietary oncolytic viruses that are being evaluated in preclinical models. A candidate is expected to be selected with the aim of submitting a clinical trial application in 2H 2020 ahead of starting a clinical trial in 2021.
Summary of key ongoing clinical trials

TG4001
+ Bavencio

(avelumab)
Phase 2

Targets: HPV16 E6 and E7 oncoproteins

HPV-positive cancers including oropharyngeal head and neck cancer – 2nd line

✓ Clinical collaboration with Merck KGaA and Pfizer, for the supply of avelumab

✓ Publication of the results of a Phase 2b trial of TG4001 in Gynecologic Oncology (April 2019), demonstrating the biological activity of this immunotherapeutic in CIN 2/3 lesions; editorial in The Lancet Oncology (April 2019)

✓ Positive results of the Phase 1b part of the trial presented at ESMO (Free ESMO Whitepaper) (Sept. 2019) Three of the six patients who received the recommended dose responded to the treatment. The observed responses were durable.

→ Interim Phase 2 results expected in 2Q 2020

myvac
TG4050
Phase 1

Targets: tumor neoantigens

Ovarian cancer – after first-line surgery and adjuvant therapy

✓ Trial authorized in the United States (May 2019) and in France (Sept. 2019)

✓ Principal investigator: Matthew Block (Mayo Clinic)

✓ First patient enrolled in January 2020

→ First data expected in 1H 2021

myvac
TG4050
Phase 1

HPV-negative head and neck cancer – after surgery and adjuvant therapy

✓ Trial authorized in the United Kingdom (July 2019) and in France (Sept. 2019)

✓ Principal investigator: Christian Ottensmeier (Southampton University)

✓ First patient enrolled in January 2020

→ First data expected in 1H 2021

TG6002
Phase 1/2a

Payload: FCU1 for the local production of a chemotherapy agent

Gastro-intestinal adenocarcinoma (colorectal cancer for Phase 2) – Intravenous (IV) route

✓ Publication in Molecular Therapy Oncolytics (March 2019) highlighting the promising activity of TG6002 in preclinical colorectal carcinoma models

✓ Multicenter trial ongoing in Belgium, France and Spain

✓ Last dose levels currently being evaluated (Phase 1 part)

→ First results of the Phase 1 part expected in 2Q 2020

TG6002
Phase 1/2a

Colorectal cancer with liver metastasis – Intrahepatic artery (IHA) route

✓ Multicenter trial authorized in the United Kingdom (July 2019)

✓ First patient treated in February 2020

→ First results expected in 1H 2021 (Phase 1 part)

Invir.IO
BT-001
Phase 1/2

Payload: anti-CTLA4 antibody and GM-CSF cytokine

Solid tumors

✓ Collaboration with BioInvent

✓ First clinical trial application submitted

→ Presentation of very encouraging preclinical results at upcoming scientific congresses

→ First clinical trial expected to start before the end of 2020

Key financials for 2019

Operating income of €13.7 million in 2019, compared to € 42.9 million in 2018.
R&D services for third parties amounted to €6.7 million in 2019 (€1.3 million in 2018). This significant increase is mainly due to the collaboration signed with AstraZeneca in 2019. This generated €5.3 million in revenue in 2019. The research tax credit amounted to €6.5 million in 2019 (€5.7 million euros in 2018). As a reminder, the much higher operating income figure in 2018 was mainly the result of the €35.6 million income generated by the transaction with Tasly Biopharmaceuticals Co, Ltd.
Net operating expenses of €39.2 million in 2019, compared to €35.5 million in 2018.
R&D expenses increased to €31.4 million in 2019 (from €27.3 million in 2018), due to the acceleration of external expenses for clinical projects and the setup of manufacturing unit dedicated to small clinical batches. General and administrative expenses stood at €7.1 million in 2019 versus €7.0 million in 2018.
Financial income of €6.7 million in 2019 versus a loss of €2.0 million in 2018.
The decision taken at the end of 2019 to stop the clinical development of TG4010 has led to a downward reassessment of the financial debt related to the repayable advances of the ADNA program of €8.7 million. This has been recognized as financial income.
Net loss of €18.8 million in 2019, compared to a net profit of €8.0 million in 2018.
Cash burn reduced to €20.5 million in 2019 (excluding the proceeds of the rights issue), versus €24.5 million in 2018.

Transgene received €8.9 million in June 2019, following the signing of the contract with AstraZeneca. This contributed to the reduced net cash burn compared to 2018 despite an increase in operating expenses during the period.
Cash available at year-end 2019: €43.3 million, compared to €16.9 million at the end of 2018, due to the successful €48.7 million rights issue completed in July 2019.
Transgene expects its cash burn for 2020 to be around €25 million.
The financial statements for 2019 as well as management’s discussion and analysis are attached to this press release (Appendices A and B).

The Board of Directors of Transgene met on March 11, 2020, under the chairmanship of Philippe Archinard and closed the 2019 financial statements. Audit procedures have been performed by the statutory auditors and the delivery of the auditors’ report is ongoing.

The Company’s universal registration document, which includes the annual financial report, will be available early April 2020 on Transgene’s website, www.transgene.fr.

A conference call in English is scheduled today, March 11, 2020, at 6:00 p.m. CET.

On March 11, 2020 Biocare Medical ("Biocare"), a leading developer of world class immunohistochemistry ("IHC") and molecular reagents and instrumentation, is reported that Luis de Luzuriaga has joined the company as Chief Executive Officer (Press release, Biocare Medical, MAR 11, 2020, View Source [SID1234555424]).

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Mr. de Luzuriaga has spent his entire career in commercial and executive leadership roles within the life sciences tools and diagnostics sector. Notably, Mr. de Luzuriaga spent six years leading Global Commercial Operations at Leica Biosystems and also served as the Divisional Vice President and General Manager of Abbott Hematology. Most recently, Mr. de Luzuriaga was the CEO of BIT Group (subsidiary of Messer Group), a leading product development and contract manufacturer for high performance clinical, medical and life science devices.

Mr. de Luzuriaga’s proven ability to drive extraordinary growth and industry leadership within the life sciences tools sector aligns well with Biocare’s strong growth trajectory and reputation for quality diagnostic tools focused on the oncology and immunotherapy markets. "Since our first interaction with Luis, it was clear that he had the experience, capabilities and expertise to propel Biocare to the forefront of the industry," said Ryan Glaws, Partner at Excellere Partners. "His extensive experience and impressive track record at Leica, Abbott and BIT make him the ideal partner to guide Biocare through this exciting and transformational period in the company’s history."

"I am excited to join Biocare and work with what I know to be both a dynamic and talented team. Having previously competed against Biocare, I know first-hand about the quality of the products and reputation in the marketplace. It is an honor and a privilege to lead this organization, and I am very excited about the future of Biocare," said Mr. de Luzuriaga.