On March 10, 2021 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its financial results for 2020 and provides an update on its product pipeline (Press release, Transgene, MAR 10, 2021, View Source [SID1234576418]).

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Hedi Ben Brahim, Chairman and Chief Executive Officer of Transgene since January 1, 2021, commented:

"It is a great honor to join Transgene as Chairman and Chief Executive Officer at the beginning of 2021, taking over from Philippe Archinard. Over the last several months, Transgene has delivered multiple significant milestones, particularly from our new cutting-edge platforms myvac and Invir.IO as we have continued to operate successfully despite the Covid-19 pandemic.

We treated the first patients with TG4050, our individualized immunotherapy based on the myvac technology. This achievement illustrates how Transgene is positioning itself at the forefront of innovation globally by developing new solutions that could deliver important benefits for patients, clinicians and potential pharmaceutical partners. This customized immunotherapy is particularly promising, and I look forward to reporting the first data from TG4050 in the fourth quarter of 2021.

The very encouraging results with TG4001 which we announced in 2H 2020, have allowed us to rapidly initiate a Phase II randomized trial. The protocol of this study has already been approved in the U.S. and we expect patient inclusion to start in the coming months, with the aim of providing the first clinical results around the end of 2022.

This acceleration of our development is also reflected in the progress we made with BT-001, the first oncolytic virus of our Invir.IO platform to enter the clinic and supported by a very exciting preclinical data set. We have also seen another clinical oncolytic virus candidate TG6002 advance and deliver first promising translational data.

With financial visibility until 2022, we have the funds needed to deliver the important clinical results we expect in 2021 and 2022. Our strategy aims to leverage Transgene’s exciting new drug candidates, notably through large-scale partnerships, to generate significant value for our shareholders. I am very confident that the globally competitive product pipeline that we have today will allow us to deliver on our ambitious goals."

GLOBAL TECHNOLOGY LEADERSHIP WITH THE MYVAC PLATFORM AND THE THERAPEUTIC VACCINE TG4050

Transgene is developing an individualized immunotherapy based on multiple advanced genetic engineering technologies that have been developed by the company. TG4050 is the first drug candidate based on the myvac platform. Together with NEC, Transgene has set up a customized approach that combines its expertise in viral engineering with NEC’s artificial intelligence capabilities. NEC’s algorithms enable the customization of the treatment for each patient, by indicating the most relevant targets (patient-specific neoantigens).

The Phase I clinical trials assessing TG4050 started in January 2020 in Europe and in the United States. The first patients have been treated in these two clinical trials (ovarian and oropharyngeal cancers). NEC is financing 50% of these studies. The first data are expected in the fourth quarter of 2021.

The Company has set up an in-house production unit dedicated to the manufacturing of the individualized clinical batches of TG4050 needed for each patient. This unit is operational and complies with good manufacturing practice (GMP) norms.

The myvac platform integrates leading-edge innovations that are based on Transgene’s technological leadership in individualized immunotherapies.

Data validating the vaccine design principle and the underlining accuracy of the algorithm and AI used to personalize TG4050 were presented at the AACR (Free AACR Whitepaper) congress (June 2020).
Transgene has implemented the first block chain solution dedicated to the traceability of this personalized treatment in clinical trials. This solution monitors and orchestrates all of the processes related to the design and manufacturing of Transgene’s individualized therapeutic vaccine TG4050.
Transgene has set up a translational research program that includes a number of very innovative genomic and transcriptomic analyses. The goal is to characterize the effect of the treatment and identify predictors of response to TG4050 in the tumor and the genome environment that may impact each patient’s response to the vaccine. These data are important as they could lead to an optimized and accelerated development pathway for TG4050.
RANDOMIZED PHASE II TRIAL OF TG4001
IN HPV16-POSITIVE ANOGENITAL CANCERS TO START,
BASED ON PROMISING INITIAL DATA FROM PHASE IB/II

Transgene has amended the initial Phase Ib/II trial protocol to allow the more rapid start of this randomized Phase II study comparing the efficacy of TG4001 + avelumab versus avelumab monotherapy. This trial will be supported by a continuing collaboration with the alliance of Merck KGaA, Darmstadt, Germany, and Pfizer, which is supplying avelumab. Transgene retains all rights to TG4001.

The trial will focus on patients with recurrent or metastatic HPV16-positive anogenital cancer without liver metastases. This patient population, without liver metastases, was shown in the Phase Ib/II study to derive improved clinical benefit from the combination regimen.

In spite of recent progress, median overall survival is less than 11 months with chemotherapy and immune checkpoint inhibitors. The 25,000 patients who are diagnosed with these diseases every year (U.S., Europe 27, UK) with these HPV16-positive malignancies still need better treatment options.

Transgene received U.S. FDA clearance of the revised protocol under an IND for TG4001. The submission of the amended protocol has been initiated in Europe (France and Spain) where clinical sites that participated in the Phase Ib/II part study are ready to resume patient inclusion after regulatory approval. Patient enrollment is expected to start in 2Q 2021.

Transgene expects to communicate the interim analysis data around the end of 2022. This timeline is based on patient enrollment starting in 2Q 2021 and there being no major impact on recruitment from the Covid-19 pandemic.

Transgene today issued a press release providing more background on this TG4001 trial.

BT-001, THE FIRST ONCOLYTIC VIRUS BASED ON INVIR.IO, HAS ENTERED THE CLINIC AND FIRST OBSERVATIONS FROM TG6002 CONFIRM THE POTENTIAL OF OUR NEXT-GENERATION ONCOLYTIC VIRUSES

BT-001 is a patented VVcopTK-RR- oncolytic virus, with high antitumor potential, based on the Invir.IO platform. It is being co-developed with BioInvent. By selectively targeting the tumor microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoral response. In addition, delivering the anti-CTLA4 antibody directly to the tumor microenvironment aims to induce local Treg depletion and strong therapeutic activity. As a consequence, by reducing systemic exposure, the safety and tolerability profile of the anti-CTLA4 antibody should be greatly improved. Promising preclinical results for BT-001 were presented at the AACR (Free AACR Whitepaper) and SITC (Free SITC Whitepaper) annual congresses (June and Nov. 2020). A Phase I/IIa trial targeting solid tumors has started in France and Belgium at the beginning of 2021.

Initial data from the Phase I trial of TG6002 confirm the good tolerability of TG6002 and demonstrate that this Vaccinia Virus, which is the same viral backbone on which the Invir.IO platform is based, can reach the tumor, replicate within these cancer cells and induce the production of 5-FU when administered intravenously.
These data will be detailed at the upcoming meeting of the AACR (Free AACR Whitepaper) (April 2021).

By developing the administration of TG6002 via the intravenous and intrahepatic artery routes, Transgene aims to enlarge the number of solid tumors that could be addressed by an oncolytic virus. This includes gastrointestinal tumors that are being investigated with TG6002. To-date, the oncolytic virus that has received regulatory approval has to be given via intra-tumoral administration, restricting its use to easily accessible tumors.

Our collaboration with AstraZeneca continues to develop new innovative oncolytic viruses. AstraZeneca can exercise an option to further develop each of these novel drug candidates in the clinic.

SUMMARY OF ONGOING CLINICAL TRIALS

myvac

TG4050

Phase I

NCT03839524

Targets: tumor neoantigens

✓ Data demonstrating the high accuracy of AI-based neoantigen prediction technology used to design TG4050 were presented at AACR (Free AACR Whitepaper) 2020

Ovarian cancer – after surgery and first-line chemotherapy

✓ Trial ongoing in the United States and in France

✓ First patient treated in 2020 – patient enrollment progressing in line with forecast

> First data expected in 4Q 2021

TG4050

Phase I

NCT04183166

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

✓ Trial ongoing in the United Kingdom and in France

✓ First patient treated in Jan. 2021 – patient enrollment progressing in line with forecast

> First data expected in 4Q 2021

TG4001

+ avelumab
Phase II

NCT03260023

Targets: HPV16 E6 and E7 oncoproteins

Recurrent/metastatic anogenital HPV-positive – 1st and 2nd line

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

✓ Promising Phase Ib/II results presented at SITC (Free SITC Whitepaper) and ESMO (Free ESMO Whitepaper) IO 2020

✓ A randomized Phase II trial comparing the efficacy of TG4001 + avelumab vs avelumab monotherapy has received U.S. FDA clearance. In Europe, the amended protocol has been submitted to French and Spanish health authorities

> Patient enrollment in the randomized trial expected to start in 2Q 2021

> First data from the randomized trial are expected around the end of 2022. This timeline is based on patient enrollment starting in 2Q 2021 and there being no major impact on recruitment from the Covid-19 pandemic.

Invir.IO

BT-001

Phase I/IIa

Payload: anti-CTLA4 antibody and GM-CSF cytokine

Solid tumors

✓ Co-development with BioInvent

✓ Presentation of very encouraging preclinical results at AACR (Free AACR Whitepaper) and SITC (Free SITC Whitepaper) 2020

✓ Trial authorized. Phase I ongoing in France and Belgium

✓ First patient enrolled in February 2021

> First Phase I data expected in 1H 2022

TG6002

Phase I/IIa

NCT03724071

Payload: FCU1 for the local production of a 5-FU chemotherapy

Gastro-intestinal cancer (colorectal cancer for Phase II) – Intravenous (IV) administration

✓ Multicenter trial ongoing in Belgium, France and Spain

✓ First findings confirm that 5-FU is produced in the tumor (Sept. 2020)

> Phase I part ongoing

> A poster on the first Phase I observations has been accepted at AACR (Free AACR Whitepaper) 2021

TG6002

Phase I/IIa

NCT04194034

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

✓ Multicenter trial ongoing in the United Kingdom

✓ First patient treated in February 2020; enrollment resumed in September 2020 after pausing due to Covid-19

> First observations expected in 3Q 2021

KEY FINANCIALS FOR 2020

– Operating income of €9.9 million in 2020, compared to €13.7 million in 2019.
R&D services for third parties amounted to €3.0 million in 2020 (€6.7 million in 2019), mainly due to the collaboration with AstraZeneca, which generated €2.9 million in revenues in 2020. The research tax credit reached €6.3 million in 2020 (€6.5 million in 2019).

– Net operating expenses of €33.9 million in 2020, compared to €39.2 million in 2019.
R&D expenses were €27.3 million in 2020 (€31.4 million in 2019) with the reduction due to lower clinical trial expenses in 2020 and to the decrease of external expenses related to the manufacturing of clinical batches.
General and administrative expenses amounted to €6.5 million in 2020 (€7.1 million in 2019).

– Financial income of €6.8 million in 2020, compared to €6.7 million in 2019.
The partial sale of the Tasly BioPharmaceuticals shares in July 2020 generated a net gain on asset disposal of €2.7 million. Transgene’s remaining shareholding was revalued and resulted in financial income of €6.4 million in 2020. This figure corresponds to the difference between the market price and the historical price.

– Net loss of €17.2 million in 2020, compared to €18.8 million in 2019.

– Cash burn reduced to €17.0 million in 2020, versus €20.5 million in 2019 (excluding capital increase).
The net cash inflow of €18.2 million from the sale of Tasly BioPharmaceuticals shares in July 2020 reduced net cash consumption compared to 2019. This transaction enabled the Company to reimburse in advance the €10 million bank loan from the European Investment Bank (EIB) in October 2020 (against an initial maturity scheduled for this loan of June 2021).

– Cash available at year-end 2020: €26.3 million, compared to €43.3 million at the end of 2019. In addition, Transgene still has access to a credit line of €15 million and holds Tasly BioPharmaceuticals shares valued at €32.3 million at the end of December 2020.

– As a result, Transgene has a financial visibility until 2022.

HEDI BEN BRAHIM APPOINTED CHAIRMAN AND CHIEF EXECUTIVE OFFICER

Hedi Ben Brahim was appointed as the Company’s Chairman and CEO, effective January 1, 2021. He has been a member of Transgene’s Board since May 2019. Hedi Ben Brahim replaces Philippe Archinard, who had led the company since 2005 and who remains a member of the Board of Transgene.

The financial statements for 2020 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 10, 2021, under the chairmanship of Hedi Ben Brahim and closed the 2020 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 2021 on Transgene’s website, www.transgene.fr.

On March 10, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that its Chief Executive Officer Saiid Zarrabian will participate in Maxim Group’s 2021 Emerging Growth Virtual Conference taking place March 17-18, 2021 (Press release, Kintara Therapeutics, MAR 10, 2021, View Source [SID1234576417]). Mr. Zarrabian will be a speaker on a panel discussing glioblastoma and, more specifically, chemo-based and/or DNA repair target solutions.

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Investors can view Mr. Zarrabian’s panel participation at 9:30 am ET on March 17, 2021 once they register for the conference here, and an archived replay of the panel discussion will be available on the conference website. Investors can also request a 1×1 meeting with Mr. Zarrabian to be arranged following the conclusion of the conference.

On March 10, 2021 Bavarian Nordic A/S ("Bavarian Nordic" or the "Company") reported its intention to raise new capital through an accelerated bookbuilding process (Press release, Bavarian Nordic, MAR 10, 2021, View Source [SID1234576416]). The offering (the "Offering") of new shares in Bavarian Nordic has now been successfully completed. Reference is made to company announcement no. 4 of 9 March 2021.

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Bavarian Nordic has successfully completed a directed issue and private placement of 5,150,000 new shares (the "New Shares") at an offer price of DKK 223 per share, raising gross proceeds to Bavarian Nordic of DKK 1,148.45 million.

The Offering has not been registered under the U.S. Securities Act and was made pursuant to applicable exemptions from the obligation to publish a prospectus in Denmark as well as exemptions from the U.S. Securities Act and the securities laws of other applicable jurisdictions in a directed issue and private placement and subscribed for by eligible institutional and professional investors in Denmark and in certain other jurisdictions at market price and without pre-emption rights for Bavarian Nordic’s existing shareholders.

The net proceeds from the Offering will be used in accordance with company announcement no. 4 of 9 March 2021.

Bavarian Nordic has in connection with the Offering, agreed to undertake a lock-up commitment for 180 calendar days following settlement of the Offering (subject to certain exceptions). In addition, members of Bavarian Nordic’s board of directors and executive management have in connection with the Offering, agreed to undertake a lock-up commitment for 90 calendar days following settlement of the Offering (subject to certain exceptions).

CAPITAL INCREASE
Subject to settlement, a share capital increase will be registered with the Danish Business Authority and the share capital of Bavarian Nordic will hereafter consist of 63,600,112 shares of DKK 10 each, equivalent to a registered share capital of DKK 636,001,120.

The New Shares represent approximately 8.81 % of Bavarian Nordic’s registered share capital before the capital increase and will account for approximately 8.1 % of Bavarian Nordic’s registered share capital upon completion of the capital increase.

ADMISSION TO TRADING AND OFFICIAL LISTING
The New Shares will be issued under the temporary ISIN code DK0061535853. No application for admission to trading and official listing has been, or will be, filed for the New Shares issued under the temporary ISIN code, and the temporary ISIN code will only be registered with VP Securities A/S for subscription of the New Shares. The temporary ISIN code in VP Securities A/S will be merged with the permanent ISIN code for the existing shares, DK0015998017, as soon as possible following registration of the share capital increase with the Danish Business Authority. The New Shares are expected to be admitted to trading and official listing on Nasdaq Copenhagen A/S on or around 15 March 2021.

The admission to trading and official listing of the New Shares is subject to the Offering not being withdrawn prior to the settlement of the Offering and the Company making an announcement to that effect.

EXPECTED TIMETABLE FOR THE OFFERING

Date Event
Friday 12 March 2021 Settlement and payment for the New Shares
Friday 12 March 2021 Registration of the capital increase with the Danish Business Authority
Monday 15 March 2021 Admission to trading and official listing of the New Shares on Nasdaq Copenhagen A/S
Tuesday 16 March 2021 Merger of the temporary ISIN code with the permanent ISIN code
NEW SHARES
The decision to launch an offering of new shares in a directed issue was made pursuant to Article 5a(2) in Bavarian Nordic’s articles of association pursuant to which its board of directors is authorised to make share capital increases without pre-emption rights for the existing shareholders at market price.

The New Shares will rank pari passu in all respects with existing shares in Bavarian Nordic. The New Shares will be negotiable instruments, and no restrictions will apply to their transferability. No shares, including the New Shares, carry or will carry any special rights. Rights conferred by the New Shares, including voting rights and dividend rights, will apply from the time when the capital increase is registered with the Danish Business Authority. The New Shares must be registered in the name of the holder in the Company’s register of shareholders.

MANAGERS
Danske Bank A/S, Jefferies International Limited, Jefferies GmbH and Nordea Danmark, filial af Nordea Bank Abp, Finland are acting as Joint Global Coordinators and Joint Bookrunners (jointly the "Joint Global Coordinators and Joint Bookrunners") in connection with the Offering. Nordea Danmark, filial af Nordea Bank Abp, Finland acts as settlement agent for the Offering.

Kromann Reumert and Latham & Watkins LLP act as Danish and U.S. legal advisors respectively to the Company. Plesner acts as Danish legal advisors to the Joint Global Coordinators and Joint Bookrunners.

On March 10, 2021 XOMA Corporation (Nasdaq: XOMA) reported its fourth quarter and full-year 2020 financial results and business highlights (Press release, Xoma, MAR 10, 2021, View Source [SID1234576415]).

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"Our success in 2020 is a direct reflection of our strategy at work. As a result of the commitment by our partners to improve human health, we saw multiple programs advance further in the clinic. Novartis, Merck, Takeda, Incyte, Rezolute, and an undisclosed partner individually launched Phase 2 clinical studies with an asset in the XOMA portfolio. XOMA’s shareholders benefited from the milestones we received as our partners made these advancements, highlighted by the $25 million milestone we earned as Novartis initiated its Phase 2 development of NIS793, an anti-TGFβ monoclonal antibody, in patients with metastatic pancreatic cancer," stated Jim Neal, Chief Executive Officer at XOMA.

"Our business model is unique in that we are able to expand our portfolio by taking a long-term view of the development process and potential associated economics. As an example, in 2019 we acquired interests in two exciting platform technologies that we believe will produce multiple clinical candidates to further increase our royalty license portfolio. One of those arrangements with Bioasis led to our acquisition in November of the economic rights to four lysosomal storage disorder enzymes the Chiesi Group is exploring for rare disease indications.

"We are pleased to report XOMA is in a strong financial position with more than $84.2 million in cash at the end of 2020. Our operating expenses remain at our targeted levels. Our recent perpetual preferred equity offering provided us with additional capital to continue to acquire milestone and royalty assets to further increase the potential value of our portfolio."

Business Highlights

XOMA recognized revenue of $29.4 million in 2020 and reduced its Novartis debt obligation to $9.1 million.
XOMA acquired the milestone and royalty economics associated with four lysosomal storage disorders that Chiesi Group licensed from Bioasis Technologies.
XOMA and Zydus announced IL-2-based immuno-oncology therapy licensing agreement.
XOMA raised more than $24 million in a perpetual preferred stock offering, which is listed on the NASDAQ market under the symbol XOMAP, paying a quarterly dividend of 8.625%.
The Company’s stock was added to the Russell 2000 and Russell 3000 in June.
Updates About Partnered Assets in Development
"Even in an exceptionally challenging environment, our partners made significant progress in their clinical development programs. We thank those who volunteer to be part of these clinical studies, as their participation is an important component of our partners’ process to bring novel treatments to patients in need," Mr. Neal continued. "We congratulate Sesen Bio for their recent announcement that the Food and Drug Administration has accepted the Biologics Licensing Application for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer and granted it a Priority Review."

2020 Phase 2 launches:

Novartis’ NIS793 study in patients with metastatic pancreatic cancer
Takeda’s mezagitamab (TAK-079) studies in patients with myasthenia gravis and thrombocytopenia
Rezolute’s RZ358 study in patients with congenital hyperinsulinism
Merck’s MK-4830 study in patients with non-small cell lung cancer
Incyte’s INCAGN1876 study in patients with recurrent glioblastoma
One undisclosed partner
Financial Results
XOMA recorded total revenues of $27.6 million for the fourth quarter of 2020, compared to $0.4 million for the fourth quarter of 2019. For the full year of 2020, XOMA recorded revenues of $29.4 million, compared to $18.4 million for the full year of 2019. Revenues for the full year of 2020 reflect $25.0 million in milestone revenue earned under the Company’s Anti-TGFβ Antibody License Agreement with Novartis International and $2.0 million earned under XOMA’s collaboration agreement with Takeda. Revenues for the full year of 2019 reflect $14.0 million recognized under the Company’s license agreement and common stock purchase agreement with Rezolute and $2.5 million in revenue earned from a one-time payment under XOMA’s license agreement with Janssen.

Research and development (R&D) expenses were $0.03 million for the fourth quarter of 2020, compared to $0.1 million for the fourth quarter of 2019. R&D expenses for the full year of 2020 were $0.2 million, compared to $1.3 million for the same period in 2019. The $1.1 million decrease between the periods was primarily due to a $0.5 million decrease in salary and related expenses resulting from a shift in employee duties from R&D to a general and administrative (G&A) department and a $0.5 million decrease in license fee expenses.

G&A expenses were $3.7 million for the fourth quarter of 2020, including $0.7 million in stock-based expenses, compared to $4.3 million for the fourth quarter of 2019. G&A expenses were $16.8 million for the full year of 2020, including $4.0 million in stock-based expenses, compared to $21.0 million for the full year of 2019. The $4.2 million decrease in 2020 as compared with 2019 was primarily due to a $3.9 million reduction in facilities costs due to the termination of our legacy leases and a $1.2 million reduction in salary and related expenses. The decreases in 2020 were partially offset by a $1.4 million increase in consulting and legal costs.

The Company’s net cash provided by operations during the quarter was $17.7 million. XOMA’s net cash provided by operations in 2020 was $10.1 million.

Interest expense for the fourth quarter of 2020 was $0.4 million, as compared to $0.6 million for the fourth quarter of 2019. For the full year of 2020, interest expense was $1.8 million, compared with $1.9 million reported in the full year of 2019. The decrease in interest expense during 2020 is due to a reduction in interest rates and lower outstanding debt balances.

Other expense, net was $0.8 million for the fourth quarter of 2020, compared to other income, net of $0.3 million in the corresponding quarter of 2019. Total other income, net was $1.2 million for the full year of 2020, compared to $3.8 million for the corresponding period of 2019. The decrease in 2020 primarily reflects the termination of XOMA’s legacy leases in 2019 and the sublease income the Company associated with those leases, offset by a $1.0 million increase in the fair value of equity securities XOMA holds in Rezolute, Inc.

Net income for the fourth quarter of 2020 was $22.7 million, compared to net loss of $4.3 million for the fourth quarter of 2019. Net income for the full year of 2020 was $13.3 million, compared to net loss of $2.0 million for the full year of 2019.

On December 31, 2020, XOMA had cash of $84.2 million compared with $56.7 million on December 31, 2019. The Company’s current cash position is expected to be sufficient to fund its operations for multiple years.

On March 10, 2021 Oncorus, Inc. (Nasdaq:ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported fourth quarter and full year 2020 financial results and provided business highlights (Press release, Oncorus, MAR 10, 2021, View Source [SID1234576414]).

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"2020 was a year of significant evolution for Oncorus as we successfully transitioned to a clinical-stage and publicly-traded company," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "In addition to moving our lead viral immunotherapy candidate, ONCR-177, into a clinical trial, we continued to advance multiple pipeline candidates across our oncolytic Herpes Simplex Virus (oHSV) and Synthetic Virus Platforms. We also began to plan operational and manufacturing scale-up to support our anticipated growth in the coming years."

Dr. Ashburn continued, "Bolstered by a strong cash position, we anticipate multiple milestones in 2021 that will further advance Oncorus’ leadership in the viral immunotherapy space. These include the initial interim data readout from our ongoing ONCR-177 clinical trial, the nomination of our first intravenously administered synthetic virus clinical candidates as well as our second intratumorally administered oHSV clinical candidate, and the completion of the first buildout phase of our GMP clinical manufacturing facility. We look forward to continued growth throughout 2021, driven by our mission to realize the full promise of viral immunotherapy for cancer patients."

Oncorus anticipates reporting interim data from its ongoing Phase 1 clinical trial of its lead oHSV-based clinical candidate ONCR-177 in patients with solid tumor indications in the second half of 2021 through the second half of 2022. The company plans to nominate its first synthetic virus clinical candidates, coxsackievirus A21 and Seneca Valley Virus programs, in the first half of 2021 and its second oHSV clinical candidate, which will specifically target brain cancer, including glioblastoma multiforme, in the second half of 2021.

Fourth Quarter and Full Year 2020 and Recent Highlights

Recent Highlights

Recently completed public offering of common stock. In February 2021, Oncorus completed an underwritten public offering of common stock, at a public offering price of $19.00 per share, raising $57.0 million in aggregate gross proceeds.
Announced buildout of Good Manufacturing Practice (GMP) viral immunotherapy clinical manufacturing facility. In January 2021, Oncorus announced the signing of a 15-year lease to build a state-of-the-art, 88,000 square foot GMP viral immunotherapy clinical manufacturing facility in Andover, Mass. The facility is intended to provide a comprehensive solution for Oncorus’ Chemistry, Manufacturing and Controls (CMC) development needs, enabling the manufacture, quality, control and supply of clinical-grade viral immunotherapies for investigational new drug (IND)-enabling studies and clinical studies. Oncorus anticipates the first phase of the facility’s buildout will be completed in late 2021, including process development and quality control, with GMP multi-product manufacturing capabilities and full operation commencing in early 2023. Oncorus plans to continue partnering with contract manufacturing organizations to provide additional support and capacity. The company expects to employ up to 100 Oncorus team members at the site.

Announced publication of ONCR-177 preclinical data demonstrating potent and durable antitumor activity. In January 2021, Oncorus announced the recent publication of preclinical data supporting the clinical development of ONCR-177. In the paper, entitled, "ONCR-177, an Oncolytic HSV-1 Designed to Potently Activate Systemic Antitumor Immunity" (Haines, et al., 2020), published online in the journal Cancer Immunology Research, ONCR-177 demonstrated potent and durable antitumor activity in multiple immune-competent tumor models. The preclinical activity of ONCR-177 was shown to be driven by Oncorus’ unique combination of five complementary immunomodulatory transgene payloads in addition to its retention of γ34.5. A herpes simplex virus 1 (HSV-1) gene, γ34.5 allows the virus to replicate in the presence of host antiviral immune responses.
Fourth Quarter and Full Year 2020 Highlights

Appointed Steve Harbin as Chief Operating Officer (COO) and Chief of Staff. In December 2020, Oncorus appointed Steve Harbin as COO and Chief of Staff, to lead planning and execution of its anticipated operational and manufacturing scale-up. Mr. Harbin brings more than 30 years of diverse operational experience in biotech, pharmaceuticals and in-vitro diagnostics. His experience includes serving in several executive committee roles at Moderna, Inc. for six years, where he was a key driver of the company’s successful growth strategy, overseeing clinical and non-clinical manufacturing operations, supply chain, facilities and human resources. Previously Mr. Harbin served as Senior Vice President, Global Operations for France-based bioMérieux SA, and also held multiple leadership roles within Eli Lilly and Company globally.

Expanded Board of Directors with appointment of Scott Canute. In December 2020, Oncorus expanded its Board with the appointment of Scott Canute. Mr. Canute has nearly 40 years of broad experience in the biopharmaceutical industry, including leading global manufacturing and operations strategy and execution for Genzyme Corporation and Eli Lilly and Company.

Completed initial public offering. In October 2020, Oncorus completed the initial public offering of shares of its common stock at a public offering price of $15.00 per share, and raised $98.4 million in aggregate gross proceeds, including shares sold to the underwriters pursuant to a partial exercise of their option to purchase additional shares. On October 2, 2020, Oncorus’ common stock commenced trading on the Nasdaq Global Market under the ticker symbol "ONCR".
Publication of preclinical data characterizing ONCR-177’s safety strategies. In September 2020, ONCR-177’s safety strategies and their ability to enhance oHSV tolerability without impeding potency were characterized in a paper published in Molecular Therapy on ONCR-159, the unarmed version of ONCR-177, titled, "Design of an Interferon-Resistant Oncolytic HSV-1 Incorporating Redundant Safety Modalities for Improved Tolerability." (Kennedy et al., 2020). Oncorus’ oHSV platform incorporates two complementary and proprietary safety approaches, including a microRNA attenuation strategy to allow unencumbered viral replication in tumor cells while preventing replication in healthy tissues, and engineered proprietary mutations into UL37 to eliminate the virus’ ability to transport, replicate and establish latency inside neurons.
Announced clinical trial collaboration with Merck. In July 2020, Oncorus entered into a clinical trial collaboration and supply agreement with Merck (NYSE:MRK), known as MSD outside of the United States and Canada, through a subsidiary, to evaluate the combination of ONCR-177 with KEYTRUDA (pembrolizumab), as part of the ongoing Phase 1 clinical trial of ONCR-177 in adult patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors.
Initiated Phase 1 clinical trial of ONCR-177. In June 2020, Oncorus initiated a Phase 1 clinical trial of its lead product candidate, ONCR-177, an intratumorally administered oHSV viral immunotherapy being developed for multiple solid tumor indications. The Phase 1 open-label, multi-center, dose escalation and expansion clinical trial is designed to evaluate the safety and tolerability of ONCR-177 and to determine the recommended Phase 2 dose, as well as its preliminary anti-tumor activity, alone and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors. Oncorus anticipates reporting interim data from the Phase 1 clinical trial in the second half of 2021 through the second half of 2022.
Fourth Quarter Financial Results

Cash and cash equivalents were $130.3 million as of December 31, 2020 compared to $45.3 million as of December 31, 2019.
Research and development expenses for the quarter ended December 31, 2020 were $7.6 million compared to $5.9 million for the corresponding period in 2019. The increase in research and development expenses was mainly attributable to increases in clinical trial costs for the company’s Phase 1 clinical trial as well as increased personnel-related expenses driven by increased headcount.
General and administrative expenses for the quarter ended December 31, 2020 were $4.0 million compared to $3.1 million for the corresponding period in 2019. The increase in general and administrative expenses was primarily attributable to increases in personnel-related expenses driven by increased headcount as well as increased costs associated with the Company’s transition to a public company in the fourth quarter of 2020.

Net loss attributable to common stockholders for the quarter ended December 31, 2020 was $(11.8) million, or $(0.56) per share, compared to a net loss attributable to common stockholders of $(11.5) million, or $(11.78) per share for the same period in 2019. The share and loss per share amounts in the fourth quarter of 2020 reflect the impact of the company’s IPO, which closed in October 2020.
Financial Guidance

Based upon its current operating plans and cash and cash equivalents at December 31, 2020, plus the net proceeds from the public offering of common stock in February 2021, the company expects to have sufficient capital to fund its operating expenses and capital expenditure requirements into late 2023.