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Onxeo Reports Full-Year 2020 Financial Results and Provides Business Update

On April 21, 2021 Onxeo S.A. (Euronext Growth Paris: ALONX, Nasdaq First North Copenhagen: ONXEO), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage response (DDR) in oncology, reported its consolidated financial results for the fiscal ending December 31, 2020, and provided a business update (Press release, Onxeo, APR 21, 2021, View Source [SID1234578293]).

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Judith Greciet, Chief Executive Officer of Onxeo, declared: "2020 was marked for all by an unprecedented health crisis. Yet it will have allowed Onxeo to demonstrate the resilience of its teams and strategy. The clinical program for AsiDNA, our lead candidate, made very significant progress in 2020 on its two development axes, synergy of efficacy with DNA breakers as radio or chemotherapy, and the fight against tumor resistance to targeted therapies.

On the first axis, the positive efficacy signals obtained in DRIIV-1b, combining AsiDNA with reference chemotherapies, have enabled the preparation of a randomized phase 2 trial in lung cancer. Its adaptive design would allow it to be converted into a pivotal study based on initial positive results. Enrolment will start in the second half of 2021, as soon as regulatory approval is obtained. We have also initiated a Phase 1b/2 pediatric program with the Curie Institute in recurrent high-grade glioma, a brain cancer with a poor prognosis, against which the combination of AsiDNA with radiotherapy could offer an efficacy gain.

In the fight against resistance to targeted therapies, the Phase 1b/2 Revocan study, which is evaluating the effect of AsiDNA on resistance to a PARP inhibitor in ovarian cancer, began in late 2020 and patient enrollment is ongoing. This study is sponsored by Gustave Roussy who leads its management and we expect to receive preliminary results from the first group of patients during the second half of the year. In addition, recent results presented at AACR (Free AACR Whitepaper) 2021 confirm the effect of AsiDNA on drug-tolerant cells, one of the causes of resistance to targeted therapies such as PARP, KRAS or tyrosine kinase inhibitors. These results provide a strong rationale to consider an expansion of the clinical development of AsiDNA in other very high potential combinations.

Finally, the OX400 candidates have confirmed in preclinical studies their action on tumor metabolism and the immune system, presaging promising clinical combinations with immunotherapies.

This extensive and ambitious R&D program reflects the significant potential of our candidates in multiple combinations and therapeutic areas.

Over the past twelve months, we have also significantly strengthened Onxeo’s financial and shareholder structure. Invus, an international investor specializing in biotechnology, has joined Financière de la Montagne in the capital and on the Board of Directors of the Company. Their support has contributed to extend our financial horizon to the end of 2022 – well beyond the major clinical milestones expected in the next 18 months – and validates our strategy to expand the clinical and industrial development of our candidates."

The 2020 consolidated accounts were approved by the board of directors on April 21, 2021. The audit procedures on the consolidated accounts have been carried out. The certification report is in the process of being issued.

Revenues for the year 2020 amounted to €1.8 million and include:

€1.1 million in recurring revenue corresponding to sales of Beleodaq under the European Named Patient Program (NPP) and royalties on sales of Beleodaq in the United States by the partner Acrotech Biopharma. Its decrease from €3.5 million in 2019 is explained by the transfer of this activity to Acrotech as part of the licensing agreement signed in early April 2020.
€0.7 million in non-recurring revenue, comprising contractual lump-sum royalties under the business transfer agreement signed in 2017 with Vectans Pharma.
Operating expenses amounted to €9.8 million, compared to €14.1 million in 2019. The 31% decrease is mainly related to lower R&D expenses, notably manufacturing operations of AsiDNA for clinical trials in 2019, as well as strict management of all the Company’s expenses.

Other operating income (non-current) amounted to €10.0 million and included the impacts of the agreement with Acrotech Biopharma in April 2020, namely:

a net income of 5.7 million euros corresponding to the transaction price of €6.1 million less payments to be made to Acrotech Biopharma for future product development costs estimated at €0.4 million;
a charge of 2.8 million euros corresponding to the net book value of the R&D assets related to Beleodaq/belinostat, reflecting the treatment of the contract with Acrotech under IFRS as a sale agreement;
7.1 million euros of proceeds, evaluated on the basis of the financing plan established by management, corresponding to the royalties that the Company expects to receive after the date of signature of the agreement and that are intended to repay the balance of the loan contracted with SWK Holdings Corporation. This amount includes 1.6 million euros of royalties recorded for 2020 after the transaction.
The financial result of €-0.3 million is mainly explained by the interest expense related to the bond debt with SWK.

The tax charge is €0.8 million and includes deferred taxes of €0.4 million, relating to the royalties the Company expects to receive after December 31, 2020, through which it will repay the balance of the SWK loan.

Net income for the year ended December 31, 2020 was a profit of €1.1 million, resulting mainly from the Acrotech transaction and its accounting treatment under IFRS, compared with a loss of €33.7 million for the year ended December 31, 2019 that was linked with a €12.9 million impairment of belinostat-related R&D assets as well as the impacts of the settlement agreement signed with SpePharm early 2020 (-€9.6 million).

STRENGTHENED FINANCIAL STRUCTURE

As of December 31, 2020, the Company had consolidated cash and cash equivalents of €14.5 million, compared to €5.7 million at the end of fiscal 2019. This sharp increase stems from financing obtained during the year; in particular, the Company completed a private placement in June 2020 with a new investor, Invus Public Equities LP, and Financière de la Montagne, the historical shareholder, for €7.3 million, and it also used the balance of its equity financing line for €3.2 million. The Company also received a payment of $6.6 million in consideration for the granting of additional exclusive rights to belinostat to Acrotech Biopharma LLC in April 2020.

The Company’s cash position has since been strengthened by obtaining, at the end of January 2021, a €5 million financing in the form of State Guaranteed Loans (SGL) and by the proceeds of the capital increase with shareholders’ preferential subscription rights (PSR) finalized on April 12, for a gross amount of €9.7 million. The Company’s financial visibility has thus been extended to the end of 2022.

FULL-YEAR 2020 HIGHLIGHTS, RECENT DEVELOPMENTS AND OUTLOOK FOR 2021

AsiDNA

Revocan study
At the beginning of 2020, Onxeo launched the Revocan study to evaluate the effect of AsiDNA on acquired resistance to a PARP inhibitor (PARPi), in 2nd line recurrent ovarian cancer. This Phase 1b/2 study is sponsored by Gustave Roussy. Enrollment in the study began at the end of 2020 and is continuing, albeit at a slower pace than anticipated, notably due to the epidemic situation. However, it should be noted that as study sponsor, GR is managing the project. Preliminary results of part 1b, initially expected in the first half of the year, are now expected from Gustave Roussy in the second half of the year. The study aims to confirm preclinical data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in June 2020, which showed the ability of AsiDNA to reverse PARPi resistance, notably by preventing the regrowth of drug-tolerant cells.

DRIIV1-b study – Upcoming phase 2 study
Onxeo published favorable interim results from the DRIIV-1b study of AsiDNA in combination with standard of care chemotherapies in patients with progressing metastatic tumors in November 2020. Exceptionally long disease control times were observed and are particularly encouraging signals of efficacy. As a result, the Company plans to continue development in this combination in 2021 with a randomized Phase 2 study of AsiDNA in non-small cell lung cancer. The adaptive design of this international multicenter study, currently under development, would allow its transformation into a pivotal study.

New clinical developments
In February 2021, Onxeo entered into a clinical research agreement with Institut Curie, France’s leading cancer center, to conduct a Phase 1b/2 study to evaluate the effect of AsiDNA in combination with radiotherapy in children with recurrent high-grade glioma (HGG) eligible for re-irradiation. This study is supported by a grant from the European Fight Kids Cancer program and is being conducted as part of the European Innovative Therapies for Children with Cancer (ITCC) consortium.

As part of the acceleration of its development, the Company may also file an IND application to expand the clinical program of AsiDNA in the United States.

INTELLECTUAL PROPERTY

In 2020, Onxeo pursued an active policy of industrial protection. The Company received a notice of allowance from the U.S. Patent and Trademark Office for a new patent enhancing the protection of AsiDNA, which will be valid in the United States until 2037. A notice of intent to issue a new patent enhancing protection in Europe for AsiDNA combined with PARP inhibitors was also announced in late October 2020. Onxeo’s portfolio of candidates is now protected by several patent families in all territories of interest until 2040.

OX400

Onxeo continued preclinical studies of new OX400 candidates, next-generation PARP agonists from its proprietary platON platform, in 2020. New results presented at AACR (Free AACR Whitepaper) 2021 confirm that by specifically trapping and hyperactivating PARP, OX400 compounds have the potential to modulate the immune response and deplete tumor cell metabolism. The preclinical proof of concept of one or more OX400 compounds, expected in 2021, will be the starting point for the activities necessary for entry into the clinic, potentially in combination with immunotherapy, within 12 to 18 months.

CORPORATE & GOVERNANCE

In February 2020, Onxeo announced that it had reached an out-of-court settlement agreement with SpePharm and SpeBio. As part of this agreement, Onxeo will pay SpePharm 15 to 20% of the net amounts to be received under future commercial agreements relating to Onxeo’s R&D assets, for a total cumulative amount of 6 million euros within a period of 4 years, i.e. at the latest on January 31, 2024. The balance of this debt amounts to 5.1 million euros at December 31, 2020;
At its meeting on September 17, 2020, the Board of Directors of Onxeo co-opted Invus Public Equities LP, represented by Mr. Julien Miara, as a director of the Company to replace Mr. Jean-Pierre Kinet, who resigned;
In December 2020, Onxeo transferred the listing of its shares from the regulated market of Euronext Paris (compartment C) to the multilateral trading system Euronext Growth Paris. By coherence, Onxeo shares listed in Denmark on the Nasdaq Copenhagen regulated market have been transferred to the Nasdaq First North Growth multilateral trading facility.
CONTEXT OF THE COVID-19 PANDEMIC

The continuation of the global health crisis linked to the Covid-19 epidemic creates an uncertain situation. Even if Onxeo has been little impacted in 2020, it is difficult to measure the repercussions on the Company’s activity and financial situation, which will depend on the intensity and duration of this crisis. The Company has put in place appropriate measures to protect its employees and to ensure the continuity of its operations. It will adapt these measures to the circumstances.

The 2020 Financial Report will be available on the Company’s website as of April 23, 2021.

Cancer vaccines are goal of new Oxford University company

On April 21, 2021 OxVax, a new immuno-oncology firm based on research from Oxford University, reported that it has been created to deliver vaccines capable of targeting various forms of cancer (Press release, OXVax, APR 21, 2021, View Source [SID1234578292]).

The company is developing an off-the-shelf next-generation vaccine platform based on a unique proprietary population of dendritic cells capable of inducing a potent anti-tumour immune response. The company’s technology allows the bulk manufacture of these dendritic cells from stem cells derived from donor’s blood. When combined with tumour associated antigens, OxVax will be able to create a vaccine which can train the body to target and eliminate tumours. Once administered to patients, the Company’s dendritic cells are superior at migrating towards and activating cytotoxic T cells, giving the body the information it needs to identify and destroy the cancer.

The research is based on the work of Professor Paul J Fairchild and Tim Davies from the Fairchild Laboratory at the Sir William Dunn School of Pathology at Oxford University. Professor Fairchild, founding Director of the Oxford Stem Cell Institute, will join the company as Chair of its Scientific Advisory Board. Tim Davies, a research scientist with over 35 years’ experience in stem cell biology and immunology and instrumental in developing OxVax’s underpinning technology, will join as Head of Laboratory Operations. The founders will be joined by Marcelo Bravo as Chief Executive Officer, a serial entrepreneur who has taken two companies public via AIM and has worked with the academic founders as part of an MSc in Experimental Therapeutics at Oxford.

The company has raised its seed financing via South Korean-based biotech venture capitalist Lead Compass Investment and German biotech drug discovery and development partnership company Evotec. Financial details were not disclosed. OxVax is also a beneficiary of funding from the EPA Trust and Guy Newton Translational Fund as well as the University Challenge Seed Fund, managed by Oxford University Innovation, the research commercialisation arm of Oxford University, which also supported the creation of OxVax.

Professor Paul J Fairchild, Associate Professor of the Immunobiology of Stem Cells at Oxford University, said:

"Our research has shown how stem cells can be used to create potentially unlimited numbers of a rare cell type of the immune system responsible for orchestrating the immune response to solid tumours. We believe that access to these cells can open the field of cancer vaccination and transform the treatment of some of the most intractable cancers."

Marcelo Bravo, Chief Executive Officer at OxVax, added:

"Our platform enables the manufacture at scale of an off-the-shelf highly potent vaccine which addresses the major limitations that have frustrated cancer vaccine development in the past. Our immediate focus will be the definition of the quality profile of the product and the industrialisation of the manufacturing protocol which will put us in a strong position to proceed towards the clinic."

Dr. Thomas Hanke, Head of Academic Partnerships at Evotec, said:

"Cell therapies are finally coming of age. This investment fits well with Evotec’s ambition to become a biotech powerhouse in future off-the-shelf cell therapy offerings. We are very much looking forward to working with the Oxford researchers and Lead Compass to support the development of next-generation dendritic cell therapies to treat tumours with a high unmet medical need."

Tae-erk Kim, Chief Executive officer at Lead Compass Investment, added:

"We are excited to invest in OxVax’s technology since it addresses the low migration, cross-presentation, and T-cell activation problems of past dendritic cell cancer treatments. Promising results in an oncology setting would further pave the way for OxVax to expand its technology into other therapeutic areas and be the first company to have dendritic cells act as the true control tower of the immune system."

Synthesia announces $12.5M Series A to replace cameras with code, and scale their AI video generation platform.

On April 21, 2021 Synthesia, the AI video company, that has built and operates the world’s first and largest AI video platform, reported a $12.5M Series A financing round led by Matt Turck from FirstMark Capital with participation from all existing investors (Press release, UCLB, APR 21, 2021, View Source [SID1234578291]). The round is the largest investment to date in the synthetic AI video space.

Founded in 2017 by technology entrepreneurs Victor Riparbelli, Steffen Tjerrild and world-renowned professors of computer vision Matthias Niessner and Lourdes Agapito, Synthesia is focused on reducing the friction of video creation and making it possible for anyone to create professional-looking videos in minutes, directly from their browser.

The funding will be used to fuel both Synthesia’s rapid enterprise user growth and product development of their AI video generation platform.

Istari Oncology Announces Publication of Phase 1 Data Showing PVSRIPO Immunotherapy Leads to Objective Responses in Patients with Treatment-Refractory Melanoma

On April 21, 2021 Istari Oncology, Inc., a clinical-stage biotechnology company, reported the publication of "A phase 1 trial of intratumoral PVSRIPO in patients with unresectable, treatment-refractory melanoma" in the BMJ’s Journal for ImmunoTherapy of Cancer (Press release, Istari Oncology, APR 21, 2021, View Source [SID1234578290]). The results of this study suggest that PVSRIPO holds promise for patients with advanced melanoma refractory to both PD-1 inhibitors and BRAF-targeted therapy.1

Twelve patients received 1, 2, or 3 intratumoral injections of PVSRIPO at 21-day intervals. Four of six patients (67%) who received 3 injections had an objective response, 3 of whom received anti-PD-1 therapy within 30 days prior, suggesting that PVSRIPO was able to initiate or rekindle immune responses in patients who have failed anti–PD-1 therapy. Responses were observed in both injected and noninjected tumors, suggestive of an abscopal response. These results are consistent with the findings from mechanistic studies that PVSRIPO generates a functional antitumor CD8+ T cell response capable of mediating effective, systemic antitumor immunity.2,3

Following study completion, 11/12 patients (92%) re-initiated immune checkpoint inhibitor-based therapy, and 6/12 patients (50%) remained without progression at a median follow-up duration of 18 months. The antitumor responses observed suggest that PVSRIPO, either alone or in combination with anti–PD-1, may be an effective treatment in anti–PD-1 refractory melanoma.1

"The responses observed in patients with advanced disease, including in noninjected tumors in patients with significant in transit metastases, is potentially good news for the growing population of patients with unresectable melanoma who are refractory to anti–PD-1 and BRAF-targeted therapies," said Georgia Beasley, MD, Principal Investigator of the phase 1 study at Duke University. "These responses were observed without serious or dose-limiting toxicities."

"The responses seen in both injected and noninjected in-transit tumors with PVSRIPO are an important finding," noted Yana Najjar, MD, Assistant Professor of Medicine at the UPMC Hillman Cancer Center and Principal Investigator of the LUMINOS-102 phase 2 multicenter study (NCT04577807), which is investigating PVSRIPO alone and in combination with anti–PD-1 therapy and is now open to enrollment across the United States. "LUMINOS-102 will build on these data and further evaluate the ability of PVSRIPO to generate a systemic immune response that fights cancer in both injected and noninjected tumors and suppresses cancer growth over time in patients with unresectable anti–PD-1 refractory melanoma."

"The findings of this study are important further evidence of the therapeutic potential of PVSRIPO," said W. Garrett Nichols, MD, MS, Chief Medical Officer at Istari Oncology. "PVSRIPO appears uniquely capable of engaging both innate and adaptive immune responses to generate antitumor immunity."

For more information about Istari Oncology and their ongoing clinical trials and research on PVSRIPO, visit istarioncology.com.

About PVSRIPO
PVSRIPO is an investigational immunotherapy based on the live attenuated Sabin type 1 poliovirus vaccine that has been genetically modified for safety. PVSRIPO has a distinct point of entry (the poliovirus receptor, CD155), which is expressed on virtually all solid tumors and antigen-presenting cells. Upon entry into the cell, PVSRIPO targets tumors via two primary mechanisms: 1) direct damage to and killing of cancerous cells; and 2) generating innate and adaptive antitumor immune responses via nonlethal infection of antigen presenting cells in the tumor, which stimulates a specific signaling pathway resulting in a sustained, robust type-I/III interferon-dominant response, with minimal release of unwanted cytokines. Its effects are potentiated by prior vaccination against poliovirus. PVSRIPO has been granted Breakthrough Therapy Designation and Orphan Status by the FDA in recurrent glioblastoma. PVSRIPO has also been granted Orphan Status by the FDA for advanced melanoma.

Recursion Pharmaceuticals Announces Closing of Initial Public Offering

On April 21, 2021 Recursion Pharmaceuticals, Inc. ("Recursion" or "we") reported the closing on April 20, 2021 of its initial public offering of 27,878,787 shares of its Class A common stock, which includes the exercise in full of the underwriters’ option to purchase 3,636,363 additional shares of its Class A common stock, at a price to the public of $18.00 per share (Press release, Recursion Pharmaceuticals, APR 21, 2021, View Source [SID1234578289]). Including the option exercise, the gross proceeds from the offering were $501.8 million, before deducting underwriting discounts and commissions and other offering expenses payable by Recursion. All of the shares were offered by Recursion. The shares began trading on the Nasdaq Global Select Market on April 16, 2021 under the symbol "RXRX."

Goldman Sachs & Co. LLC and J.P. Morgan acted as lead book-running managers for the offering. BofA Securities, SVB Leerink and Allen & Company LLC also acted as active book-running managers. KeyBanc Capital Markets acted as book running manager for the offering.

Registration statements relating to this offering have been filed with the Securities and Exchange Commission and became effective on April 15, 2021. This offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526 or by email at [email protected]; or J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at (866) 803-9204 or by email at [email protected]. Copies of the final prospectus related to the offering are also available at www.sec.gov.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.