The University of Pittsburgh and Orange Grove Bio Establish Partnership to Develop and Commercialize Novel Therapeutics

On November 17, 2021 Orange Grove Bio, a preclinical drug investment and development firm, and the University of Pittsburgh reported the establishment of a collaboration designed to advance the development and commercialization of novel therapeutics by supporting the translation of scientific discoveries made by researchers at the University of Pittsburgh (Press release, Orange Grove Bio, NOV 17, 2021, View Source [SID1234633191]). The newly established partnership will aim to cultivate the Pittsburgh biotech landscape by increasing entrepreneurship, education, and scientific translation of promising technologies. These efforts will be focused in the areas of oncology and autoimmune and inflammatory diseases.

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"University of Pittsburgh innovators have a strong track record of achieving impact for their research through commercial translation," said Joe Havrilla, Associate Vice Chancellor for Innovation and Entrepreneurship. "This new collaboration with Orange Grove Bio will allow us to further our commercialization efforts and we look forward to the positive impact it will have for our faculty and students and ultimately for patients."

Under terms of the partnership, Orange Grove Bio will provide commercialization guidance and support to the University of Pittsburgh Innovation Institute, an internship program for the university’s Ph.D. students, and educational seminars for primary investigators and researchers at the university. Additionally, as part of these activities, Orange Grove Bio’s head of chemistry, William H. Miller, Ph.D., has joined the University of Pittsburgh’s external advisory board for novel technologies.

"Researchers at the University of Pittsburgh are engaged in a wide range of cutting-edge research that has the potential to meaningfully impact human health," said Dr. Miller. "At Orange Grove, we want to do our part to support these ongoing research efforts and further develop the local biotech environment to enable the development and commercialization of these discoveries."

In addition to working closely with the technology transfer office and supporting educational initiatives, Orange Grove Bio will increase its on-the-ground presence by onboarding new team members from the Pittsburgh area, who will perform critical scientific and business functions.

Orange Grove Bio’s mission is to develop new therapeutic options for patients by harnessing the significant research potential found in universities across the United States. Orange Grove Bio fosters strong relationships with technology transfer offices outside of the traditional medical technology hubs of Boston and San Francisco. Collectively, Orange Grove Bio’s team possesses more than one hundred years of drug development and company creation experience, allowing it to build and finance innovative programs from the research and development stage to clinical trials.

"We believe that the University of Pittsburgh and its talented researchers are well positioned to serve as a hotbed for the incubation of innovative drug development companies capable of delivering the ground-breaking therapies of tomorrow," said Marc Appel, Orange Grove Bio’s chief executive officer. "We are committed to fostering and supporting this rich scientific ecosystem through collaboration with the University of Pittsburgh, academic researchers, and investors to drive the commercialization of novel therapies for patients."

NANOBIOTIX to Present at the 4th Annual Evercore ISI HealthCONx Conference

On November 17, 2021 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ‘‘Company’’) (Paris:NANO) (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that Laurent Levy, co-founder and chief executive officer, will participate in a virtual fireside chat at the 4th annual Evercore ISI HealthCONx Conference on Thursday, December 2, 2021, at 1:00 PM EST / 7:00 PM CET (Press release, Nanobiotix, NOV 17, 2021, View Source [SID1234595736]).

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A link to the live audio webcast will be available on the Events section of the company’s website at www.nanobiotix.com. An archived recording of the presentation will be available for 90 days.

Evogene Reports Third Quarter 2021 Financial Results

On November 17, 2021 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading computational biology company targeting to revolutionize life-science product discovery and development across multiple market segments, reported its financial results for the first nine months and the third quarter of 2021, ended September 30, 2021 (Press release, Evogene, NOV 17, 2021, View Source [SID1234595752]).

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Mr. Ofer Haviv, Evogene’s President and Chief Executive Officer, stated, "I am very pleased with the overall progress and achievement of milestones we see across the board in our subsidiaries and in Evogene itself. Our subsidiaries are progressing according to plan, and we expect to hit additional milestones in the coming months. With this rapid progress, we see significant inherent value developing within each of our subsidiaries.

"As stated previously, we believe that each subsidiary, valued independently, would result in a far greater combined market value for Evogene. In this regard, we wish to unlock the value of our subsidiaries and, as disclosed, are currently examining the possibility of turning one or more of our subsidiaries into public companies. This would allow investors access to the specific subsidiary of interest and the opportunity for the markets to assign it an independent value. We are currently undertaking the required preparations in our subsidiaries to support this process and are reviewing our options regarding investment banks to achieve this target.

"Of course, the decision, if when and how to spin out a subsidiary will depend on many considerations, including market conditions, the subsidiaries financial needs, pipeline maturity, valuation, applicable regulations and other relevant aspects." Mr. Haviv concluded.

Recent Achievements:

Biomica

Immuno-Oncology program – Biomica recently signed an agreement with Rambam Health Care Campus for a clinical trial for its microbiome-based Immuno-Oncology Drug. Biomica expects to initiate its first-in-human, proof-of-concept clinical trials with Rambam later this year and is currently waiting for the approval of the Israeli Ministry of Health in order to begin.

Canonic

MetaYield program – During October 2021, Canonic initiated commercial sales of G200 and G150, part of the G-nnovation series, following positive feedback from a pre-launch campaign, in which these products were marketed in Israel to a limited number of licensed patients.

Canonic’s G200 and G150 are cannabis inflorescence products marketed under the T20/C4 and T15/C3 categories, respectively[1]. This commercial launch, which was originally scheduled for 2022, was moved forward following the aforementioned positive feedback in Israel.

AgPlenus

Appointment of a new CEO – Dr. Brian Ember has been appointed as Chief Executive Officer of AgPlenus. Dr. Ember brings extensive experience in the ag-chemicals industry, holding various senior leadership roles, including Head of Global Portfolio Management and Head of Marketing and Business Development, Americas for Biotalys, an agricultural technology company focused on reinventing food protection with protein-based biocontrol solutions; Senior Director, Business Development for AgriMetis, an innovative crop protection company; and various management roles at BASF and Syngenta.

Lavie Bio

result inoculant (previously LAV.211) – Lavie Bio announced initial commercial launch of its first microbiome-based product for yield improvement – result. This inoculant is being introduced for spring wheat following positive four-year field trials. The first phase of marketing, and initial market penetration, in the upcoming 2022 spring wheat season will be limited to target regions in North Dakota, which is estimated as an overall 6-million-acre spring-wheat market[2]. This initial phase of marketing will be accomplished under a distribution agreement with United Agronomy, as recently announced[3]. Initial sales are expected to be recorded in 2022.

Change in management – Mr. Ido Dor, Lavie Bio’s Chief Executive Officer, has announced that he is stepping down from his position. Evogene thanks Mr. Dor, who has been an integral part of the Evogene group over the past 10 years and significantly contributed to the activities and success over the years. Mr. Dor will continue to serve as a consultant of Lavie Bio. Lavie Bio is currently seeking a replacement for this position and during that period Mr. Ofer Haviv, Evogene’s President and Chief Executive Officer, will serve as an active chairman of Lavie Bio.

Evogene

CRISPR-IL consortium – The Israeli Innovation Authority (IIA) informed Evogene of its decision to fund a second 18-month period of the CRISPR-IL consortium established last year. The consortium’s mission is to develop and validate an end-to-end artificial intelligence (AI) system – "Go-Genome" – for genome-editing in multi-species for applications in pharma, agriculture, and aquaculture.

Beyond activities within the consortium’s scope, companies participating in the consortium may use "Go-Genome" for their own product development activities. In this respect, Evogene is currently conducting various proof-of-concept experiments in plant tissue, examining the feasibility of increasing the production of ingredients such as natural colors and anti-aging agents for food or cosmetic purposes.

Appointment of a new board member – Mr. Dan Falk has been appointed to Evogene’s Board of Directors, commencing November 17, 2021. Mr. Falk has extensive experience of more than 20 years in serving as a financial expert on public and private company boards, most recently on the boards of Nice Ltd., Ormat Technologies Inc. and Innoviz Technologies Ltd.. Additionally, in the past Mr. Falk held various executive positions in Orbotech Ltd. and Sapiens International Corporation.

Consolidated Financial Results Summary

Cash position: Evogene maintains a strong financial position for its activities with $61.6 million in consolidated cash, cash related accounts, bank deposits and marketable securities as of September 30, 2021, of which $9.3 million of Evogene’s consolidated cash is appropriated to its subsidiary, Lavie Bio.

During the first nine months of 2021, the consolidated net cash usage was approximately $17.3 million, or $13.6 million, if excluding Lavie Bio. This is in comparison to the first nine months of 2020, during which the consolidated cash usage was $13.4 million, or $9.3 million, if excluding Lavie Bio. These sums in 2021 exclude $29.6 million net raised through Evogene’s at-the-market, or ATM, offerings (including $2.6 million raised under its current ATM, announced in March 2021) and excludes an additional $1.0 million in proceeds from grants received and exercises of options.

During the third quarter, the consolidated cash usage, was $6.0 million, or $4.6 million, excluding Lavie Bio. This is in comparison to the third quarter of 2020, during which the consolidated cash usage was $4.6 million, or $3.0 million, if excluding Lavie Bio.

The cash burn rate during the first nine months of 2021 and in the third quarter, was higher than during the same period in 2020, for the following reasons:

During the second and third quarter of 2020, the burn rate was relatively low due to certain measures the company initiated to mitigate the impact of the COVID-19 pandemic on the Company.
During the first nine months of 2021 Evogene’s subsidiaries significantly expanded product development activities, including:
– Biomica’s ongoing preparations for the initiation of its first-in-human proof-of-concept study in the immuno-oncology program, later this year.
– Lavie Bio’s activities supporting the commercial launch of its inoculant product branded as result in 2022.
– Canonic’s pre-launch campaign, initiated in September 2021, prior to product commercialization, which took place in Israel during the fourth quarter of 2021.
Management continues to estimate that the cash usage for the full year of 2021 will be within the anticipated range of $20-$22 million. These guidelines exclude the cash usage of Evogene’s subsidiary Lavie Bio.

Research and Development ("R&D") expenses: R&D expenses for the third quarter of 2021, which are reported net of grants received, were $5.8 million, in comparison to $4.0 million in the third quarter of 2020. The increase in R&D expenses was mainly attributed to the product development activities of the Company and its subsidiaries, as mentioned above.

Business Development ("BD") expenses: BD expenses were $0.8 million for the third quarter of 2021, in comparison to $0.6 million in the third quarter of 2020. The increase was attributed mainly to Canonic’s and Lavie Bio’s preparations for commercialization.

General and Administrative ("G&A") expenses: G&A expenses for the third quarter of 2021 were $2.0 million, in comparison to $1.2 million in the third quarter of 2020. The increase was mainly attributed to the increase of the costs of directors’ and officers’ insurance policies and a relative increase in salary expenses following a temporary reduction in such expenses in the corresponding quarter in 2020, due to steps taken to mitigate the financial impact of the COVID-19 pandemic on the Company

Operating loss: Operating loss for the third quarter of 2021 was $8.6 million in comparison to $5.6 million in the third quarter of 2020.

Net loss: The net loss for the third quarter of 2021 was $8.3 million in comparison to a net loss of $5.4 million during third quarter of 2020. The increase in loss is attributed to the increase in product development activities, an increase in commercialization and marketing expenses and an increase in directors’ and officers’ insurance cost.

Replay Information: A replay of the conference call will be available approximately two hours following the completion of the call.

To access the replay, please dial 1-888-326-9310 toll free from the United States, or +972-3-925-5901 internationally. The replay will be accessible through November 19, 2021, and an archive of the webcast will be available on the Company’s website.

Oncorus to Present at the Jefferies London Healthcare Conference

On November 17, 2021 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported that President and Chief Executive Officer, Theodore (Ted) Ashburn, M.D., Ph.D., will present at the Jefferies London Healthcare Conference (Press release, Oncorus, NOV 17, 2021, View Source [SID1234595737]).

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The presentation will be available for on-demand viewing beginning Thursday, November 18, 2021 at 3:00 a.m. ET under the Investors & Media section of Oncorus’ website at View Source A replay of the presentation will be archived on Oncorus’ site for 30 days following the event.

Photocure ASA: Results for the third quarter of 2021

On November 17, 2021 Photocure ASA (OSE: PHO) reported Hexvix/Cysview revenues of NOK 86.7 million in the third quarter of 2021 (Q3 2020: NOK 49.6), and EBITDA of NOK -0.2 million (-5.4), following the continued successful launch in markets previously operated by Ipsen Pharma SAS (Press release, PhotoCure, NOV 17, 2021, View Source [SID1234595753]). The Company plans to increase its investment in commercial activities to further penetrate the large potential market opportunity for its bladder cancer treatment.

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"Photocure continued to grow its business during the third quarter of 2021, despite the challenges that arose from the surge of Covid-19 Delta which impacted medical procedures around the world. We delivered Hexvix/Cysview revenue of NOK 86.7 million, up 75% compared to the third quarter of 2020. These results were primarily driven by our reacquisition of the Hexvix business in continental Europe and our focus on territories where healthcare access improved in the third quarter. Importantly, demand for blue light cystoscopy (BLC) equipment remains strong with 14 towers placed in the U.S. in Q3. We remain conservative on the number of towers that we expect to place over the next couple of quarters, given Karl Storz’s planned transition to a new high-definition system in 2022. We believe that launch of the upgraded BLC system is an exciting opportunity with the potential to significantly increase the installed base of BLC towers in the U.S. next year and beyond," said Daniel Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 87.4 million in the third quarter of 2021 (NOK 49.9 million), and EBITDA* of NOK -0.2 million (NOK -5.4 million). Hexvix/Cysview revenues were NOK 86.7 million (NOK 49.6 million) following the successful transition of the Ipsen territories and unit sales growth of 6% in the U.S. EBIT ended at NOK -6.3 million (-16.4) and the cash balance at the end of third quarter 2021 was NOK 330.1 million, compared to NOK 321.8 million reported in the third quarter of 2020.

The installed base of blue light cystoscopes in the U.S. was 302 at the end of the third quarter, an increase of 49 units or 19% since the same period in 2020. BLC with Cysview in the surveillance setting is a priority for Photocure in the U.S. market. By the end of the third quarter, a total base of 45 flexible cystoscopes had been installed giving more patients access to the procedure with less constraints.

"We continue to maintain a strong financial position with NOK 330 million in cash and minimal debt. We reported break-even EBITDA in the third quarter, as we continue to manage through what appears to be the tail end of the pandemic and have begun to invest more aggressively in initiatives to regain growth in our direct markets. We also reacquired the commercial rights to Cysview in Canada and are preparing to begin growing that business in January," Schneider added.

After regaining sales and marketing rights to the European markets that were previously out-licensed, the Company has established a strong commercial presence in the largest markets of the world and believes that it is well-positioned to accelerate revenues in a post Covid-19 environment. Assuming that the effects of Covid-19 and its variants can be appropriately managed, Photocure plans to increase spending back to normalized business levels in the fourth quarter of 2021, increasing investment primarily in commercial activities to grow Hexvix/Cysview unit sales.

"We are optimistic that the challenging conditions of the pandemic that have persisted for nearly two years will improve going forward. Our teams are energized to deliver patient value and revenue growth in 2022, with the expectation of new enhanced BLC equipment and focus from Karl Storz, expansion of our business into Canada, the ability of our strengthened European commercial team to have broader access to our new customers and territories, the potential to execute on enriching our portfolio through partnerships or M&A opportunities, and anticipated progress on the ongoing Phase 3 trial for Cevira. With the impact of Covid-19 expected to abate in H1 2022, Photocure remains in a strong position to get back to the growth rates that we were delivering pre-pandemic, and to capitalize on other opportunities that can enhance our growth and path toward sustainable profitability," Schneider concluded.

Please find the full financial report and presentation enclosed.

*EBITDA and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the third quarter 2021 financial report on page 25.

Photocure will present its third quarter 2021 report on Wednesday 17 November 2021 at 14:00 CET. The investor presentation will be streamed live and be hosted by Daniel Schneider, CEO and Erik Dahl, CFO.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through https://channel.royalcast.com/landingpage/hegnarmedia/20211117_5/