On May 28, 2019 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that they will attend the Jefferies annual Healthcare Conference in New York between June 4-7th and make a plenum presentation on June 7th 11.30am EST (Press release, Oncopeptides, MAY 28, 2019, View Source [SID1234536603]).

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The presentation will be webcasted and will available under:
www.oncopeptides.com / Investors & Media / Presentations / Jefferies 2019 Global Healthcare Conference

For further information, please contact:
Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: [email protected]
Cell phone: +46 (0)70 853 72 92

This information was submitted for publication at 10.00 CET May 28, 2019.

On May 28, 2019 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading biotechnology company developing novel products for life science markets, reported its financial results for the first quarter ending March 31, 2019 (Press release, Evogene LTD, MAY 28, 2019, View Source [SID1234536620]).

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Ofer Haviv, Evogene’s President and CEO, stated: "In 2019 we have completed the transition, as planned, to our new corporate structure consisting of Evogene, the company, as a technology hub for multiple divisions and subsidiaries in different life-science markets, each with an exclusive access to the CPB platform, our core technology, for its specific field. We currently apply the CPB platform in three general life-science markets: agriculture, human health and life-science based industrial applications."

"Looking forward, we expect Evogene’s value will stem from the activities and the derived value of its divisions and subsidiaries. When substantial milestones in their product development pipeline are achieved, or strategic collaboration agreements are announced, these should be reflected in the valuations of our divisions’ and subsidiaries’ and subsequently in Evogene’s as well, as a major shareholder. Moreover, since one of the tasks of our subsidiaries is to secure external financial resources in addition to the potential revenue they will generate through collaborations, third-party investments could provide color on our subsidiaries’ valuation as well."

"A key motivation in the establishment of our subsidiaries is to enable increased management focus and a more efficient path to product development and an important parameter in their success is the quality of their leadership. Most of our CEO’s have been with Evogene for several years, previously filling the position of general manager of our internal divisions that were the basis of our subsidiaries’ activities. I am confident that under these subsidiaries’ current leadership, each company is paving its independent path to success."

Recent Developments:

Corporate Structure:

Establishment of Lavie Bio Ltd., a subsidiary focused on ag-biologicals, aiming to improve food quality, health and sustainability, led by Mr. Ido Dor.
Establishment of Canonic Ltd., a subsidiary focused on developing next generation medical cannabis products, led by Dr. Arnon Heyman, who will participate in this quarterly call. The company’s presentation can be accessed at: View Source
Evofuel was rebranded as Casterra to better reflect its change in business focus from the castor growers for the alternative fuel industry to castor oil for industrial uses. This subsidiary is led by Mr. Assaf Dotan.
Pipeline advancement included:

Biomica announced the initiation of pre-clinical studies in its immuno-oncology program, aiming to augment current cancer therapies by altering patients’ gut microbiome to improve response
AgPlenus:
Herbicide pipeline: a leading molecule family demonstrated in-planta proof of new Mode-of-Action (MoA) and demonstrated activity on a broad panel of important weeds in greenhouse assays.
Insecticide pipeline: computational identification of a new target representing a new MoA in insect pests has been achieved. Efforts are now focused on the computational prediction of molecule families that should inhibit this target.
"I expect the achievements during the coming months will begin to reflect the existing value and potential represented by each of our divisions and subsidiaries, all powered by the CPB platform." – Mr. Haviv concluded

Consolidated financial results for the period ending March 31, 2019:

Cash position: As of March 31, 2019, Evogene had approximately $50 million in cash, short-term bank deposits and marketable securities, representing a net cash usage of approximately $4.5 million during the first quarter of 2019.

Assuming that no external financial resources are secured, such as through collaborations or external fund raising, the Company estimates that its net cash usage in 2019 will be in the range of $16 to $18 million dollars. The Company does not have bank debts.

Revenues primarily consist of research and development payments. These revenues represent R&D cost reimbursement and milestone payments under our various collaboration agreements. The majority of these agreements also provide for royalties or other forms of revenue sharing from successfully developed products.

Gross profit for the first quarter of 2019 was approximately $0.3 million in comparison to approximately $0.1 million for the first quarter of 2018.

R&D expenses for the first quarter of 2019 remained stable at approximately $3.5 million in comparison to the first quarter of 2018. This stability in R&D expenses reflects increased expenses due to advancement in the Company’s activities to later stages of product development, including field trials and pre-clinical studies provided by third parties, which was offset by operating efficiencies achieved with the new corporate structure.

Operating loss for the first quarter of 2019 was approximately $4.7 million in comparison to approximately $4.9 million in the first quarter of 2018.

The net financing income for the first quarter of 2019 was approximately $0.9 million in comparison to net financing expenses of approximately $0.4 million in the first quarter of 2018. This increase in the first quarter is due to translation of Israeli Shekel nominated cash and marketable securities to US Dollars, revaluation of the Company’s marketable securities and interest income on bank deposits.

Loss for the first quarter of 2019 decreased to approximately to $3.8 million in comparison to a loss of $5.4 million during first quarter of 2018.

Conference Call & Webcast Details:

Evogene’s management will host a conference call to discuss the results at 09:00 AM Eastern time, 16:00 Israel time. To access the conference call, please dial 1-888-668-9141 toll free from the United States, or +972-3-918-0609 internationally. Access to the call will also be available via live webcast through the Company’s website at www.evogene.com.

Dr. Arnon Heyman, CEO of Evogene’s cannabis subsidiary, Canonic, will join the conference call to discuss the company’s activity with highlights from Canonic’s presentation, which can be found on Evogene’s website under the investor relations section.

A replay of the conference call will be available approximately three hours following the completion of the call. To access the replay, please dial 1-888-326-9310 toll free from the United States, or +972-3-925-5904 internationally. The replay will be accessible through May 28, 2019, and an archive of the webcast will be available on the Company’s website through June 8, 2019.

On May 28, 2019 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) in oncology, in particular against rare or resistant cancers, reported positive final results from the DRIIV-1 phase 1 study assessing the safety and the activity of AsiDNA, the Company’s first-in-class DNA repair inhibitor, when administered intravenously in patients with advanced solid tumors (Press release, Onxeo, MAY 28, 2019, View Source [SID1234536604]).

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Olivier de Beaumont, Medical Director of Onxeo, commented: "DRIIV-1 successfully achieved each of its core objectives, including further demonstrating the favorable safety profile of AsiDNA, confirming its ability to be combined with other agents and validating its mechanism of action in patients’ tumor cells through the marked activation of its targets. Importantly, the optimal active dose of AsiDNA has been determined and is being utilized in our ongoing DRIIV-1b study combining AsiDNA with chemotherapy. We intend to present the full results of the DRIIV-1 study at future scientific meetings."

AsiDNA is the first compound of a novel class of anti-tumor products. By simulating a DNA break (decoy effect), it binds to the DNA-repairing proteins, thereby preventing the recruitment of these proteins to the damaged genomic site, leading to tumor cells death.

DRIIV-1, a phase 1 dose-escalation study of AsiDNA administered intravenously, was designed to evaluate its toxicity profile as well as its pharmacokinetics and pharmacodynamics parameters via intratumoral activity biomarkers. The study was conducted in four centers in France and Belgium and enrolled twenty-two adult patients. All patients had metastatic cancers and were failing or progressing after one or more standard treatments with no further therapeutic options.

Five dose levels have been tested (from 200 to 1,300mg) out of the six planned. It was deemed unnecessary to test the sixth dose (1,800mg) since the therapeutic window between the optimal dose of 600mg and the highest tested dose of 1,300mg is considered sufficient.

Overall, the tolerance profile of AsiDNA was considered favorable by the DSMB experts, with 90% of all product-related adverse events being non-specific grade 1 and 2 events. The maximum tolerated dose (MTD) was not reached.

Most importantly, AsiDNA demonstrated systemic activity in DRIIV-1 through the strong activation of its targets, as evidenced by the significant increase, of two intratumoral biomarkers of DNA-PK and the decrease of a tumor proliferation biomarker. At the dose of 600mg, among the 3 patients included in the cohort, 2 patients with relapsed multi-treated metastatic colorectal cancer were controlled without progression at medical imaging at the end of the second cycle of treatment with AsiDNA, with maintenance of treatment for 3 months.

This dose was considered optimal for the further development of AsiDNA in combination with chemotherapy (carboplatin and carboplatin plus paclitaxel) which started early May 2019 with the first patient treated in the phase 1b trial, DRIIV-1b.

Judith Greciet, Chief Executive Officer of Onxeo, concluded: "The successful completion of DRIIV-1 is a major milestone for Onxeo as this study validates both the systemic activity of AsiDNA and its tolerance profile well-suited for combination treatments. We expect to maintain a strong development momentum and have already started the evaluation of AsiDNA in combination with chemotherapy in the DRIIV-1b study. Our teams are already actively working on other clinical development pathways in combination, notably with PARP inhibitors. We would like to warmly thank our investigators and their teams for their support and valuable contributions to this trial and the upcoming ones."

On May 28, 2019 Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development of female-specific oncology products, reported that its lead investigational drug, lasofoxifene, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) (Press release, Sermonix Pharmaceuticals, MAY 28, 2019, View Source [SID1234536622]). Sermonix is currently engaged in a Phase 2 clinical study of lasofoxifene in estrogen receptor-positive (ER+) metastatic breast cancer.

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Fast Track designation allows companies to "get important new drugs to the patient earlier," according to the FDA. It is designed to facilitate the development of and expedite the review of drugs that treat serious conditions and fill an unmet medical need. The Fast Track designation will allow Sermonix more frequent interactions with the FDA during Phase 2 and for the potential to obtain breakthrough designation and priority review of a New Drug Application.

"Lasofoxifene’s Fast Track designation highlights the significant unmet medical needs of women who have estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation," said Sermonix Chief Executive Officer Dr. David Portman. "Fast Track will allow us to more quickly complete our development program and, if successful, make lasofoxifene available to patients sooner."

Sermonix’s open-label, randomized, multi-center Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) study will assess the activity of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation. ESR1 mutations are commonly found in women with ER+ metastatic breast cancer progressing after prior endocrine treatment and confer poorer prognosis. A liquid biopsy test will be utilized to identify women for inclusion in the ELAINE study.

"We are very encouraged to receive Fast Track designation, a recognition of lasofoxifene’s potential promise as a precision medicine for women with ER+ metastatic breast cancer," said Sermonix Chairman Dr. Anthony Wild.

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance and ESR1 mutations, a common mutation in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was recently discovered and Sermonix has exclusive rights to develop and commercialize it in this area. A potent, well-characterized SERM, lasofoxifene, if approved, could play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

On May 28, 2019 Axial Biotherapeutics, a biotechnology company dedicated to building a unique class of gut-targeted programs for neurodegenerative diseases and neurodevelopmental disorders, reported that the company will participate in the following conferences in June (Press release, Axial Biotech, MAY 28, 2019, View Source [SID1234537218]):

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BIO International Convention 2019 on Monday, June 3, 2019 at 3:00 p.m. ET in Philadelphia, PA
Panel Presentation: What’s Next: The Landscape of Innovation in 2019 and Beyond
Session ID: 537703
CNS Targets and Translational Strategies on Wednesday, June 19, 2019 at 8:05 a.m. ET in
Boston, MA
Presentation: Harnessing the Gut-Brain Axis to Discover Novel CNS Therapeutics
JMP Securities Life Sciences Conference on Thursday, June 20, 2019 at 11:30 a.m. ET in New
York, NY