On November 17, 2022 Evogene Ltd. (Nasdaq: EVGN) (TASE: EVGN), a leading computational biology company targeting to revolutionize life-science based product discovery and development utilizing cutting edge computational biology technologies, across multiple market segments, reported its financial results for the third quarter, ended September 30, 2022 (Press release, Evogene, NOV 17, 2022, View Source [SID1234624224]).

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Mr. Ofer Haviv, Evogene’s President and Chief Executive Officer, stated, "Reviewing our developments in 2022, the activities of Evogene and our subsidiaries are advancing well, and we have met important milestones. Each one, whose technology leverages Evogene’s AI tech engines, is generating significant value for the Evogene Group, and I am very pleased with our progress.

"An example for such milestone progress can be seen in our clinical trial for subsidiary Biomica’s microbiome-based immuno-oncology drug candidate, which was launched earlier this year and developed using Evogene’s MicroBoost AI tech engine. In recent weeks, we progressed to our third patient out of twelve, and we aim to have our first data readout in spring 2023, as these first few patients conclude their treatment programs. Another important milestone achieved recently by our subsidiary Lavie Bio, was the submission of the registration package to the U.S. Environmental Protection Agency in October, for its novel bio-fungicide product, developed using Evogene’s MicroBoost AI tech engine. We expect this process to take around 18 months. Our goal is a soft launch for the 2024 growing season, pending the regulatory approval."

Continued Mr. Haviv, "In these challenging times in the capital markets, it’s important to emphasize that we maintain a strong consolidated cash position of approximately $38 million, which based on our business plan, we expect will be enough to take us towards late 2024. Furthermore, with the strategic steps we continue to pursue, the fundraising at our subsidiary level, as well as the collaborations with non-dilutive payments, we believe we will extend this runway out further.

"The strategic collaboration and $10 million investment in the quarter by ICL, a leading specialty minerals company, into our subsidiary, Lavie Bio, is a great example of the successful execution of this strategy. It brought a new and additional source of capital to that subsidiary, it brought a value-adding partner to the subsidiary, which has a strong share in the ultimate success and upside in that subsidiary, and it also demonstrated the inherent financial value of the subsidiary and ultimately Evogene’s share in it. We continue to work hard in identifying additional value-adding partners and investors and bringing them into our subsidiaries."

Added Mr. Haviv, "In parallel, we continue to pursue collaborations which can add new revenue streams for both Evogene and its subsidiaries, built upon the successful products all developed using Evogene’s underlying AI tech-engines. A recent example for this strategy was the announcement made by our subsidiary Casterra, focusing on castor seed technology development. They signed a royalty agreement with Zambian company, Titan, for sales of castor oil produced by Titan, which are based on Casterra’s castor seeds and developed using Evogene’s GeneRator AI tech engine.

"Another collaboration we are proud of was announced by our subsidiary Canonic, developing cannabis products, leveraging Evogene’s GeneRator AI tech engine. They announced a new licensing and royalty agreement signed with GroVida, a Portuguese cannabis cultivation company, in European markets for two of our new cannabis lines. Europe is a first and key target market for Canonic beyond our local market in Israel, with total medical cannabis market sales estimated at approximately €400 million."

Concluded Mr, Haviv, "These represent some of the initial fruits of our focus on this strategy and I look forward to further such deals in the coming months."

Consolidated Financial Results Summary

Cash position: Evogene continues to maintain a solid financial position for its activities with approximately $38 million in consolidated cash, cash equivalents and marketable securities as of September 30, 2022. Approximately $11.9 million of Evogene’s consolidated cash is appropriated to its subsidiary, Lavie Bio.

During the third quarter, the consolidated cash usage was approximately $7.3 million, or approximately $4.7 million, excluding Lavie Bio.

Revenues: Revenues for the third quarter of 2022 were $466 thousand, in comparison to $151 thousand in the same period the previous year and were primarily due to revenues recognized per the collaboration agreement of Evogene’s subsidiary AgPlenus with Corteva.

R&D expenses for the third quarter of 2022, which are reported net of non-refundable grants received, were $5.0 million, in comparison to $5.8 million in the same period the previous year. The main contributors to R&D expenses were Lavie Bio’s activities supporting the production and commercialization of its inoculant product and Evogene’s ongoing development of its technology engines.

Business Development expenses were approximately $0.9 million for the third quarter of 2022, in comparison to $0.8 million in the same period the previous year.

General and Administrative expenses were $1.6 million in the third quarter of 2022, in comparison to $2.0 million in the same period in the previous year.

Operating loss: Operating loss for the third quarter of 2022 was $7.1 million in comparison to $8.6 million in the same period in the previous year.

Financing expenses for the third quarter of 2022 were $61 thousand, in comparison to financing income of $221 thousand in the same period in the previous year. The difference between periods was mainly due to U.S. Dollar and New Israeli Shekel exchange rate differences between periods and a change in the value of marketable securities.

Net loss: Net loss for the third quarter of 2022 was $7.2 million, in comparison to a net loss of $8.3 million in the same period in the previous year.

The Company’s investor presentation can be viewed at the above link, which is in the investor relations section of the company website.

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 following the call for three days. An archive of the webcast will be available on the Company’s website.

On November 17, 2022 Avenge Bio, Inc. ("Avenge" or the "Company"), a biotechnology company developing the LOCOcyte Immunotherapy platform for the precision administration of potent immune effector molecules to treat solid tumors, reported Michael Heffernan, Founder and Chief Executive Officer, will present at the Piper Sandler 34th Annual Healthcare Conference in New York (Press release, Avenge Bio, NOV 17, 2022, View Source [SID1234624223]).

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About LOCOcyte Platform
Our LOCOcyte allogeneic cell-based immunotherapy platform enables potent localized modulation of the immune system which also precipitates a systemic immune response, allowing us to treat previously intractable cancers. The technology leverage three unique advantages:

Potent immune effector molecules are generated by synthetically engineering allogeneic cells creating a ready-to-use therapy,
Therapy is localized in proximity to the primary tumor site and generates innate and adaptive immune response, and
The immunomodulator trains the patient’s immune system generating a robust immune response that seeks and eradicates distal metastasis without systemic toxicity.

On November 17, 2022 LadRx Corporation (OTCQB: LADX) ("LadRx" or the "Company"), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, reported the below update to stockholders (Press release, LadRx, NOV 17, 2022, View Source [SID1234624222]).

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Dear Stockholders,

Welcome to LadRx’s latest update for the quarter ending September 30, 2022. Please see our 10Q filed on November 10, 2022, for detailed financial reporting and analysis.

As a reminder, the Company has developed a chemotherapeutic delivery system called LADR (Linker-Activated Drug Release). LADR is a small organic molecule that can be attached to chemotherapeutic agents in order to target the delivery and release of the chemotherapeutic agent to solid cancers. The LADR-mediated targeting of chemotherapeutics to cancers could be reasonably expected to increase the amount of chemotherapeutic that can be safely dosed in a human (or in some cases allow for safe use of chemotherapeutics too powerful to be used without targeted delivery), and to reduce off-target side effects attributable to the chemotherapeutic agent.

The first-gen LADR-based chemotherapeutic that is most advanced is Aldoxorubicin. Aldoxorubicin is composed of the first-gen LADR molecule linked to the widely-used chemotherapeutic agent doxorubicin. Aldoxorubicin has proven the concept of LADR in that it can be dosed several times higher than doxorubicin, with fewer side effects. The Company out-licensed Aldoxorubicin to Immunity Bio, and Aldoxorubicin is currently in human clinical trials (see below).

The next-gen LADR-based drugs employ an improved linker. The Company’s current pre-clinical drug candidates are based on this next-gen LADR design, namely LADR7-10. LADR7 and 8 employ the highly potent chemotoxin Auristatin E, while LADR9 and 10 employ another highly potent chemotoxin called Maytansine.

LADR7

During Q3, we continued to move LADR7 towards IND in the most capital-efficient way possible. The IND-enabling activities for LADR7 at this stage include a full inventory of IND-enabling data generated thus far for LADR7, and developing the strategy for completing the IND-enabling work for LADR7, as well as dovetailing that strategy into future LADR products. As we have stated previously, we are pleased with the amount and quality of IND-enabling work that has been completed for LADRs7-10, and we feel that the IND-enabling work remaining for LADR7 is minimal. The next steps for LADR7 are to manufacture clinical-grade product, and to perform basic toxicology studies using the clinical-grade material (toxicology studies have already been performed with non-clinical-grade material). It is our current opinion that successful completion of these activities will position LADR7 for submission of an IND to the FDA. The steps of clinical-grade manufacture and final toxicology are expected to cost approximately $2M in direct costs, so we will not initiate this work until further funding is received (variations to this estimate can be expected as the project initiates).

Aldoxorubicin

The Company has out-licensed the development and commercialization of Aldoxorubicin to Immunity Bio (NASDAQ:IBRX) for approximately $343M in milestones and additional royalties on sales (dependent on certain regulatory approvals, which are not guaranteed). Immunity Bio recently announced that they have completed enrollment in a registrational-intent Phase II in pancreatic cancer, and have scheduled a Type B meeting with the FDA in December of 2022. In the same release (see Immunity Bio Overview Presentation, November 2022), Immunity Bio indicated that a Phase II in glioblastoma is planned. We look forward to continued updates from Immunity Bio’s testing of Aldoxorubicin in these two very high-need patient populations.

Arimoclomol

The Company’s non-oncology asset, Arimoclomol, was out-licensed to Orphazyme for the treatment of Nieman-Pick Type C, a neurological disease. In May of 2022, after receiving a Complete Response Letter from the FDA, Orphazyme’s assets were purchased by KemPharm Denmark A/S, a wholly-owned subsidiary of KemPharm, Inc. In KemPharm’s most recent update on Arimoclomol, KemPharm stated, "…Based on the recent completion of the 4-year open-label safety trial, the ongoing and constructive dialogue with the FDA and the new wealth of data generated since the CRL, we now anticipate resubmitting the updated NDA as early as Q3 2023. And, while no new or unanticipated issues related to resubmission have arisen, we believe the added time will be well-spent in preparation of an NDA filing with the highest likelihood of approval." The Company’s agreement with KemPharm could, if milestones are achieved, bring up to $120M to LadRx and additional royalties on sales.

Financial Results

The Company worked diligently during the quarter to maximize our runway for the current cash, while we seek additional capital through multiple pathways. The Company is operating very efficiently, and management now estimates that current cash is sufficient to fund operations to approximately mid-2Q2023. This runway estimate includes no revenues from licensed products, and very little expenditure (or progress) on LADR product development. Despite very challenging capital market conditions, the Company continues its efforts to bring in additional capital through the least expensive means possible, and plans to continue to operate the Company efficiently.

On November 17, 2022 ImmunoMet Therapeutics, Inc., a clinical stage biotechnology company targeting metabolism to develop novel anti-cancer and anti-fibrotic therapies, reported that the first patient has been dosed in the single-arm Phase 1b trial of IM156 in combination with gemcitabine and nab-paclitaxel as frontline therapy in patients with advanced pancreatic cancer (Press release, ImmunoMet Therapeutics, NOV 17, 2022, View Source [SID1234624221]). The study is led by Shubham Pant, MD, Professor in Department of Gastrointestinal (GI) Medical Oncology and Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center.

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This clinical trial evaluates the potential of IM156 in combination with gemcitabine and nab-paclitaxel to address resistance and improve patient outcomes. The trial includes a dose escalation phase followed by an expansion phase, treating a total of approximately 25 patients with advanced pancreatic cancer. The primary endpoint is to evaluate the safety and tolerability of the combination. Exploratory efficacy endpoints include objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) using RECIST v1.1 criteria.

"Pancreatic cancer continues to be defined by high unmet need, morbidity, and mortality. There is substantial evidence that differential cancer cell metabolism, and oxidative phosphorylation (OxPhos) in particular, plays a key role in the development of resistance to current therapies. We are hopeful that this potentially best-in-class OxPhos inhibitor can improve outcomes for these patients," said Dean Welsch, CEO of ImmunoMet Therapeutics. Additional information about the trial, which is recruiting patients, can be found on clinicaltrials.gov using the identifier NCT05497778.

ImmunoMet is also pleased to announce that it has received Orphan Drug Designation status for IM156 in patients with pancreatic cancer and closed a Series C-1 financing in October 2022. ImmunoMet continues to investigate additional indications where emerging data implicate OxPhos inhibition will demonstrate anti-tumor effects.

About IM156
IM156 is a Protein Complex 1 (PC1) inhibitor that targets the oxidative phosphorylation (OXPHOS) pathway that is required to drive tumor growth and proliferation in some tumors. IM156, ImmunoMet’s lead drug candidate, is solely owned by ImmunoMet and is currently in development for the treatment of selected cancers.

On November 17, 2022 AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving quality of life for patients, reported that Jim Clemmer, President and Chief Executive Officer, and Stephen Trowbridge, Executive Vice President and Chief Financial Officer, will present at the Piper Sandler 34th Annual Healthcare Conference at 10:10 a.m. ET on Wednesday, November 30, 2022 (Press release, AngioDynamics, NOV 17, 2022, View Source [SID1234624220]).

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A live webcast of the presentation will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.