Evogene Reports Second Quarter 2024 Financial Results

On August 22, 2024 Evogene Ltd. (Nasdaq: EVGN, TASE: EVGN), a leading computational biology company aiming to revolutionize the development of life-science-based products, reported its financial results for the second quarter period ended June 30, 2024 (Press release, Evogene, AUG 22, 2024, View Source [SID1234646056]).

Mr. Ofer Haviv, Evogene’s President and CEO, stated: "In our vision, we see Evogene as a pioneering company for creating groundbreaking life-science products, to improve life quality and longevity. During the past years we developed three innovative AI tech-engines addressing the main development challenges of products rooted in microbes, small molecules and genomics. Our AI tech-engines were structured to be compatible with the tremendous potential of various market segments and not limited to only one specific segment.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In order to capture the value of our AI tech-engines, our business strategy is to establish diverse collaborative partnerships through licensing or collaboration, with expert partners in specific fields that complement our technology. Together, we’ll develop novel products, aiming for full or partial ownership upon project completion. This approach maximizes the potential of our AI tech-engines, while aiming to reduce financial and development risks. Today, Evogene has 4 subsidiaries, each focusing on a different market segment, and in addition, Evogene has diverse engagements with leading companies in additional market segments, not covered by our subsidiaries.

I am very pleased to share with you the main achievements made by Evogene’s subsidiaries from the last report of our financial results."

Casterra Ag Ltd. – focuses on developing an integrated solution to enable large-scale commercial cultivation of castor to address the global demand for stable castor oil supply, mainly for the biodiesel industry. Casterra is utilizing Evogene’s GeneRator AI tech engine to direct and accelerate the development of its unique elite castor seed varieties.

-
On June 25, Casterra announced receiving a $440K purchase order to supply castor seeds to a new African country in 2024. This order from an existing customer expands Casterra’s operations and strengthens its position in the bio-fuel market.

-
On July 31, Casterra announced the successful completion of its castor seed growing and harvesting season in Brazil, with shipments planned for the third quarter of 2024. Additionally, the castor harvest season in Africa has begun as scheduled.

-
Castor seeds produced in 2024 in both Brazilian and African territories are expected to enable Casterra to meet all its existing orders, amounting to approximately $8.4M, with completion anticipated by the end of this year.

Lavie Bio Ltd. – a leading ag-biologicals company that develops microbiome-based, computational-driven novel bio-stimulant and bio-pesticide products, utilizing Evogene’s MicroBoost AI tech-engine.

-
On July 2, Lavie Bio announced the commercial expansion of its bio-inoculant Yalos to winter wheat following successful trials, with sales starting across the US for the 2024-2025 season, effectively doubling its market potential.

-
On July 22, 2024, Lavie Bio announced a milestone in its collaboration with ICL in developing bio-stimulant solutions for row crops facing extreme weather conditions by leveraging AI to identify over a dozen novel microbes within 12 months.

-
Lavie Bio’s pipeline is advancing according to plan, with field trials initiated in Q2 in most of the company’s programs, following successful optimization processes. Results are expected during Q4.

Biomica Ltd. – a clinical-stage biopharmaceutical company developing innovative microbiome-based therapeutics, utilizing Evogene’s MicroBoost AI tech-engine.

-
On May 23, positive safety and tolerability data for BMC128 was published. 72% of the patients treated have exhibited clinical benefits. 55% of patients showed sustained clinical benefit, with notable durations of effect (more than 24 months).

-
These clinical results were presented at the prestigious 2024 ASCO (Free ASCO Whitepaper) annual conference in June.

-
We look forward to continuing to evaluate BMC128’s beneficial activity in subsequent phases of clinical development.

Financial Highlights:

Cash Position: As of June 30, 2024, Evogene held consolidated cash, cash equivalents, and short-term bank deposits of approximately $20.9 million. This amount does not include $8.4 million of expected payments for the open purchase orders of Casterra . The consolidated cash usage during the second quarter of 2024 was approximately $5.7 million. Excluding Lavie Bio and Biomica, Evogene and its other subsidiaries used approximately $2.7 million in cash during the second quarter of 2024. Projected cash usage for 2024, excluding Lavie Bio and Biomica, is expected to be around $8.0 million, marking a notable 36% decrease from approximately $12.5 million in 2023.

Revenue: Revenues for the first half of 2024 were approximately $5.1 million, a significant increase from $1.3 million in the same period the previous year. This growth was primarily driven by revenues recognized from Lavie Bio’s licensing agreement with Corteva and AgPlenus’s new collaboration with Bayer. Revenues for the second quarter of 2024 were approximately $0.9 million, compared to approximately $0.7 million in the same period the previous year. The increase was mainly attributable to increased revenue in Lavie Bio.
Evogene anticipates continued revenue growth in the second half of 2024 compared to the previous year, mainly based on Casterra’s forecast for seed-order supply.

R&D Expenses: Research and development expenses, net of non-refundable grants, for the first half of 2024 were approximately $8.8 million, a decrease from $10.2 million in the first half of 2023. The decrease in expenses is mainly due to the cease of Canonic’s activities and a decrease in certain development expenses in Biomica as compared to the same period the previous year. Research and development expenses, net of non-refundable grants, for the second quarter of 2024 were approximately $4.0 million, and decreased significantly as compared to approximately $5.4 million in the same period in the previous year. The decrease is mainly attributable to decreased expenses in Canonic and Biomica, as mentioned above.

Sales and Marketing Expenses: Sales and Marketing expenses for the first half of 2024 were approximately $1.9 million, a slight increase from approximately $1.7 million in the same period in the previous year. The increase is mainly attributable to increased sales and marketing activities in Casterra during the first half of 2024 as compared to the same period in 2023. Sales and Marketing expenses for the second quarter of 2024 were approximately $0.9 million and remained stable as compared to approximately $0.9 million in the same period in the previous year.

General and Administrative Expenses: General and administrative expenses for the first half of 2024 decreased slightly to approximately $3.2 million from approximately $3.3 million in the same period last year. General and administrative expenses for the second quarter of 2024 decreased to approximately $1.5 million compared to approximately $1.8 million in the same period of the previous year, mainly due to decreased non-cash compensation and salary related expenses in Lavie Bio and Biomica, respectively, in the second quarter of 2024.

Other Expenses: The decision to cease Canonic’s operations in the first half of 2024 resulted in other expenses of approximately $0.5 million, mainly due to impairment of fixed assets in the first quarter of 2024.

Operating Loss: The operating loss for the first half of 2024 was approximately $10.2 million, a significant decrease from approximately $14.7 million in the same period of the previous year, mainly due to increased revenues as mentioned above. The operating loss for the second quarter of 2024 was approximately $6.1 million, a decrease from $7.9 million in the same period of the previous year, mainly due to decreased operating expenses as mentioned above.

Financing Income: Financing income, net for the first half of 2024 was $379 thousand, compared to financing expenses, net of $86 thousand in the same period of the previous year. This increase was primarily due to increased interest income and a revaluation of convertible SAFE. Financing income, net for the second quarter of 2024 was $138 thousand, compared to financing income, net of $144 thousand in the same period of the previous year.

Net Loss: The net loss for the first half of 2024 was approximately $9.8 million, compared to approximately $14.8 million in the same period last year. The $5.0 million decrease in net loss was primarily due to increased revenues, decreased operating expenses, partially offset by the one-time $0.5 million of other expenses, related to ceasing Canonic’s operations and an increase in financial income. The net loss for the second quarter of 2024 was approximately $6.0 million, compared to approximately $7.8 million in the same period last year. The $1.8 million decrease in net loss was primarily due to decreased operating expenses as mentioned above.

Lilly to participate in Morgan Stanley 22nd Annual Global Healthcare Conference

On August 22, 2024 Eli Lilly and Company (NYSE: LLY) reported that it will attend the Morgan Stanley 22nd Annual Global Healthcare Conference on Sept. 5, 2024. Jacob Van Naarden, executive vice president and president, Lilly Oncology, will participate in a fireside chat at 7:45 a.m. Eastern time (Press release, Eli Lilly, AUG 22, 2024, View Source [SID1234646055]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

Bristol Myers Squibb Statement on Oncologic Drugs Advisory Committee (ODAC) Meeting to Discuss PD-L1 Expression Levels in Gastric and Esophageal Cancers

On August 22, 2024 The U.S. Food and Drug Administration (FDA) reported that it will hold a public meeting of the Oncologic Drugs Advisory Committee (ODAC) on September 26, 2024, to discuss a class-wide risk-benefit assessment of PD-L1 expression level cutoffs for immune checkpoint inhibitors in gastric and esophageal cancers. Cumulative data have shown that PD-L1 expression appears to be a predictive biomarker of treatment efficacy in these patient populations. As part of this meeting, Bristol Myers Squibb will meet with the Committee to discuss approved U.S. indications for Opdivo (nivolumab)-based combinations in advanced or metastatic gastric cancer (GC), gastroesophageal junction cancer (GEJC), and esophageal adenocarcinoma (EAC), and unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) (Press release, Bristol-Myers Squibb, AUG 22, 2024, View Source [SID1234646054]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"With proven survival benefits, Opdivo-based regimens have changed the outlook for patients with GC, GEJC, EAC and ESCC regardless of PD-L1 status," said Ian M. Waxman, M.D., vice president, senior global program lead, late development, oncology, Bristol Myers Squibb. "We look forward to the opportunity to discuss the importance of Opdivo-based regimens as treatment options for appropriate gastric and esophageal cancer patients more in depth with the Committee."

Opdivo in combination with fluoropyrimidine and platinum-containing chemotherapy was granted full approval by the FDA for the treatment of adult patients with advanced or metastatic GC, GEJC, and EAC in 2021. This approval was supported by results of the Phase 3 CheckMate -649 trial. In CheckMate -649, Opdivo plus chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared with chemotherapy in all randomized patients regardless of PD-L1 status. CheckMate -649 is the largest Phase 3 trial of an immunotherapy in advanced or metastatic GC, GEJC, and EAC.

Opdivo in combination with fluoropyrimidine and platinum-containing chemotherapy and Opdivo in combination with Yervoy (ipilimumab) were granted full FDA approval in 2022 for the first-line treatment of adult patients with unresectable advanced or metastatic ESCC. This approval was supported by results of CheckMate -648, the largest Phase 3 trial of an immunotherapy in first line ESCC, which showed that the two Opdivo-based regimens demonstrated a statistically significant and clinically meaningful OS benefit compared to chemotherapy alone in all randomized patients who were enrolled regardless of PD-L1 status.

Opdivo and Opdivo-based combinations are important treatment options for multiple types of cancers with FDA approvals across 11 cancer types. In addition to GC, GEJC, EAC, and ESCC, Opdivo and Opdivo-based combinations are also approved in melanoma, renal cell carcinoma, urothelial carcinoma, classic Hodgkin lymphoma, colorectal cancer, non-small cell lung cancer, malignant pleural mesothelioma, hepatocellular carcinoma and squamous cell carcinoma of the head & neck.

BioCryst to Present at Upcoming Investor Conferences

On August 22, 2024 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company plans to present at the following conferences (Press release, BioCryst Pharmaceuticals, AUG 22, 2024, View Source [SID1234646053]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

2024 Wells Fargo Healthcare Conference in Boston on Thursday, September 5, 2024, at 1:30 p.m. ET.
H.C. Wainwright 26th Annual Global Investment Conference in New York on Monday, September 9, 2024, at 9:00 a.m. ET.
2024 Cantor Global Healthcare Conference in New York on Thursday, September 19, 2024, at 12:45 p.m. ET.

Links to the live audio webcasts and replays of the presentations may be accessed in the Investors & Media section of BioCryst’s website at http://www.biocryst.com.

FDA Grants Fast Track Designation to Aveta Biomics’ Drug APG-157 for Neoadjuvant Treatment of Head and Neck Cancer

On August 22, 2024 Aveta Biomics, a pioneering oncology company developing first-in-class oral immuno-oncology drugs, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to APG-157, its next-generation immuno-oncology drug, for the neoadjuvant treatment of Head and Neck Cancer (HNC) (Press release, Aveta Biomics, AUG 22, 2024, View Source [SID1234646052]). This designation underscores the potential of APG- 157 to address a significant unmet medical need in treating a highly challenging form of cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The FDA’s Fast Track Designation is intended to facilitate the development and to expedite the review of drugs aimed at treating serious conditions with unmet medical needs. This designation allows for more frequent interactions with the FDA, eligibility for rolling submissions for a marketing application, and potential Accelerated Approval, ultimately aiming to bring promising new treatments to patients more rapidly.

"There is an urgent need for new treatments for head and neck cancer patients, many of whom face poor survival odds and considerable morbidities following current standard-of-care treatments, including surgery, radiotherapy, and chemotherapy/targeted treatments. The rare grant of Fast Track Designation for neoadjuvant treatment in Head and Neck Cancer underscores the FDA’s recognition of the potential role of APG-157 in providing meaningful treatment benefits to these patients," said Parag Mehta, PhD, Chief Executive Officer of Aveta Biomics.

Head and Neck Cancer affects approximately 900,000 people globally, with an overall five-year mortality rate of around 50%, a figure that has remained largely unchanged for decades. The molecular complexity of these tumors presents significant challenges for existing treatments, including targeted therapies. APG-157 is a first-in-class drug that acts through a dual mechanism: inducing selective apoptosis of cancer cells while also reprogramming the immune environment.

"This Fast Track Designation, based on our comprehensive Phase 1 and Phase 2 data, accelerates our ability to bring our promising first-line therapy to all newly diagnosed, locally advanced Head and Neck Cancer patients in a frontline setting," added Karim Malek, MD, MTh, MBA, Chief Medical Officer of Aveta Biomics.