On March 9, 2023 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported a business update and reported fourth quarter and full year 2022 financial results (Press release, Oncternal Therapeutics, MAR 9, 2023, View Source [SID1234628421]).

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"2022 was an important year for Oncternal. With the recent initiation of our Phase 1/2 clinical study for ONCT-808 in advanced hematological malignancies, and the upcoming filing of our IND for ONCT-534 in advanced prostate cancer, we expect to have three product candidates in the clinic later this year," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "The data presented at ASH (Free ASH Whitepaper) 2022 further validated the rationale for our Phase 3 study for patients with MCL, and also strengthened our belief that zilovertamab may provide a new treatment option for patients with CLL with 17p deletion or TP53 mutations, which is a substantial and highly underserved group of patients. We look forward to a catalyst-rich year ahead while continuing to exercise prudent cash management as we expect our existing cash resources will last into the first quarter of 2024."

Recent Highlights

In December 2022, we announced an interim clinical data update from ongoing Study CIRM-0001, a Phase 1/2 clinical trial of zilovertamab in combination with ibrutinib for the patients with relapsed or refractory (R/R) Mantle Cell Lymphoma (MCL) and treatment naïve or R/R chronic lymphocytic leukemia (CLL) [NCT03088878] at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2022 Annual Meeting.
Objective response rate (ORR) of 89% (25 of 28 evaluable patients) observed for patients with R/R MCL treated with zilovertamab plus ibrutinib, which compares favorably to the historical ORR of 66% for ibrutinib monotherapy
Complete response (CR) rate of 43% for R/R MCL patients treated with zilovertamab plus ibrutinib (12 of 28 evaluable patients), which compares favorably to the historical ORR of 20% for ibrutinib monotherapy
The combination of zilovertamab and ibrutinib continued to be well tolerated, with a safety profile consistent with or improved compared with historical data for ibrutinib monotherapy
Median progression-free survival (PFS) had not been reached for R/R MCL patients with TP53 mutation treated with zilovertamab plus ibrutinib, with a landmark PFS of approximately 85% at 15 months, which compares favorably to the historical ibrutinib monotherapy median PFS of 4 months
Landmark PFS of 100% at 42 months for patients with CLL with 17p deletion or TP53 mutations treated with zilovertamab plus ibrutinib, which compares favorably to a recent data update from the ALPINE study of patients with R/R CLL, with a landmark PFS of 55.7% at 24 months for ibrutinib monotherapy, and 77.6% at 24 months for zanubrutinib monotherapy
Mutation in the TP53 gene is the most commonly acquired mutation in cancer, including hematological malignancies. TP53 aberrations are associated with markedly decreased survival and predict inadequate therapeutic response, thus being among the strongest predictive and prognostic factors guiding treatment decisions in CLL and MCL
In December 2022, we received helpful feedback from the FDA from our pre- Investigational New Drug (IND) meeting for ONCT-534, our novel dual-action androgen receptor inhibitor (DAARI)
In January 2023, we obtained our first Institutional Review Board (IRB) approval for the Phase 1/2 study of ONCT-808, our autologous CAR-T targeting ROR1-expressing hematologic malignancies (NCT05588440)
Expected Upcoming Milestones

Zilovertamab, our ROR1 antibody
Opening of additional countries for global clinical registrational Phase 3 Study ZILO-301
Continuing evaluation of potential to treat patients with CLL & MCL and TP53 mutations and/or 17p deletions
ONCT-808, our autologous ROR1-targeted CAR T cell therapy
Initial clinical data available by the end of 2023
ONCT-534, our dual-action androgen receptor inhibitor
U.S. IND application submission planned in mid-2023
Fourth Quarter and Full Year 2022 Financial Results
Our grant revenue was $0.2 million for the fourth quarter ended December 31, 2022, and was $1.5 million for the full year 2022.
Our total operating expenses for the fourth quarter ended December 31, 2022 were $12.1 million, including $1.8 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $8.8 million, and general and administrative expenses for the quarter totaled $3.3 million. Net loss for the fourth quarter was $11.4 million, or a loss of $0.20 per share, basic and diluted. For the full year 2022, total operating expenses were $46.4 million, including $7.4 million in non-cash stock-based compensation expense, and our net loss was $44.2 million, or a loss of $0.84 per share, basic and diluted.
As of December 31, 2022, we had approximately 57.5 million shares of common stock outstanding, $63.7 million in cash, cash equivalents and short-term investments and no debt. We believe these funds will be sufficient to fund our operations into the first quarter of 2024.

On March 9, 2023 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) ("Merrimack" or the "Company") reported its full year 2022 financial results for the period ended December 31, 2022 (Press release, Merrimack, MAR 9, 2023, View Source [SID1234628420]).

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"We are encouraged by the results of the NAPOLI 3 trial as reported by Ipsen in November 2022 and the guidance that Ipsen has subsequently provided regarding its intention to file a supplemental New Drug Application with the U.S. Food and Drug Administration for Onivyde in previously untreated patients with metastatic pancreatic ductal adenocarcinoma ("mPDAC"), which could lead to a potential future milestone payment from Ipsen" said Gary Crocker, CEO and Chairman of Merrimack’s Board of Directors. "As a result of the exercise of stock options during the fourth quarter of 2022 and continued reductions in our operating expenses during 2022 we expect that our cash and cash equivalents as of December 31, 2022, will be sufficient to continue our operations beyond 2027, which we estimate to be the latest date when the longest-term potential Ipsen milestone may be achieved."

Full Year 2022 Financial Results

Merrimack reported net loss of $1.5 million for the year ended December 31, 2022, or $0.11 per basic share, compared to a net loss of $2.5 million, or $0.18 per basic share, for the same period in 2021.

Merrimack reported a gain on sale of assets for the year ended December 31, 2022, of $0.4 million compared to $0.1 million for the same period in 2021.

General and administrative expenses for the year ended December 31, 2022 were $2.2 million, compared to $2.6 million for the same period in 2021.

As of December 31, 2022, Merrimack had cash and cash equivalents of $19.4 million, compared to $14.2 million as of December 31, 2021 The increase in cash was primarily a result of $6.5 million of proceeds from the exercise of stock options.

As of December 31, 2022, Merrimack had 14.2 million shares of common stock outstanding.

Updates on Programs Underlying Potential Milestone Payments

Ipsen

Metastatic Pancreatic Ductal Adenocarcinoma

In November 2022, Ipsen announced the Phase III NAPOLI 3 trial of Onivyde (irinotecan liposome injection) plus 5-fluorouracil/leucovorin and oxaliplatin (the "NALIRIFOX regimen") met its primary endpoint demonstrating clinically meaningful and statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine in 770 previously untreated patients with mPDAC and key secondary efficacy outcome of progression-free survival (PFS) also showed significant improvement over the comparator arm. Ipsen also announced that the safety profile of Onivyde in the NAPOLI 3 trial was consistent with those observed in the previous phase I/II mPDAC study

In January 2023, Ipsen presented clinical trial results at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium

In February 2023 Ipsen provided guidance to investors that it intends to file a supplemental New Drug Application with the U.S. Food and Drug Administration during the first half of 2023 following the Fast Track Designation granted in 2020 for the use of Onivyde in combination with oxaliplatin plus 5-fluorouracil/leucovorin for the treatment of patients with previously untreated mPDAC.

Small Cell Lung Cancer

In August 2022, Ipsen announced that the Phase III RESILIENT trial did not meet its primary endpoint of overall survival compared to topotecan. The trial is evaluating Onivyde versus topotecan in patients with small cell lung cancer, who have progressed on or after platinum-based first-line therapy treatment. In the announcement, Ipsen indicated that detailed results from the RESILIENT trial would be presented at an upcoming medical conference. The analysis concluded that the primary endpoint overall survival was not met in patients treated with Onivyde versus topotecan. However, a doubling of the secondary endpoint of objective response rate in favor of Onivyde was observed. In the August 2022 announcement, Ipsen reported that the clinical study results would be communicated with the regulatory agency. Ipsen indicated that while the results from the analysis of the RESILIENT trial have not demonstrated an overall survival benefit with Onivyde in patients in second-line small cell lung cancer, Ipsen intends to analyze the data further before decisions regarding next steps are made

To date, there have been no further announcements by Ipsen regarding these matters and it remains unclear as to whether Ipsen will continue to seek approval for the use of Onivyde in the small cell lung cancer application. If Ipsen elects not to proceed with seeking regulatory approval, or if regulatory approval is not obtained, Merrimack would not be entitled to the $150 million milestone payment tied to FDA approval of Onivyde for treatment of small cell lung cancer.

Elevation Oncology

In January 2023, Elevation announced it is pausing further investment in the clinical development of seribantumab and intends to pursue further development only in collaboration with a partner. Elevation also announced that it intends to present additional interim data from its study of seribantumab in the first half of 2023.

On March 9, 2023 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported financial and operating results for the fourth quarter and full year ended December 31, 2022 and will host a conference call today at 4:30 p.m. Eastern Time to discuss these results (Press release, Lineage Cell Therapeutics, MAR 9, 2023, View Source [SID1234628419]).

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"2022 marked a year of clinical and regulatory execution for the Lineage team, as we worked alongside our partners and internally to advance our clinical and preclinical programs," stated Brian M. Culley, Lineage CEO. "A significant area of focus last year was our alliance with Roche and Genentech, including supporting the initiation of a Phase 2a clinical study of OpRegen in patients with GA secondary to AMD. We believe we have selected the most capable partner to advance OpRegen and we anticipate that the findings from the Phase 2a study will be highly informative to the OpRegen development program in any future larger, comparative trials. We also made considerable progress expanding and diversifying our pipeline, primarily through the addition of two new cell transplant programs. We believe the learnings from our dry AMD program may prove valuable to our newer product opportunities, which are similarly based on our differentiated cell transplant technology.

"We also completed key regulatory activities for our OPC1 and VAC2 programs, which help provide insights into their continued development," Mr. Culley added. "Our corporate objectives for 2023 will be to emphasize the further progression of our allogeneic cell therapy programs, making responsible investments in the expansion of our novel approach to cell transplant medicine in disease settings where we believe we can make a meaningful impact, and the continued support of both our newly established and existing collaborations, all in support of our overarching vision of building Lineage into a leading cell therapy company."

Other significant milestones achieved in 2022 include:

RG6501 (OpRegen)
Continued execution under our collaboration with Roche and Genentech across multiple functional areas, including support for ongoing Phase 2a clinical study in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Long-term follow-up of patients from the Phase 1/2a clinical study of OpRegen:
Positive clinical data presented at 2022 Association for Research in Vision and Ophthalmology Annual Meeting.
OPC1
Completed verification and validation and preclinical testing activities for a novel parenchymal spinal delivery (PSD) system to support planned regulatory submissions.
Key data from OPC1, a Phase 1 clinical study in acute thoracic spinal cord injury and a Phase 1/2a clinical study in subacute cervical spinal cord injury, were published in the Journal of Neurosurgery: Spine.
Preclinical testing of a new thaw and inject formulation of OPC1, manufactured via an improved and larger-scale process, demonstrated functional recovery, improvement in gait coordination and motor performance with a reduction of the area of cavitation.
Engagement with the California Institute of Regenerative Medicine (CIRM), as well as various patient advocacy organizations and patient advocates continued.
VAC2
Pre-Investigational New Drug (IND) application briefing package submitted to the FDA to support U.S. clinical development for immuno-oncology.
Reported completion of enrollment in VAC2 Phase 1 non-small cell lung cancer (NSCLC) Study by Cancer Research UK.
Following technology transfer of the program from Cancer Research UK to Lineage and improvement of manufacturing processes, production scale increased and accordingly the cost of goods was reduced significantly, along with marked improvements in the purity and functionality of the manufactured material.
Launched two new cell therapy programs for the treatment of hearing and vision loss.
Process development and related activities were ongoing in support of planned preclinical testing.
Established new U.S. R&D facility and expanded current GMP manufacturing facility in Israel.
Strengthened intellectual property portfolio with Notice of Allowance for various patent applications including but not limited to covering oligodendrocyte progenitor cells.
Announced appointment of Jill Howe as Chief Financial Officer.
Some of the events and milestones anticipated by Lineage in 2023 include:

Results from imaging analyses of structural changes in addition to visual data from a Phase 1/2a clinical study of RG6501 (OpRegen), to be presented at the 2023 Association for Research in Vision and Ophthalmology Annual Meeting.
Type B Meeting with FDA to discuss our proposed amendment to the Investigational New Drug Application (IND) for OPC1 to enable clinical testing of a novel spinal cord delivery system, anticipated in the second quarter.
Clinical data update from the ongoing VAC2 Phase 1 NSCLC study, pending release from Cancer Research UK, anticipated in the second quarter.
Amendment of an IND for OPC1 to enable clinical testing of a novel spinal cord delivery system.
Initiation of DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study of OPC1.
Submission of an additional OPC1 manuscript describing magnetic resonance imaging (MRI) findings from the subacute studies in both thoracic and cervical spinal cord injury.
Submission of a grant application to CIRM for the continued support of the clinical development of OPC1.
Development update on hypo immune induced pluripotent stem cell (iPSC) lines for neurology indications, under collaboration with Eterna Therapeutics.
Updates from ongoing ANP1 preclinical testing at the University of Michigan Kresge Hearing Research Institute under a collaboration with the University of Michigan.
Evaluation of new partnership opportunities and/or expansion of existing collaborations.
Continued participation in investor and partnering meetings and medical and industry conferences to broaden awareness of our mission, programs, and accomplishments.
Balance Sheet Highlights

Cash, cash equivalents, and marketable securities totaled $57.9 million as of December 31, 2022, which is expected to support planned operations into Q3 2024.

Fourth Quarter Operating Results

Revenues: Lineage’s revenue is generated primarily from licensing fees, collaboration revenues, royalties, and research grants. Total revenues for the three months ended December 31, 2022 were approximately $1.9 million, a net increase of $0.7 million as compared to $1.2 million for the same period in 2021. The increase was related to the recognition of deferred collaboration revenues in connection with a Collaboration and License Agreement (the "Roche Agreement") we entered into with F. Hoffmann-La Roche Ltd. and Genentech, Inc., a member of the Roche Group (collectively or individually, "Roche" or "Genentech"), in 2021, partially offset by lower royalty and grant revenues.

Operating Expenses: Operating expenses are comprised of research and development ("R&D") expenses and general and administrative ("G&A") expenses. Total operating expenses for the three months ended December 31, 2022 were $8.5 million, a decrease of $20.7 million as compared to $29.2 million for the same period in 2021. The overall decrease was almost entirely driven by a decrease in R&D expenses under the Roche Agreement.

R&D Expenses: R&D expenses for the three months ended December 31, 2022 were $4.1 million, a decrease of $20.7 million as compared to $24.8 million for the same period in 2021. The decrease was substantially driven by the prior year $21.0 million accrual for financial obligations payable to the Israel Innovation Authority ("IIA") and Hadasit Medical Research Services and Development Ltd ("Hadasit"), in connection with the $50.0 million upfront payment received under the Roche Agreement. This decrease was partially offset by $0.1 million and $0.2 million in higher expenses to support the development of the new photoreceptor and auditory neuron cell therapy program, respectively.

G&A Expenses: G&A expenses for the three months ended December 31, 2022 were $4.3 million, a decrease of $0.1 million as compared to $4.4 million for the same period in 2021. The decrease was primarily attributable to a decrease of $0.4 million in legal and litigation expenses, partially offset by approximately $0.1 million in higher salaries and related benefit fees, and $0.1 million in higher share-based compensation expense.

Loss from Operations: Loss from operations for the three months ended December 31, 2022 was $6.6 million, a decrease of $21.6 million as compared to $28.2 million for the same period in 2021, principally owing to collaboration-related expense accruals of $21.0 million under the Roche Agreement.

Other Income, Net: Other income, net for the three months ended December 31, 2022 was $0.3 million, compared to other income, net of $0.2 million for the same period in 2021. The net variance was primarily related to offsetting variances between the changes in the value of marketable equity securities, as well as exchange rate fluctuations related to Lineage’s international subsidiaries for the applicable periods.

Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended December 31, 2022 was $6.4 million, or $0.03 per share (basic and diluted), compared to a net loss attributable to Lineage of $29.0 million, or $0.17 per share (basic and diluted), for the same period in 2021.

Full Year Operating Results

Revenues: Lineage’s revenue is generated primarily from licensing fees, collaboration revenues, royalties, and research grants. Total revenues for the year ended December 31, 2022 were $14.7 million, an increase of $10.4 million as compared to $4.3 million for the same period in 2021. The increase was primarily related to a $12.2 million increase in collaboration revenues recognized from deferred revenues stemming from the $50.0 million upfront payment under the Roche Agreement, partially offset by lower royalty and grant revenues.

Operating Expenses: Operating expenses are comprised of R&D expenses and G&A expenses. Total operating expenses for the year ended December 31, 2022 were $36.5 million, a decrease of $15.6 million as compared to $52.1 million for the same period in 2021.

R&D Expenses: R&D expenses for the year ended December 31, 2022 were $14.0 million, a decrease of $19.9 million as compared to $33.9 million for the same period in 2021. The decrease was substantially driven by the prior year $21.0 million accrual for financial obligations payable to the IIA and Hadasit. This decrease was partially offset by $0.7 million and $0.5 million in R&D spending on the new auditory neuron and photoreceptor cell therapy programs, respectively.

G&A Expenses: G&A expenses for the year ended December 31, 2022 were $22.5 million, an increase of approximately $4.3 million as compared to $18.2 million for the same period in 2021. The increase was primarily attributable to increases of $2.1 million in litigation and legal expenses, $1.3 million in salaries and related benefit fees, $0.9 million in share-based compensation expenses, and $0.4 million in audit and tax services, partially offset by $0.5 million in lower investor relations expense.

Loss from Operations: Loss from operations for the year ended December 31, 2022 was $22.5 million, a decrease of $26.7 million as compared to $49.2 million for the same period in 2021.

Other Income/(Expenses), Net: Other income (expenses), net for the year ended December 31, 2022 reflected other expense, net of ($3.3) million, compared to other income, net of $5.9 million for the same period in 2021. The net variance was primarily related to a prior year gain on sale of marketable equity securities, as well exchange rate fluctuations related to Lineage’s international subsidiaries for the applicable periods.

Net Loss Attributable to Lineage: The net loss attributable to Lineage for the year ended December 31, 2022 was $26.3 million, or $0.15 per share (basic and diluted), compared to a net loss attributable to Lineage of $43.0 million, or $0.26 per share (basic and diluted), for 2021.

Conference Call and Webcast

Interested parties may access today’s conference call by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through March 16, 2023, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 5707771.

On March 9, 2023 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported that it will release its fourth quarter and full-year 2022 financial results after the market closes on Thursday, March 16, 2023 via press release, which will be available on the Company’s website at www.geron.com/investors (Press release, Geron, MAR 9, 2023, View Source [SID1234628417]). Geron will host a conference call to discuss the financial results as well as upcoming milestones at 4:30 p.m. ET the same day.

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A live webcast of the conference call and related presentation will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.

Participants may access the webcast by registering online using the following link, View Source

On March 9, 2023 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 fourth quarter and full year period ending December 31, 2022 (Press release, Evogene, MAR 9, 2023, View Source [SID1234628415]).

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Mr. Ofer Haviv, Evogene’s President and Chief Executive Officer, stated, "We are very proud of the achievements made by Evogene and its subsidiaries in the past year. Throughout 2022, we made progress and have advanced the artificial-intelligence technology underlying our tech engines which are MicroBoost AI supporting the discovery and development of microbe-based products, ChemPass AI supporting small-molecule based products and GeneRator AI supporting products based on modifying genetic elements."

"Lavie Bio, our subsidiary focused on developing and commercializing microbiome-based ag-biological products, leveraging Evogene’s MicroBoost AI tech-engine, has not only seen progress in 2022, but also received external validation of its value, via a $10 million SAFE investment and strategic collaboration with ICL, a leading global specialty mineral and ag-tech company. In spring 2022, Lavie Bio saw initial sales and revenue from ThrivusTM, our inoculant product for spring wheat, which is a combination of bacterial strains which improve nutrient availability and uptake, improving plant health and we expect sales to be significantly expanded in the 2023 spring season. Furthermore, Lavie Bio’s product development pipeline continues to advance. Throughout 2022, we conducted a number of successful field trials for our bio-fungicide products with positive results and in October 2022, we submitted the registration to the U.S. Environmental Protection Agency for our novel bio-fungicide LAV311 product, targeting fruit rots and mildews, which is a final step prior to the commercialization of LAV311 in the US."

"Another external validation to the value contained within our subsidiaries and now becoming more apparent is through an investment in Biomica, our subsidiary developing microbiome-based therapeutics for the treatment of immune-mediated and infectious diseases, leveraging Evogene’s MicroBoost AI tech-engine. It is a vote of confidence from leading Chinese private equity fund, Shanghai Healthcare Capital ("SHC"), the lead investor of a $10 million seed investment round into Biomica, at a post money valuation of $50 million. This external and independent endorsement of Biomica, validates our belief in Biomica’s long-term potential to achieve its targets. In terms of its product pipeline, Biomica continues to advance its phase-I clinical trial for its microbiome-based immuno-oncology drug candidate, with results expected later in 2023. Biomica’s IBD (inflammatory bowel disease) program, completed the pre-clinical phase successfully and aims to progress to a phase-1 US clinical trial. Biomica’s third program for IBS (irritable bowel syndrome), has completed the discovery-phase in 2022 and is progressing into a pre-clinical phase."

"Our subsidiary AgPlenus has a goal to discover new mode-of-action crop protection products including herbicides, insecticides and fungicides, leveraging our ChemPass AI tech-engine. AgPlenus continues to work closely with Corteva, already under a three-year collaboration agreement, to develop new mode-of-action herbicides to target resistant weeds and we look to broadening AgPlenus’ collaboration to other major global players. The most advanced program within the internal product pipeline, focuses on the target protein APH1, representing a novel mode-of-action for herbicides, aiming to provide broad spectrum weed control. In 2022, we achieved our milestone in this program to expand its data package as preparation for potential license agreements. We see strong market interest from the major ag-tech companies for our products in the pipeline and especially for our unique technology, which we aim to materialize into additional collaboration agreements."

"Following our recent generation-2 product launch and commercialization, Canonic, our subsidiary that has developed attractive medical cannabis products, using Evogene’s GeneRator AI tech-engine to select genes to provide maximal levels of THC and unique terpenes profiles, is seeing increasing sales. At the same time, we understand the global cannabis market has become increasingly competitive during the past year and we don’t expect that situation to change in the near term. While we are continuing to support Canonic’s growth, we have made some recent structural changes to lower expenses and we are considering various longer-term options."

"Finally, Casterra is a subsidiary that was established many years ago focused on developing castor seeds for biofuel and leveraging Evogene’s GeneRator AI tech-engine. We always held a long belief in the advantages of castor as a bioenergy and biopolymer source. While our activities in this arena were somewhat dormant in recent years, the biofuel industry is finally beginning to follow our vision that castor oil can serve as a source for bio-diesel and we have seen a great recent resurgence in interest. Our technology not only produces an energy-dense seed, we have also created a plant tailored specifically for efficient mechanized harvesting, previously a hurdle limiting the use of castor. Casterra recently signed an agreement with one of the world’s leading energy companies based in Europe, selling them our seeds for growing castor to be used as biofuel in Africa. We have built a strong relationship with our EU partner, and hope to expend the scope of our engagement in the coming years."

"Not only have we seen strong success in 2022, but it has been validated by major external players by their investments. It ties their interests with ours into the long-term growth and value potential of our subsidiary companies. This is a substantial validation of all our hard work and our collective achievements to date, and demonstrates significant credibility of the value that Evogene’s AI tech-engines provide."

Consolidated Financial Results Summary

Cash position: Evogene continues to maintain a solid financial position for its activities with approximately $35 million in consolidated cash, cash equivalents and marketable securities as of December 31, 2022. This amount does not include the $10 million investment to Biomica by SHC that is expected to be closed in the coming weeks. Approximately $9.7 million of Evogene’s consolidated cash is appropriated to its subsidiary, Lavie Bio.

During the fourth quarter, the consolidated cash usage was approximately $2.6 million, or approximately $0.4 million, excluding Lavie Bio. For 2022 as a whole, the consolidated cash usage was approximately $28.5 million, or approximately $20.0 million, excluding Lavie Bio. The consolidated cash usage for 2022 included financing expenses in the amount of $2.3 million due to U.S. Dollar and New Israeli Shekel exchange rate differences and a decrease in the market value of marketable securities in the amount of $0.8 million.

Revenues: Revenues for the fourth quarter of 2022 were $660 thousand, in comparison to $311 thousand in the same period the previous year. Revenues for the full year 2022 were $1.7 million, in comparison to $0.9 million in 2021. The increase in revenues was primarily due to revenues recognized per the collaboration agreement of Evogene’s subsidiary AgPlenus with Corteva, as well as revenues from sales of Canonic’s medical cannabis products in Israel.

R&D expenses for the fourth quarter of 2022, which are reported net of non-refundable grants received, were $4.8 million, in comparison to $6.0 million in the same period in the previous year. For the full year 2022, these expenses were $20.8 million, in comparison to $21.1 million in 2021. The main contributors to R&D expenses were Lavie Bio’s activities supporting the production and commercialization of its inoculant product ThrivusTM, Evogene’s ongoing development of its technology engines and Biomica’s microbiome-based therapeutics development efforts.

Sales and marketing expenses were approximately $1.2 million for the fourth quarter of 2022, in comparison to $0.7 million in the same period the previous year. For the full year 2022, these expenses were $3.9 million, in comparison to $2.7 million in 2021. The increase was mainly due to Lavie Bio’s increased business development personnel and commercial trials of its inoculant product, ThrivusTM, performed during 2022 and increased business development personnel in Canonic.

General and Administrative expenses were $1.7 million in the fourth quarter of 2022, in comparison to $2.0 million in the same period in the previous year. For the full year 2022, these expenses were $6.5 million, in comparison to $7.3 million in 2021. The decrease was mainly attributed to the decrease of the costs of directors’ and officers’ insurance, and to the decrease of share-based compensation expenses.

Other income was $3.5 million in the fourth quarter and full year of 2022. This was received from Bayer under their joint seed traits collaboration agreement with Evogene, as part of a restructuring and release of the patent filing, prosecution, and maintenance obligations under the collaboration.

Operating loss: Operating loss for the fourth quarter of 2022 was $3.8 million, in comparison to $8.7 million in the same period in the previous year. Operating loss for the full year 2022 was $26.9 million, in comparison to $31.0 million in 2021. The decrease in operating loss is mainly due to the other income received from Bayer, as described above.

Financing income for the fourth quarter of 2022 was $6 thousand, in comparison to financing income of $602 thousand in the same period in the previous year. Financing expenses for the full year 2022 were $2.8 million, in comparison to financing income of $0.5 million in 2021. 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 fourth quarter of 2022 was $3.8 million, in comparison to a net loss of $8.1 million in the same period in the previous year. Net loss for the full year 2022 was $29.8 million, in comparison to a loss of $30.4 million for 2021.

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Conference Call & Webcast Details:

Date: March 9, 2022

Time: 9:00 am ET; 16:00 Israel time

Dial-in numbers:1-888-281-1167 toll free from the United States, or +972-3-918-0609 internationally

Webcast & Presentation link available at:

View Source

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

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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.