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.

***
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.

4

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 March 9, 2023 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported financial results for the quarter ended December 31, 2022, and highlighted recent progress (Press release, Elevation Oncology, MAR 9, 2023, View Source;utm_medium=rss&utm_campaign=elevation-oncology-reports-fourth-quarter-and-full-year-2022-financial-results [SID1234628414]).

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"Following the recently announced pipeline prioritization and realignment of resources, our clinical development strategy is focused on advancing EO-3021, a potential best-in-class antibody-drug conjugate targeting solid tumors expressing Claudin 18.2, and other pipeline programs to benefit patients with significant unmet medical needs," said Joseph Ferra, Interim Chief Executive Officer of Elevation Oncology. "We have cash runway into the fourth quarter of 2024 and expect to achieve multiple milestones during 2023, including the reporting of preclinical proof-of-concept data for EO-3021 during the first half of the year and the initiation of a U.S. Phase 1 clinical trial evaluating EO-3021 during the second half of the year."

Recent Progress and Highlights

Corporate

Announced pipeline prioritization and realignment of resources in January 2023. As part of the announcement, the Company decided to prioritize key research and development efforts to advance EO-3021 and other pipeline programs including those through its existing partnership with Caris Life Sciences. The pipeline prioritization involved pausing further investment in the clinical development of seribantumab, and Elevation Oncology intends to pursue further clinical development of seribantumab only in collaboration with a partner. Further enrollment into the CRESTONE study has also paused, pending entering into a partnership. As part of the realignment of resources, the Company’s workforce was reduced by approximately 30%.
Joseph Ferra appointed Interim Chief Executive Officer in January 2023. The Company’s Board of Directors appointed Mr. Ferra as Interim Chief Executive Officer. Mr. Ferra also remains as the Company’s Chief Financial Officer.
EO-3021

Phase 1 clinical trial in the US to evaluate EO-3021 expected to initiate in the second half of 2023. The Investigational New Drug application has been cleared with the U.S. Food and Drug Administration, and preparations are ongoing to initiate a Phase 1 clinical trial in the US. Elevation Oncology’s partner, CSPC Pharmaceutical Group Limited (HKEX: 01093), is actively recruiting patients in the Phase I clinical trial of EO-3021 (SYSA1801) in China (NCT05009966).
Plan to present preclinical proof-of-concept data of EO-3021 at a major medical conference in the first half of 2023. EO-3021 is a potential best-in-class, clinical-stage antibody-drug conjugate (ADC) designed to target Claudin 18.2 and selectively deliver a cytotoxic payload directly to cancer cells expressing Claudin 18.2. Claudin 18.2 is a clinically validated oncology target expressed in several solid tumor types including many gastrointestinal cancers such as gastric, gastroesophageal junction and pancreatic cancer.
Other Pipeline Programs

Plan to present additional interim data of seribantumab from the CRESTONE study in the first half of 2023.
Continue research and development efforts to advance novel therapeutic drug candidates and targets. Additional pipeline programs include those through its existing partnership with Caris Life Sciences.
Expected Upcoming Milestones and Operational Objectives

Present preclinical proof-of-concept data of EO-3021 at a major medical meeting in the first half of 2023
Initiate Phase 1 clinical trial of EO-3021 in the US in the second half of 2023
Report additional interim data of seribantumab from the CRESTONE study in the first half of 2023
Ongoing target evaluation for future pipeline expansion
Fourth Quarter and Full Year 2022 Financial Results

As of December 31, 2022, the Company had cash, cash equivalents and marketable securities totaling $90.3 million, compared to $107.9 million as of September 30, 2022.

Research and development expense for the fourth quarter 2022 was $14.5 million, compared to $6.2 million for the fourth quarter 2021. The increase in R&D expense was primarily related to seribantumab manufacturing and clinical trial expenses. For the year ended December 31, 2022, R&D expense was $78.7 million, compared to $23.6 million for the year ended December 31, 2021. The increase was primarily related to seribantumab manufacturing and clinical trial expenses and a one-time upfront license fee of $27.0 million paid to CSPC Megalith Biopharmaceutical Co., Ltd., a subsidiary of CSPC Pharmaceutical Group Limited, for the exclusive rights to develop and commercialize EO-3021 outside of Greater China.

General and administrative expense for the fourth quarter 2022 was $4.0 million, compared to $3.4 million for the fourth quarter 2021. The increase was primarily related to personnel costs. For the year ended December 31, 2022, G&A expense was $15.8 million, compared to $8.5 million for the year ended December 31, 2021. The increase was primarily related to personnel costs, professional services and other administrative costs.

Net loss for the fourth quarter 2022 was $19.0 million, compared to $9.6 million for the fourth quarter 2021.

Financial Outlook

Elevation Oncology expects its existing cash, cash equivalents and marketable securities as of December 31, 2022, will be sufficient to fund its current operations into the fourth quarter of 2024, without giving effect to financial covenant compliance under the Company’s debt facility.

On March 9, 2023 Cullinan Oncology, Inc. (Nasdaq: CGEM; "Cullinan") a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, reported on recent and upcoming business highlights and announced its financial results for the fourth quarter and full year ended December 31, 2022 (Press release, Cullinan Oncology, MAR 9, 2023, View Source [SID1234628413]).

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"2022 was a year of remarkable execution at Cullinan Oncology, and the momentum with which we ended the year has continued into early 2023. With our partners at Taiho Oncology, we initiated the pivotal study of zipalertinib in the fourth quarter, while continuing to advance enrollment in the Phase 1 trials of CLN-049 and CLN-619, with initial clinical data expected mid-year" said Nadim Ahmed, Chief Executive Officer of Cullinan. "The first two months of 2023 have resulted in similarly exciting developments, as we recently expanded our pipeline through the licensing of U.S. development and commercial rights to CLN-418, a potential first-in-class B7H4x4-1BB bispecific immune activator currently in a Phase 1 study across a variety of solid-tumor indications. This transaction provides us with the opportunity to have six programs in the clinic by the end of the year, as we recently received IND clearance for CLN-978 and also recently filed the IND for CLN-617, consistent with prior guidance. Importantly, our cash position following the CLN-418 transaction provides us with runway into 2026 which gives us the flexibility needed to fund our ongoing development efforts and reach multiple potential value creating milestones."

Portfolio Highlights

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Zipalertinib: In the fourth quarter of 2022, Cullinan Oncology, in collaboration with our partners at Taiho Oncology, Inc., initiated a pivotal study of zipalertinib in EGFR exon 20 insertion mutation non-small-cell lung cancer patients progressing after prior systemic therapy. As previously planned, the study will enroll patients at the 100mg BID dose under fasted conditions, and also will include a limited cohort of patients to evaluate safety and efficacy at 150mg BID administered with food.

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CLN-049: CLN-049 is a FLT3xCD3 T cell-engaging bispecific antibody being investigated in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Enrollment continues in the ongoing Phase 1 dose escalation clinical study with initial clinical data expected in mid-2023.

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CLN-619: CLN-619 is a monoclonal antibody that stabilizes expression of MICA/MICB on the tumor cell surface to promote tumor cell lysis by both cytotoxic innate and adaptive immune cells. CLN-619 has broad therapeutic potential and is being investigated as both monotherapy and in combination with checkpoint inhibitor therapy in an ongoing Phase 1 dose escalation study in patients with advanced solid tumors with initial clinical data expected in mid-2023.

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CLN-418: CLN-418 is a B7H4x4-1BB fully human bispecific immune activator designed to achieve conditional activation of 4-1BB by targeting B7H4, a tumor associated antigen that is highly expressed across multiple cancers with minimal expression on normal tissues. Enrollment is ongoing in a Phase 1 dose escalation study at U.S. and Australian sites in patients with advanced solid tumors with initial clinical data expected in 2024.

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In February, Cullinan Oncology licensed the exclusive U.S. development and commercial rights to CLN-418 from Harbour Biomed for an upfront fee of $25 million, with the potential for up to an additional $148 million in development and regulatory milestones and up to $415 million in sales-based milestones, as well as tiered royalties on potential U.S. commercial sales.

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CLN-978: CLN-978 is a novel CD19xCD3-bispecific therapeutic with extended serum half-life and robust potency against target cells expressing low levels of CD19. Consistent with prior guidance, Cullinan received FDA clearance of its Investigational New Drug (IND) application for CLN-978 in January and anticipates initiating a Phase 1 clinical study by the end of 2023.

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CLN-617: CLN-617 is a cytokine fusion protein uniquely combining IL-12 and IL-2 with a collagen binding domain designed for retention in the tumor microenvironment (TME) following intratumoral injection. Consistent with prior guidance, Cullinan recently filed the IND application for CLN-617 in February 2023 and intends to initiate a Phase 1 clinical study by the end of 2023, pending IND clearance.

Fourth Quarter 2022 Financial Results

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Cash Position: Cash and investments were $550.1 million as of December 31, 2022. During the fourth quarter of 2022, Cullinan acquired additional equity in its subsidiary, Cullinan Mica, which holds the worldwide rights to CLN-619, for $33 million, increasing its ownership from 54% to 95% of the entity. In the first quarter of 2023, the Company spent $25 million on the upfront payment under the recently announced licensing agreement for CLN-418 with Harbour Biomed. Cullinan expects its cash resources to provide runway into 2026 based on its current operating plan.

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R&D Expenses: Research and development (R&D) expenses were $21.3 million for the fourth quarter of 2022, compared to $19.7 million for the third quarter of 2022. R&D expenses for the fourth and third quarters of 2022 included $2.9 million and $1.1 million of equity-based compensation expenses, respectively. Excluding the impact of equity-based compensation expenses, the decrease in R&D expenses was primarily related to a decrease in preclinical costs, partially offset by increased personnel costs.

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G&A Expenses: General and administrative (G&A) expenses were $11.3 million for the fourth quarter of 2022, compared to $10.1 million for the third quarter of 2022. G&A expenses in the fourth and third quarters of 2022 included $4.6 million and $4.2 of equity-based compensation expenses, respectively. The increase in G&A expenses was primarily driven by increased personnel costs.

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Net Loss: Net loss (before items attributable to noncontrolling interest) for the fourth quarter of 2022 was $27.1 million, compared with net loss of $24.9 million for the third quarter of 2022. Net losses included the items described above, partially offset by interest income of $3.4 million and $2.4 million and income tax benefit recognized of $1.9 million and $2.5 million in the fourth and third quarters of 2022, respectively.

Full Year 2022 Financial Results

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R&D Expenses: R&D expenses were $91.9 million for 2022, compared to $57.8 million for 2021. R&D expenses for 2022 and 2021 included $11.0 million and $8.9 million of equity-based compensation expenses, respectively. The increase in R&D expenses was primarily related to CRO and CMC activities to support our ongoing clinical trials and pre-clinical research and CMC costs to support IND enabling activities.

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G&A Expenses: G&A expenses were $40.2 million for 2022, compared to $29.1 million in 2021. G&A expenses in 2022 and 2021 included $16.9 million and $15.4 million of equity-based compensation expenses, respectively. The increase in G&A expenses was primarily driven by increase in personnel and professional services due to increased headcount to support our expanded operations, and non-recurring costs related to the previously announced Cullinan Pearl sale, described below.

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Gain on sale of Cullinan Pearl: In June 2022, Cullinan sold its equity interest in its subsidiary, Cullinan Pearl, which has worldwide rights to zipalertinib, excluding Japan and Greater China, to Taiho Pharmaceutical Co., Ltd. (Taiho). Cullinan recognized a gain from the sale of $276.8 million, which includes the upfront payment of $275 million, as well as the impact of net liabilities transferred to Taiho. Cullinan also recognized income tax expenses of $42.1 million as a result of the gain and offsetting operating expenses.

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Net Income (Loss): Net income (before items attributable to noncontrolling interest) for 2022 was $109.2 million, compared with a net loss of $67.5 million in 2021. Net income in 2022 was related to the items described above, as well as $6.6 million of interest income. In 2021, operating expenses described above were partially offset by $18.9 million of license revenue.