On March 3, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted therapies for rare and difficult to treat cancers, reported that Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics, will present at the following upcoming virtual conferences (Press release, Cytori Therapeutics, MAR 3, 2021, View Source [SID1234576013]).

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Event H.C. Wainwright Global Life Sciences Conference
Date March 9-10, 2021
Presentation Available on demand beginning March 9

Event Maxim Emerging Growth Conference
Date March 17-18, 2021
Presentation Available on demand beginning March 17
Investors interested in arranging a meeting with the Company’s management for these conferences should contact the respective conference coordinator.

Webcast of the H.C. Wainwright conference presentation will be available under the ‘Events’ tab of the Investor Relations section of the Plus Therapeutics website at www.plustherapeutics.com. Access to the Maxim conference presentation will be available HERE.

On March 3, 2021 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN.TA), a leading computational biology company targeting to revolutionize life-science product discovery and development across several market segments, reported its financial results for the fourth quarter and full year ended December 31, 2020 (Press release, Evogene, MAR 3, 2021, View Source [SID1234576012]).

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Mr. Ofer Haviv, Evogene’s President and CEO, stated, "2020 was a year of significant accomplishment for Evogene as we successfully realigned our organizational structure and core capabilities to dramatically accelerate the company’s progress and value creation. Our excitement at Evogene today is primarily due to two substantial value creators that have resulted from our long-term commitment to computational predictive biology (CPB) for the development of life science-based products. The first value creator is our growing group of highly focused subsidiaries in multiple key markets, each with what we believe are very attractive products under development and a unique capability to advance them relatively rapidly towards commercialization. The second value creator is Evogene’s powerful technology hub, our CPB platform and three dedicated engines: MicroBoost AI, ChemPass AI, and GeneRator AI, for products based on three core components: microbes, small molecules and genetic elements, respectively. This hub is allowing us, in addition to supporting our subsidiaries, to establish product pipelines in new fields of activity.

I would like to provide key information on our subsidiaries’ main achievements in 2020 and lead on to their intended future plans for 2021-2022."

2020 main achievements

Biomica

Immuno-oncology program – positive results in pre-clinical study were achieved.
Immuno-oncology program – initial scale-up and first GMP production of drug candidates, as preparation for first-in-man clinical trial, expected to be initiated in 2021.
Canonic

MetaYield product family – identification of leading lines to be further developed into commercial varieties, towards expected commercial launch in Israel in 2022.
Go-to-market strategy – signed an agreement with a commercial partner for cultivation and production of proprietary cannabis varieties, as part of the strategic goal to build an end-to-end value chain – from seed to product sale.
AgPlenus

Herbicide program – entry into a strategic collaboration with Corteva Agriscience (NYSE: CTVA), to develop a novel herbicide, based on pre-lead candidates.
Herbicide program – reaching a lead phase for lead candidate APH1, following the completion of field tests that demonstrated APH1’s effective control over a broad panel of weeds, including ones known to have resistance to existing herbicides. These results were confirmed in independent field tests, conducted by SynTech Research.
Lavie Bio

Bio-pesticide program – LAV312 showed positive results in protecting grapes from Botritis, in a trial that took place in an Italian vineyard. Product is expected to reach the market in 2024.
Bio-stimulant program – LAV211 was successfully combined with harvesting spring wheat in North Dakota. Based on results gained during the last three years, product launch is expected in 2022.
Future expected milestones

Biomica

2021

Inflammatory Bowel Disease (IBD) program – extend pre-clinical study.
Immuno-oncology program – initiate proof of concept, first-in-man study.
2022

IBD program – initiate first GMP production of drug candidates for IBD.
Immuno-oncology program – readout from proof of concept, first-in-man study.
Canonic

2021

MetaYield product family – reach first commercial variety; sign distribution agreements in anticipation for commercialization in 2022.
Precise product family – identify specific lines that exhibit distinct effect in model systems for reducing pain or inflammation.
2022

MetaYield product family- commercial launch and initial sales of first product in Israel.
Precise product family – reach first commercial variety for reducing pain or inflammation as preparation for commercial launch in 2023.
AgPlenus

2021

Herbicide program – reach a herbicide tolerance trait proof of concept for APH1.
Herbicide program / insecticide program – sign a licensing agreement for a leading candidate.
2022

Herbicide program – reach an ‘Optimized Lead’ phase for APH1.
Herbicide program – sign a strategic agreement for the development of an ‘Optimized Lead’ compound.
Lavie Bio

2021

Bio-pesticide program – complete LAV311/312 development towards regulation.
Bio-stimulant program – conduct pre-commercial trials for LAV211 in spring wheat.
2022

Bio-stimulant program – initial product sales of LAV211 for spring wheat.
Bio-pesticide program – file for regulatory approval for leading product candidate LAV311 / LAV312.
Mr. Haviv continued: "I hope you are as excited as I am about Evogene’s subsidiaries’ expected future milestones. But these are not all the highlights I wish to update you about today. Evogene is currently evaluating entry into various new fields of activity in which our technology could provide significant competitive advantages, such as:

Developing products based on microbes to address various market needs in the aqua-culture industry, using MicroBoost AI;
Drug optimization in human health, using ChemPass AI; and
Developing high quality plant-based food based on genome editing, using GeneRator AI.
2020 was Evogene’s coming of age and it is only the beginning. We enthusiastically look forward to continuing our progress, achieving our defined targets, and expanding the use of our technology into new fields of activity," Mr. Haviv concluded.

Consolidated financial results for the fourth quarter and full year ended December 31, 2020:

Cash position: As of December 31, 2020, the company’s consolidated cash, cash related accounts and bank deposits amounted to approximately $48.2 million. Approximately $13.0 million of Evogene’s consolidated cash is appropriated to its subsidiary, Lavie Bio.

The $48.2 million does not include $28.0 million received after year end from the company’s "At the Market Offering" (ATM) initiated in January 2021 and concluded during February 2021. The weighted average selling price under the ATM offering was $7.36 per share. As a result of such offering, Evogene exhausted the remaining amount under the shelf prospectus filed in July 2020.

During the fourth quarter of 2020, the company’s consolidated net cash usage was approximately $6.1 million, or $5.1 million, if excluding Lavie Bio. During the full year 2020, consolidated net cash usage was approximately $19.3 million, or $14.7 million, if excluding Lavie Bio, which is in the range estimated for the full year 2020.

For the year ending December 31, 2021, Evogene expects to see an increase in the cash usage as its subsidiaries enter advanced stages of product development and commercialization: Biomica is expecting to conduct its first in-man clinical trial, AgPlenus is expecting to conduct a broad field trial in its herbicide program towards an ‘Optimized Lead’, and both Canonic and LavieBio are preparing for their respective first product launches during 2022.

For the year ending December 31, 2021, we estimate that net cash usage will be within the range of $26.0 – $28.0 million. Excluding cash usage by Evogene’s subsidiary Lavie Bio, the company estimates net cash usage will be within the range of $20.0 – $22.0 million.

We do not currently have any bank debt.

Pre-funded warrants: A new line item on the balance sheet this quarter relates to pre-funded warrants that were issued in conjunction with the $12.0 million registered direct offering that was completed in November 2020. In accordance with the International Financial Reporting Standards, these warrants were recorded as a liability as of December 31, 2020. These warrants were exercised for ordinary shares of Evogene at the beginning of January 2021, and therefore will not appear on our balance sheet next quarter.

Research and Development ("R&D") expenses: R&D expenses, which are reported net of grants received, were approximately $4.8 million for the fourth quarter of 2020, in comparison to $5.2 million in the fourth quarter of 2019. This decrease in R&D expenses during the fourth quarter was mainly due to grants received from the Israeli Innovation Authority. For the full year 2020, R&D expenses were approximately $17.3 million, compared to $15.8 million in 2019. The increase in R&D expenses for 2020 was mainly attributed to payments made to third parties in connection with pre-clinical studies conducted for Biomica, field trials conducted in target locations for Lavie Bio, and an increase in non-cash expenses of $1.4 million for amortization of share-based compensation.

General and Administrative ("G&A") expenses: G&A expenses were approximately $1.7 million for the fourth quarter of 2020, in comparison to $1.1 million in the fourth quarter of 2019. The increase during the fourth quarter of 2020 was partly attributed to the impact of an industry-wide increase in the cost of directors’ and officers’ insurance. For the full year 2020, G&A expenses were approximately $5.3 million, compared with $3.8 million in 2019. For the full year 2020, the increase was also primarily attributed to the impact of the cost of directors’ and officers’ insurance as well as due to an increase in non-cash expenses of amortization of share-based compensation.

Operating loss: Operating loss for the fourth quarter of 2020 was $7.2 million, in comparison to $6.9 million for the fourth quarter of 2019. For the full year 2020, the operating loss was $24.8 million, compared with $21.2 million in 2019. The increase in operating loss during the fourth quarter and for the full year of 2020 is primarily attributed to the increase in the aforementioned operating expenses.

Loss: For the fourth quarter of 2020, the company’s loss was $8.8 million, in comparison to $6.7 million during the fourth quarter of 2019. For the full year 2020, the loss was $26.2 million, compared with $19.1 million in 2019. The increase in the loss during the fourth quarter and for the full year 2020 is primarily attributed to the increase in operating expenses and an increase in financing expenses mainly attributed to $1.9 million of non-cash expenses related to the revaluation of pre-funded warrants mentioned above.

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 +972-3-925-5904 internationally. The replay will be accessible through March 5, 2021, and an archive of the webcast will be available on the Company’s website.

On March 3, 2021 Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. ("Coherus", Nasdaq: CHRS) reported the initiation of the rolling submission of the Biologics License Application ("BLA") for toripalimab to the U.S. Food and Drug Administration ("FDA") for the treatment of recurrent or metastatic nasopharyngeal carcinoma ("NPC") (Press release, Coherus Biosciences, MAR 3, 2021, View Source [SID1234576011]). A rolling submission allows Junshi Biosciences to submit sections of the BLA to the FDA as they are completed.

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Toripalimab has been granted Breakthrough Therapy Designation by the FDA for the treatment of recurrent or metastatic nasopharyngeal carcinoma based on preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies. The designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. Toripalimab is the first anti-PD-1 monoclonal antibody developed in China with a BLA submission to the FDA in process.

In February 2021, Junshi Biosciences and Coherus entered into a collaboration for the development and commercialization of toripalimab in the United States and Canada. Coherus will be responsible for all commercial activities in the licensed territory. Closing of the collaboration agreement is subject to clearance under the Hart-Scott Rodino Antitrust Improvements Act, which is expected later this month.

"There has been limited development of treatment approaches for patients with advanced NPC in the U.S.," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "We are determined to advance effective treatments in the U.S. by leveraging the successful experience with toripalimab, a safe and effective treatment for previously treated NPC that is now approved for marketing in China. We appreciate the FDA’s recognition of this potentially important new treatment through its Breakthrough Therapy Designation, which enables the acceleration of the review process. We will work closely with the FDA to facilitate the review of the U.S. marketing application in order to make toripalimab available for patients in the U.S. as soon as possible."

"Toripalimab could address a significant unmet medical need as a new treatment for advanced NPC, and we are encouraged by the initiation of the BLA submission," said Denny Lanfear, CEO of Coherus. "With an extensive clinical development program across a range of tumor types, a broad therapeutic profile is developing for toripalimab. We look forward to working with Junshi Biosciences to bring this new anti-PD-1 antibody to patients in the U.S. and Canada."

Following potential approval of toripalimab for the treatment of recurrent or metastatic nasopharyngeal carcinoma, and assuming successful closing of their collaboration agreement, Coherus and Junshi Biosciences plan to file additional toripalimab BLA supplements with the FDA over the next three years for multiple rare cancers as well as highly prevalent cancers, including non-small cell lung cancer ("NSCLC").

About Toripalimab

Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. More than thirty company-sponsored clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. Toripalimab was included in the 2019 and 2020 Guidelines of Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Melanoma. The supplemental NDA of Toripalimab for the second-line treatment of metastatic urothelial carcinoma was accepted by the NMPA in May 2020 and received priority review designation from the NMPA in July 2020. In September 2020, Toripalimab was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) for the treatment of recurrent or metastatic nasopharyngeal carcinoma. In December 2020, Toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the supplemental NDA for Toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA. In the same month, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. Currently, Toripalimab has been granted 1 Breakthrough, 1 Fast Track, and 3 Orphan Drug Designations by the FDA for the treatment of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma.

On March 3, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Michael T. Nally, chief marketing officer, is scheduled to participate in the Barclays Global Healthcare Conference on March 9, 2021 at 1:50 p.m. EST (Press release, Merck & Co, MAR 3, 2021, View Source [SID1234576010]).

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Investors, analysts, members of the media and the general public are invited to watch a live video webcast of the presentations at View Source

On March 3, 2021 IVERIC bio, Inc. (Nasdaq: ISEE) reported financial and operating results for the fourth quarter and full year ended December 31, 2020 and provided a general business update (Press release, Ophthotech, MAR 3, 2021, View Source [SID1234576009]).

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The Company also announced that patient enrollment and retention for GATHER2, its second Phase 3 clinical trial for Zimura (avacincaptad pegol), a novel complement C5 inhibitor, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) are progressing well with enrollment ahead of schedule. The Company is accelerating the timeline for when it expects to complete enrollment in GATHER2 to the third quarter of 2021. If the prespecified 12-month results from GATHER2 are positive, the Company plans to file applications with the results from GATHER1 and GATHER2 to the U.S. Food and Drug Administration and the European Medicines Agency for marketing approval of Zimura for GA.

"We start 2021 with significant momentum as we continue to enroll patients into our Zimura GATHER2 clinical trial and now expect to complete enrollment in the third quarter of this year," stated Glenn P. Sblendorio, Chief Executive Officer and President of Iveric Bio. "We are extremely encouraged by the progress of our clinical trial sites to enroll and retain patients. We continue to work with our investigators to provide a safe environment for patients, which we believe increases the patients’ comfort and confidence to participate in the GATHER2 clinical trial. We are committed to continuing patient enrollment and retention aggressively in the GATHER2 clinical trial while prioritizing patient safety."

Pravin U. Dugel, M.D., Chief Strategy and Business Officer of Iveric Bio added, "Although bringing Zimura to patients suffering from geographic atrophy secondary to age-related macular degeneration remains our top priority, in 2021 and thereafter we will continue to explore the potential development of Zimura in earlier stages of age-related macular degeneration as well as neovascular (wet) macular degeneration. Additionally, in our IC-500 program, we are pursuing HtrA1 inhibition as a target in the treatment of GA and potentially earlier stages of AMD. We are focused on advancing our pipeline of both therapeutic and gene therapy product candidates for treating retinal diseases with the potential to create long-term shareholder value."

Therapeutics Programs Targeting Age-Related Macular Degeneration

Zimura (avacincaptad pegol): Complement C5 Inhibitor

In April 2020, the U.S. FDA granted Fast Track designation for Zimura for the treatment of GA secondary to dry AMD.
In June 2020, the Company announced positive 18-month results from GATHER1, its first Phase 3 clinical trial for Zimura for the treatment of GA secondary to AMD. The 18-month data supports the previously announced 12-month data from this trial, at which time point Zimura met the pre-specified primary efficacy endpoint with statistical significance. Zimura was generally well tolerated after 18 months of administration.
In late June 2020, the Company announced that the first patient had been dosed in the GATHER2 clinical trial.
In September 2020, the Company announced that the positive 12-month Phase 3 results from its GATHER1 clinical trial with Zimura were published in Ophthalmology, the Journal of the American Academy of Ophthalmology.
In February 2021, Dr. Dugel presented the positive results from GATHER1 at the Angiogenesis, Exudation, Degeneration 2021 – Virtual Edition meeting.
The Company increased the enrollment target in its ongoing Phase 2b screening clinical trial of Zimura for the treatment of autosomal recessive Stargardt disease. After initially enrolling 95 patients in this trial, the Company plans to enroll approximately 25 additional patients, with the goal of enrolling a total of 120 patients.
IC-500: HtrA1 (high temperature requirement A serine peptidase 1 protein) Inhibitor

The Company recently revised its development plans for IC-500 to include plans to investigate multiple dosing schedules for this product candidate. Based on current timelines, the Company expects to submit an IND to the FDA for IC-500 in GA secondary to AMD in the second half of 2022.
Gene Therapy Programs in Orphan Inherited Retinal Diseases (IRDs)

IC-100: Rhodopsin-Mediated Autosomal Dominant Retinitis Pigmentosa (RHO-adRP)
The Company is preparing an IND for IC-100 and plans to meet with regulatory authorities to discuss its selected doses for a first-in-human clinical trial prior to the submission. The Company plans to file an IND for IC-100 with the FDA and begin enrolling patients in a Phase 1/2 clinical trial for IC-100 in the second half of 2021.
IC-200: BEST1-Related IRDs
The Company is completing IND-enabling activities for IC-200 and plans to file an IND for IC-200 with the FDA and begin enrolling patients in a Phase 1/2 clinical trial for IC-200 in the second half of 2021.
Minigene Programs
The Company, in collaboration with the University of Massachusetts Medical School (UMMS), continues to advance its minigene programs for Leber Congenital Amaurosis Type 10 (LCA10), autosomal recessive Stargardt Disease (ABCA4), and USH2A-related IRDs. The Company expects to select a lead construct for its LCA10 minigene program in the second quarter of 2021. The Company expects to obtain additional results from its Stargardt Disease minigene program in the first half of 2021. The Company expects to obtain preliminary results from its USH2A minigene program in the first half 2021.
Corporate Highlights

During 2020, the Company expanded its Board of Directors and management by adding a number of leading industry experts. Mark S. Blumenkranz, M.D., M.M.S., HJ Smead Professor Emeritus, Department of Ophthalmology, Stanford University joined the Company’s board of directors in July 2020. Pravin U. Dugel, M.D. joined the Company as Chief Strategy and Business Officer in March 2020. Dr. Dugel was previously Managing Partner, Retinal Consultants of Arizona and the Retinal Research Institute; Clinical Professor, USC Eye Institute, Keck School of Medicine, University of Southern California; and Founding Member, Spectra Eye Institute in Sun City, Arizona. Dhaval Desai, PharmD, joined the Company as Chief of Staff in August 2020. Previously, Mr. Desai served as Medical Unit Head at Novartis Eye Care.

In June 2020, the Company raised approximately $150 million in net proceeds in an underwritten public offering of common stock, and pre-funded warrants in lieu of common stock, and a concurrent private placement of common stock.

Fourth Quarter and Year End 2020 Operational Update and 2021 Cash Guidance

As of December 31, 2020, the Company had $210 million in cash, cash equivalents and available for sale securities.
The Company estimates its year-end 2021 cash, cash equivalents and available for sale securities will range between $130 and $140 million. The Company also estimates that its cash, cash equivalents and available for sale securities will be sufficient to fund its planned capital expenditure requirements and operating expenses, excluding any potential approval or sales milestones payable to Archemix Corp. or any commercialization expenses for Zimura, into 2024. These estimates are based on the Company’s current business plan, including the continuation of its ongoing clinical development programs for Zimura, the progression of its IC-100 and IC-200 programs into the clinic, and the advancement of its IC-500 development program. These estimates also assume that the Company will enroll approximately 400 patients in the GATHER2 trial. These estimates do not reflect any additional expenditures related to potentially studying Zimura in other indications or resulting from the potential in-licensing or acquisition of additional product candidates or technologies or commencement of new sponsored research programs, and any associated development the Company may pursue.
2020 Financial Highlights

R&D Expenses: Research and development expenses were $17.5 million for the quarter ended December 31, 2020, compared to $11.6 million for the same period in 2019. For the year ended December 31, 2020, research and development expenses were $62.8 million compared to $39.6 million for 2019. Research and development expenses increased primarily due to the initiation of GATHER2 and increased manufacturing activities for Zimura, increased manufacturing and preclinical development activities associated with the Company’s IC-100 and IC-200 gene therapy programs and the progression of its IC-500 development program.
G&A Expenses: General and administrative expenses were $8.0 million for the quarter ended December 31, 2020, compared to $6.3 million for the same period in 2019. For the year ended December 31, 2020 general and administrative expenses were $26.0 million compared to $21.6 million for 2019. General and administration expenses increased primarily due to increases in general consulting costs and professional fees.
Income Tax (Benefit): Income tax benefits of $3.7 million and $0.1 million for the years ended December 31, 2020 and 2019, respectively, were recognized to reflect the favorable settlement of local tax audits.
Net Income: The Company reported a net loss for the quarter ended December 31, 2020 of $25.4 million, or ($0.27) per diluted share, compared to a net loss of $17.5 million, or ($0.39) per diluted share, for the same period in 2019. For the year ended December 31, 2020, the Company reported a net loss of $84.5 million or ($1.14) per diluted share, compared to a net loss of $58.9 million or ($1.39) for the same period in 2019.
Conference Call/Web Cast Information

Iveric Bio will host a conference call/webcast to discuss the Company’s financial and operating results and provide a business update. The call is scheduled for March 3, 2021 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 888-221-3881 (USA) or 323-794-2590 (International), passcode 9597743. A live, listen-only audio webcast of the conference call can be accessed on the Investors section of the Iveric Bio website at www.ivericbio.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 888-203-1112 (USA), passcode 9597743.