On March 10, 2022 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported financial results for the fourth quarter and year ended December 31, 2021 and provided recent corporate updates (Press release, Galera Therapeutics, MAR 10, 2022, View Source [SID1234609899]).

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"In 2021, we were pleased to report positive data from our lead program evaluating avasopasem for the treatment of severe oral mucositis, a radiotherapy-induced toxicity, in patients with head and neck cancer," said Mel Sorensen, M.D., Galera’s President and CEO. "The Phase 3 ROMAN trial demonstrated a statistically significant reduction in the incidence of SOM, the primary endpoint, and in the number of days patients experienced SOM. This data is in line with the topline results observed in the Phase 2a EUSOM trial and our previously completed randomized Phase 2b trial, reinforcing avasopasem’s potentially transformative clinical benefit for patients undergoing radiotherapy for head and neck cancer. With this robust package of data in hand, we are preparing to meet with the FDA to discuss the potential NDA submission. Concurrently, we remain on track to report data from our Phase 2a AESOP trial evaluating avasopasem in esophagitis in the first half of this year."

Dr. Sorensen continued: "We also continue to progress our Phase 1/2 GRECO-1 and Phase 2b GRECO-2 clinical trials evaluating our second product candidate, rucosopasem, in increasing the anti-cancer efficacy of higher daily doses of radiotherapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer, respectively. We look forward to reporting initial data from our GRECO-1 trial in the first half of this year."

Recent Corporate Updates

Radiotherapy-Induced Toxicity Programs:

Severe Oral Mucositis (SOM)

On December 14, 2021, the Company announced corrected topline efficacy results from the Phase 3 ROMAN trial of avasopasem for the reduction of SOM in patients with locally advanced head and neck cancer (HNC). The Company had previously announced topline results from the ROMAN trial on October 19, 2021. Upon further analysis following the October announcement, an error by the contract research organization was identified in the statistical program. Correction of this error resulted in improved p-values for the primary and secondary endpoints. The corrected results demonstrated efficacy across multiple SOM endpoints with a statistically significant reduction on the primary endpoint of incidence of SOM and the secondary endpoint of number of days of SOM, more than halving the median number of days a patient experienced SOM. Avasopasem appeared to be generally well tolerated compared to placebo. The Company announced that it plans to meet with the U.S. Food and Drug Administration (FDA) in 2022 to discuss a potential New Drug Application (NDA) submission.
On December 14, 2021, the Company also reported topline data from the Phase 2a EUSOM multicenter trial of avasopasem in Europe in patients with HNC undergoing standard-of-care radiotherapy. Avasopasem appeared to be generally well tolerated and the incidence and number of days of SOM was in line with the avasopasem data reported in the Phase 3 ROMAN trial.
Esophagitis

The Company expects to report topline data from the Phase 2a AESOP trial of avasopasem evaluating its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer in the first half of 2022.
Anti-Cancer Programs:

Locally Advanced Pancreatic Cancer (LAPC)

Enrollment is ongoing in the Phase 2b, 160-patient randomized, multicenter, placebo-controlled GRECO-2 trial of rucosopasem, Galera’s second dismutase mimetic product candidate, in combination with stereotactic body radiation therapy (SBRT) in patients with LAPC. The primary endpoint of the trial is overall survival.
Non-Small Cell Lung Cancer (NSCLC)

Enrollment is ongoing in the Phase 1/2 GRECO-1 trial of rucosopasem in combination with SBRT in patients with NSCLC. The Company expects to report initial data from this trial in the first half of 2022.
Fourth Quarter 2021 Financial Highlights

Research and development expenses were $9.2 million in the fourth quarter of 2021, compared to $14.6 million for the same period in 2020. The decrease was primarily attributable to a decrease in avasopasem development costs, partially offset by an increase in rucosopasem development costs.
General and administrative expenses were $5.3 million in the fourth quarter of 2021, compared to $4.3 million for the same period in 2020. The increase was primarily attributable to employee-related costs from increased headcount and share-based compensation expense, and increased insurance expense and professional fees.
Galera reported a net loss of $(16.8) million, or $(0.64) per share, for the fourth quarter of 2021, compared to a net loss of $(20.1) million, or $(0.80) per share, for the same period in 2020.
As of December 31, 2021, Galera had cash, cash equivalents and short-term investments of $71.2 million. Galera expects that its existing cash, cash equivalents and short-term investments will enable Galera to fund its operating expenses and capital expenditure requirements into the second half of 2023.
Full Year 2021 Financial Highlights

Research and development expenses were $52.4 million for the year ended December 31, 2021, compared to $54.8 million for the year ended December 31, 2020. The decrease was primarily attributable to a decrease in avasopasem development costs, partially offset by an increase in rucosopasem development costs.
General and administrative expenses were $21.0 million for the year ended December 31, 2021, compared to $15.7 million for the year ended December 31, 2020. The increase was primarily attributable to employee-related costs from increased headcount and share-based compensation expense, increased expenses related to preparation for potential commercialization of avasopasem, and increased insurance expense and professional fees.
Galera reported a net loss of $(80.5) million, or $(3.12) per share, for the year ended December 31, 2021, compared to a net loss of $(74.2) million, or $(2.98) per share, for the year ended December 31, 2020.

On March 10, 2022 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported that President and Chief Executive Officer, Theodore (Ted) Ashburn, M.D., Ph.D., will present at the Oppenheimer 32nd Annual Healthcare Conference on Tuesday, March 15, 2022 at 4:40 p.m. ET (Press release, Oncorus, MAR 10, 2022, View Source [SID1234609898]).

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A live webcast of the presentation can be accessed by visiting the Investors & Media section of Oncorus’ website at View Source A replay of the presentation will be archived on Oncorus’ site for 30 days following the event.

On March 10, 2022 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading computational biology company targeting to revolutionize life-science product discovery and development across multiple market segments, reported its financial results for the fourth quarter and full year of 2021, ended December 31, 2021 (Press release, Evogene, MAR 10, 2022, View Source [SID1234609897]).

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Mr. Ofer Haviv, Evogene’s President and Chief Executive Officer, stated, "With 2022 well on its way and our subsidiaries successfully advancing on their developmental activities, we believe that we are progressing to significant value enhancing milestones. Moreover, we are very proud that our subsidiaries, Lavie Bio and Canonic, recently began commercializing their products in target markets. The rapid advancement from concept to marketable product indicates the invaluable contribution Evogene’s technological engines MicroBoost AI, ChemPass AI and GeneRator AI have on life-science product development.

"As the activities of our subsidiaries mature, we continue to develop our engines with the goal of further improving their offering and potential, as engines underpinning and empowering the development of life-science products. In the years to come we intend to expand the eco-system of each of our technological engines, with the goal of expanding into new areas and new product types. Over the year, we hope to discuss this in more detail.

"It is important for us to state that we believe that our strong cash position of approximately $54 million is a demonstration of financial strength, which is particularly important in current times of instability in the financial markets. Still, to support our subsidiaries’ growth and to strengthen their position as independent companies, we are currently evaluating different funding options for the group and are in different levels of discussions with potential strategic and financial investors," – Mr. Haviv concluded.

2021 Achievements & 2022 Milestones:

Biomica Ltd.

Immuno-oncology program – Biomica recently received clearance from the Israeli Ministry of Health to proceed to a first-in-human phase I study, which is set to be held at the Rambam Healthcare Campus in Israel, following the completion of a series of pre-clinical trials with BMC128 given in combination with Immune Checkpoint Inhibitors immunotherapy, indicating significant improvement in anti-tumor activity. Biomica is currently advancing towards the initiation of the study.

Milestone for 2022 – readout from proof of concept, first in human study.

Inflammatory Bowel Disease (IBD) program – During 2021, Biomica achieved positive results from a series of pre-clinical studies, indicating reduction of intestinal tissue damage resulting from inflammation. These results provided the evidential groundwork to proceed to the scale up development process of BMC333.

Milestone for 2022 – initiate scale-up for GMP production of BMC333 as preparation for clinical trials.

Canonic Ltd.

MetaYield program – During October 2021, Canonic began initial commercial sales in Israel of G200 and G150, cannabis inflorescence products marketed under the T20/C4 and T15/C3 categories, respectively[1].

Milestone for 2022 – commercial launch of second-generation products in Israel and preparations towards commercialization in Europe in 2023.

Precise program – During 2021, Canonic conducted pre-clinical trials, identifying cannabis varieties with pain relief and anti-inflammatory properties, for which Canonic recently filed a patent application.

Milestone for 2022 – collect user data for clinical indications to support commercial launch in 2023 in Israel.

AgPlenus Ltd.

New Mode-of-Action (MoA) herbicides – In 2021, the company gathered additional information regarding its leading new MoA target protein, APTH1, for herbicide development and reached proof-of-concept regarding a seed trait presenting crop resistance to APH1 (a chemical compound that is the basis for the development of a herbicide).

The collaboration with Corteva, which is focused on other modes-of-action, is progressing according to plan.

Milestones for 2022 –

– enter an additional collaboration agreement.
– expand data package for APTH1, AgPlenus’ leading new MoA protein for the development of novel herbicides.

Lavie Bio Ltd.

Inoculant (bio-stimulant) for spring wheat – During late 2021, Lavie Bio began the commercialization of its inoculant result aiming at the improvement of yield based on microbes. The product’s initial market penetration for spring wheat is planned for the upcoming 2022 sowing season and will be limited to target regions in North Dakota.

Milestone for 2022 – build infrastructure for scale-up in result sales in 2023.

Bio-fungicide fruit rot program – Following the completion of three consecutive years of vineyard trials, conducted in Europe and in the U.S., Lavie Bio has prioritized LAV311 as its lead candidate for final development and submission of a regulatory dossier, expected to be filed with the federal U.S. Environmental Protection Agency (EPA) and California EPA during 2022.

Milestone for 2022 – file for regulatory approval for leading product candidate LAV311 targeting fruit rot, as preparation for commercialization in 2024.

Consolidated Financial Results Summary

Cash position: Evogene maintains a strong financial position for its activities with $53.9 million in consolidated cash, cash related accounts, bank deposits and marketable securities as of December 31, 2021, of which $7.8 million is appropriated to its subsidiary, Lavie Bio.

During 2021, the consolidated cash usage was approximately $25.8 million, or $20.6 million, excluding Lavie Bio. These sums in 2021 are before giving effect to $29.6 million net raised through Evogene’s at-the-market, or ATM, programs and exclude $1.8 million of proceeds from non-refundable grants and exercises of options. This is in comparison to 2020, during which the consolidated cash usage was $19.3 million, or $14.7 million, excluding Lavie Bio. The cash usage in 2020 was unusually low due to certain measures, regarding salary expenses, that the Company initiated to mitigate the impact of the COVID-19 pandemic during that year.

During the fourth quarter of 2021, the consolidated cash usage was approximately $8.4 million, or $7.0 million, excluding Lavie Bio. This is in comparison to the fourth quarter of 2020, during which the consolidated cash usage was approximately $6.1 million, or $5.1 million, excluding Lavie Bio.

The cash burn rate during 2021 and in the fourth quarter was higher than during the same periods in 2020, for the following reasons:

– During the second and third quarters of 2020 the burn rate was significantly lower due to certain measures the Company initiated to mitigate the impact of the COVID-19 pandemic, as mentioned above.
– During 2021, Evogene’s subsidiaries significantly expanded product development activities, including:

Biomica’s ongoing preparations, including the GMP production of microbes, for the initiation of its first-in-human proof-of-concept study in the immuno-oncology program,
Lavie Bio’s activities supporting the commercial launch of its inoculant product branded as result in 2022,
Canonic’s product commercialization in Israel during the fourth quarter of 2021.
– Expenses related to accelerating and expanding Evogene’s technological engines.

The Company’s management estimates that the cash usage for the full year of 2022 will be within the range of $26-$28 million. These guidelines include the cash usage of Evogene’s subsidiary Lavie Bio, which is estimated at approximately $8 million.

Research and Development ("R&D") expenses:
R&D expenses for the fourth quarter of 2021, which are reported net of non-refundable grants received, were $6.0 million, in comparison to $4.8 million in the fourth quarter of 2020. For the full year 2021, these expenses were $21.1 million, in comparison to $17.3 million in 2020.

The increase in R&D expenses was mainly attributed to an increase in expenses due to an expansion in product development activities of the Company and its subsidiaries, as mentioned above.

Business Development ("BD") expenses:
BD expenses were approximately $720 thousand for the fourth quarter of 2021, in comparison to $670 thousand in the fourth quarter of 2020. Such expenses remained stable for the full year 2021 in comparison to 2020 and were approximately $2.7 million.

General and Administrative ("G&A") expenses:
G&A expenses for the fourth quarter of 2021 were $2.0 million, in comparison to $1.7 million in the fourth quarter of 2020. G&A expenses for the full year 2021 were $7.3 million, in comparison to $5.3 million in 2020. The increase was mainly attributed to the increase of the costs of directors’ and officers’ insurance policies, an increase in salary-based expenses and an increase in other professional services.

Operating loss:
Operating loss for the fourth quarter for the full year 2021 was $8.7 million in comparison to $7.2 million in the fourth quarter of 2020. Operating loss for 2021 was $31.0 million in comparison to $24.8 million in 2020. The operating loss increased due to an increase in overall operating expenses, as described above, as well as due to an increase in salary-based expenses in comparison to 2020, mainly for the following reasons:

– relatively low salary-based expenses in 2020 due to measures taken by the company to mitigate the impact of the COVID-19 pandemic; and
– an increase in salaries in 2021 due to an increase in the market demand for highly skilled workers.

Loss:
The loss for the fourth quarter of 2021 was $8.1 million in comparison to a loss of $8.8 million during the fourth quarter of 2020. The loss for the full year 2021 was $30.4 million in comparison to a loss of $26.2 million for 2020. The increase in loss is attributed mainly to the increase in operating expenses, as described above, which was partially offset by net financing income for 2021 in comparison to net financing expenses for 2020.

Conference Call & Webcast Details:
Date: March 10, 2022
Time: 9:00 am EST; 16:00 Israel time
Dial-in number:1-888-281-1167 toll free from the United States, or +972-3-918-0609 internationally
Webcast: Link available at View Source
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 through March 11, 2022, and an archive of the webcast will be available on the Company’s website.

The Company filed an updated presentation which can be viewed here: View Source

On March 10, 2022 Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, reported the Company will release its fourth quarter and full year 2021 financial results before the market opens on Thursday, March 17, 2022 (Press release, Synlogic, MAR 10, 2022, View Source [SID1234609896]). The press release will be followed by a conference call at 8:30 am ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a corporate update.

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The conference call dial-in numbers are (844) 815-2882 for domestic callers and (213) 660-0926 for international callers. The conference ID number for the call is 1719849. Participants may access the live webcast in the "Events Calendar" of the Investors & Media section of the website. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Company’s website.

On March 10, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that multiple abstracts were selected for oral and poster presentations at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer to be held on March 18-21, 2022 in Phoenix, Arizona (Press release, ImmunoGen, MAR 10, 2022, View Source [SID1234609895]).

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ORAL PRESENTATION
Full results from the pivotal SORAYA trial of mirvetuximab soravtansine (mirvetuximab) in ovarian cancer will be shared in a late-breaking oral presentation.

Title: Efficacy and Safety of Mirvetuximab Soravtansine in Patients with Platinum-Resistant Ovarian Cancer with High Folate Receptor Alpha Expression: Results from the SORAYA Study
Presenter: Dr. Ursula Matulonis, Chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute, Professor of Medicine at the Harvard Medical School, and SORAYA Co-Principal Investigator
Session: Scientific Plenary IV: Late-Breaking Abstracts
Session Date: Saturday, March 19, 2022
Session Time: 4:15 pm to 5:45 pm MST

POSTER PRESENTATIONS
Trial in progress posters from ImmunoGen’s MIRASOL and PICCOLO trials of mirvetuximab in ovarian cancer and a Phase 2 investigator-sponsored combination trial of mirvetuximab with carboplatin in the neoadjuvant setting will also be presented.

Title: MIRASOL: A Randomized, Open-Label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor Alpha Expression
Presenter: Dr. Kathleen Moore, Director of the Oklahoma TSET Phase I Program, Associate Professor of the Section of Gynecologic Oncology at The University of Oklahoma College of Medicine, and MIRASOL Principal Investigator

Title: PICCOLO: An Open-Label, Single Arm, Phase 2 Study of Mirvetuximab Soravtansine in Recurrent Platinum-Sensitive, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor Alpha Expression
Presenter: Dr. Angeles Alvarez Secord, Professor of Obstetrics and Gynecology at Duke University School of Medicine in Durham, North Carolina

Title: Single-Arm Phase II Trial of Carboplatin and Mirvetuximab Soravtansine as Neoadjuvant Chemotherapy for Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer who are Folate Receptor α Positive
Presenter: Dr. Jhalak Dholakia, Department of Obstetrics and Gynecology at the University of Alabama

OTHER PRESENTATIONS
Final data from the mirvetuximab plus bevacizumab platinum-agnostic combination study, which were originally shared at ASCO (Free ASCO Whitepaper) 2021, will be re-presented.

Title: Mirvetuximab Soravtansine, a Folate Receptor Alpha-Targeting Antibody Drug Conjugate in Combination with Bevacizumab in Patients with Platinum-Agnostic Ovarian Cancer: Final Analysis
Session: Seminal Abstracts: The Best of ASCO (Free ASCO Whitepaper), ESMO (Free ESMO Whitepaper), IGCS, and ESGO
Presenter: Dr. David O’Malley, Professor, Director of Gynecologic Oncology and the Director of the Division of Gynecologic Oncology at The Ohio State University and the James Cancer Center

Additional information can be found on the SGO website.

INVESTOR EVENT INFORMATION

ImmunoGen will hold an investor event to discuss the SORAYA data, featuring a roundtable with key opinion leaders, on Sunday, March 20 at 7:30 am MST/10:30 am EDT in the Moly Meeting Room at the Westin Phoenix Downtown. To access the live event by phone, dial (877) 621-5803; the conference ID is 1986619. The event may also be accessed via webstream on the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.