On March 19, 2020 Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, reported results for the fourth quarter and full year 2019 and provided a corporate and clinical update (Press release, AmpliPhi Biosciences, MAR 19, 2020, View Source [SID1234555703]).

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Key Fourth Quarter and Subsequent Period Highlights:

·Entered into a $25 million securities purchase agreement pursuant to which Innoviva, Inc. ("Innoviva") will purchase approximately 8.7 million shares of Armata common stock at $2.87 per share and warrants to purchase an additional approximately 8.7 million shares with an exercise price of $2.87 per share.

·Announced the closing of the first tranche of the Innoviva securities purchase agreement, issuing 993,139 common shares and warrants to purchase 993,139 common shares in exchange for gross proceeds of approximately $2.8 million. The Company obtained voting agreements from shareholders representing approximately 55% of its outstanding shares that have agreed to vote in favor of the financing at the special shareholder meeting now scheduled for March 26, 2020. Following approval at the meeting, the second tranche of $22.2 million will be received by Armata.

·In connection with the financing transaction, appointed Sarah Schlesinger, M.D. and Odysseas Kostas, M.D. to its Board of Directors, both of whom also serve on the Board of Innoviva.

·Continued to advance development of its lead program, a Pseudomonas aeruginosa phage product candidate AP-PA02, toward submission of an Investigational New Drug application (IND) seeking regulatory approval to initiate a first-in-human clinical trial this year. GMP production of the product candidate has been completed at the Company’s Marina del Rey facility.

·Announced that the Company has been awarded up to $5 million in a development award grant from the Cystic Fibrosis Foundation to help fund the Pseudomonas aeruginosa phage development.

·Expanded the Board of Directors with the appointment of research and development veteran Todd C. Peterson, Ph.D., and strengthened its clinical team with the appointment of Heather Dale Jones, M.D., as Vice President, Clinical Development.

"During the fourth quarter, we continued to efficiently advance development of our lead phage candidate programs, most notably AP-PA02 for Pseudomonas aeruginosa," said Todd R. Patrick, Chief Executive Officer of Armata. "Pseudomonas aeruginosa is an increasingly multi-drug resistant bacteria that causes severe acute and chronic infections and is particularly problematic for cystic fibrosis patients. This promising therapeutic is just one example of the potent and highly targeted phage candidates that are emerging from our proprietary manufacturing and screening capabilities, and we are eager to initiate formal clinical development with our first-in-human study in 2020."

"The securities purchase agreement that we recently entered into with Innoviva significantly strengthened our financial position and, upon closing of the second and final tranche, will provide us with the resources necessary to achieve significant and potentially value-creating development milestones this year and next. We look forward to a successful year." Mr. Patrick concluded.

Anticipated 2020 Milestones:

·Close the second tranche of the previously announced securities purchase agreement with Innoviva

·File an IND and initiate a clinical trial evaluating the safety and tolerability of AP-PA02 in cystic fibrosis patients chronically infected with Pseudomonas aeruginosa

·Obtain third party, non-dilutive funding to advance its Staphylococcus aureus phage candidate, AP-SA02, into clinical trials

·Continue to screen pathogens against the Company’s proprietary phage library to identify additional high-quality bacteriophage product candidates and expand the pipeline

Fourth Quarter Financial Results

Research and Development. Research and development expenses for the three months ended December 31, 2019 were $1.7 million as compared to $2.0 million for the comparable period in 2018.

General and Administrative. General and administrative expenses for the three months ended December 31, 2019 were $2.1 million as compared to approximately $0.8 million for the comparable period in 2018. The increase was due to expenses resulting from the merger of C3J Therapeutics, Inc. and AmpliPhi Biosciences Corp. (the "Merger").

Loss from Operations. Loss from operations for the three months ended December 31, 2019 was $4.4 million as compared to $2.8 million for the comparable period in 2018.

Full Year 2019 Financial Results

Research and Development. Research and development expenses for the year ended December 31, 2019 were $9.8 million as compared to $8.4 million for the comparable period in 2018. The net increase of $1.4 million was primarily related to a $0.9 million increase in non-cash stock-based compensation expense, a $0.7 million increase in personnel expenses resulting from the Merger, a $0.5 million increase in laboratory supplies, a $0.4 million increase for outside services, a $0.2 million increase of rent and utilities expenses, offset by a $1.3 million of tax rebate from the Australian tax authorities.

General and Administrative. General and administrative expenses for the year ended December 31, 2019 were $9.3 million as compared to $2.5 million in the comparable period in 2018. The increase of $6.8 million was primarily due to a $3.3 million increase in non-cash stock-based compensation expense, a $2.1 million increase in professional fees (legal, audit and investment banking) primarily associated with the Merger, a $0.4 million increase in personnel-related expenses, and $0.5 million increase in insurance costs.

Loss from Operations. Loss from operations for the year ended December 31, 2019 was $19.8 million as compared to $17.7 million for the comparable period in 2018. The increase was due to an increase in non-cash stock-based compensation and additional operating costs in connection with the Merger.

Cash and Equivalents. As of December 31, 2019, Armata held $6.0 million of unrestricted cash and cash equivalents as compared to $9.7 million as of December 31, 2018. Subsequent to the end of the fourth quarter, the Company announced that it had entered into a $25 million private placement securities agreement with Innoviva. The first tranche, in which Armata issued 993,139 common shares and warrants to purchase an additional 993,139 common shares in exchange for gross proceeds of approximately $2.8 million, closed in February.

The audit opinion included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 contains a going concern explanatory paragraph.

As of March 17, 2020, there were approximately 10.9 million shares of common stock outstanding.

On March 19, 2020 Abbott (NYSE: ABT) reported that it will announce its first-quarter 2020 financial results on Thursday, April 16, 2020, before the market opens (Press release, Abbott, MAR 19, 2020, View Source [SID1234555702]).

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The announcement will be followed by a live webcast of the earnings conference call at 8:00 a.m. Central time (9:00 a.m. Eastern), and will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.

On March 19, 2020 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the year ended December 31, 2019, and provided a corporate update (Press release, VBL Therapeutics, MAR 19, 2020, View Source [SID1234555698]).

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"We are excited to advance our clinical program for VB-111 in ovarian cancer towards an important interim analysis, while collaborating with the National Cancer Institute and top US neuro-oncology centers in externally-sponsored studies of VB-111 for colon cancer and recurrent GBM," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "The ongoing Phase 3 OVAL trial in platinum resistant ovarian cancer continues to enroll patients as planned and we expect the readout from an important interim analysis by the end of the first quarter. VBL made significant advancement during 2019 on all fronts. We now look forward to 2020 as a potential turn around year for the company, with three parallel clinical trials for VB-111 and upcoming results from our MOSPD2 programs for inflammation and oncology."

Amos Ron, Chief Financial Officer of VBL Therapeutics stated, "We had more than $37 million in cash, cash equivalents and restricted bank deposits at December 31, 2019. This is expected to provide us with sufficient resources to continue to develop VB-111 and other product candidates and to fund our operating expenses and capital expenditure requirements into the third quarter of 2021."

Fourth Quarter and Key Corporate Highlights:

VB-111 program in ovarian cancer – The OVAL Phase 3 potential-registration study of VB-111 in ovarian cancer continues as planned towards the important interim analysis in 1Q 2020. This analysis will focus on CA-125 response rate, which will be analyzed according to GCIG strict criteria in 60 evaluable patients. The data will help to inform whether the positive outcome observed with VB-111 in the Phase 2 study in ovarian cancer is being replicated in the OVAL Phase 3 trial.
Results from a Phase 1/2 clinical trial of VB-111 in the treatment of patients with recurrent platinum resistant ovarian cancer were presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. Data demonstrated a median overall survival (OS) of 498 days in the VB-111 therapeutic-dose arm, versus 172.5 days in the low-dose arm (p=0.03). 58% of evaluable patients treated with the therapeutic dose of VB-111 had a GCIG CA-125 response. In comparison, in the AURELIA trial, the GCIG CA-125 response rate was 31.8% with bevacizumab and chemotherapy, and only 11.6% with chemotherapy alone.
VB-111 for colon cancer – In February 2020, we announced the launch of a Phase 2 clinical trial of VB-111 in combination with nivolumab (Opdivo), an immune checkpoint inhibitor, in the treatment of metastatic colorectal cancer, under a Cooperative Research and Development Agreement (CRADA) between VBL and the U.S. National Cancer Institute (NCI). NCI will serve as the IND sponsor for this study (ClinicalTrials.gov Identifier: NCT04166383).
VB-111 program in recurrent glioblastoma (rGBM) – VBL announced the publication of clinical data from the Phase 2 and GLOBE Phase 3 studies of VB-111 in rGBM in two manuscripts published in December 2019 in the peer-reviewed journal Neuro-Oncology, the official journal of the Society for Neuro-Oncology.
Study results attribute the contradictory outcomes between the Phase 2 and Phase 3 trials to the lack of VB-111 monotherapy priming in the GLOBE Phase 3 study, providing clinical, mechanistic and radiographic support for this hypothesis.
With the understanding that study regimen may be a key factor for VB-111 activity in rGBM, a new study, under U.S. IND sponsorship by Dana-Farber Cancer Institute, in collaboration with a group of leading U.S. neuro-oncology investigators, will assess neo-adjuvant and adjuvant treatment with VB-111 in rGBM patients undergoing a second surgery. Launch of this study is expected in the first half of 2020.
VB-111 GMP Facility – VBL’s new gene therapy pharmaceutical grade manufacturing facility in Modiin, Israel, was certified by the European Union (EU) Qualified Person (QP) as being in compliance with EU Good Manufacturing Practices (GMP). The facility has also been certified by the Israeli Ministry of Health as being in compliance with the Israeli law and regulations of GMP. These important steps are expected to support future commercialization of VB-111, if approved.
MOSPD2 bi-specific mAbs for cancer – We are developing bi-specific antibodies designed to kill tumor cells, based on MOSPD2 as a novel target whose expression is induced in multiple tumors. We previously presented preclinical proof-of-concept for this approach using a BiTE antibody, and are currently advancing our lead bi-specific antibody candidate towards an IND filing. New data from this program were accepted for presentation in a late breaking abstract session at the 2020 American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting.
MOSPD2 mAb program for inflammation – VBL continues to advance the development of lead MOSPD2 antibodies for immune-inflammatory indications, with potential for MS, RA and NASH. The Company signed a service agreement with Thermo Fisher Scientific, one of the leading vendors in the antibody field, for production of lead candidate VB-601 for toxicology and clinical development. A pre-IND submission for VB-601 is expected in 2Q 2020. New data on MOSPD2 as a target for inflammatory digestive disorders were accepted for presentation at EASL’s annual International Liver Congress, ILC 2020, and Digestive Disease Week (DDW) conferences later this year. Our abstract for DDW was rated in the top 10% of all abstracts in this category and was selected as Poster of Distinction.
Lecinoxoids platform – VBL executed a strategic exclusive option to license agreement with one of the world-leading European animal health companies for the development of VBL’s proprietary anti-inflammatory molecule, VB-201, for veterinary use. VBL received an undisclosed up-front payment. Upon exercise of the license option, VBL expects to receive additional milestones and royalties, which have the potential to exceed €50 million. VBL retains worldwide rights for the use of VB-201 for the treatment of humans.
Fiscal Year Ended December 31, 2019 Financial Results:

Cash Position: At December 31, 2019, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposit of $37.0 million and working capital of $29.1 million. VBL expects that its cash and cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements into 3Q 2021.
Revenues: Revenues related to VBL’s collaboration in Japan and with an animal health company amounted to $0.6 million in the year ended December 31, 2019.
R&D Expenses: Research and development expenses, net, after government grants, for the year ended December 31, 2019, were approximately $15.5 million, compared to approximately $15.9 million in the same period in 2018.
G&A Expenses: General, administrative and marketing expenses for the year ended December 31, 2019, were $4.9 million, compared to $5.6 million for the same period in 2018.
Comprehensive Loss: VBL reported a net loss for year ended December 31, 2019, of $19.5 million, or ($0.54) per share, compared to a net loss of $20.4 million, or ($0.62) per share, in the year ended December 31, 2018.
For further details on VBL’s financials, please refer to Form 20-F filed with the SEC.

Conference Call:
Thursday, March 19th @ 8:30am Eastern Time
From the US: 877-407-9208
International: 201-493-6784
Conference ID: 13699636
Webcast: View Source

On March 19, 2020 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported positive preliminary top-line results for its pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial evaluating SGX301 (Synthetic Hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) (Press release, Soligenix, MAR 19, 2020, View Source [SID1234555697]). The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo, demonstrating statistically significant treatment response (p=0.04) in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessment at 8 weeks for Cycle 1. In addition, preliminary assessment of the open-label Cycle 2 results suggest a significantly more robust response rate after 12 weeks of SGX301 treatment. These data are expected to be announced in June 2020.

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"This is an important outcome for patients suffering from CTCL. SGX301 has successfully demonstrated efficacy in this challenging chronic cancer, with no safety concerns, making it a potentially preferred first-line option for the treatment of early stage CTCL, which is the large majority of patients suffering from this disease," stated Ellen Kim, MD, Director of the Dermatology Clinic, Perelman Center for Advanced Medicine and Lead Investigator of the FLASH study. "The treatment showed a statistically significant improvement after just 6 weeks of treatment. This successfully proves that the drug has biologic activity in combating this disease in a relatively short time window, with preliminary data suggesting that the improvement continues to increase with extended treatment. In addition to the efficacy demonstrated, SGX301 was well-tolerated and its mechanism of action is not associated with DNA damage like other currently available therapies."

"On behalf of everyone at Soligenix, I would like to extend my sincere appreciation to the patients, families, investigators, and advisors involved in the pivotal Phase 3 FLASH study," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We are extremely pleased with the results, which demonstrate successful treatment with SGX301 and reinforces its potential to be an important new treatment for early stage CTCL. We will now look to move as quickly as possible to complete a full analysis of the data for publication, as well as begin preparations for a robust discussion with the FDA regarding this important dataset."

Dr. Schaber continued, "With approximately $7.6M in cash, not including the anticipated sale of our New Jersey net operating loss carryovers and United Kingdom tax incentive receivable of approximately $1.0M or our non-dilutive government funding, we will evaluate the potential need for a larger capital raise only after top-line results from our Phase 3 study in oral mucositis. This will afford us the opportunity to more thoroughly assess commercialization and/or partnership of SGX301 in tandem with preparing for the New Drug Application submission to FDA. These results support our long-standing belief that SGX301 has the potential to be a valuable therapy in the treatment of early stage CTCL, which is an orphan disease and area of unmet medical need."

Conference Call Thursday, March 19 at 8:30 AM Eastern Time

The Company will share trial results on Thursday, March 19, 2020 during an investor conference call. Investors may submit questions electronically at: [email protected] at least 15 minutes prior to the scheduled start of the call.

U.S. toll free: 1-866-652-5200

International: 1-412-317-6060

Please request to be entered into the Soligenix call.

A transcript of the conference call will be archived for 30 days following the event.

The Phase 3 FLASH trial enrolled 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consists of three treatment cycles, each of 8 weeks duration. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle, 116 subjects received SGX301 treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving SGX301 achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04). SGX301 treatment in the first cycle was safe and well tolerated. In the second open-label treatment cycle (Cycle 2), all patients received SGX301 treatment. Of note, preliminary results from blinded data to date suggest more than a 35% response rate (inclusive of patients receiving both 12 weeks and 6 weeks of therapy), indicating the response increases with continued treatment. Further independent review of lesion photographs may be conducted to provide for a more uniform confirmation of response. Results from Cycle 2 are expected to be announced in June 2020.

In the third (optional) treatment cycle (Cycle 3), all subjects could receive SGX301 treatment of all their lesions. Of note, the majority of patients enrolled have elected to continue with this optional cycle of the study. Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that SGX301 is not systemically available, consistent with the general safety of this topical product observed to date. Results from Cycle 3 and the subsequent 6-month follow-up after completion of treatment will be further announced as the final patients continue to complete their designated visits.

About Cutaneous T-Cell Lymphoma (CTCL)

CTCL is a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as a rash and eventually forming raised plaques and tumors as the disease progresses. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 25,000 individuals in the US, with approximately 3,000 new cases seen annually.

About SGX301

SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. SGX301 has received orphan drug and fast track designations from the US Food and Drug Administration (FDA), as well as orphan designation from the European Medicines Agency (EMA).

Based on the positive results demonstrated in the Phase 2 study of SGX301, the Phase 3 protocol is a highly powered, double-blind, randomized, placebo-controlled, multicenter trial targeted to enroll 160 evaluable subjects. The trial consists of three treatment cycles, each of 8 weeks duration. Treatments are administered twice weekly for the first 6 weeks and treatment response will be determined at the end of Week 8. In the first treatment cycle, 116 subjects received SGX301 and 50 subjects received placebo treatment of their index lesions. In the second cycle, all subjects received SGX301 treatment of their index lesions and in the third cycle all subjects could receive SGX301 treatment of all their lesions. Subjects are followed for an additional 6 months after the completion of treatment. The primary efficacy endpoint was assessed on the percent of patients in each of the two treatment groups (i.e., SGX301 and placebo) achieving a Partial or Complete Response (yes/no) of the treated lesions defined as a ≥ 50% reduction in the total Composite Assessment of Index Lesion Disease Severity (CAILS) score for three index lesions at the Cycle 1 evaluation visit (Week 8) compared to the total CAILS score at baseline. Assessment of the primary endpoint revealed that 16% patients receiving SGX301 responded (i.e., had ≥ 50% reduction in index lesion size) while only 4% receiving placebo responded (p=0.04). Preliminary results from blinded data to date suggest more than a 35% response rate (inclusive of patients receiving both 12 weeks and 6 weeks of therapy), indicating the response increases with continued treatment.

Other secondary measures assessed are treatment response (including duration), degree of improvement, time to relapse and safety, and will be available as the subsequent cycles and follow-up visits are completed for all subjects.

Overall safety of SGX301 is a critical attribute of this treatment and will continue to be monitored throughout the additional treatment cycles and the 6-month follow-up period. SGX301’s mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects. Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available. Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product. SGX301 potentially represents the safest available efficacious treatment for CTCL. With no systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues.

The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc.

On March 19, 2020 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that it will report its fourth quarter and year-end 2019 financial results on Thursday, March 26, 2020 (Press release, IGM Biosciences, MAR 19, 2020, View Source [SID1234555696]).

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In connection with the earnings release, IGM’s management team will host a live conference call and webcast at 4:30 p.m. ET on Thursday, March 26, 2020, to discuss the Company’s financial results and provide a corporate update.

Conference ID: 2991398
Domestic Dial-in Number: (866) 649-1996
International Dial-in Number: (409) 217-8769
Live Webcast: View Source

A replay of the audio webcast will be available for 30 days on the Investors section of the Company’s website, www.igmbio.com.