On March 9, 2021 Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), a commercial-stage biopharmaceutical stage company focused on the development and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) infection, reported financial results for fourth quarter and full year 2020 and provided a business update (Press release, Eiger Biopharmaceuticals, MAR 9, 2021, View Source [SID1234576353]).

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"In 2021, we plan to achieve important, value creating milestones in both of our HDV clinical programs," said David Cory, President and CEO of Eiger. "We will complete enrollment of the Phase 3 D-LIVR study of Lonafarnib, the first and only oral agent in development for HDV, and we will initiate the Phase 3 LIMT-2 study of Lambda, a well-tolerated interferon. Lonafarnib and Lambda are potential foundational treatments for HDV that will offer convenience and optionality for patients affected by this serious disease."

Program & Product Updates

Lonafarnib for HDV

First and only oral therapy in development for HDV
Global Phase 3 D-LIVR study enrollment completion planned in 2021
Peginterferon Lambda for HDV

Well-tolerated interferon with weekly subcutaneous injection
Global Phase 3 LIMT-2 study initiation planned in 2021
Zokinvy (lonafarnib) for Progeria and Processing-Deficient Progeroid Laminopathies

U.S. commercial launch in January 2021
EMA decision expected in 2H21
Lambda for COVID-19

Positive Phase 2 ILIAD study in Lancet Respiratory Medicine (Feld et al, 2021)
Considering strategic options to advance program
Avexitide for Post-Bariatric Hypoglycemia (PBH)

Positive Phase 2 PREVENT study published in JCEM (Craig et al, 2021)
Corporate

Pro-forma cash, cash equivalents and investments of $176.2M, including $128.8M as of December 31, 2020 plus $47.4M from net PRV sale proceeds received in January 2021, expected to fund planned operations through Q4 2023
Fourth Quarter and Full Year 2020 Financial Results

Cash, cash equivalents, and short-term investments as of December 31, 2020 totaled $128.8 million compared to $95.0 million on December 31, 2019. In addition, the Company received net proceeds of $47.4 million in January 2021 for sale of a Priority Review Voucher (PRV) issued in conjunction with FDA approval of Zokinvy.

The Company reported net losses of $18.8 million, or $0.58 per share, and $65.1 million, or $2.31 per share, for fourth quarter and full year 2020, respectively, as compared to $16.9 million, or $0.69 per share, and $70.3 million, or $3.08 per share, for the same periods in 2019.

Research and Development expenses were $12.5 million and $41.6 million for fourth quarter and full year 2020, respectively, as compared to $11.9 million and $51.8 million for the same periods in 2019. The increase in fourth quarter 2020 was primarily due to an increase in regulatory expenses. The decrease in full year 2020 expenses was primarily due to a decrease in contract manufacturing and clinical expenditures, partially offset by an increase in regulatory, headcount related, and other operating expenses.

General and Administrative expenses were $5.4 million and $20.6 million for fourth quarter and full year 2020, respectively, as compared to $4.6 million and $17.1 million for the same periods in 2019. The increases in fourth quarter 2020 and full year 2020 were primarily due to an increase in personnel related expenses attributed to an increase in headcount and an increase in outside services, including consulting and advisory services.

Total operating expenses include non-cash expenses of $2.1 million and $7.8 million for fourth quarter and full year 2020, respectively, as compared to $1.6 million and $6.6 million for the same periods in 2019.

As of December 31, 2020, the company had 33.9 million of common shares outstanding.

On March 9, 2021 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported a corporate update and reported financial results for the fiscal year ended December 31, 2020 (Press release, Marker Therapeutics, MAR 9, 2021, View Source [SID1234576352]).

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"We are proud of our Company’s continued progress, which has positioned us for a busy and productive year ahead," said Peter L. Hoang, President & CEO of Marker Therapeutics. "Recently, we dosed the first patient in the safety lead-in portion of our Phase 2 trial in post-transplant acute myeloid leukemia (AML). In the fourth quarter, we completed construction of a new in-house cGMP manufacturing facility in Houston, which we anticipate will be fully operational in the first half of this year. We also continue to optimize the MT-401 cell therapy manufacturing process, which we believe could result in an increase in the number of T cells available for patient administration, superior T cell phenotype and antigen specificity, and the potential for improved patient outcomes."

RECENT PROGRAM UPDATES

MT-401: Multi-Antigen Targeted (MultiTAA)-Specific T Cell Product Candidate for AML

Phase 2 AML Trial

In March 2021, Marker dosed the first patient in the safety lead-in portion of its Phase 2 trial in AML. The safety lead-in is expected to enroll a total of six patients: three of which will be treated with MT-401 manufactured with a legacy reagent, and the remaining three to be treated with MT-401 manufactured with a new reagent from an alternate supplier.
To date, Marker has activated seven clinical sites and is in the start-up phase with additional clinical sites to enroll patients for the safety lead-in portion of the AML trial. The Company has also received commitments from additional clinical sites to participate in the Phase 2 AML trial following the safety lead-in phase and anticipates activating a total of approximately 20 sites.
Manufacturing and Process Improvements

Marker continues to streamline and simplify the MT-401 manufacturing process. The technical improvements include a 50% reduction in manufacturing time, a 90%+ reduction in the number of required operator interventions, and significant improvement in the consistency and reproducibility of the manufacturing process, while yielding a significant increase in the number of T cells available for patient administration. The Company believes the new process could yield a measurably improved product, with superior T cell phenotype and antigen specificity as compared to the original process. The new process improvements have been updated in the CMC section of the IND and will be used for all patients in the Marker AML Phase 2 clinical trial.
BUSINESS UPDATES

The Company completed the construction and qualification of its cGMP manufacturing facility in Houston, TX, located near the George Bush Intercontinental Airport. The facility will allow production of MultiTAA-specific T cell products according to U.S. FDA guidelines and is designed to be scalable using modular processes. The facility will be used to support the manufacture of study drug for Marker’s Phase 2 AML trial (MT-401) and for future hematological and solid tumor trials, in addition to the potential commercialization of any approved products. The Company has initiated the technology transfer process and expects the facility to be fully operational in the first half of 2021.
FISCAL YEAR 2020 FINANCIAL RESULTS

Cash Position and Guidance: At December 31, 2020, Marker had cash and cash equivalents of $21.4 million. The Company raised $6.2 million through the previously executed $30 million common stock purchase agreement with Aspire Capital Fund, LLC. The remaining $23.8 million available to Marker from Aspire Capital, along with current cash available, funds operations into Q1 2022.

R&D Expenses: Research and development expenses were $18.9 million for the year ended December 31, 2020, compared to $12.8 million for the year ended December 31, 2019.

G&A Expenses: General and administrative expenses were $10.5 million for the year ended December 31, 2020, compared to $10.0 million for the year ended December 31, 2019.

Net Loss: Marker reported a net loss of $28.7 million for the year ended December 31, 2020, compared to a net loss of $21.4 million for the year ended December 31, 2019.

On March 9, 2021 Kiromic Biopharma, Inc. (Nasdaq: KRBP), a target discovery and gene-editing company utilizing artificial intelligence and its proprietary neural network platform with a therapeutic focus on immuno-oncology, reported the planned resubmission of two investigational new drug (IND) applications with the U.S. Food and Drug Administration (FDA) (Press release, Kiromic, MAR 9, 2021, View Source [SID1234576350]).

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The revised INDs will be for first in-human dosing of our Off-the-Shelf, Allogenic Gamma-Delta T cell therapy for metastatic and progressive locally advanced solid malignancies.

The revised INDs have protocols which retain approximately 80% of the original INDs. The differences between the INDs are detailed below:

Revised INDs

Original INDs

Enrollment

Open enrollment,
multiple solid tumors

Single enrollment
1 solid tumor (ovarian)

Administration

Only IV

Either IV or IP

Chimeric T cell therapies

Separate INDs
for 2 chimeric T cell therapies

IND-1: chPD1 (solid tumors, IV)

IND-2: Iso-Mesothelin (solid tumors, IV)

Separate INDs for
varying routes of administration

IND-1: chPD1 (ovarian, IV)

IND-2: chPD1 (ovarian, IP)

IND-3: Iso-Mesothelin (ovarian IV & IP)

BENEFITS

Shorten the time
required to reach full enrollment

Expanded potential future indications

** IV = Intravenous, IP = Intraperitoneal

Timelines for the planned two INDs:

— 2Q-2021, Expected timeline for planned two IND resubmissions

— 30 days, Expected review and return by the FDA post IND submissions

— 3Q-2021, Expected timeline of first-in-human dosing

— 4Q-2021, Expected timeline of first-in-human safety and efficacy data from the trial

Since filing the original INDs in December 2020, the Company has had many discussions with the FDA, and numerous consults with scientific board and clinical advisors regarding the changes listed above. These changes shown above were made to ensure the optimal chances for success for the planned clinical trials.

Open-Enrollment and Impact on Timing

"We believe the changes in the two revised IND’s are very positive for Kiromic. The open enrollment will add breast, prostate, colorectal, and lung to our existing ovarian cancer. It is expected that the change to an open enrollment will decrease the time to reach full enrollment," says Dr. Maurizio Chiriva-Internati, CEO of Kiromic.

Single Mode of Administration (IV)

"One of the most strategic modifications was the move to a single route of administration. The new INDs will have only IV administration versus previous INDs having IV and IP. IV administration reflects the dominant and preferred mode of administration for cancer therapies in the clinic today whereby intracavitary infusions are considered more invasive. The feedbacks from the clinical sites on the new IV administration and open enrollment have been very well received," commented Dr. Scott Dahlbeck, Chief Medical Officer of Kiromic.

** IV = Intravenous, IP = Intraperitoneal

Market Expansion with Multiple Solid Tumors

"Ovarian cancer is already a significant indication by itself. However, having multiple solid tumors that are eligible in our new open enrollment protocol, including cancers such as breast, prostate, colorectal, and lung for example, will only increase the potential applications of our Off-the-Shelf, Allogenic Gamma-Delta T cell therapies," says Mr. Gianluca Rotino, Chief of Strategy and Innovation of Kiromic.

GMP Facility Readiness

"Kiromic continues to prepare itself for the upcoming first in-human trials by making sure that its GMP manufacturing facility is ready, staffed, and fully equipped. Despite COVID and the recent ice-storms which made national news, Kiromic is still running daily batch testing and validations of our Off-the-Shelf, Allogenic Gamma-Delta T cell manufacturing in full preparation for the upcoming trial," says Mr. Tony Tontat, CFO and COO of Kiromic.

Upcoming Events

— Kiromic CEO interview on Bloomberg TV Europe (March 2021)

— Kiromic CEO, CFO presentation at Benzinga Small Cap Conference (Mar 25th, 2021)

— Kiromic Abstracts highlighting our AI Neoantigen discovery engine, and our Off-the-Shelf, Allogenic Gamma-Delta T cell manufacturing at AACR (Free AACR Whitepaper) 2021 conference (April 9-14, 2021). www.aacr.org

On March 9, 2021 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that Jim Clemmer, President and Chief Executive Officer, and Stephen Trowbridge, Executive Vice President and Chief Financial Officer, will participate in a virtual fireside chat at the 31st Annual Oppenheimer Healthcare Conference at 9:20 a.m. ET on Tuesday, March 16, 2021 (Press release, AngioDynamics, MAR 9, 2021, View Source [SID1234576349]).

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A live webcast of the presentation will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.

On March 9, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic which addresses a fundamental biologic mechanism of immune suppression in cancer, reported that it will host a conference call on Tuesday, March 16, 2021 at 4:30 p.m. ET to report its financial results for the fourth quarter and full year 2020 financial results and provide an update on eganelisib development (Press release, Infinity Pharmaceuticals, MAR 9, 2021, View Source [SID1234576348]).

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A live webcast of the conference call can be accessed in the Investors/Media section of Infinity’s website at www.infi.com. An archived version of the webcast will be available on Infinity’s website for 30 days.