Mustang Bio Completes a $75 Million Debt Financing with Runway Growth Capital

On March 8, 2022 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported completion of a $75 million long-term debt facility with Runway Growth Capital LLC ("Runway"), a leading provider of growth loans to both venture and non-venture backed companies seeking an alternative to raising equity (Press release, Mustang Bio, MAR 8, 2022, View Source [SID1234609687]).

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"This financing provides us with enhanced financial flexibility as we continue to develop our gene and cell therapies in our fully integrated cell processing facility in Worcester, Mass. that has capacity to launch at commercial scale. We expect to initiate two Mustang-sponsored multicenter pivotal clinical trials and one Mustang-sponsored multicenter Phase 1/2 clinical trial in 2022. Additionally, we anticipate multiple investigator-IND gene and CAR T cell therapy interim data readouts across our pipeline this year," said Manuel Litchman, M.D., President and Chief Executive Officer of Mustang. "Partnering with Runway, a prominent provider of growth loans with an extensive history of supporting innovative life science companies, bolsters our cash position and supports Mustang’s growth trajectory while furthering our mission of bringing potentially life-saving treatments to patients in need."

Igor DaCruz, Managing Director, Life Sciences at Runway, said, "We are pleased to partner with Mustang by providing capital to potentially help expedite the development of Mustang’s robust pipeline of cell and gene therapies targeting cancers and rare diseases."

Thirty million of the $75 million loan was funded upon closing. The additional $45 million available under the facility may be funded upon Mustang’s achieving certain predetermined milestones. The loan will be repaid in 60 monthly payments consisting of 24 monthly payments of interest only, followed by 36 monthly payments of principal and accrued interest, and will be payable monthly in arrears, with all repayments ending on the same date as the initial tranche. The interest-only period may be extended to 36 months contingent upon Mustang’s achieving certain milestones. In connection with the debt financing, Mustang issued Runway warrants to purchase up to 748,036 of its common shares at an exercise price of $0.8021 per share. Proceeds from the facility will be used to support the ongoing clinical development of key investigational product candidates within Mustang’s pipeline and for general working capital purposes.

Cantor Fitzgerald served as sole placement agent to Mustang in conjunction with this transaction.

DiaMedica Therapeutics to Report Fourth Quarter 2021 Financial Results and Provide a Business Update March 15, 2022

On March 8, 2022 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported that its fourth quarter 2021 financial results will be released after the markets close on Monday, March 14th (Press release, DiaMedica, MAR 8, 2022, View Source [SID1234609686]). DiaMedica will host a live conference call on Tuesday, March 15th at 7:00 AM Central Time to provide a business update and discuss financial results.

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Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on our website, under investor relations – events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until March 22, 2022, by dialing (800) 770-2030 (US Toll Free) and entering the replay passcode: 4814247.

Altimmune To Report Fourth Quarter And Full Year 2021 Financial Results On March 15, 2022

On March 8, 2022 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported that it will report its fourth quarter and full year 2021 financial results on Tuesday, March 15, 2022 (Press release, Altimmune, MAR 8, 2022, View Source [SID1234609685]).

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Altimmune management will host a conference call at 8:30 am E.T. on March 15 to discuss financial results and provide a business update.

XOMA Reports Full Year 2021 Financial Results and Highlights Recent Operational Events

On March 8, 2022 XOMA Corporation (Nasdaq: XOMA), a biotech royalty aggregator playing a distinctive role in helping companies achieve their goal of improving human health, reported its 2021 financial results and provided a recent operations update (Press release, Xoma, MAR 8, 2022, View Source [SID1234609682]).

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"XOMA’s milestone and royalty aggregator business model really began to demonstrate its potential in 2021 and in the first few months of 2022. In 2021, we received $36.2 million in milestone payments, which allowed XOMA to report positive operating cash-flow for the second consecutive year. The anti-TGFß asset we licensed to Novartis in 2015 entered Phase 3 development in 2021, a milestone that resulted in us receiving a $35 million payment. In the past two years, this asset, NIS793, has provided us with a total of $60 million in milestone revenue. Last October, we announced a significant transaction for XOMA, the purchase of rights to a 0.5% commercial payment on faricimab, a BLA-review-stage asset, for a $6 million upfront payment plus potential future milestone payments to Affitech SA. In late January 2022, the FDA gave commercialization approval to this novel bispecific antibody for the treatment of nAMD and DME. This is the first asset under our royalty aggregator model to receive commercialization approval. We recently paid $5 million in milestone payments to Affitech, triggered by these FDA approvals. Another advancement in January 2022 came as Rezolute dosed the final patient

with RZ358 in its Phase 2 congenital hyperinsulinism (CHI) study, which triggered a $2 million milestone payment to XOMA. Given our history with RZ358 and the connections we made with the CHI community, we are looking forward to seeing the clinical results when they are announced publicly," stated Jim Neal, Chairman and Chief Executive Officer of XOMA.

"These are just a few of the advances we’ve seen in our portfolio over the past year. We wish all our partners success in their clinical development efforts, as there are patients in need of additional therapeutic options.

"Our team continues to identify and acquire milestone and royalty licenses to expand and diversify XOMA’s portfolio, with eight assets added in 2021. With a strong foundation firmly established and an outstanding team in place, I decided it was the right time for the Company to proactively initiate a CEO succession plan, and we have launched a formal search. In the meantime, I will remain as CEO and continue to help shape XOMA’s future as Chairman of the Board. I believe 2021 and these first few months of 2022 are just the beginning of what’s to come," Mr. Neal concluded.

Financial Results

XOMA recorded total revenues of $35.9 million for the fourth quarter of 2021, compared with $27.6 million in the fourth quarter of 2020. The increase for the three months ended December 31, 2021, as compared to the corresponding period of 2020, was primarily due to the $35.0 million milestone earned under the Company’s Anti-TGFß Antibody License Agreement with Novartis International. For the full year of 2021, XOMA recorded revenues of $38.2 million, compared to $29.4 million for the full year of 2020. In 2021, XOMA received milestone revenue of $35.0 million earned under its Anti-TGFß Antibody License Agreement with Novartis, $0.5 million under its license agreement with Compugen, and $0.7 million under its license agreement with Janssen. Revenues for the full year of 2020 reflect $25.0 million in milestone revenue earned under the Company’s Anti-TGFß Antibody License Agreement with Novartis International and $2.0 million earned under XOMA’s collaboration agreement with Takeda.

Research and development ("R&D") expenses were $42,000 and $36,000, respectively, for the fourth quarters of 2021 and 2020. R&D expenses for the full years of 2021 and 2020 and were $0.2 million.

General and administrative ("G&A") expenses were $5.5 million for the fourth quarter of 2021, compared to $3.7 million for the fourth quarter of 2020. The increase of $1.8 million for the three months ended December 31, 2021, as compared to the corresponding period of 2020, was due primarily to a $1.1 million increase in stock compensation expense related to a grant of options in connection with Mr. Neal’s amended employment agreement and the reversal of $1.4 million in bad debt expense in the fourth quarter of 2020, partially offset by a decrease of $0.5 million in legal and consulting costs. G&A expenses were $20.5 million for the full year of 2021, compared to $16.8 million for the full year of 2020. The increase of $3.7 million in 2021 as compared with 2020 was primarily due to a $2.2 million increase in stock compensation expense, $0.8 million increase in salary and related expenses, $0.4 million increase in legal and consulting costs and $0.2 million increase in insurance costs.

In the fourth quarter of 2021, G&A expenses included $1.7 million in non-cash stock-based compensation expense, compared with $0.7 million in the fourth quarter of 2020. For the full year of 2021, G&A expenses included $6.2 million in non-cash stock-based compensation expense, compared with $3.9 million of non-cash stock-based compensation expense in 2020. XOMA’s net cash provided by operations in the fourth quarter of 2021 was $30.7 million, as compared with $17.7 million during the fourth quarter of 2020.

XOMA’s net cash provided by operations for the full year of 2021 was $22.7 million compared to $10.1 million in 2020.

In June 2021, the Company repaid its outstanding debt obligations to Silicon Valley Bank and Novartis in full. For the full year of 2021, interest expense was $0.5 million, compared with $1.8 million reported in the full year of 2020. The decrease in interest expense during 2021 reflects the extinguishment of XOMA’s debt obligations.

Other expense, net was $0.4 million for the fourth quarter of 2021, compared to other expense, net of $0.8 million in the corresponding quarter of 2020. Other expense, net was $0.9 million for the full year of 2021, compared to other income, net of $1.2 million for the corresponding period of 2020. The fluctuation in other (expense) income, net for the quarter and year ended December 31, 2021, as compared to the same periods in 2020, is primarily due to the change in the fair value of equity securities XOMA holds in Rezolute, Inc.

Net income for the fourth quarter of 2021 was $29.8 million, compared to net income of $22.7 million for the fourth quarter of 2020. For the full year of 2021, net income was $15.8 million, as compared to $13.3 million for the full year of 2020.

On December 31, 2021, XOMA had cash and restricted cash of $95.4 million. The Company ended December 31, 2020, with cash and restricted cash of $85.8 million. After paying its remaining debt obligations in the second quarter of 2021, XOMA has no debt on its balance sheet. The Company continues to believe its current cash position will be sufficient to fund XOMA’s operations for multiple years.

Genmab Announces U.S. Food and Drug Administration Granted Orphan-Drug Designation to Epcoritamab (DuoBody®-CD3xCD20) in Follicular Lymphoma

On March 8, 2022 Genmab A/S (Nasdaq: GMAB) reported that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to the investigational medicine, epcoritamab (DuoBody-CD3xCD20), for the treatment of follicular lymphoma (FL) (Press release, Genmab, MAR 8, 2022, View Source [SID1234609681]). Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV).

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Orphan drug status is designated by the FDA to medicines and biologics that are defined as those intended for the prevention, diagnosis, or treatment of a rare disease or condition affecting less than 200,000 people in the U.S.i

Approximately 2.7 per 100,000 people in the U.S. are newly diagnosed with follicular lymphoma (FL)ii every year and the median age of patients at diagnoses with FL is 63.iii,iv,v FL is typically a slow-growing or indolent form of non-Hodgkin’s lymphoma (NHL) that arises from B-lymphocytes.vi Although FL is an indolent lymphoma, patients who relapse or become refractory are incurable with conventional therapy and there is a need for additional treatment options.vii,viii Globally, FL is the second most common form of NHL, accounting for approximately 25 percent of adult NHL.ix

"This orphan drug designation is an important milestone for epcoritamab," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "With AbbVie, we remain committed to further developing epcoritamab in this patient population, as well as in patients diagnosed with other B-cell hematologic malignancies."

Epcoritamab is currently being evaluated as a treatment option for patients with FL in several clinical trials, including the phase 1/2 EPCORE NHL-1 evaluating the efficacy and safety of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (B-NHL), including diffuse large B-cell Lymphoma (DLCBL), follicular lymphoma (FL), and mantle cell lymphoma (MCL) (NCT: 03625037). Additional trials evaluating epcoritamab in patients with FL include a phase 1b/2, open-label, multinational, interventional trial to evaluate the safety and preliminary efficacy of epcoritamab in combination with other standard of care (SOC) agents across different lines of therapy in patients with DLBCL or FL (NCT: 04663347) and a phase 1/2 trial evaluating the safety and efficacy of epcoritamab in Japanese patients with relapsed/refractory B-NHL (NCT: 04542824).

About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to tumors to elicit an immune response towards malignant cells. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T cell mediated killing of lymphoma B cells.x CD20 is a clinically validated therapeutic target, and is expressed on many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.xi,xii Epcoritamab is an investigational medicine not currently approved by the FDA. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ broad oncology collaboration.