On February 25, 2021 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported fourth quarter and full year financial results for the periods ended December 31, 2020 (Press release, Allogene, FEB 25, 2021, View Source [SID1234575665]).

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"By all measures, 2020 was a year of exceptional growth and success as we progressed development of our AlloCAR T candidates and continued to establish Allogene as a leader in the cell therapy field. We’ve now treated over 75 patients with our AlloCAR T therapies, more than any other company in the field. Continued progress on our first three Phase 1 trials, ALPHA, ALPHA2, and UNIVERSAL, two new IND submissions, including our first in solid tumors, and the establishment of our Allogene Overland Biopharm joint venture highlight our executional capabilities," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "Looking ahead to key milestones this year, we are looking forward to presenting an update on our CD19 program and the possibility of launching our first pivotal trial as well as operationalizing our state-of-the-art AlloCAR T production facility in Newark, California."

Pipeline Highlights

Anti-CD19 AlloCAR T Program

Additional data from the Phase 1 ALPHA study of ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL) and initial data from the Phase 1 ALPHA2 study of ALLO-501A are planned for Q2 2021. The Company intends to initiate a potentially pivotal Phase 2 trial of ALLO-501A by the end of 2021.
ALLO-501A was recently granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory diffuse large B cell lymphoma (DLBCL), a type of NHL. FTD is intended to facilitate the development, and expedites the review of, medicines to treat serious conditions and fill unmet medical need. FTD allows for potentially greater access to the FDA for the purpose of expediting the drug product candidate’s development, review and potential approval.
Anti-BCMA AlloCAR T Program
The Company continues to expand its portfolio of anti-BCMA therapies to realize the potential benefits of an allogeneic approach to patients with multiple myeloma.

ALLO-715 UNIVERSAL Trial
In December 2020, at an oral session of the 62nd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), the Company reported initial data on ALLO-715, its first AlloCAR T candidate for relapsed/refractory multiple myeloma (MM). The Phase I UNIVERSAL trial utilizes a proprietary lymphodepletion regimen consisting of ALLO-647 (anti-CD52 mAb) and chemotherapy.
As per the ASH (Free ASH Whitepaper) presentation, 31 ALLO-715 treated patients were evaluable for safety and 26 patients were evaluable for efficacy.
Higher CAR T cell doses were associated with an increased response rate and greater AlloCAR T cell expansion.
In the DL3 cohort (320M CAR T+ cells), the overall response rate (ORR) was 60% with 40% of patients achieving a very good partial response (VGPR) or better (VGPR+).
Minimal Residual Disease (MRD) was assessed in five patients with VGPR+ and all five were MRD negative.
Approximately 90% of patients were treated within five days of study enrollment. No bridging therapy was required.
No graft-vs-host disease or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) was observed. Cytokine Release Syndrome (Grade 1 or 2) was reported in 14 patients (45%) and was manageable with standard therapies. The rate of Grade 3+ infection events was similar to what has been reported in other advanced MM studies. Any Grade 3+ adverse events reported as serious adverse events occurred in 19% of patients. A single Grade 5 event related to progressive myeloma and a cyclophosphamide and ALLO-647 conditioning regimen was reported.
ALLO-715 + nirogacestat
The FDA cleared the Investigational New Drug Application (IND) to evaluate ALLO-715 in combination with the investigational gamma secretase inhibitor nirogacestat, in patients with relapsed/refractory MM. Enrollment has been initiated. Nirogacestat is being developed by SpringWorks Therapeutics.
ALLO-605 TurboCAR
An IND submission is planned for 1H 2021 for ALLO-605, the first anti-BCMA TurboCAR T cell therapy, for use in relapsed/refractory MM. Upon clearance, the IGNITE trial is expected to begin this year. The Company presented preclinical findings supporting ALLO-605 at ASH (Free ASH Whitepaper) in December 2020. TurboCAR technology allows cytokine activation signaling to be engineered selectively into CAR T cells. TurboCAR has the potential to improve efficacy, overcome cell exhaustion, and reduce dosing requirements of AlloCAR T therapy.
Solid Tumor AlloCAR T Program

ALLO-316 (anti-CD70) – TRAVERSE Trial
The FDA cleared an IND to evaluate ALLO-316, Allogene’s first CAR T candidate for solid tumors. The Company expects to initiate the Phase 1 TRAVERSE trial in Q1 2021 to examine safety, tolerability, anti-tumor efficacy, pharmacokinetics, and pharmacodynamics of ALLO-316 in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC).
ALLO-316 also has potential application in hematologic malignancies. The Company presented preclinical findings of ALLO-316 targeting CD70 in models of acute myeloid leukemia (AML) at ASH (Free ASH Whitepaper) in December and plans to explore AML as a potential second indication for ALLO-316.
Corporate Highlights

Establishment of Allogene Overland Biopharm
The Company and Overland Pharmaceuticals, which is backed by Hillhouse Capital, announced the formation of Allogene Overland Biopharm. The joint venture will have an exclusive license to develop, manufacture and commercialize specific Allogene candidates targeting BCMA, CD70, FLT3, and DLL3 in the licensed territories.
Cell Forge 1 Manufacturing Facility
Construction of the Company’s new state-of-the-art cGMP cell manufacturing facility, Cell Forge 1, in Newark, California has been completed. cGMP manufacturing from this facility is expected to begin in 2021.
Fourth Quarter Financial Results

Research and development expenses were $52.2 million for the fourth quarter of 2020, which includes $7.9 million of non-cash stock-based compensation expense. For the full year of 2020, research and development expenses were $193.0 million. Research and development expense for the year includes $31.3 million of non-cash stock-based compensation expense.
General and administrative expenses were $17.1 million for the fourth quarter of 2020, which includes $8.6 million of non-cash stock-based compensation expense. For the full year of 2020, general and administrative expenses were $65.3 million, which includes $34.0 million of non-cash stock-based compensation expense.
Net loss for the fourth quarter of 2020 was $68.6 million, or $0.53 per share, including non-cash stock-based compensation expense of $16.5 million. For the full year of 2020, net loss was $250.2 million, or $2.08 per share, including non-cash stock-based compensation expense of $65.3 million.
The Company had $1.0 billion in cash, cash equivalents, and investments as of December 31, 2020.
2021 Financial Guidance

Allogene expects full year GAAP Operating Expenses to be between $300 million and $330 million including estimated non-cash stock-based compensation expense of $80 million to $90 million and excluding any impact from potential new business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time /5:00 p.m. Eastern Time to discuss financial results and provide a business update. To access the live conference call by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409) 216-0618 (International). The conference ID number for the live call is 4973969. The webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

On February 25, 2021 Cullgen Inc., a leading biotechnology company developing small molecule therapeutics based on its proprietary uSMITE platform of targeted protein degradation technology, reported that it has closed a $50 million Series B financing (assuming exercise of warrant) (Press release, Cullgen, FEB 25, 2021, View Source [SID1234575681]). In addition to receiving funding from existing Cullgen investors, five new prominent international venture capital firms also participated in the financing, including the lead investor, 3E Bioventures Capital, as well as Heights Capital Management (an affiliate of Susquehanna International Group), Octagon Capital, MSA Capital and South China Venture Capital. The financing will support the development of Cullgen’s technology platform and internal pipeline of targeted protein degraders in oncology and other diseases. Cullgen is also pleased to announce that Frank Yan, from 3E Bioventures, will be joining Cullgen’s board of directors.

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"There was overwhelming interest from the investment community to participate in this round of funding", said Dr. Ying Luo, Chairman of Cullgen. "We are grateful to have received financial backing from prominent venture capital firms that are convinced that Cullgen has built a world-class targeted protein degradation company. We plan to file an IND later this year for our most advanced program, CG001419, which is a TRK protein degrader for cancer and other disease applications. We plan to utilize the new capital to help advance this program into human clinical studies, as well as advance our other pipeline products closer to human clinical studies. In addition, we believe that the future of targeted protein degradation lies in the use of novel E3 ligands. The new funding will allow us to continue discovering and optimizing our exciting pipeline of novel E3 ligands".

On February 25, 2021 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported financial results for the fourth quarter and full year ended December 31, 2020 (Press release, Compugen, FEB 25, 2021, View Source [SID1234575719]).

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"Our encouraging new data reinforces our conviction in our clinical development strategy to comprehensively evaluate dual and triple blockade of DNAM axis members, PVRIG and TIGIT, along with the intersecting PD-1 pathway, across our clinical studies," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We have now observed durable responses in patients treated with COM701 as a monotherapy and in combination with Opdivo, including a patient with a confirmed complete response we reported earlier today. Most notably, the durable responses and signals of anti-tumor activity reported across our COM701 studies were achieved in highly refractory patients in indications usually unresponsive to available checkpoint inhibitors. These encouraging signals demonstrate that COM701 is clinically active and strengthen our hypothesis that PVRIG is an important new checkpoint target for immunotherapy and served as the basis for expanding our collaboration with Bristol Myers Squibb."

Dr. Cohen-Dayag added, "With these data in hand, we are now focused on executing across our expanded clinical programs. Most importantly, as the only company with wholly owned clinical assets targeting PVRIG and TIGIT, we are uniquely positioned to evaluate PVRIG in monotherapy and in dual blockade with PD-1 or TIGIT, as well as the triple blockade of PVRIG with PD-1 and TIGIT. We expect to initiate our combination study for COM701 with COM902 in the second half of this year and to share initial data from our COM902 monotherapy and triple combination dose escalation studies in the fourth quarter of this year. We look forward to further revealing the potential of DNAM axis blockade to expand the reach of immunotherapy to patients unresponsive or refractory to current treatment options."

Recent and Fourth Quarter 2020 Corporate Highlights

Announced updated data from COM701 monotherapy and combination with Opdivo (nivolumab) studies
Announced expansion of clinical collaboration agreement with Bristol Myers Squibb with planned Phase 1b cohort expansion study evaluating COM701 with Opdivo in patients with ovarian, breast, endometrial and microsatellite-stable colorectal cancers. The study is on track to initiate in the second quarter of 2021
Announced first development milestone of $2 million received under the license agreement with AstraZeneca for the development of bispecific and multi-specific antibody products
Presented preclinical data at the 2020 TIGIT Therapies Digital Summit demonstrating the potential of PVRIG inhibition to enhance T cell priming and infiltration into both inflamed and less inflamed tumors, as well as providing further support for the therapeutic combination of TIGIT and PD-1 inhibitors to address patient populations who do not benefit from available immune checkpoint inhibitors
Expanded IP portfolio for COM902 with composition of matter patent in China, in addition to composition of matter and use patents for COM902 previously issued in the United States and Europe
Financial Results

Revenues for the fourth quarter ended December 31, 2020, were $2.0 million, related to the milestone payment in the license agreement with AstraZeneca for the development of bispecific and multi-specific antibody products.

R&D expenses for the fourth quarter and year ended December 31, 2020, were $8.1 million, and $22.8 million, respectively, compared with $4.3 million and $19.8 million for the comparable periods in 2019. The increase in both cases is attributed mostly to increase in expenses associated with our various Phase 1 clinical studies, COM701 and COM902 manufacturing and other chemistry, manufacturing and controls activities.

General and administrative expenses for the fourth quarter and year ended December 31, 2020, were $2.7 million, and $9.8 million, respectively, compared with $2.2 million and $8.4 million for the comparable periods in 2019. The increase in both the quarterly and annual periods is attributed mainly to headcount-related expenses and increased corporate-related expenses.

Net loss for the fourth quarter of 2020 was $8.6 million, or $0.10 per basic and diluted share, compared with a net loss of $6.5 million, or $0.10 per basic and diluted share, in the comparable period of 2019. Net loss for the year ended December 31, 2020 was $29.7 million, or $0.37 per basic and diluted share, compared with a net loss of $27.3 million, or $0.43 per basic and diluted share, for the year ended December 31, 2019.

As of December 31, 2020, cash, cash related accounts, short-term and long-term bank deposits totaled approximately $124.4 million, compared with approximately $43.9 million on December 31, 2019. The Company has no debt.

Opdivo is a registered trademark of Bristol Myers Squibb.

Conference Call and Webcast Information

The Company will hold a conference call today, February 25, 2021, at 8:30 AM ET to review its fourth quarter and full year 2020 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0610 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

On February 25, 2021 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, reported that it will host a conference call and audio webcast on March 4, 2021 at 2:30 p.m. CET (8:30 a.m. ET) to discuss its full year 2020 financial results and provide a fourth quarter business update (Press release, argenx, FEB 25, 2021, View Source [SID1234575740]).

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A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website for one year following the call.

On February 25, 2021 MannKind Corporation (NASDAQ:MNKD) reported financial results for the fourth quarter and full year ended December 31, 2020 (Press release, Mannkind, FEB 25, 2021, View Source [SID1234575584]).

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"Our fourth quarter produced exceptional results, with $10.1 million in Afrezza net revenue and positive clinical data for Tyvaso DPI from the BREEZE study conducted by United Therapeutics," said Michael Castagna, Chief Executive Officer of MannKind Corporation. "UT also announced their plan to submit a new drug application for Tyvaso DPI to the FDA in April 2021. During the fourth quarter, we solidified our new direction with the acquisition of QrumPharma, which added a nebulized version of clofazimine to our pipeline of therapies for orphan lung diseases, and we entered into a collaboration agreement with Vertice for the co-promotion of Thyquidity, which is indicated for hyperthyroidism and is expected to expand our reach into endocrine diseases."

Fourth Quarter 2020 Results

Total revenues were $18.4 million for the fourth quarter of 2020, reflecting Afrezza net revenue of $10.1 million and collaborations and services revenue of $8.4 million. Afrezza net revenue increased 30% compared to $7.8 million in the fourth quarter of 2019, primarily driven by higher product demand with a more favorable mix of Afrezza cartridges and more favorable gross-to-net deductions. Collaborations and services revenue increased $0.2 million compared to the fourth quarter of 2019.

Afrezza gross profit for the fourth quarter of 2020 was $6.4 million compared to $3.1 million in the same period of 2019, an increase of $3.3 million, or 105%, that was driven by a combination of increased Afrezza revenue and a reduction in cost of goods sold.

In-process research and development expense for the fourth quarter of 2020 was $13.2 million, reflecting the acquisition of QrumPharma for approximately $12.8 million in total consideration and approximately $0.4 million in transaction costs. The acquisition of QrumPharma was accounted for as an asset acquisition and expensed on the date of acquisition as substantially all of the fair value of the assets acquired was concentrated in a single asset that consisted of in-process research and development in a pre-clinical development state.

Research and development expenses for the fourth quarter of 2020 were $1.5 million compared to $2.0 million for the fourth quarter of 2019. This decrease was mainly related to lower clinical trial spending.

Selling, general and administrative expenses for the fourth quarter of 2020 were $17.1 million compared to $15.7 million for the fourth quarter of 2019. This increase of $1.4 million, or 9%, was primarily attributable to a $1.2 million increase in personnel costs related to the expansion of our sales and medical field force.

During the fourth quarter of 2020, loss on foreign currency translation for insulin purchase commitments, which are denominated in Euros, was $4.0 million compared to $2.6 million for the fourth quarter of 2019. The fluctuation was due to a change in the U.S. dollar to Euro foreign exchange rate.

Interest expense on debt for the fourth quarter of 2020 was $2.4 million compared to $2.3 million for the fourth quarter of 2019.

The net loss for the fourth quarter of 2020 was $26.4 million, or $0.11 per share, compared to $14.3 million in the fourth quarter of 2019, or $0.07 per share. The increase in the net loss of $12.1 million was primarily due to the write-off of in-process research and development related to the acquisition of QrumPharma. On a non-GAAP basis, excluding the expense incurred for the acquisition of QrumPharma, the net loss for the fourth quarter of 2020 was $13.2 million, or $0.06 per share.

Twelve Months Ended December 31, 2020

Total revenues were $65.1 million for the year ended December 31, 2020, reflecting Afrezza net revenue of $32.3 million and collaborations and services revenue of $32.8 million. Afrezza net revenue increased 28% compared to $25.3 million for the year ended December 31, 2019, primarily driven by higher product demand with a more favorable mix of Afrezza cartridges, a price increase and more favorable gross-to-net deductions, all of which was partially offset by a reduction in sales to Biomm (Brazil). Collaborations and services revenue decreased $4.9 million compared to the full year ended December 31, 2019, primarily driven by a $5.8 million decrease in revenue recognized from the UT Research Agreement, which was substantially completed in the second quarter of 2019.

Afrezza gross profit was $17.2 million for the year ended December 31, 2020, an increase of $12.0 million, or 230%, compared to a gross profit of $5.2 million in the same period in 2019, primarily due higher commercial product sales combined with a reduction in cost of goods sold.

In-process research and development expense for the year ended December 31, 2020 was $13.2 million, reflecting the research and development acquired and expensed from the acquisition of QrumPharma for approximately $12.8 million in total consideration and approximately $0.4 million in transaction costs.

Research and development expenses for the year ended December 31, 2020 were $6.2 million compared to $6.9 million for the year ended December 31, 2019. This decrease of $0.7 million, or 9%, was primarily attributable to lower clinical trial spending.

Selling, general and administrative expenses for the year ended December 31, 2020 were $59.0 million compared to $74.7 million for the year ended December 31, 2019. This decrease of $15.6 million, or 21%, was primarily attributable a $9.3 million decrease in costs for television advertising for Afrezza, a $4.1 million decrease in promotional and marketing activities in response to the COVID-19 pandemic and a $2.5 million decrease in professional fees.

An impairment of $1.9 million was recognized for the year ended December 31, 2020 on a commitment asset and debt issuance costs related to future funding commitments of the MidCap Credit Facility. There were no asset impairments for the year ended December 31, 2019.

For the year ended December 31, 2020, foreign currency translation for insulin purchase commitments, which are denominated in Euros, resulted in a loss of $8.0 million compared to a gain of $1.9 million for the year ended December 31, 2019. The fluctuation was due to a change in the U.S. dollar to Euro foreign exchange rate.

Interest expense on debt for the year ended December 31, 2020 was $9.5 million compared to $10.9 million for the year ended December 31, 2019. This $1.4 million decrease was primarily attributable to a $3.4 million milestone obligation to Deerfield that was achieved in the third quarter of 2019 and a decrease of $0.8 million of interest expense related to the Deerfield Credit Facility, which was extinguished in the third quarter of 2019. This decrease was partially offset by an increase in interest expense from the MidCap Credit Facility of $2.3 million and an increase in interest expense from our Mann Group promissory notes of $0.6 million in 2020.

The net loss for the year ended December 31, 2020 was $57.2 million, or $0.26 per share, compared to $51.9 million net loss for the year ended December 31, 2019, or $0.27 per share. The higher net loss was mainly attributable to the write-off of in-process research and development related to the acquisition of QrumPharma and a loss on foreign currency translation related to insulin purchase commitments denominated in Euros, offset by a decrease in selling, general and administrative expenses. On a non-GAAP basis, excluding the expense incurred for the acquisition of QrumPharma, the net loss for the year ended December 31, 2020 was $44.0 million, or $0.20 per share.

Cash, cash equivalents, restricted cash, and short-term investments at December 31, 2020 was $67.2 million compared to $50.2 million at December 31, 2019.

Debt Reductions Subsequent to December 31, 2020

Pursuant to the terms of the senior convertible notes, the Company forced the conversion of all $5.0 million in principal of such notes into 1,666,667 shares of the Company’s common stock.

In addition, the Mann Group converted $9.6 million of principal and $0.4 million of accrued interest on its convertible promissory note into 4.0 million shares of the Company’s common stock. As of the date hereof, $53.4 million in principal remains outstanding under the promissory notes held by the Mann Group ($18.4 of which is convertible).

Sale-Leaseback of the Danbury Manufacturing Facility

Subsequent to December 31, 2020, the Company entered into a non-binding letter of intent ("LOI") with a third party to sell and lease back a portion of the Company’s Danbury manufacturing facility and administrative offices. The terms of the LOI include a sales price of approximately $95 million – $105 million, a lease term of 20 years with four 5-year renewal options, and annual rent of approximately $10 million – $11 million at the beginning of the lease. If the transaction is completed, the Company intends to use the proceeds for general corporate purposes, and may also pay down a portion of its senior secured debt. The completion of the transactions contemplated by the LOI is subject to certain conditions, including the negotiation of satisfactory definitive agreements and satisfactory results of the buyer’s inspections and other investigations, all of which are anticipated to be completed during the first quarter of 2021. However, there can be no assurances that this proposed transaction will be completed in the timeframe or on the principal terms set forth above, or at all.

Non-GAAP Measures

Certain financial information contained in this press release is presented on both a reported basis (GAAP) and a non-GAAP basis. Reported results were prepared in accordance with GAAP whereas non-GAAP measures exclude items described in the reconciliation tables below. Non-GAAP financial information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current and past periods. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 9:00 a.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at View Source under News & Events. A replay will be available on MannKind’s website for 14 days.