On March 27, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported financial results for the year ended December 31, 2019 (Press release, Can-Fite BioPharma, MAR 27, 2020, View Source [SID1234555950]).

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Clinical Developments and Corporate Highlights Include:

Piclidenoson as Potential Treatment for Coronavirus – Piclidenoson’s anti-rheumatic and anti-viral effects, combined with its excellent safety profile, make it a potential candidate for the treatment of coronavirus. Can-Fite recently submitted Piclidenoson to the Institutional Review Board at Rabin Medical Center for a compassionate use program to treat coronavirus patients. If approved, the compassionate use program will be led by Dr. Dror Diker, M.D., Head of Internal Medicine D at the Rabin Medical Center. Concurrently, through a collaborative research agreement with the Lewis Katz School of Medicine at Temple University in Philadelphia, Can-Fite is conducting studies on the anti-viral activity of Piclidenoson on the coronavirus. The anti-viral effect of Piclidenoson is protected by US patent US7589075. Rheumatoid arthritis drugs are now being evaluated for the treatment of coronavirus in global studies, and China recently approved the use of Roche’s Actemra, a rheumatoid arthritis drug, to treat coronavirus.

Namodenoson Phase II NASH Data Expected in April 2020 – Can-Fite completed enrollment of 60 patients with NAFLD (non-alcoholic fatty liver disease) with or without NASH (non-alcoholic steatohepatitis), and plans to announce topline results during April 2020. The end points of this study include serum ALT levels, percentage change in liver fat, as measured by PDFF (proton density fat fraction), weight loss and additional serum parameters.

Namodenoson is Headed into Pivotal Phase III Liver Cancer Study – Following a successful End-of-Phase II Meeting with the U.S. Food and Drug Administration (FDA) regarding Namodenoson in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer, the FDA agreed with Can-Fite’s proposed pivotal Phase III trial design to support a New Drug Application submission and approval. The Phase III study protocol and registration plan have also been submitted to the European Medicines Agency (EMA). Namodenoson is currently being used to treat liver cancer patients in a compassionate use program in Israel, which has enrolled seven patients. In addition, two patients who were enrolled in the Company’s former Phase II study, who responded well to the drug, are continuing treatment. Those two advanced liver cancer patients have reached an overall survival of over 2.5 years while being treated with Namodenoson.

Piclidenoson Phase III Rheumatoid Arthritis and Psoriasis Studies Complete 50% Enrollment; Interim Data for Rheumatoid Arthritis Expected Q4 2020 – Can-Fite continues to enroll patients in its Phase IIII study for psoriasis. An interim analysis is being implemented for the rheumatoid arthritis study. Data will be monitored by an independent data monitoring committee (IDMC) which will have un-blinded access to the data in Q3 2020, with an announcement of interim results expected in Q4 2020.

Developing Cannabinoid-based Drug Candidates – During 2019, Can-Fite signed an agreement with Univo Pharmaceuticals (TASE:UNVO), a medical cannabis company, to identify and co-develop specific formulations of cannabis components for the treatment of diseases in which there is an overexpression of A3AR, Can-Fite’s target. Based on its recent scientific findings, Can-Fite has filed patents for the use of cannabinoid-based drugs to treat cancer, autoimmune, inflammatory and metabolic diseases. The Company’s most recent research revealed that cannabis-derived CBD enriched fractions inhibit fat cell expansion and have beneficial effects against liver cancer.

Cash Infusion of $11 Million from Distribution Deals and Equity Raise – During 2019, Can-Fite raised a total of $9.2 million through equity offerings, and received upfront payments from distribution agreements for its drugs in specific territories and indications in the amount of $1.75 million. The upfront payments from distributors were part of agreements that totaled $10 million plus royalties based on the achievement of milestones. Following the end of 2019, Can-Fite received an additional cash infusion of $8.4 million through a combination of $5 million raised through an equity offering and $3.4 million through cash exercises of warrants.

"We are focused on delivering our advanced stage drug candidates to meet the immediate medical needs of patients who lack safe and effective treatments to life threatening conditions. This includes Piclidenoson for the treatment of coronavirus and Namodenoson for advanced liver cancer," stated Can-Fite CEO Pnina Fishman. "In 2019, we achieved very significant progress in our Phase III trials of Piclidenoson and are now over 50% complete with patient enrollment. In 2020, we are well positioned for achieving milestones which we believe may generate more non-dilutive funding for Can-Fite through new global distribution agreements, as well as trigger milestone payments from our current agreements."

Financial Results

Revenues for the year ended December 31, 2019 were $2.0 million, a decrease of $1.8 million, or 47.3%, compared to $3.8 million for the year ended December 31, 2018. The decrease in revenue was mainly due to the recognition of a $2 million advance payment received in August 2018 under the License, Collaboration and Distribution Agreement with CMS Medical.

Research and development expenses for the year ended December 31, 2019 were $10.9 million, an increase of $4.9 million, or 81.6%, compared to $6 million for the year ended December 31, 2018. Research and developments expenses for the year ended 2019 comprised primarily of expenses associated with the Phase II studies for Namodenoson and Phase III studies of Piclidenoson. The increase is primarily due to increased costs associated with the initiation of the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis. We expect that the research and development expenses will increase through 2020 and beyond.

General and administrative expenses were $3.0 million for the year ended December 31, 2019 a decrease of $0.1 million, or 3.1%, compared to $3.1 million for the year ended December 31, 2018. The decrease is primarily due to decrease in investor relations expense and a decrease in salary and related expenses which was partly offset by an increase in insurance expenses. We expect that general and administrative expenses will remain at the same level through 2020.

Financial income, net for the year ended December 31, 2019 were $2.4 million compared to financial expenses, net of $1.1 million in the same period in 2018. The decrease in financial expense, net was mainly due to decrease in a loss from short-term investment revaluation and increase in income from changes in fair value of warrants liability exercisable into shares.

Net loss for the year ended December 31, 2019 was $9.5 million compared with a net loss of $6.6 million for the year ended December 31, 2018. The increase in net loss for the year ended December 31, 2019 was primarily attributable to decrease in revenues in 2019 and an increase in research and development expenses which were partly offset by an increase in finance income, net.

As of December 31, 2019, Can-Fite had cash and cash equivalents of $2.7 million as compared to $3.6 million at December 31, 2018. The decrease in cash during the year ended December 31, 2019 is due to increase in net cash provided by financing activity which was offset by an increase in net cash used in operating activity. In February 2020, Can-Fite raised $5 million in a registered direct offering, and in January and March 2019 the Company received approximately $3.4 million through warrant exercises.

More detailed information can be found in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2019, a copy of which has been filed with the Securities and Exchange Commission (SEC). The Annual Report, which contains the Company’s audited consolidated financial statements, can be accessed on the SEC’s website at View Source as well as via the Company’s investor relations website at View Source The Company will deliver a hard copy of its Annual Report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to Can-Fite Investor Relations at 10 Bareket Street, Kiryat Matalon, Petah-Tikva 4951778, Israel or by phone at +972-3-9241114.

On March 27, 2020 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the year ended December 31, 2019 and provided a corporate update (Press release, Altimmune, MAR 27, 2020, View Source [SID1234555951]).

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"2019 was a productive year for the Company with the acquisition of ALT-801, a supplemental award for the development of NasoShield from BARDA, and the advancement of ALT-702 as a preclinical program," said Vipin K. Garg, Ph.D., President and Chief Executive Officer. "However, we all find ourselves in a very different world in 2020 with the COVID-19 global pandemic causing substantial disruption to many of our lives."

Dr. Garg continued, "We face an unprecedented time, which will require companies, organizations, academic institutions, and governments to come together as a united front against this pandemic. At Altimmune, we believe we can leverage our intranasal vaccine technology platform and experience with both influenza and anthrax to rapidly develop a COVID-19 vaccine candidate. Our entire Company is working tirelessly to address this crisis as we progress our vaccine candidate for COVID-19 towards the initiation of a Phase 1 clinical trial as early as Q3 of this year. We believe our vaccine platform has the potential to offer specific and substantial benefits to address a pandemic situation, and we will continue to press forward in our effort to address this challenge."

Corporate Update and 2019 Highlights

2020 Activity:

Initiated development of "AdCOVID", our single-dose intranasal COVID-19 vaccine candidate

Utilizing our proprietary intranasal vaccine technology, the Company began development of AdCOVID, a vaccine candidate to protect against COVID-19. We believe, our vaccine technology is particularly well positioned to respond to pandemic respiratory infections as it combines intranasal dosing, a broad, rapid immune response and room temperature stability with avoidance of cold chain shipping requirements, making it easier to distribute across communities. The Company designed and created the vaccine candidate in February and plans to begin animal testing in Q2 2020. The Company is engaged in discussions with a number of organizations who are addressing this crisis, including The United States Medical Countermeasures Task Force, The World Health Organization, academia, and other institutions engaged in the effort.
Announced positive results for ALT-702 in a preclinical model of colorectal cancer

ALT-702 met a key preclinical milestone with the demonstration of systemic antitumor activity in a preclinical model of colorectal cancer following its local injection into solid tumors. ALT-702 is a depot-forming immune stimulant candidate designed to safely activate tumor immunity. In these studies, regression of both treated and non-treated tumors was observed following combination treatment with ALT-702 and a CTLA-4 immune checkpoint inhibitor, with overall survival in the combination group markedly better than either agent alone. These findings highlight the potential benefits of ALT-702 in both local and metastatic disease and support continued development activities.
2019 Activity:

Acquired Spitfire Pharma, Inc. with NASH Candidate ALT-801

The Company acquired Spitfire Pharma, Inc. including the product candidate ALT-801, a potent GLP-1/Glucagon receptor dual agonist for the treatment of non-alcoholic steatohepatitis (NASH). ALT-801 is a peptide-based therapeutic candidate with balanced agonist activity on the GLP-1 and glucagon receptors and a differentiated PK profile to improve tolerability. ALT-801 is designed to treat obesity, the basic underlying cause of NASH, the most severe form of non-alcoholic fatty liver disease (NAFLD). The Company is preparing for a Phase 1 clinical trial anticipated to begin in 2020.
Awarded $3.7 million BARDA funding for NasoShield Phase 1b trial

In Q3, the Company modified its existing anthrax vaccine development contract with the Biomedical Advanced Research and Development Authority (BARDA), resulting in $3.7 million of additional funding. The supplemental funding will support the initiation and conduct of a Phase 1b clinical trial of NasoShield in 2020 to evaluate alternative methods of intranasal dosing in humans. NasoShield is being developed as a single-dose, intranasal post-exposure anthrax vaccine, and is the only anthrax product candidate supported by BARDA. We believe it offers potentially transformational improvements over the current two and three dose vaccines. The NasoShield program is funded through a contract with BARDA (HHSO100201600008C), with a total potential value of $133.7 million if all options in the contact are exercised.
Financial Results for the Year Ended December 31, 2019

At December 31, 2019, the Company had cash, cash equivalents and short-term investments of $37.3 million.
Revenue was $5.8 million for the year ended December 31, 2019 compared to $10.3 million in the prior year. The change was due to a decrease in billings under the Company’s U.S. government contracts due to timing of manufacturing and clinical trials for the NasoShield program and the 2018 completion of the primary activities under the SparVax-L contract.
Research and development expenses were $17.8 million for the year ended December 31, 2019 compared to $18.5 million in the prior year period. The decrease was attributable to lower manufacturing and clinical trial costs on existing programs offset by IPR&D expense recognized in conjunction with the acquisition of Spitfire Pharma, Inc.
General and administrative expenses were $8.5 million for the year ended December 31, 2019 compared to $9.8 million in the prior year period. The decrease was attributable to lower compensation, professional services and legal costs; offset by an increase in insurance premiums.
Impairment charges were $1.0 million for the year ended December 31, 2019 compared to $24.9 million for the prior year. Impairment in both years was due primarily to the SparVax-L program as the development contract with NIAID ended in Q3 2019, with no further funding identified. As disclosed by BARDA, U.S. government funding for anthrax will now focus on post-exposure vaccines that offer transformational improvements over a two-dose vaccine. Since SparVax-L was being developed as a two-dose vaccine candidate and our NasoShield program fits the government’s funding profile with active funding, additional development of SparVax-L is not expected.
Other income (expense) was $0.9 million for the year ended December 31, 2019 compared to ($2.5) million in the prior year. The 2019 activity is attributable to interest income earned on cash and investments while the 2018 expense was primarily due to changes in the fair value of the Company’s warrant liability, including loss on exchange.
Net loss attributed to common stockholders for the year ended December 31, 2019 was $20.97 million, or ($1.60) per share, compared to $42.48 million in the prior year, or ($15.16) per share. The difference in net loss is primarily attributable to the $24.9 million impairment recognized in 2018.
Conference Call Information

Altimmune will host a conference call to discuss the company’s year end results and other business information.

Date: Friday, March 27, 2020
Time: 8:30 am Eastern Time
Domestic: 877-423-9813
International: 201-689-8573
Conference ID: 13701071
Webcast: View Source
Following the conclusion of the call, the webcast will be available for replay on the Investor Relations page of the Company’s website at www.altimmune.com. The company has used, and intends to continue to use, the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

On March 26, 2020 Vivoryon Therapeutics AG (Euronext Amsterdam: VVY; ISIN: DE007921835), reported its financial results for the twelve month period ending December 31, 2019, prepared in accordance with German GAAP ("HGB") and on a voluntary basis, in accordance with IFRS as endorsed by the European Union (Press release, Vivoryon Therapeutics, MAR 26, 2020, View Source [SID1234555877]). The Financial Statements are available on the company website (www.vivoryon.com/investors-news/financial-information/).

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KEY HIGHLIGHTS – January – December 2019

USD 15 million grant from National Institutes for Health (NIH) for a US-based Phase 2b trial received, together with the Alzheimer’s Disease Cooperative Study (ADCS)
EUR 8.2 million raised from investors in successful private placement of new shares in April 2019
Probiodrug AG became Vivoryon Therapeutics AG
Vivoryon entered into a collaboration with University of Kiel to select candidates from its QPCTL inhibitor portfolio
MorphoSys and Vivoryon entered an agreement on small molecule inhibitors of CD47-SIRP alpha signaling in immuno-oncology
Vivoryon successfully completed a EUR 43 million capital raise in October 2019
Vivoryon included in AScX index

POST PERIOD HIGHLIGHTS – January – March 2020

Vivoryon and Nordic Bioscience entered research and development collaboration
Vivoryon announced update on Phase 2b Alzheimer’s clinical trial, VIVIAD

Comment from, Dr. Ulrich Dauer, Chief Executive Officer of Vivoryon Therapeutics:

"2019 proved to be a pivotal year for Vivoryon during which the Company established itself with a new name and a re-energized corporate vision unified by the same goal: to discover and develop small molecule therapeutics to meet complex medical needs. During the past 12 months, Vivoryon has undergone a corporate transformation designed to build value for shareholders, patients and collaborators and that will ultimately steer the Company toward success. Equipped with a secure financial position, strong strategic partnerships and growing clinical knowledge, Vivoryon has entered 2020 with the momentum required to reach future milestones.

First, from a financial perspective, 2019 was an important year for the Company in which securing adequate funding was particularly critical for the advancement of PQ912 in Alzheimer’s Disease. At the start of the year, we received a USD 15 million grant from the NIH. After that, the Company raised EUR 8.2 million from investors in a successful private placement of new shares in April, followed by a EUR 43 million capital raise in October. These monetary developments fortify our fiscal well-being and place us in an optimal position to continue to advance our pipeline.

Based on our clinical development efforts in 2019, we are now reaching the final stages of preparation for the European Phase 2b clinical trial, VIVIAD, testing PQ912 in patients with early-stage Alzheimer’s Disease. In parallel, the funding from the NIH will be allocated to our US Phase 2b trial in Alzheimer’s which we aim to initiate as soon as the required financial resources have been secured. Our lead candidate, PQ912 is a first-in-class inhibitor of the QPCT enzyme that addresses a very distinct disease pathway and provides a mode of action affecting multiple pathology hallmarks in contrast to many other Alzheimer’s Disease drug candidates in development. Building on positive Phase 2a data, we aim to continue to validate our approach in this complex neurodegenerative disease and look forward to initiating VIVAD in Europe within the second quarter of 2020. We expect to announce the topline results of this important trial towards the end of 2022.

The preparation for the VIVIAD trial also involved two strategic relationships that add significant value to the trial design. We kicked-off the new year by announcing our research and development collaboration with Nordic Bioscience for the clinical development of PQ912 for Alzheimer’s Disease as well as for the development of blood-based biomarkers for the identification of specific patients that may benefit most from treatment with PQ912. We also entered into a collaboration with Winterlight Labs, a company that has developed a proprietary, tablet-based technology that assesses cognitive health (including memory, thinking, and reasoning) by analyzing hundreds of language markers from short snippets of speech. This collaboration will enable Vivoryon to perform an additional non-invasive, cognitive test on patients that will further enhance the full data package from the Phase 2b European VIVIAD clinical trial. Prof. Dr. Scheltens, VU Amsterdam will act as coordinating investigator for VIVIAD.

During last year, we also made rapid progress in the immuno-oncology space as illustrated by both the collaboration with the University of Kiel as well as our option-agreement with MorphoSys. The MorphoSys relationship combines our portfolio of proprietary small molecule QPCTL inhibitors with their leading antibody technology. Both collaborations underscore the potential of our therapeutic agents as well as our ability to forge meaningful and strategic partnerships to advance our pipeline.

In closing, 2019 was a defining year for Vivoryon. I therefore want to extend our thanks to our shareholders for all the support throughout our transformation as well as to the team at Vivoryon. 2020 will bring both new opportunities and challenges and together, we have the resources and the clear objective to positively change the lives of patients battling difficult-to-treat diseases."

Details of the Financial Results (according to IFRS)

Net loss

The operating loss slightly rose in 2019 to EUR 7,715 (2018: EUR 7,698k). Research and development expenses slightly decreased to EUR 4,751k (2018: EUR 4,836). General and administrative expenses increased to EUR 3,023k (2018: EUR 2,891k). The net loss is slightly higher than last year at EUR 7,823k (2018: EUR 7,737k).

All expenditures are in line with the projections of Vivoryon Therapeutics.

Equity

The equity as of December 31, 2019 amounts to EUR 42,665k (December 31, 2018: EUR 1,230k), corresponding to an equity ratio of 93,0 %. In 2019, the share capital increased at EUR 19,975k.

Cash

The cash flow used in investing activities amounted to EUR -47k (2018: EUR 460k) consisting of costs in intangible assets and equipment. Cash and cash equivalents at year end 2018 were EUR 41,524k (2018: EUR 3,783k).

Noncurrent/ current liabilities

As of December 31, 2019, non-current liabilities amounted to EUR 2,266k (December 31, 2018: EUR 1,854k) and consist of pension obligations of EUR 1,951k (2018: EUR 1,854k ) and long-term lease liabilities in accordance with IFRS 16, which was applicable for the first time in 2019 of EUR 315k. Short-term liabilities as of December 31, 2019 of EUR 930k remained almost the same as in the previous year (December 31, 2018 EUR 964k). Trade payables of EUR 539k (2018: EUR 772k) result from the normal course of business. They have a remaining term of up to one year. The short-term lease liabilities of EUR 91k reported for the first time on December 31 also result from the first-time application of the new IFRS 16.

OUTLOOK

The mid-term focus of Vivoryon’s business activities can be summarized as follows:

Initiate Phase 2b clinical study program for PQ912 in Europe
Continue the development of PQ912 in oncology
Conclude one or more industrial partnerships
Further scientific analysis of potential indications for the use of QC inhibitors

ANNUAL FINANCIAL REPORT 2019

Vivoryon Therapeutics has finalized its financial statements for the year ended December 31, 2019 according to German GAAP ("HGB") and IFRS. The auditor KPMG has issued an unqualified auditors report for both statements. The reports are available on the company website (View Source).

FINANCIAL CALENDAR

May 14, 2020 Interim Management Statement Q1 2020
June 24, 2020 Annual General Meeting 2020
August 27, 2020 Interim Report, Half Year Results 2020
November 26, 2020 Interim Management Statement Q3 2020

CONFERENCE CALL AND WEBCAST

Vivoryon Therapeutics will host a conference call and webcast open to the public today, March 26, 2020, at 3:00 pm CET (10:00 am EDT); the presentation will also be available on the company website. The conference will be held in English. A Question & Answer session will follow the presentation of results.

To participate in the conference call, please call one of the following numbers listed below 10 minutes prior to the commencement of the webcast.

A live webcast and slides will be made available at: View Source

On March 26, 2020 Asieris Pharma, located in Taizhou’s China Medical City, reported that it has raised $14 million in a C round to advance its genito-urinary tumor treatments (Press release, Asieris Pharmaceuticals, MAR 26, 2020, View Source [SID1234555896]). Its lead candidate, a novel treatment for non-muscular invasive bladder cancer, has completed China Phase III trials and a US Phase I trial. Unlike other treatments for the condition, usually bladder resection, APL-1202 is convenient, painless and does not cause damage to the urethra. A repurposed oral inhibitor of MetAP2, APL-1202 is a 50-year-old wide spectrum antibiotic that had been shown to have an anti-angiogenesis effect.

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On March 26, 2020 Innovent Biologics, Inc. ("Innovent" or the "Company") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, and Alector, Inc. ("Alector", Nasdaq ticker symbol: ALEC), a clinical stage biotechnology company and leader in the discovery and development of immune system focused therapeutics, jointly reported that they have entered into a licensing agreement to develop and commercialize an anti-SIRP-alpha antibody (Alector’s project code: AL008) for the treatment of oncology indications in China (Press release, Innovent Biologics, MAR 26, 2020, View Source [SID1234555834]).

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AL008 is Alector’s novel antibody targeting the CD47-SIRP-alpha pathway, a potent survival pathway co-opted by tumors to evade the innate immune system. AL008 is a first-in-class SIRP-alpha inhibitor with a unique dual mechanism of action that non-competitively antagonizes the CD47-SIRP-alpha pathway by inducing the internalization and degradation of the inhibitory receptor on macrophages to relieve immune suppression (a "don’t eat me signal") while also engaging Fc gamma to promote immuno-stimulatory pathways that drive anti-tumor immunity.

"Alector has been a pioneer in discovering and developing first-in-class therapeutics modulating the innate immune system since their founding and AL008 represents another successful program from their pipeline," said Dr. Michael Yu, Founder, Chairman and CEO of Innovent Biologics. "Currently, we have a successfully commercialized PD-1 inhibiting antibody, Tyvyt (sintilimab injection), targeting the adaptive immune system and we believe in the importance of modulating innate immune system in oncology as well, especially the SIRP-alpha-CD47 pathway. We believe that AL008 will complement perfectly with our current pipeline, further solidifying our position in this promising space while providing more options to patients in need."

"We are excited to enter into a collaboration with Innovent, one of the premier Chinese biologics companies, which has a fully-integrated multi-functional platform. We have been impressed with the diligence and speed that the Innovent team brings to bear to advance their development programs through clinical trials and beyond. We believe AL008 has great potential and look forward to demonstrating this in the clinic," said Dr. Arnon Rosenthal, Co-Founder and CEO of Alector. "We will be collaborating closely with Innovent to rapidly advance AL008 through clinical trials in order to get this program to benefit more patients both in China and globally."

Under the agreement, Innovent will lead the development and commercialization of the molecule in China, including the manufacturing of the product. Alector will lead development of AL008 outside of China. Financial terms are not disclosed.

About AL008

AL008 is an anti-SIRP-alpha antibody that non-competitively antagonizes the CD47-SIRP-alpha pathway by inducing the internalization and degradation of the inhibitory receptor on macrophages to relieve immune suppression (a "don’t eat me signal) while also engaging Fc gamma to promote immuno-stimulatory pathways that drive anti-tumor immunity. Tumor associated macrophages are associated with poor prognosis in many cancer types and are believed to inhibit the anti-tumor immune response. Targeting the CD47-SIRP-alpha pathway has shown activity in myeloid and lymphoid cancers, but additional agents targeting this pathway are needed to enhance activity and improve safety in solid tumors. AL008 monotherapy reduces tumor growth and enhances M1 macrophage activation in a humanized pre-clinical model. In comparison with other SIRP-alpha targeting antibodies, AL008 binds to all common alleles of SIRP-alpha and has best-in-class potency in tumor cell phagocytosis. AL008 promotes T cell function and in preclinical studies is not associated with depletion of red blood cells or platelets. These data highlight the potential potency of this differentiated mechanism of simultaneously providing immune-activating signals while removing immune-checkpoint signals and demonstrate the potential activity for AL008.