On March 4, 2021 NGM Biopharmaceuticals, Inc. (NGM) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, reported financial results for the periods ending December 31, 2020 (Press release, NGM Biopharmaceuticals, MAR 4, 2021, View Source [SID1234576090]).

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"Our vision at NGM is to build an iconic biologic therapeutics company that delivers transformative medicines for patients. Our team made notable progress across multiple fronts in 2020: presenting aldafermin Cohort 4 data and NGM621 first-in-human data at major medical conferences, advancing multiple programs into Phase 2 clinical testing and announcing the expansion of our oncology portfolio including the nomination of two immuno-oncology candidates," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM. "Behind every disease name and statistic, whether it is NASH, cancer-related cachexia, geographic atrophy or solid tumor cancers, are countless individuals who are hoping for better treatment options, all of whom fuel our motivation and mission to improve human health."

Key Fourth Quarter and Recent Highlights

Liver and metabolic diseases

•Anticipate reporting topline data from the Phase 2b ALPINE 2/3 study of aldafermin in patients with NASH in second quarter 2021. ALPINE 2/3 is a Phase 2b clinical study of aldafermin in patients with biopsy-confirmed NASH and liver fibrosis stage 2 or 3 (F2-F3). The 24-week study is assessing the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo. The primary objective of the ALPINE 2/3 study is to evaluate a dose response showing an improvement in liver fibrosis by ≥ 1 stage with no worsening of steatohepatitis at week 24.
•Continued enrollment in Phase 2b ALPINE 4 study of aldafermin in patients with NASH with liver fibrosis stage 4 (F4) and well-compensated cirrhosis. NGM continued enrollment in the Phase 2b ALPINE 4 clinical study of aldafermin in patients with biopsy-confirmed NASH with F4 liver fibrosis and well-compensated cirrhosis. The 48-week study is designed to enroll approximately 160 patients and will assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo. The primary objective of ALPINE 4 is to evaluate a dose response showing an improvement in liver fibrosis by > 1 stage with no worsening of steatohepatitis at week 48.
•Presented data from 24-week double-blind, randomized, placebo-controlled Phase 2 study (Cohort 4) of aldafermin in NASH patients at AASLD The Liver Meeting. Cohort 4 demonstrated statistically significant dual activity in fibrosis improvement and NASH resolution in patients with F2 and F3 liver fibrosis. Analysis of Cohort 4 data at AASLD also showed that 30% of patients with more advanced F3 liver fibrosis treated with aldafermin 1 mg achieved fibrosis improvement >1 stage without worsening of NASH compared to 0% in the placebo arm. In Cohort 4, aldafermin continued to demonstrate a favorable tolerability profile. Cohort 4 was the final reported cohort from NGM’s adaptive Phase 2 clinical study of aldafermin in NASH and the results observed in Cohort 4 were consistent with data from the three previous cohorts.
•Merck initiated Phase 2b study of MK-3655 (formerly NGM313) in patients with NASH with F2-F3 liver fibrosis. In November, Merck initiated a global Phase 2b multicenter, randomized, double-blind study of MK-3655 in patients with biopsy-confirmed NASH. The 52-week study is designed to enroll approximately 320 patients and will assess the efficacy, safety and tolerability of 50 mg, 100 mg and 300 mg doses of MK-3655 administered every 4 weeks compared to placebo in patients with biopsy-confirmed NASH and F2-F3 liver fibrosis. The primary objective of the Phase 2b study is NASH resolution without worsening of fibrosis after 52 weeks. Merck licensed MK-3655 following NGM’s completion of a proof-of-concept study.
Retinal diseases

•Continued enrollment in Phase 2 CATALINA study of NGM621 in patients with Geographic Atrophy (GA). NGM continued enrollment in the Phase 2 CATALINA study, a multicenter, randomized, double-masked, sham-controlled clinical trial to evaluate the safety and efficacy of intravitreal (IVT) injections of NGM621 every four weeks or every eight weeks in patients with GA secondary to age-related macular degeneration. The primary endpoint is the rate of change in GA lesion area, as measured by fundus autofluorescence imaging over 52 weeks of treatment.
•Presented Phase 1 safety and pharmacokinetics data for NGM621 in patients with GA at the American Academy of Ophthalmology 2020 Virtual. Single and multiple IVT injections of NGM621 appeared safe and well tolerated in this first-in-human study, with no patients experiencing serious adverse events, drug-related AEs, endophthalmitis, intraocular inflammation or choroidal neovascularization. The serum PK of NGM621 was linear and dose-proportional.
Cancer

•Completed enrollment in the Phase 1a/1b dose-finding study of NGM120 in patients with cancer in November 2020. NGM completed enrollment in the Phase 1a/1b dose-finding trial to assess NGM120’s effect on cancer-related cachexia and cancer. This Phase 1a/1b study was conducted in two cohorts: a Phase 1a cohort evaluating NGM120 as a monotherapy in patients with select advanced solid tumors and a Phase 1b cohort evaluating NGM120 in combination with gemcitabine and Abraxane (paclitaxel protein bound) in patients with metastatic pancreatic cancer.
•Initiated placebo-controlled, proof-of-concept expansion of Phase 1b dose-finding study of NGM120 as a first-line treatment in patients with metastatic pancreatic cancer in January 2021. NGM initiated a multi-center, randomized, single-blind (sponsor unblinded), placebo-controlled expansion of the ongoing Phase 1a/1b study to evaluate NGM120 in combination with gemcitabine and Abraxane as a first-line treatment in patients with metastatic pancreatic cancer.
•Announced two new oncology clinical candidates, NGM707 and NGM438, in fourth quarter 2020. NGM707 is a dual antagonist antibody that inhibits Immunoglobulin-like transcript 2 (ILT2) and Immunoglobulin-like transcript 4 (ILT4). NGM438 is an antagonist antibody that inhibits Leukocyte-associated immunoglobulin-like receptor 1 (LAIR1).
Fourth Quarter and Full Year 2020 Financial Results

•NGM reported a net loss of $28.0 million and $102.5 million for the quarter and year ended December 31, 2020, respectively, compared to a net loss of $15.9 million and $42.8 million for the corresponding periods in 2019.
•Related party revenue from our collaboration with Merck was $19.8 million and $87.4 million for the quarter and year ended December 31, 2020, respectively, compared to $31.1 million and $103.5 million for the corresponding periods in 2019. The decrease in related party revenue of $16.1 million in 2020 was primarily attributable to a decrease in the recognition of the initial upfront payment received from Merck in 2015 that was included in the transaction price and fully recognized by March 2020.
•Research and development, or R&D, expenses were $40.1 million and $164.0 million for the quarter and year ended December 31, 2020, respectively, compared to $42.0 million and $129.3 million for the corresponding periods in 2019. R&D expenses increased $34.7 million in 2020, primarily due to an increase in external expenses driven by our manufacturing activities and ongoing clinical trials of aldafermin, NGM621, NGM120 and NGM395 and an increase in costs associated with pre-clinical IND-enabling studies for NGM707 and NGM438. The increase in R&D expenses in 2020 also included an increase in personnel-related expenses partially offset by a decrease in unallocated R&D expenses related to multiple R&D programs.
•General and administrative expenses were $7.4 million and $27.2 million for the quarter and year ended December 31, 2020, respectively, compared to $6.4 million and $23.6 million for the corresponding periods in 2019. The $3.6 million increase in general and administrative expenses in 2020 was primarily attributable to increases in personnel-related expenses driven by increased headcount, as well as external expenses to support our operations as a public company.
•Cash, cash equivalents and short-term marketable securities were $295.2 million as of December 31, 2020, compared to $344.5 million as of December 31, 2019.

On March 4, 2021 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, reported fourth quarter and full year 2020 financial results and provided a business update (Press release, NextCure, MAR 4, 2021, View Source [SID1234576089]).

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"Our team has worked diligently throughout 2020 to advance our programs despite the difficult environment created by the COVID-19 pandemic. We are thrilled that Dr. Han Myint has recently joined NextCure as our Chief Medical Officer and we are poised to harness his expertise in oncology product development to further advance our product pipeline. As we enter 2021, we are excited to announce the expansion of our pipeline. We remain encouraged with the potential of NC318 given the evidence of clinical activity seen to date and are now reexploring the treatment of lung cancer through an investigator-initiated trial at Yale University," said Michael Richman, NextCure’s president and chief executive officer. "In addition, the NC410 Phase 1 trial is advancing and we look forward to reporting initial data in the second half of the year and we are very excited to introduce NC762, a B7-H4 antibody expected to enter the clinic next quarter."

Business Highlights

NC318
The two previously announced objective responder patients in the Phase 1 portion of the company’s ongoing Phase 1/2 clinical trial are continuing to receive drug and remain on study at over 118 weeks and over 92 weeks.
The trial continues in head and neck squamous cell carcinoma (HNSCC) and triple-negative breast cancer (TNBC) patients.
The previously announced confirmed partial response (PR) seen in the HNSCC cohort is off study after 40 weeks.
A confirmed PR has been observed in the TNBC cohort and the patient remains on study at over 21 weeks.
Given these responses in the HNSCC and TNBC cohorts, these cohorts met the criteria to advance into the stage 2 portion of the Simon 2-stage trial.
The NC318 Phase 2 monotherapy protocol will be revised to select S15+ patients for enrollment starting in the second quarter of this year.
Yale University plans to initiate in the second quarter of 2021, an investigator-initiated Phase 2 trial of NC318 as a monotherapy and in combination with pembrolizumab in patients with advanced non-small cell lung cancer.
NC410
Enrollment is on track and the company expects to announce initial clinical data from the Phase 1 portion of the trial in the second half of 2021.
NC762
An investigational new drug (IND) application has been filed with the U.S. Food and Drug Administration (FDA) for NC762, a humanized monoclonal antibody targeting B7-H4, which is upregulated in multiple solid tumor types, and which we believe is differentiated from other B7-H4-targeted antibodies.
Announced the appointment of Dr. Han Myint as Chief Medical Officer.
Expected Upcoming Milestones

Initiate in the second quarter of 2021, the Yale University Phase 2 investigator-initiated trial of NC318 in NSCLC with anticipated initial data first half of 2022.
Report NC318 Phase 2 monotherapy data in the fourth quarter of 2021.
Initiate the NC762 Phase 1 trial in the second quarter of 2021 and report initial data in mid-2022.
Report NC410 initial Phase 1 data in the second half of 2021.
Financial Guidance
Based on its current research and development plans, NextCure expects its existing cash, cash equivalents and marketable securities will enable it to fund operating expenses and capital expenditure requirements into the second half of 2023.

Financial Results for Fourth Quarter and Full Year Ended December 31, 2020

Cash, cash equivalents, and marketable securities, excluding restricted cash as of December 31, 2020, were $283.4 million as compared with $334.6 million as of December 31, 2019. The decrease of $51.2 million as of December 31, 2020 as compared to December 31, 2019 primarily reflects cash used to fund operations of $44.9 million and cash used to purchase fixed assets of $7.2 million, offset by a reduction in restricted cash of $1.5 million.
Research and development expenses were $46.6 million and $12.1 million for the year and quarter ended December 31, 2020, respectively, as compared with $34.2 million and $11.4 million for the year and quarter ended December 31, 2019, respectively. The increase was primarily related to increase in headcount and clinical research costs related to advancing NC318 and NC410.
General and administrative expenses were $17.0 million and $4.1 million for the year and quarter ended December 31, 2020, respectively, as compared with $9.6 million and $2.6 million for the year and quarter ended December 31, 2019, respectively. The increase in general and administrative expenses for the year and quarter primarily related to increasing infrastructure costs and being a public company for a full year in 2020.
Revenue was $22.4 million for the year ended December 31, 2020. There was no revenue recognized in the quarter ended December 31, 2020, as compared with $6.3 million and $2.0 million for the year and quarter ended December 31, 2019, respectively. Revenue generated was from our former research and development agreement with Eli Lilly.
Net loss was $36.6 million and $15.5 million for the year and quarter ended December 31, 2020, respectively, as compared with $33.7 million and $10.9 million for the year and quarter ended December 31, 2019, respectively. The increases in net loss for the year and quarter were primarily due to increased research and development expenses and increased general and administrative expenses from an increase in headcount, offset by the recognition of the remaining deferred revenue under the former agreement with Lilly.
Conference Call
NextCure will host a virtual R&D update event today at 5 pm Eastern time. To participate via telephone, please dial (877) 665-6632 from the U.S. or (602) 563-8471 from outside the U.S., using the conference ID 6773907. To participate via live or replay webcast, a link is available through the Investors section of the company’s website at www.nextcure.com.

About NC318
NC318 is a first-in-class immunomedicine against S15, a novel immunomodulatory target found on highly immunosuppressive cells called M2 macrophages in the tumor microenvironment and on certain tumor types including lung, ovarian and head and neck cancers. In preclinical research, it was observed that S15 promoted the survival and differentiation of suppressive myeloid cells and negatively regulated T cell function, allowing cancer to avoid immune destruction. In preclinical studies, NC318 blocked the negative effects of S15. NextCure believes NC318 has the potential to treat multiple cancer types.

About NC410
NC410 is a first-in-class immunomedicine designed to block immune suppression mediated by LAIR-1, an immunomodulatory receptor expressed on T cells and dendritic cells, a type of antigen presenting cell. In preclinical research, it was observed that LAIR-1 inhibited T cell function and dendritic cell activity allowing tumor cells to grow. In preclinical studies, NC410 blocked the negative effects of LAIR-1 and promoted T cell function and dendritic cell activity. NextCure believes NC410 has the potential to treat multiple cancer types.

About NC762
NC762 is a monoclonal antibody that binds specifically to B7-H4, a protein expressed on multiple tumor types. We believe NC762 acts by inhibiting tumor cell growth and killing tumor cells, including by enhancing immune response. We have observed in preclinical studies that NC762 inhibits the growth of human melanoma tumors in mice, and we believe that NC762 has the potential to treat multiple tumor types. Our research indicates that NC762 inhibits tumor cell growth independently of immune cell infiltration in the tumor microenvironment.

On March 4, 2021 NuCana plc (NASDAQ: NCNA) reported its financial results for the fourth quarter and year ended December 31, 2020 and provided an update on its broad clinical program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, MAR 4, 2021, View Source [SID1234576088]).

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As of December 31, 2020, NuCana had cash and cash equivalents of £87.4 million compared to £100.7 million at September 30, 2020 and £52.0 million at December 31, 2019. NuCana continues to advance its various clinical programs and reported a net loss of £12.3 million for the quarter ended December 31, 2020, as compared to £7.7 million for the quarter ended December 31, 2019. Net loss for the year ended December 31, 2020 was £30.7 million, compared to a net loss of £21.4 million for the year ended December 31, 2019. Basic and diluted loss per share was £0.24 for the quarter and £0.81 for the year ended December 31, 2020, as compared to £0.24 per share for the comparable quarter and £0.66 for the year ended December 31, 2019.

"2020 was a very successful year for NuCana," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "Against the challenging backdrop of the COVID-19 pandemic, we continued to advance all of our clinical programs and generate encouraging clinical and non-clinical data. Throughout 2020, we made good progress in the Phase III NuTide:121 biliary tract cancer study and expect to enroll sufficient patients in 2021 to complete the first interim analysis in 2022, which may support an accelerated approval filing. In September, we provided an update on two of our lead programs at ESMO (Free ESMO Whitepaper) that further validate the use of our proprietary ProTide technology. NUC-3373 continued to demonstrate its potential to offer enhanced efficacy, an improved safety profile and a more convenient dosing regimen as compared to 5-FU in patients with colorectal cancer. We also announced the first-ever clinical data for NUC-7738, which showed promising indications of anti-cancer activity and a favorable tolerability profile."

Mr. Griffith continued: "During 2020, we completed a successful $80 million follow-on offering that significantly strengthens our balance sheet. We also appointed a new non-executive Chairman, Andrew Kay and a new non-executive director, Bali Muralidhar. Both individuals bring a wealth of experience and we look forward to their contributions as we advance NuCana’s programs."

Mr. Griffith concluded: "We were excited to begin 2021 with the announcement of additional interim data for NUC-3373 in patients with colorectal cancer that continued to demonstrate encouraging efficacy and safety at ASCO (Free ASCO Whitepaper) GI. We look forward to continuing to drive recruitment across all of our ongoing studies, announce additional clinical data, and initiate new studies in 2021. We remain focused on our mission of significantly improving treatment outcomes for patients with cancer."

Anticipated 2021 Milestones

Acelarin is a ProTide transformation of gemcitabine. In 2021, NuCana expects to:

Complete recruitment sufficient to enable the first interim analysis in 2022 of the Phase III study of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer.

NUC-3373 is a ProTide transformation of the active anti-cancer metabolite of 5-FU. In 2021, NuCana expects to:

Report data from the Phase Ib study (NuTide:302) of NUC-3373 in combination with other agents with which 5-FU is typically combined, such as leucovorin, oxaliplatin and irinotecan in patients with advanced colorectal cancer.
Initiate and report data from a Phase Ib expansion / Phase II study of NUC-3373 in combination with other agents for patients with colorectal cancer.
Initiate a Phase III study of NUC-3373 in combination with other agents for patients with colorectal cancer.
Report data from the Phase I study (NuTide:301) of NUC-3373 in patients with advanced solid tumors.
NUC-7738 is a ProTide transformation of a novel nucleoside analog, 3’-deoxyadenosine. In 2021, NuCana expects to:

Report data from the Phase I study (NuTide:701) of NUC-7738 in patients with advanced solid tumors.
Initiate a Phase II study of NUC-7738 in patients with solid tumors.

On March 4, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that it has executed an agreement with the Company’s largest shareholder, John K. Scott, Jr., to purchase $5 million of newly-designated Series E Redeemable Convertible Preferred Stock (Press release, Navidea Biopharmaceuticals, MAR 4, 2021, View Source [SID1234576087]). Over the next 18 months, the Series E Preferred can be converted into approximately 2.17 million shares of Navidea’s common stock.

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"We are pleased to receive continued support from our largest shareholder. Today’s financing provides additional strength to our balance sheet and will allow our company to accelerate potential value-accretive investments, including our therapeutics pipeline," commented Jed Latkin, Chief Executive Officer of Navidea. "We look forward to providing additional updates on the progress of our ongoing studies across our portfolio on our earnings call later this month."

John K. Scott, Jr. commented, "I am pleased to be given the opportunity to continue to support Navidea as it moves some of its key assets into the next phase of development. As a stockholder in Navidea since December 2003, I believe in the Company’s drug candidates and the positive contributions they can make to individuals and the scientific community."

The securities offered and to be sold by Navidea in the private placement to Mr. Scott have not been registered under the Securities Act of 1933 (the "Securities Act"), as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (the "SEC") or an applicable exemption from registration requirements. Navidea has agreed to file a registration statement with the SEC covering the resale of the shares of common stock to be issued to Mr. Scott.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of Navidea’s securities. No offer, solicitation or sale will be made in any state or other jurisdiction in which such offering, solicitation or sale would be unlawful.

On March 4, 2021 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported that Shehnaaz Suliman, M.D., MBA, M.Phil., president and chief operating officer of Alector, will participate in a fireside chat at the Barclays Global Healthcare Conference on Thursday, March 11, 2021, at 2:25 p.m. ET.

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A live webcast of the fireside chat will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for 30 days following the event.