On June 10, 2022 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that the Company will host a virtual R&D Day today, Friday, June 10th from 10:00 a.m. to 1:00 p.m. ET (Press release, SpringWorks Therapeutics, JUN 10, 2022, View Source [SID1234615859]).

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SpringWorks’ R&D Day will feature presentations by Saqib Islam, Chief Executive Officer; Badreddin Edris, PhD., Chief Operating Officer; L. Mary Smith, PhD, Chief Development Officer; Bhavesh Ashar, Chief Commercial Officer; Mike Burgess, MBChB, PhD, Head of R&D; and Jim Cassidy, MD, PhD, Chief Medical Officer. The event will also include presentations from two external key opinion leaders: Breelyn Wilky, MD, Director of Sarcoma Medical Oncology at the University of Colorado, Denver (CU Denver) and Neal Rosen, MD, PhD, Director of the Center for Mechanism-Based Therapy and the Enid A. Haupt Chair in Medical Oncology at Memorial Sloan Kettering Cancer Center (MSKCC).

"SpringWorks is at an exciting juncture in terms of data generation, regulatory discussions, and launch preparations. Our goal is to provide the first approved therapy for patients with desmoid tumors in 2023, and we expect to have two approved products with the potential to serve patients across four distinct oncology indications by 2025," said Saqib Islam, Chief Executive Officer of SpringWorks. "We are confident that our strong execution across our R&D programs, our disciplined, rigorous approach to business development, and our focused commercial buildout will drive our success in 2022 and beyond."

Agenda

Introduction and Business Overview (Saqib Islam, Badreddin Edris, PhD)
KOL Presentation: Unmet Need in Desmoid Tumors (Bree Wilky, MD, CU Denver)
Nirogacestat
Clinical Experience in Desmoid Tumors (L. Mary Smith, PhD)
Desmoid Tumor Commercial Opportunity (Bhavesh Ashar)
Additional Expansion Opportunity (Badreddin Edris, PhD)
BCMA Therapy Combination Development (Mike Burgess, MBChB, PhD)
Mirdametinib
NF1-PN (L. Mary Smith, PhD)
Additional Expansion Opportunities (Jim Cassidy, MD, PhD)
Mirdametinib + Lifirafenib: Combination Development (Jim Cassidy, MD, PhD)
KOL Presentation: Introduction to BGB-3245 (Neal Rosen, MD, PhD, MSKCC)
BGB-3245
Initial Clinical Data and Program Update (Jim Cassidy, MD, PhD)
Preclinical
TEAD and EGFR Inhibitor Program Overview (Mike Burgess, MBChB, PhD)
Closing Remarks and Q&A (Saqib Islam)
Webcast and Conference Call Information:
The Company’s R&D Day will be held today, Friday, June 10th, from 10:00 a.m. to 1:00 p.m. ET. The webcast can be accessed here. Participants can also listen to the event by dialing + 1 (844) 946-0285 (domestic) or +1 (602) 585-9676 (international) and providing the conference ID 4453188. A replay will be available on the SpringWorks website for a limited period of time following the event.

On June 10, 2022 Imago BioSciences, Inc. ("Imago" or the "company") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported that updated positive data from its ongoing global Phase 2 clinical study evaluating bomedemstat in patients with advanced myelofibrosis (MF) (Press release, Imago BioSciences, JUN 10, 2022, View Source [SID1234615858]).

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The data were presented in a poster session during the 30th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting and Congress (EHA) (Free EHA Whitepaper), taking place 9-12 June 2022. Previously, a Phase 2 data set with a cut-off of 31 October 2021 was presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2021.

Updated Highlights (as of 29 April 2022 data cutoff):

Of the evaluable patients at 24 weeks,
55% (28/51) showed a decrease in Total Symptom Score (TSS).
22% (11/51) showed a ≥50% decrease in TSS.
64% (32/50) showed spleen volume reductions.
52% (36/69) of patients had a decrease in mutant allele frequencies (MAFs) including driver mutations (e.g., JAK2) with the greatest reduction in ASXL1, a high molecular risk (HMR) mutation.
90% (37/41) of transfusion-independent patients had stable or improved hemoglobin at Week 12.
85% (50/59) of patients had an improved (19/59) or stable (31/59) bone marrow fibrosis score post-baseline.
No new mutations or transformation to acute myeloid lymphoma (AML) in patients with high risk of progression.
"The potential of bomedemstat to be a unique and differentiated monotherapy for patients living with advanced myelofibrosis is underscored by the data presented at EHA (Free EHA Whitepaper) today," said Hugh Young Rienhoff, Jr., M.D., CEO of Imago. "The data continue to show improvements across multiple hallmarks of disease, such as symptom scores, spleen volume, fibrosis, and anemia, while at the same time demonstrating a favorable safety and tolerability profile relative to the current available therapies. Of particular interest is the effect on patients with ASXL1 mutations, a mutation that confers an increased risk of leukemia. Importantly, these data also point to the potential utility of bomedemstat in other myeloproliferative diseases, such as polycythemia vera and essential thrombocythemia, with similar mutation profiles. Patients in this study will continue to be treated in an extension study while we further explore these patient responses and evaluate the added value of bomedemstat combined with ruxolitinib."

Safety & Tolerability

Bomedemstat was generally safe and well-tolerated in patients with myelofibrosis.
The most common non-hematologic adverse event (AE) related to bomedemstat was dysgeusia (altered taste), which occurred in 36% of patients and dysgeusia led to discontinuation in 1 patient
There were 14 serious adverse events (SAEs) deemed related to bomedemstat per the Investigator
Details on the Imago EHA (Free EHA Whitepaper) Presentation

Poster Presentation Title: A Phase 2 Study of IMG-7289 (Bomedemstat) in Patients With Advanced Myelofibrosis
Session: 16. Myeloproliferative neoplasms – Clinical
Presenter: Harinder Gill, M.D., study investigator and presenter of the data, Department of Medicine, University of Hong Kong, Queen Mary Hospital, Pok Fu Lam, Hong Kong
Date & Time: Friday, June 10, 2022, at 10:30 AM ET

For further details, please see the EHA (Free EHA Whitepaper) 2022 abstract and presentation on the Imago website here.

Virtual Investor Event Details

Individuals interested in listening to the event at 10:30 a.m. ET on Saturday, June 11, 2022 may do so by dialing (844) 348-6880 for domestic callers, or +1 (914) 800-3944 for international callers, and reference conference ID: 3493998; or from the webcast link in the investor relations section of the company’s website at: www.imagobio.com. The webcast will be available in the investor relations section on the company’s website for 90 days following the completion of the call.

About the Imago Phase 2 Advanced Myelofibrosis Program

Myelofibrosis (MF) is a progressive cancer in which the bone marrow is gradually replaced by fibrous, scar-like tissue. There is a significant unmet need for a disease-modifying therapy. The need is greatest in patients with MF whose disease is not adequately managed with current JAK inhibitors, the current standard of care.

This Phase 2 multi-center, open-label study is designed to assess the safety, efficacy, pharmacodynamics, and spleen volume reduction of bomedemstat, an oral inhibitor of lysine-specific demethylase 1 (LSD1). Eligible patients aged 18 or older with MF who were refractory or resistant to, intolerant of, were inadequately controlled by or ineligible for approved therapies were considered for the study. Exploratory assessments include symptom reduction, changes in cytokine profiles, changes in the frequency of mutant alleles and bone marrow fibrosis. The trial was conducted in the United States, the United Kingdom, European Union, Australia, and Hong Kong. This 24-week study completed enrollment in May 2021 with a total of 89 patients.

On June 10, 2022 Imago BioSciences, Inc. ("Imago" or the "company") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported that updated positive data from its ongoing global Phase 2 clinical study evaluating bomedemstat in patients with essential thrombocythemia (ET) (Press release, Imago BioSciences, JUN 10, 2022, View Source [SID1234615857]).

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The data were presented in a poster session during the 30th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting and Congress (EHA) (Free EHA Whitepaper) taking place 9-12 June 2022. A Phase 2 data set with a cut-off of 1 November 2021 was previously presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2021.

Updated Highlights (available data as of 29 April 2022):

Enrollment completed with 73 patients in April 2022
Of the 32 patients treated with bomedemstat for more than 24 weeks:
97% (31/32) achieved platelet count reduction to ≤400 x 109/L.
94% (30/32) achieved platelet count reduction to ≤400 x 109/L with no thromboembolic events, the primary efficacy endpoint of this study.
81% (26/32) of patients achieved a durable response, defined as platelet count of ≤400 x 109/L for at least 12 weeks.
Of the 31 patients with Total Symptom Score (TSS) data available at 24 weeks:
58% (18/31) showed a decrease in TSS.
32% (10/31) showed improvements ≥10 points, one component of the ELN criteria for response.
Importantly, platelet response rates were similar across all genotypes identified in the study (CALR, JAK2V617F, MPL and triple negative). Additionally, 67% (16/24) patients demonstrated a net decrease in mutation allele frequencies including both CALR and JAK2.
"I am genuinely thrilled with the results of our ongoing Phase 2 clinical study of bomedemstat in essential thrombocythemia (ET) that continues to support the tremendous potential of our drug candidate. Based on the most recent data cutoff for this Phase 2 trial, as monotherapy in patients with ET who have failed a standard-of-care treatment, bomedemstat demonstrated both favorable platelet and white count reduction and sustained durability of treatment effects," said Hugh Young Rienhoff, Jr. MD, CEO of Imago. "Having now completed, indeed exceeded, our target enrollment in the study, we remain on track for an End-of-Phase 2 meeting with the FDA later this year. Based on our clinical results to date and our productive interactions with regulatory authorities, we are excited about the upcoming Phase 3 registrational trial."

Safety & Tolerability

Bomedemstat was generally well-tolerated with no safety signals identified per the Safety Advisory Board.
The most common adverse events (AEs) (>20%) regardless of causality were dysgeusia (altered taste), fatigue, constipation, and arthralgia.
There were 19 reported serious adverse events (SAEs), 6 of which were deemed drug-related by the Investigator in 5% (3/67) of patients.
14 patients have discontinued treatment, with 10 due to AEs (1 death from aspiration pneumonia unrelated to bomedemstat), 2 due to withdrawal of consent, and 2 due to investigator decision.
Details on the Imago EHA (Free EHA Whitepaper) Presentation

Oral Presentation Title: A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (Bomedemstat) for the Treatment of Essential Thrombocythemia (ET)
Session: 16. Myeloproliferative neoplasms – Clinical
Presenter: Francesca Palandri, M.D., Ph.D., Institute of Hematology "L. & A. Seràgnoli" Sant’Orsola-Malpighi University Hospital, Bologna, Italy
Date & Time: Friday, June 10, 2022, at 10:30 AM ET

For further details, please see the EHA (Free EHA Whitepaper) 2022 abstract and presentation on the Imago website here.

Virtual Investor Event Details

Individuals interested in listening to the event at 10:30 a.m. ET on Saturday, 11 June 2022 may do so by dialing (844) 348-6880 for domestic callers, or +1 (914) 800-3944 for international callers, and reference conference ID: 3493998; or from the webcast link in the investor relations section of the company’s website at: www.imagobio.com. The webcast will be available in the investor relations section on the company’s website for 90 days following the completion of the call.

About Imago’s Phase 2 Essential Thrombocythemia Program

Essential thrombocythemia (ET) is a rare blood cancer resulting in the overproduction of platelets which increases the risk of blood clots and bleeding. It is one of the myeloproliferative neoplasms (MPN) family of rare bone marrow diseases and affects approximately 80,000 – 100,000 patients in the U.S. Imago BioSciences is developing bomedemstat (IMG-7289), an orally administered LSD1 inhibitor, as a potential therapy for patients with ET.

This Phase 2 multi-center, open-label study was designed to assess the safety, efficacy, and pharmacodynamics of bomedemstat, an oral inhibitor of lysine-specific demethylase 1 (LSD1) (www.clinicaltrials.gov Identifier NCT04254978). Eligible patients aged 18 or older with ET who had failed at least one standard therapy and required treatment in order to lower their platelet count were considered for participation in this study. Exploratory assessments include the serial measurement of mutant allele frequencies and changing plasma cytokine profiles. The trial is being conducted in the United States, the United Kingdom, Europe, Hong Kong, New Zealand, and Australia. Imago announced first patient dosed on October 1, 2020. As of April 29, 2022, the trial completed enrollment with 73 participants.

On June 10, 2022 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported positive initial data from its ongoing Phase 2 APEX clinical trial evaluating the selective KIT D816V inhibitor bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) (Press release, Cogent Biosciences, JUN 10, 2022, View Source [SID1234615856]). The data are being presented today in a poster presentation at the 2022 European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Vienna, Austria.

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"Advanced systemic mastocytosis is a severe, debilitating hematologic disorder and physicians and patients remain in search of more effective and better tolerated treatment options to fight this disease," said Daniel DeAngelo, M.D., Ph.D., Chief of the Division of Leukemia at the Dana-Farber Cancer Institute and APEX clinical trial investigator. "I am very impressed with the early, encouraging results presented today from the APEX study. If results like these can be shown in a larger set of patients with AdvSM, I believe bezuclastinib has the potential to help us take a big step forward in treating systemic mastocytosis patients."

"We are very excited to present initial clinical data from the APEX study of bezuclastinib in advanced systemic mastocytosis," said Andrew Robbins, Chief Executive Officer at Cogent Biosciences. "These results reinforce the hypothesis that a potent, selective KIT D816V inhibitor with limited CNS penetration has the potential to provide meaningful clinical activity to all systemic mastocytosis patients, without the tolerability challenges seen with other available treatment options. Based on these results, we expect to accelerate our timelines and investment and look forward to providing another APEX clinical update by the end of 2022, and to presenting SUMMIT clinical data in non-advanced systemic mastocytosis (NonAdvSM) patients in the first half of 2023."

Data from Ongoing Phase 2 APEX Clinical Trial
APEX is a global, open-label, multi-center, two-part Phase 2 clinical trial in patients with AdvSM evaluating the safety, efficacy, pharmacokinetic, and pharmacodynamic profiles of bezuclastinib. As of the data cutoff date of May 24, 2022, 11 patients had been treated in Part 1 at one of four dose levels (50 mg BID, 100 mg BID, 200 mg BID or 400 mg QD). The median age of patients at study entry was 70 years (ranging from 48-87 years). Patients were enrolled with the following sub-types: two patients with aggressive systemic mastocytosis (ASM), eight patients with systemic mastocytosis with associated hematologic neoplasm (SM-AHN), and one patient with mast cell leukemia (MCL). Two patients had received prior avapritinib and midostaurin treatment.

Initial Safety Data 
As of the cutoff date, May 24, 2022, bezuclastinib was generally well-tolerated at all doses. The majority of adverse events were Grade 1/2 and seen in no more than one patient with one serious adverse event and no Grade 4 events reported. Grade 3 events reported as at least possibly related were anemia (1 patient), neutropenia (1 patient) and hypersensitivity/mediator flare (1 patient). There were no reported cases of periorbital/peripheral edema, cognitive effects or intracranial bleeding events, which have been associated with other KIT inhibitors. As of the cutoff date, all patients remained on study. Subsequently, one SM-AHN patient with chronic myelomonocytic leukemia (CMML) transformed to acute myeloid leukemia (AML) and discontinued participation in the trial.

Initial Clinical Activity Data
As of the data cutoff date of May 24, 2022, all 11 patients treated were evaluated for signs of clinical activity. Eight of 11 patients had been treated for at least two cycles, had available data from bone marrow biopsy, and were evaluated for additional endpoints Cycle 3 Day 1 (C3D1) evaluable.

11/11 patients achieved ≥50% reduction in serum tryptase levels by central assessment
89% median reduction in serum tryptase
Six of these patients achieved reduction to <20 ng/mL
8/8 patients (C3D1 evaluable) achieved ≥50% reduction in bone marrow mast cells by central review
Six of these patients achieved complete clearance of bone marrow mast cell aggregates
8/8 patients (C3D1 evaluable) demonstrated decreases in KIT D816V variant allele fraction (VAF) by droplet digital polymerase chain reaction (ddPCR)
All patients remained on treatment with treatment duration ranging from 0.5 – 4.8 months
Two patients enrolled had previously received and discontinued avapritinib for toxicity reasons (intracranial hemorrhage, thrombocytopenia). Both patients have demonstrated clinical outcomes consistent with the avapritinib-naïve patients, including similar magnitude reductions in serum tryptase.

Bezuclastinib Clinical Development 
Based on the favorable initial safety and tolerability profile and clinical activity observed to date in the Phase 2 APEX clinical trial with bezuclastinib for AdvSM, Cogent will continue enrolling patients in Part 1 of APEX to determine a recommended dose for use in Part 2 of the trial. A pre-planned interim analysis is scheduled once approximately 28 patients have received at least two cycles of study treatment in Part 1. Cogent plans to present additional data from APEX by the end of 2022. In addition, Cogent continues to actively enroll patients in SUMMIT, a Phase 2 clinical trial with bezuclastinib for NonAdvSM, and PEAK, a registrational randomized, open-label, global, Phase 3 clinical trial in patients with imatinib-resistant Gastrointestinal Stromal Tumors (GIST). Cogent plans to present initial data from SUMMIT and lead-in data from PEAK in the first half 2023.

Conference Call Information & EHA (Free EHA Whitepaper) poster
Cogent will host a webcast today at 8:00 am ET to discuss today’s APEX results. The webcast will be accessible through the Investors and Media section of Cogent’s website at View Source Following the live webcast, an archived replay will also be available.

The APEX poster to be presented at EHA (Free EHA Whitepaper) is available to registered conference attendees as well as on the Cogent Biosciences website in the Posters and Publications section of www.cogentbio.com/research.

On June 10, 2022 ChromaDex Corp. (NASDAQ:CDXC) ("the Company") a global bioscience company dedicated to healthy aging, reported a signed distribution agreement with Sinopharm Xingsha to accelerate cross-border sales of Tru Niagen into mainland China (Press release, ChromaDex, JUN 10, 2022, View Source [SID1234615855]). Tru Niagen features ChromaDex’s proprietary Niagen (patented nicotinamide riboside or NR) ingredient, which is the world’s most efficient NAD+ (nicotinamide adenine dinucleotide) precursor on the market, particularly over NMN (nicotinamide mononucleotide). Sinopharm Xingsha is the main platform of Sinopharm Group for food supplements and healthcare products and is a subsidiary of Sinopharm Group, with businesses including pharmaceutical manufacturing, marketing and distribution of drugs, and food supplements and healthcare products. Sinopharm Group is a large healthcare group directly under the State-owned Assets Supervision and Administration Commission (SASAC) of the State Council, with a full value chain in the industry covering R&D, manufacturing, logistics and distribution, retail chains, healthcare, engineering services, exhibitions and conferences, international business, and financial services. In line with ChromaDex’s recent China Joint Venture announcement, Sinopharm Xingsha will collaborate to secure Health Food Registration in China.

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"We are delighted to announce the official launch of our partnership with Sinopharm Xingsha which will support accelerated cross-border sales of Tru Niagen across mainland China," said Rob Fried, CEO of ChromaDex. "China’s marketplace remains strategically important with more than 260 million people over the age of 60 and it is our intention to become the leading provider of NAD+ boosting supplements in the market."

According to a recently commissioned "Sizing the Market for NAD+ Supplements in China" report by Euromonitor, white space is considerable ― growing from a standing start in 2018 to annual NAD+ sales in excess of $700 million in 2021, with leading NMN brands each capturing approximately $30 to $50 million of retail sales. The report further estimates that NAD+ sales will reach in excess of $1.5 billion in 20241.

"ChromaDex is a global leader in the NAD+ supplement market, and Tru Niagen is a product endorsed by strong science," said Pan Lei, General Manager of Sinopharm Xingsha. "We are very honored to have this strategic cooperation with ChromaDex to jointly bring this excellent product to the Chinese consumers. Going forward, Sinopharm Xingsha will leverage its advantages and expertise in brand incubation, promotion, marketing, online and offline channel construction, registration of imported health supplements, etc., to offer a full range of services to support the brand promotion and sales channel development of Tru Niagen products in China."

Tru Niagen is currently available for sale to Chinese consumers on several cross-border online and marketplace platforms, primarily through T-mall, and JD. Under terms of the agreement, ChromaDex’s existing cross-border activity in this region will be transitioned to Sinopharm Xingsha in a coordinated effort to accelerate growth of Tru Niagen by leveraging Sinopharm’s established infrastructure, and marketing capabilities. The expansion of Tru Niagen will be supported by the introduction of a new premium Tru Niagen SKU, which will be launched in the future. Tru Niagen is also available in over 200 Watsons stores in Hong Kong and Macau, as well as over 100 Watsons stores in Singapore.

Tru Niagen, featuring Niagen, is one of the top-selling brands in the Vitamin B3 category on Amazon U.S. for boosting NAD+ levels. Supplementation with Niagen is backed by 20 published and peer-reviewed clinical trials. Niagen has achieved regulatory acceptance for use in supplements by the US FDA. Additionally, Niagen has been approved for use in food supplements by the European Commission, complementary medicines by the Therapeutic Goods Administration of Australia (TGA), medical foods by the Brazilian Health Regulatory Agency (ANVISA), and medical foods by the Food Standards Australia New Zealand (FSANZ). Tru Niagen has also been approved by Health Canada as a Natural Health Product. ChromaDex continues to lead the industry in NAD+ research, with the ChromaDex External Research Program (CERPTM) celebrating over 250 material transfer agreements (MTAs) featuring Niagen and other proprietary ingredients.