On May 12, 2022 Bolt Biotherapeutics, Inc. (NASDAQ: BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported financial results for the first quarter ended March 31, 2022 and provided an update on recent business highlights (Press release, Bolt Biotherapeutics, MAY 12, 2022, View Source [SID1234614473]).

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"Our lead program, BDC-1001, for patients with HER2-expressing solid tumors is on track and we expect to complete both our monotherapy and combination dose escalation arms and select a recommended Phase 2 dose in the second half of 2022," said Randall C. Schatzman, Ph.D., Chief Executive Officer of Bolt Biotherapeutics. "We continue to apply our expertise in myeloid biology to advance our diversified pipeline of novel Boltbody ISACs and our first-in-class Dectin-2 agonist antibody program. Our strong cash position and multiple collaborations with leading therapeutic antibody companies are expected to provide us with the funding to achieve key clinical milestones with our most promising candidates in a cash-efficient manner."

Recent Business Highlights

Boltbody ISAC BDC-1001 monotherapy and combination clinical trial arms are progressing on schedule with data anticipated in the second half of 2022 – BDC-1001, a HER2-targeting immune-stimulating antibody conjugate (ISAC), is being evaluated in dose escalation as a monotherapy and in combination with OPDIVO in an ongoing multi-center, multi-dose Phase 1/2 clinical trial. To date, BDC-1001 has demonstrated early signs of clinical disease control, a favorable safety profile, and changes in intratumoral biomarkers consistent with the novel mechanism of action.

Presented data from three preclinical pipeline programs at the 2022 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting – In April, Bolt Biotherapeutics scientists presented three posters at the AACR (Free AACR Whitepaper) Annual Meeting highlighting the Company’s proprietary pipeline, including BDC-2034, BDC-3042, and a PD-L1 Boltbody ISAC.

Advancing novel immuno-oncology pipeline focused on myeloid biology

On-track with IND-enabling studies with BDC-2034 – Bolt Biotherapeutics is currently conducting Investigational New Drug (IND)-enabling activities for BDC-2034, a novel CEA-targeted ISAC, including GLP toxicology studies and GMP manufacturing. Data presented at the 2022 AACR (Free AACR Whitepaper) Annual Meeting demonstrated activity in multiple preclinical cancer models.

On-track with IND-enabling activities with BDC-3042 – Bolt Biotherapeutics is currently conducting IND-enabling activities for BDC-3042. BDC-3042 is an agonist antibody that binds to and stimulates Dectin-2, a novel target found on tumor-associated macrophages across a broad range of solid tumors. Stimulating Dectin-2 leads to tumor macrophage reprogramming and anti-cancer activity. BDC-3042’s anti-tumor activity was demonstrated in humanized mouse models and presented in a poster at the AACR (Free AACR Whitepaper) Annual Meeting. The Company plans to initiate clinical development of BDC-3042 in 2023.

Ramping up corporate collaboration activity supporting future pipeline and offsetting R&D expenses – Bolt Biotherapeutics’ collaboration with Genmab A/S is exploring multiple bispecific ISACs, with Bolt Biotherapeutics having the option to develop and commercialize one product candidate. Bolt Biotherapeutics’ collaboration with Innovent Biologics, Inc. will develop three new Boltbody ISAC programs, with Bolt Biotherapeutics having the option to develop and commercialize two of the programs. Under these valued collaborations, all research and development expenses through clinical proof of concept will be funded by partners.

Cash, cash equivalents, and marketable securities were $246.8 million as of March 31, 2022 – Cash on hand, which includes long-term marketable securities, is expected to fund the completion of multiple key milestones and to fund operations into 2024.
Upcoming Events

At the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Bolt Biotherapeutics’ Jason Ptacek, Ph.D., will present a poster entitled, "Characterization of tumor antigen expression and myeloid immune profiles to inform the development of immune stimulating antibody conjugates (ISACs)."
Title: Characterization of tumor antigen expression and myeloid immune profiles to inform the development of immune stimulating antibody conjugates (ISACs)​
Authors: Lisa K. Blum, Jason Ptacek, Heidi LeBlanc, Andrea Horvath, William G. Mallet, Bruce A. Hug, Michael N. Alonso, Edith A. Perez, David Dornan, Marcin Kowanetz ​
Abstract ID: 2557​
Abstract category: Developmental Therapeutics—Immunotherapy​
Presentation date: Sunday, June 5, 2022, 8:00 a.m. – 11:00 a.m. CDT

First Quarter 2022 Financial Results

Collaboration Revenue – Collaboration revenue was $0.8 million and nil for the three months ended March 31, 2022 and 2021, respectively. Revenue in 2022 was generated from the services performed under the R&D collaborations with Genmab A/S and Innovent Biologics, Inc.

Research and Development Expenses – R&D expenses were $18.4 million for the quarter ended March 31, 2022, compared to $14.1 million for the same quarter in 2021. The increase is primarily due to IND-enabling activities for BDC-2034 and continued progress in the clinical trial for BDC-1001, including an increase in consulting expenses and higher personnel expenses relating to an increase in headcount.

General and Administrative (G&A) Expenses – G&A expenses were $6.3 million for the quarter ended March 31, 2022, compared to $4.3 million for the same quarter in 2021, primarily due to increased expenses related to being a public company, including higher personnel expenses relating to increased headcount.

Loss from Operations – Loss from operations was $23.9 million for the quarter ended March 31, 2022, compared to $18.4 million for the same quarter in 2021.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
ISACs are a new category of immunotherapy combining the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs comprise three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient’s innate immune system. By initially targeting a single marker on the surface of a patient’s tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, which can lead to the conversion of immunologically "cold" tumors to "hot" tumors with the goal of durable responses for patients with cancer.

On May 12, 2022 Imago BioSciences, Inc. ("Imago") (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 financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Imago BioSciences, MAY 12, 2022, View Source [SID1234614472]).

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"I am delighted by the clinical progress Imago has made, which was underscored by the completion of enrollment in the Phase 2 trial of bomedemstat for treatment of ET as well as positive interim data from our two Phase 2 trials in ET and MF presented at ASH (Free ASH Whitepaper) 2021 with additional data from these trials to be presented at the upcoming EHA (Free EHA Whitepaper) congress in June. In addition, the Fred Hutchinson Cancer Research Center has initiated dosing in a Phase 1/2 combination study of bomedemstat and atezolizumab for the treatment of small cell lung cancer and we remain on track to initiate our second combination study in the first half of 2022, which is a Phase 2 trial of bomedemstat and ruxolitinib for the treatment of MF," said Hugh Young Rienhoff, Jr., M.D., Chief Executive Officer of Imago BioSciences. "As we continue to assemble a seasoned leadership team, I am pleased to have had Mike join as Chief Operating and Business Officer, as Laura Eichorn transitioned from the Chief Operating Officer role into the Chief Financial Officer on a permanent basis. Looking ahead, Imago expects to initiate a registrational study of bomedemstat for the treatment of ET, subject to an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), around the end of 2022."

First Quarter 2022 Highlights

Announced results of preliminary discussions with the U.S. Food and Drug Administration (FDA), about key trial design parameters for a registration-directed Phase 3 program of bomedemstat for the treatment of ET. Based on these discussions, we believe a two-arm trial comparing bomedemstat to best available therapy may provide the basis for regulatory approval for the second-line treatment of ET. Subject to final review of the Phase 3 protocol, we have alignment on the study population of patients with ET, viz., those patients who are intolerant of or resistant to hydroxyurea, the agents in the control arm and the composite primary endpoint of durable normalization of platelet and white counts and hemostasis in the absence of progression. Based on completion of enrollment for the Phase 2 clinical trial in ET, and subsequent End of Phase 2 meeting, we expect to submit a final protocol for a registrational Phase 3 pivotal program in 2022, with the first patient dosed thereafter. With positive results from the pivotal clinical program, we would expect to submit applications for regulatory approval with the FDA and the EMA for ET.
Announced completion of enrollment in the Phase 2 trial of bomedemstat for the treatment of ET with 73 patients enrolled on May 3, 2022. To be enrolled in the Phase 2 ET trial, patients had to be intolerant of, or inadequately managed by treatment with one standard-of-care drug, generally hydroxyurea, and also had one or more high-risk prognostic factors, such as being over 60 years of age or having a history of clotting or bleeding events. Primary endpoints of this clinical trial are safety and tolerability, as well as the reduction of platelet count to ≤400 x 109/L, in the absence of any clotting or bleeding events. We are also evaluating several exploratory endpoints, including reduction in mutant allele frequency and prevention of transformation to MF or acute myeloid leukemia. In this Phase 2 trial, as well as our Phase 2 MF trial, we have used platelet count as a biomarker of bomedemstat activity on megakaryocyte function, allowing for individualized dosing. Patients from this trial are eligible to transition into an ongoing Phase 2 Extension Study initiated in 2021 enabling the collection of long-term safety and pharmacodynamic data.
Expanded Executive Leadership. In March 2022, Imago announced the appointments of Michael Arenberg as Chief Operating and Business Officer and Laura G. Eichorn as our Chief Financial Officer. Mr. Arenberg succeeds Ms. Eichorn as COO and is charged with leading strategic operations, investor relations, commercial development and business development of Imago. Ms. Eichorn has transitioned from interim Chief Financial Officer to serving in that role on a permanent basis.
Recent Highlights

Announced that the Fred Hutchinson Cancer Research Center has dosed the initial participant in an investigator-sponsored Phase 1/2 study of bomedemstat in combination with atezolizumab (Tencentriq) in people newly diagnosed with extensive stage small cell lung cancer (ES-SCLC). The study is being led by Rafael Santana-Davila, M.D., associate professor in the University of Washington School of Medicine and Joseph Hiatt, M.D., Ph.D., of Fred Hutchinson Cancer Center ("Fred Hutch"), and in collaboration with the National Cancer Institute (NCI) funded Fred Hutch Lung Specialized Project of Research Excellence. This single-center, open-label study is designed to assess the safety, dose-limiting toxicity, and progression-free survival of bomedemstat in approximately 34 patients with ES-SCLC. More information on this trial can be found on www.clinicaltrials.gov under the identifier NCT05191797.
Announced Data Presentations at the Upcoming 27th EHA (Free EHA Whitepaper) Congress. In May 2022, Imago announced that two abstracts have been accepted for poster presentation at EHA (Free EHA Whitepaper), to be presented on June 10, 2022: "A Phase 2 Study of The LSD1 Inhibitor IMG-7289 (Bomedemstat) For The Treatment Of Essential Thrombocythemia (ET)"; and "A Phase 2 Study of IMG-7289 (Bomedemstat) in Patients With Advanced Myelofibrosis."
Anticipated Upcoming Milestones

Data updates for bomedemstat in MF and ET at EHA (Free EHA Whitepaper) on June 10, 2022
Anticipate initiating Phase 2 combination study of bomedemstat with ruxolitinib in MF in 1H 2022
Expect an End-of-Phase 2 meeting with FDA for bomedemstat in ET in 2H 2022
Expect data updates for the bomedemstat Phase 2 trials in ET and MF at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2022
First Quarter 2022 Financial Results

Cash and Cash Equivalents: As of March 31, 2022, Imago had cash and cash equivalents and short-term investments of $205.8 million, compared to $82.7 million as of March 31, 2021 and $217.4 million as of December 31, 2021.
Research & Development (R&D) Expenses: R&D expenses for the quarter ended March 31, 2022 were $12.5 million (including stock-based compensation expense of $0.7 million) as compared to $4.8 million for the same period in 2021. The overall increase in R&D expenses was primarily related to increased manufacturing costs of drug supplies for our ongoing and planned clinical trials, continued clinical development activities in separate Phase 2 clinical trials for ET and MF, commencement of a Phase 2 extension study started in the second half of 2021 for the long-term follow-up of patients from the ongoing ET and MF clinical trials, and an increase in personnel-related costs, particularly with respect to an increase in the number of research and development employees, including stock-based compensation expense, as we ramped up our operations.
General and Administrative (G&A) Expenses: G&A expenses for the quarter ended March 31, 2022 were $4.0 million (including stock-based compensation expense of $0.7 million) as compared to $2.4 million for the same period in 2021 primarily due to increasing expense associated with operating a publicly traded company and personnel-related costs.
Net Loss: Net loss for the quarter ended March 31, 2022 was $16.4 million compared to $7.1 million for the same period in 2021.

On May 12, 2022 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat oncology indications, reported its financial results for the first quarter of 2022 and provided a business update (Press release, Xenetic Biosciences, MAY 12, 2022, View Source [SID1234614471]).

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"Our strategic focus throughout the first quarter was working towards the completion of our exclusive license agreement with CLS Therapeutics ("CLS") to develop its interventional DNase based oncology platform. This platform was extremely attractive to us as we realized that adding the licensed programs could expand and enhance our oncology pipeline, provide an accelerated path to the clinic, create the potential for value-driving clinical and regulatory milestones, and position us as an emerging clinical-stage company," commented, Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "Our team, along with advisors and preeminent key opinion leaders in this space, will make it a priority to advance the systemic DNase program into the clinic as an adjunctive therapy for locally advanced or metastatic cancers, as quickly and efficiently as possible."

DNase Oncology Platform: Targeting Neutrophil Extracellular Traps ("NETs") to improve cancer therapies with a focus on advancing systemic DNase program into the clinic as an adjunctive therapy for locally advanced or metastatic cancers.

The Company’s interventional DNase based oncology platform is aimed at improving outcomes of existing treatments, including immunotherapies. The exclusive license to CLS’ intellectual property for uses of DNases in cancer include systemic co-administration of DNases along with standard therapies, including chemotherapy, radiation and checkpoint inhibitors, or along with conventional chimeric antigen receptor (CAR) T therapies. In addition, the licenses cover "DNase-armored" CAR T therapies in which novel CAR T products are engineered to secrete DNases into the tumor microenvironment to potentially improve T-cell infiltration, activity and persistence.

The licensed DNase platform is designed to target NETs, which are weblike structures composed of extracellular chromatin coated with histones and other proteins. NETs are expelled by activated neutrophils, in response to microbial or pro-inflammatory challenges. However, excessive production or reduced clearance of NETs can lead to aggravated inflammatory and autoimmune pathologies, as well as creation of pro-tumorigenic niches in the case of cancer growth and metastasis.

A substantial amount of scientific literature has implicated NETs in the context of cancer pathogenesis and resistance to cancer therapies (including chemo, radio, and immunotherapies such as checkpoint inhibitors and cell therapies). In published reports, elevated levels of NETs have been a biomarker associated with poor prognosis in patients with a variety of cancers.

In addition, resistance to existing therapeutic agents can involve the release of immunosuppressive signaling factors from NETs, or physical barriers created by NETs which can impede the infiltration, activity, and survival of cytotoxic T cells in the tumor microenvironment.

Published pre-clinical models have demonstrated the effectiveness of systemically administered DNase, alone or in combination with other agents, for the elimination of NETs and prevention of tumor growth and metastasis.

Adoptive transfer of CAR T cells has emerged as one of the most promising advances in cancer immunotherapy. Engineered CAR T cells, designed to recognize cancer-associated antigens, are capable of sustained and selective killing of tumor cells, with substantial reduction of tumor burden. CAR T therapies have exhibited remarkable clinical success against hematological malignancies but thus far have failed to demonstrate success in the context of solid tumors. Recent approaches to CAR T design include "armored" CAR-T cells, so named because they can express additional factors to resist immunosuppression or degrade physical components of the tumor’s extracellular matrix, including NETs. The Company plans to conduct pre-clinical research with the goal of demonstrating that armoring CAR T cells to secrete DNase can support depth and durability of response against solid tumor indications.

Program Highlights:

In April 2022, executed exclusive license and sublicense agreements with CLS Therapeutics to develop its interventional DNase based oncology platform, which is aimed at improving outcomes of existing treatments, including immunotherapies.
Advancing toward first-in-human study with IND filing targeted for the end of 2023.
Systemic DNase program initially targeting multi-billion-dollar indications including pancreatic carcinoma.
DNase armored CAR T program focused on demonstrating that armoring CAR T cells to secrete DNase can support depth and durability of response against solid tumor indications.
XCART Platform Technology: Significantly differentiated, proprietary approach to personalized CAR T lymphoma therapy targeting tumor-specific neoantigens that target independently of CD19 or other surface antigens that are common to both normal and malignant B-cells.

Program Highlights:

Advancing preclinical efforts through ongoing research and development collaborations including with The Scripps Research Institute and other institutions in the U.S. covering design and implementation of the pre-clinical development program, as well as activities supporting process development for clinical manufacturing.
Bolstered intellectual property portfolio with issuance of a U.S. patent covering the co-administration of XCART-derived CAR T cells, together with a personalized vaccine designed to enhance the effectiveness of the CAR T therapy.
PolyXen Platform Technology: Patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug’s circulating half-life and potentially improving other pharmacological properties.

Program Highlight:

Royalty payments of approximately $0.4 million were received in the three months ended March 31, 2022, representing an approximate 103.4% increase over the same period in 2021 as Takeda’s sublicensee continued its worldwide launch of the product.
Summary of Financial Results for First Quarter 2022

Net loss for the quarter ended March 31, 2022 was approximately $1.6 million. Research & development expenses for the three months ended March 31, 2022 increased by approximately $0.5 million, or 74.9%, to approximately $1.1 million from approximately $0.6 million in the comparable quarter in 2021. The increase was primarily due to the Company’s increase in spending related to XCART U.S. pre-clinical development efforts. General and administrative expenses for the three months ended March 31, 2022 decreased by approximately $23,000, or 2.5%, to approximately $0.9 million from approximately $0.9 million in the comparable quarter in 2021. The decrease was primarily due to lower consulting costs offset by an increase in legal costs related to the CLS transaction during the three months ended March 31, 2022 compared to the same period in 2021.

The Company ended the quarter with approximately $16.2 million of cash.

On May 12, 2022 ChromaDex Corp. (NASDAQ:CDXC) reported financial results for the first quarter of 2022 (Press release, ChromaDex, MAY 12, 2022, View Source [SID1234614470]).

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First Quarter 2022 and Recent Highlights

Total net sales were $17.3 million, up 18% from the prior year quarter.
Tru Niagen net sales were $14.9 million, a 20% increase from the prior year quarter.
In April 2022, the ChromaDex External Research Program (CERP) achieved its 250th material transfer agreement since 2013, resulting in over 100 peer-reviewed preclinical and clinical studies, many including the study of Niagen and its impact on healthy aging.
Clinical study published in Cell Metabolism revealed NR as a potential neuroprotective therapy for Parkinson’s Disease (PD) patients, warranting further investigation in additional trials. Two additional studies are underway, including a 400 patient study at 1,000 milligrams per day, and a 20 patient study at 3,000 milligrams per day.
Launched new consumer product, Tru Niagen Immune, a first-of-its kind combination of immune-boosting nutrition with ChromaDex’s proprietary NAD+ boosting ingredient Niagen, beginning April 2022.
Granted additional U.S. continuation patent to protect the novel manufacturing process of NR and its various salt forms, which now cover NR Chloride, NR Malate, and NR Tartrate salts, through 2037.
"We delivered solid financial results in the first quarter, while strengthening our patent portfolio, and announcing dramatic new scientific research on Niagen(R)," said CEO, Rob Fried. "Following the quarter, we launched Tru Niagen(R) Immune and ramped up our new TV campaign to encouraging early results."

Results of operations for the three months ended March 31, 2022 compared to the prior year quarter

For the three months ended March 31, 2022 ("Q1 2022"), ChromaDex reported net sales of $17.3 million, up $2.6 million or 18% compared to the first quarter of 2021 ("Q1 2021"). The increase in Q1 2022 revenues was largely driven by growth in sales of Tru Niagen (primarily e-commerce) paired with slight growth in ingredient sales.

Gross margin percentage declined to 61.0% in Q1 2022 compared to 62.9% in Q1 2021 primarily due to business mix and increases in supply chain headcount to scale the business.

Operating expenses increased by $1.7 million to $18.3 million in Q1 2022, compared to $16.6 million in Q1 2021. The increase in operating expenses was driven by $2.0 million of higher selling and marketing expenses partially offset by a $0.6 million decrease in general and administrative expense. The increase in selling and marketing expenses are largely due to brand building activities, including new Tru Niagen television campaign.

The net loss for Q1 2022 was $7.7 million or $(0.11) per share compared to a net loss of $7.4 million or $(0.12) per share for Q1 2021. Adjusted EBITDA including legal expense, a non-GAAP measure, delivered a loss of $4.5 million for Q1 2022, a $1.2 million improvement from Q1 2021. Adjusted EBITDA excluding legal expense, a non-GAAP measure, was a loss of $2.1 million for Q1 2022. See "Reconciliation of Non-GAAP Financial Measures" for a reconciliation of non-GAAP Adjusted EBITDA excluding legal expense to net loss, the most directly comparable GAAP measure.

For Q1 2022, the net cash outflow from operating activities was $7.2 million, compared to $5.4 million in Q1 2021 largely due to changes in working capital.

2022 Full Year Outlook

Looking forward, for the full year, the Company expects 15-20% revenue growth, driven by its global e-commerce business, as well as growth with existing and new strategic partners. The outlook does not include revenue upside from potential new partnerships in the pipeline. The outlook contemplates continued COVID-19 headwinds for international partners. The Company expects slightly better than 60% gross margin and a reduction in general and administrative expense of $5.0 to $6.0 million, as reported, for full year 2022, driven by lower legal expense. The Company expects to increase investments and resources to drive brand awareness and accelerate its research and development pipeline to capitalize on growth in the nicotinamide adenine dinucleotide (NAD+) market globally. Accordingly, the Company expects an increase in research and development expense of approximately $2.0 million. Selling and marketing expense is expected to be up in absolute dollars, but down slightly as a percentage of net sales, year-over-year.

Investor Conference Call

A live webcast will be held Thursday, May 12, 2022 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss ChromaDex’s first-quarter financial results and provide a general business update.

To listen to the webcast, or to view the earnings press release and its accompanying financial exhibits, please visit the Investors Relations section of ChromaDex’s website at View Source The toll-free dial-in information for this call is 1-888-330-2446 with Conference ID: 4126168.

The webcast will be recorded, and will be available for replay via the website from 7:30 p.m. Eastern time on May 12, 2022 to 11:59 p.m. Eastern time on May 19, 2022. The replay of the call can also be accessed by dialing 800-770-2030, using the Replay ID: 4126168.

Important Note on Forward Looking Statements:

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as "expects," "anticipates," "intends" "estimates," "plans," "potential," "possible," "probable," "believes" "seeks," "may," "will," "should," "could," "predicts," "projects," "continue," "would" or the negative of such terms or other similar expressions. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the quotation from ChromaDex’s Chief Executive Officer, and statements related to the Company’s 2022 financial outlook including but not limited to revenue growth, gross margin, expenses, and investment plans. Other risks that contribute to the uncertain nature of the forward-looking statements include: the impact of the COVID-19 pandemic on our business and the global economy; our history of operating losses and need to obtain additional financing; the growth and profitability of our product sales; our ability to maintain sales, marketing and distribution capabilities; changing consumer perceptions of our products; our reliance on a single or limited number of third-party suppliers; and the risks and uncertainties associated with our business and financial condition in general, described in our filings with the Securities and Exchange Commission (SEC), including, without limitation, our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q as filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and ChromaDex undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.

On May 12, 2022 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported financial results for the first quarter ended March 31, 2022 and provided an update on recent business events (Press release, CorMedix, MAY 12, 2022, View Source [SID1234614469]).

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Recent Corporate Highlights:

CorMedix announced on March 28 that the resubmission of the DefenCath NDA has been accepted for filing by the FDA as a complete Class 2 response, with a six-month review cycle. In addition, our third-party manufacturer was notified that FDA will conduct an inspection during the review period.
CorMedix announced on April 7 that the Company formed a new Scientific Advisory Board to support commercialization of DefenCath as well as pipeline development.
CorMedix announced on May 12 several updates to the leadership team, including that Joe Todisco officially joined the organization as CEO on May 10 and that CorMedix has hired a new Head of Global Quality and an experienced Supply Chain leader.
CorMedix also announced on May 12 that the Company will begin the process of winding down its European operations and will discontinue the distribution of Neutrolin in the EU as CorMedix intends to focus near-term efforts on securing NDA approval for, and commercialization of, DefenCath in the US market.
Cash and short-term investments, excluding restricted cash, at March 31, 2022 amounted to $61.7 million.
Joe Todisco, CorMedix CEO, commented, "We are very pleased to share the updates this week regarding the business and plans for commercialization. If approved by FDA, DefenCath has the potential to meaningfully improve patient outcomes while also having an impact on the health equity disparity that is pervasive in our healthcare system. We look forward to providing additional updates as we aim to deliver on our commitment to these patients."

First Quarter 2022 Financial Highlights

For the first quarter of 2022, CorMedix recorded a net loss of $7.0 million, or $0.18 per share, compared with a net loss of $7.2 million, or $0.20 per share, in the first quarter of 2021, a decrease of $0.2 million, driven by a decrease in operating expenses.

Operating expenses in the first quarter 2022 were $7.0 million, compared with $7.2 million in the first quarter of 2021, a decrease of approximately 3%. The decrease was driven by lower R&D expense, which decreased by 13% to $2.3 million, primarily due to net decreases in personnel expenses and non-cash charges for stock-based compensation, offset by an increase in costs related to the manufacturing of DefenCath prior to its potential marketing approval. SG&A expenses increased approximately 3% to $4.8 million, primarily driven by increased legal fees mainly due to the securities litigation, and an increase in personnel expenses, partially offset by a decrease in non-cash charges for stock-based compensation, and reduced costs related to market research in preparation for the potential approval of DefenCath.

The Company reported cash and short-term investments of $61.7 million at March 31, 2022, excluding restricted cash. The Company believes that it has sufficient resources to fund operations at least through the first half of 2023.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, May 12, 2022, at 4:30PM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows: