ChromaDex Corporation Reports First Quarter 2022 Financial Results

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.

CorMedix Inc. Reports First Quarter 2022 Financial Results and Provides Business Update

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:

Race Receives Governance Approval for Extramedullary AML & MDS Human Trial

On May 12, 2022 Race Oncology Limited ("Race") reported it has received Research Governance Office (RGO) approval from the Calvary Mater Newcastle Hospital for its open label clinical trial of Zantrene (bisantrene dihydrochloride) in patients with extramedullary Acute Myeloid Leukaemia (AML) or high-risk Myelodysplastic Syndrome (MDS). Human ethics approval for this trial has been granted (ASX Announcement: 5 April 2022) (Press release, Race Oncology, MAY 12, 2022, View Source [SID1234614468]).

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Representatives of the Race Oncology clinical team, the contract research organisation Paraxel, and associated clinical teams of the Calvary Mater Hospital are scheduled to meet for site initiation and training on the May 31, 2022. Completion of this site training will enable the first patient to be recruited into the trial.

This open label Phase 1 trial with a dose expansion Phase 2 stage will recruit up to 60 patients with extramedullary AML or MDS using a two-stratum (arm) design at trial sites in Australia and Europe (ASX Announcement: November 1, 2021).

JCRI – ABTS and USMI to Present a Two-year Follow-up of Phase I Clinical Trial Using Cold Atmospheric Plasma for the Treatment of Solid Tumors at Israeli Society of Surgical Oncology

On May 12, 2022 Jerome Canady Research Institute for Advanced and Biological Technological Sciences (JCRI-ABTS) and US Medical Innovations, LLC (USMI) reported that Jerome Canady MD, Chief Science Officer at JCRI-ABTS and a Surgical Oncologist at Holy Cross Hospitals Silver Spring/Germantown, MD will present the results of a Two-year follow up, "Phase I Clinical Trial of Canady Helios Cold Atmospheric Plasma (CHCP) Treatment for Patients with Advanced Stage IV Metastatic and Recurrent Solid Tumors: A Novel Potential 4th Treatment Arm for Cancer" at The Biannual Conference of the Israeli Society of Surgical Oncology (ISSO), May 11-13, 2022 in Haifa, Israel (Press release, JCRI-ABTS, MAY 12, 2022, View Source;ABTS-and-USMI-to-Present-a-Two-year-Follow-up-of-Phase-I-Clinical-Trial-Using-Cold-Atmospheric-Plasma-for-the-Treatment-of-Solid-Tumors-at-Israeli-Society-of-Surgical-Oncology [SID1234614439]).

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Dr. Canady stated, "Metastatic and recurrent Stage IV solid tumors have a poor overall survival (OS) despite the advancement of surgery, chemotherapy, radiation, and immunotherapy. The CHCP Trial was a Phase I, multiple-center, open labelled, prospective controlled trial which enrolled eligible subjects undergoing surgery and intra-operative CHCP treatment. Between March 2020 to April 2021, twenty (20) patients were recruited from Rush University Medical Center Chicago, Illinois and Sheba Medical Center Tel HaShomer, Israel. Patients received intra-operative CHCP treatment at the operative site after the tumor was removed. The primary end point was safety, and the secondary end point was to demonstrate ablation and slowing down tumor growth in cancer patients without damaging surrounding normal biological tissue."

Patients from 26 to 85 years of age (mean age 59) were enrolled in the study. Physiological data was recorded throughout surgery (i.e. blood pressure, pulse, body temperature, End Tidal CO2, and oxygen saturation which demonstrated no significant changes (p > 0.05) during the intra-operative CHCP treatment period). There were no adverse events related to CHCP.

As of May 12, 2022, four patients died of their disease at 3, 4, 8 and 10 months. Kaplan-Meier survival analysis showed that interim OS rate at 26 months was 80.0% (95% confidence interval [CI], 64.3 – 99.6%). Median survival was 14.5 months. Histology of the surgical margins revealed cancer cell death and no damage to normal tissue. Ex vivo culture confirmed reduction of cancer cell growth.

CHCP treatment in combination with surgery for high-risk stage IV solid tumors is safe, induces tumor death and slows down tumor growth in vitro, ex vivo and in cancer patients without damaging non-cancerous tissue. CHCP is potentially a 4th Treatment Arm for Solid Tumor Cancers. (ClinicalTrials.gov identifier: NCT04267575.)

The FDA Phase One Clinical trial was completed April 15, 2021, at Rush University Medical Center (Chicago, IL) and Sheba Medical Center-Tel HaShomer (Ramat Gan, Israel). The Principal Investigators were Professor Steven Gitelis, M.D., and Professor Aviram Nissan, M.D. respectively.

REHEVA BIOSCIENCES ANNOUNCES FIRST PATIENT ENROLLED IN RH324 PHASE I SAFETY TRIAL

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