ASLAN Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update

  • TREK-AD Phase 2b study of   eblasakimab   fully enrolled, topline data readout expected early July 2023
  • Phase 2 proof-of-concept trial of   farudodstat   in alopecia areata expected to commence in the second quarter of 2023 with topline data readout expected in the first quarter of 2024
  • Expected cash runway extended through at least the second quarter of 2024 with recent $20 million in financing, with potential to receive up an additional $80 million

ASLAN Pharmaceuticals (Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced financial results for the fourth quarter and full year ended December 31, 2022, and provided an update on recent corporate activities.

"We ended 2022 and have begun 2023 achieving a number of milestones across our clinical pipeline that position ASLAN for strong momentum throughout this year and into 2024," said Dr Carl Firth, CEO, ASLAN Pharmaceuticals . "At the end of 2022, we commenced dosing atopic dermatitis (AD) patients in our dupilumab -experienced (TREK-DX) trial. Most notably, we completed enrollment at the start of 2023 in our TREK-AD Phase 2b trial, testing eblasakimab as a novel treatment for moderate-to-severe AD, and we look forward to reporting topline data from this study in early July 2023. In addition, we formed a collaboration with Thermo Fisher Scientific to manufacture a high concentration formulation of eblasakimab that will allow us to administer 400mg in a single subcutaneous injection with a range of different devices."

Dr Firth continued, "We recently announced strong support from BVF Partners and additional investors on a $20 million financing, allowing us to advance farudodstat into a Phase 2, proof-of-concept study in alopecia areata (AA) in the second quarter of 2023. This is a common autoimmune disease that is associated with a severe psychological burden yet there are few effective treatments that are safe for long-term use. Farudodstat potently inhibits key drivers of AA disease pathophysiology and has the potential to be a novel, first-in-class treatment."

Fourth quarter 2022 and recent business highlights

Q4 and recent clinical developments

  • In March 2023, two abstracts showcasing new data on eblasakimab were accepted for poster presentation at the First International Societies for Investigative Dermatology (ISID) Meeting, taking place from May 10 to 13, 2023, in Tokyo, Japan. Posters being presented at the meeting will explore eblasakimab 's efficacy in difficult to treat areas in patients with AD, such as the head and neck, and its potential for alleviating the underlying itch and hypersensitized sensory nerve fibers through multiple molecular pathways in AD.
  • In February 2023, ASLAN announced the advancement of its clinical program to investigate farudodstat , a highly selective, oral dihydroorotate dehydrogenase (DHODH) inhibitor, in a Phase 2 proof-of-concept trial as a potential first-in-class treatment for AA. Farudodstat is 30-fold more potent than approved drugs in its class and has demonstrated a well-tolerated safety profile. The trial will recruit about 60 patients in the US and enrollment is expected to begin in the second quarter of 2023. The interim topline readout following the first 12-week treatment period is expected in the first quarter of 2024 and will inform the design of the subsequent Phase 2b dose-ranging study.
  • In February 2023, the final patient was enrolled in the TREK-AD (TRials with EblasaKimab in Atopic Dermatitis) study, a Phase 2b, dose-ranging, randomized, double-blind, placebo-controlled clinical trial of eblasakimab in adults with moderate-to-severe AD. ASLAN expects to report topline data from this study in early July 2023. The study is evaluating the efficacy and safety of eblasakimab in biologic naïve AD patients over a 16-week treatment period.
  • In January 2023, ASLAN and Thermo Fisher Scientific Inc (NYSE: TMO) announced a partnership to manufacture a high concentration formulation of eblasakimab for Phase 3 clinical trials. ASLAN has developed a high concentration formulation of eblasakimab , allowing up to 400mg eblasakimab to be administered in a single subcutaneous injection and suitable for use with different devices.
  • In December 2022, the first patient was screened in the TREK-DX study of eblasakimab in adult patients with moderate-to-severe AD who have previously been treated with dupilumab . The randomized, double-blind, placebo-controlled, Phase 2 clinical trial is expected to enroll 75 patients in North America and will assess the efficacy and safety of eblasakimab in dupilumab experienced patients who have discontinued their treatment for any reason, including inadequate disease control, loss of access to drug or an adverse event.

Corporate updates

  • In March 2023, ASLAN's management team hosted a virtual farudodstat Research and Development Day with Key Opinion Leader (KOL) Brett King, MD PhD, Associate Professor of Dermatology, Yale University School of Medicine, to discuss the unmet medical need and current treatment landscape in AA. A replay of the event and presentation materials are available on the Investor Relations section of ASLAN's website .
  • In February 2023, ASLAN announced that it entered into a definitive purchase agreement ("Purchase Agreement") to raise gross proceeds of approximately $20 million resulting from the sale of its ordinary shares (or pre-funded warrants) and accompanying purchase warrants, at a purchase price of $0.178 per ordinary share (or the equivalent of $4.45 per American Depositary Share ("ADS") after giving effect to the ADS Ratio Change described below to BVF Partners LP, K2 HealthVentures and certain existing investors. In addition, ASLAN has the potential to receive up to an additional $80 million in proceeds if all purchase warrants issued in connection with the Purchase Agreement are fully exercised.

Anticipated upcoming milestones

  • New clinical and translational data on eblasakimab will be presented at the ISID Meeting in Tokyo, Japan. Posters will be available to view at the meeting on May 10, 2023, and will be uploaded to ASLAN's website at this link following presentation.
  • The first patient is expected to be enrolled in the farudodstat proof-of-concept Phase 2a study in AA in the second quarter of 2023.
  • Topline data from the Phase 2b TREK-AD trial of eblasakimab is expected in early July 2023.
  • Topline data from the TREK-DX trial of eblasakimab is expected in the first quarter of 2024.
  • Topline interim data from the farudodstat Phase 2a study in AA is expected in the first quarter of 2024.

Fourth quarter 2022 financial highlights

  • Cash used in operations for the fourth quarter of 2022 was $12.0 million compared to $11.9 million in the same period in 2021.
  • Research and development expenses were $10.7 million in the fourth quarter of 2022 compared to $9.0 million in the fourth quarter of 2021. The increase was primarily driven by higher clinical development and manufacturing costs for eblasakimab .
  • General and administrative expenses were $2.7 million in the fourth quarter of 2022 compared to $2.2 million in the fourth quarter of 2021.
  • Net loss attributable to stockholders for the fourth quarter of 2022 was $14.5 million compared to a net loss of $9.1 million for the fourth quarter of 2021, which included a gain of $2.3 million resulting from the dilution of JAGUAHR Therapeutics in December 2021 and recognition of its associates. The increase was primarily driven by higher clinical development and manufacturing costs for eblasakimab.
  • The weighted average number of ADSs outstanding in the computation of basic loss per share for the fourth quarter of 2022 was 13.95 million (representing 348.7 million ordinary shares) compared to 13.92 million (representing 348.0 million ordinary shares) for the fourth quarter of 2021. After the ADS Ratio Change described below was effected, one ADS is the equivalent of twenty-five ordinary shares.

Full-year 2022 financial highlights

  • Cash used in operations for the year ended December 31, 2022, was $38.4 million compared to $34.0 million in 2021.
  • Research and development expenses were $38.0 million for the year ended December 31, 2022, compared to $22.0 million in 2021. The increase was driven primarily by the increase in clinical development and manufacturing costs for eblasakimab .
  • General and administrative expenses were $9.9 million for the year ended December 31, 2022, compared to $11.8 million in 2021. The decrease in general and administrative expenses was mainly due to lower fundraising costs compared to 2021.
  • Net loss attributable to stockholders for the year ended December 31, 2022, was $51.4 million compared to a loss of $31.3 million in 2021. The increase was primarily due to the increase of clinical development and manufacturing costs for eblasakimab .
  • Cash and cash equivalents total $56.9 million as of December 31, 2022, compared to $90.2 million as of December 31, 2021. On February 28, 2023, ASLAN received gross proceeds of $20.0 million upon the closing of the Purchase Agreement with BVF and other investors. Management believes that the Company's cash and cash equivalents will be sufficient to fund operations through at least the second quarter of 2024.
  • The weighted average number of ADSs outstanding in the computation of basic loss per share for the year ended December 31, 2022, was 13.9 million (representing 348.7 million ordinary shares) compared to 13.0 million (representing 325.7 million ordinary shares) for the year ended 2021.
  • At the opening of trading on the Nasdaq Capital Market on March 13, 2023, the Company effected a change in the ratio of its ADSs to its ordinary shares from one (1) ADS representing five (5) ordinary shares to one (1) ADS representing twenty-five (25) ordinary shares (the "ADS Ratio Change"). For the Company's existing ADS holders, the ADS Ratio Change had the same effect as a one-for-five reverse ADS split.


ASLAN Pharmaceuticals Limited
CONSOLIDATED BALANCE SHEETS
(In US Dollars, other than shares or share data)

December 31, 2021
(audited)
December 31, 2022
(audited)
ASSETS
CURRENT ASSETS
Cash and cash equivalents $ 90,167,967 $ 56,902,077
Total cash and cash equivalents 90,167,967 56,902,077
Other assets 3,612,846 3,976,350
Total current assets $ 93,780,813 $ 60,878,427
NON-CURRENT ASSETS
Investment in associate company 494,728 8,587
Property, plant and equipment 34,979 43,140
Right-of-use assets 197,746 249,601
Intangible assets 9,956 5,836
Total non-current assets 737,409 307,164
TOTAL ASSETS $ 94,518,222 $ 61,185,591
LIABILITIES AND EQUITY
CURRENT LIABILITIES
Trade payables $ 3,116,786 $ 12,784,485
Other payables 2,817,909 2,325,038
Lease liabilities - current 199,124 215,671
Current borrowings 7,748,831
Financial liabilities at fair value through profit or loss 223,352 90,213
Total current liabilities 6,357,171 23,164,238
NON-CURRENT LIABILITIES
Long-term borrowings 30,857,308 29,656,133
Total non-current liabilities 30,857,308 29,656,133
Total liabilities 37,214,479 52,820,371
EQUITY ATTRIBUTABLE TO STOCKHOLDERS OF THE COMPANY
Ordinary shares 63,019,962 63,019,962
Capital surplus 221,467,061 223,910,955
Accumulated deficits (227,004,332 ) (278,386,749 )
Other reserves (178,948 ) (178,948 )
Total equity attributable to stockholders of the Company 57,303,743 8,365,220
Total equity 57,303,743 8,365,220
TOTAL LIABILITIES AND EQUITY $ 94,518,222 $ 61,185,591


ASLAN Pharmaceuticals Limited
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(In US Dollars, other than shares or share data)
 
 
For the Three Months Ended
December 31 (unaudited)
For the Twelve Months Ended
December 31 (audited)
2021 2022 2021 2022
OPERATING EXPENSES
General and administrative expenses $ (2,171,896 ) $ (2,708,055 ) $ (11,825,131 ) $ (9,881,993 )
Research and development expenses (8,964,318 ) (10,685,486 ) (22,021,321 ) (38,000,494 )
Total operating expenses (11,136,214 ) (13,393,541 ) (33,846,452 ) (47,882,487 )
LOSS FROM OPERATIONS (11,136,214 ) (13,393,541 ) (33,846,452 ) (47,882,487 )
NON-OPERATING INCOME AND EXPENSES
Interest income 42 224,018 219 354,457
Other income 772,113 162,711 1,108,072 386,138
Gain on dilution of subsidiary and recognition of associate 2,307,735 2,307,735
Other gains and losses (143,731 ) (571,079 ) 1,106,510 (29,583 )
Finance costs (747,902 ) (778,257 ) (1,860,954 ) (3,675,689 )
Total non-operating income and
expenses
2,188,257 (962,607 ) 2,661,582 (2,964,677 )
Share in losses of associated company, accounted for using equity method (190,309 ) (45,516 ) (405,712 ) (436,032 )
LOSS BEFORE INCOME TAX (9,138,266 ) (14,401,664 ) (31,590,582 ) (51,283,196 )
INCOME TAX EXPENSE (79,379 ) (99,221 )
NET LOSS FOR THE PERIOD (9,138,266 ) (14,481,043 ) (31,590,582 ) (51,382,417 )
OTHER COMPREHENSIVE LOSS
Unrealized loss on investments
TOTAL COMPREHENSIVE LOSS FOR THE PERIOD (9,138,266 ) $ (14,481,043 ) $ (31,590,582 ) $ (51,382,417 )
NET LOSS ATTRIBUTABLE TO:
Stockholders of the Company $ (9,138,266 ) $ (14,481,043 ) $ (31,321,618 ) $ (51,382,417 )
Non-controlling interests (268,964 )
$ (9,138,266 ) $ (14,481,043 ) $ (31,590,582 ) $ (51,382,417 )
TOTAL COMPREHENSIVE LOSS ATTRIBUTABLE TO:
Stockholders of the Company $ (9,138,266 ) $ (14,481,043 ) $ (31,321,618 ) $ (51,382,417 )
Non-controlling interests (268,964 )
$ (9,138,266 ) $ (14,481,043 ) $ (31,590,582 ) $ (51,382,417 )
LOSS PER ORDINARY SHARE
Basic and diluted $ (0.03 ) $ (0.04 ) $ (0.10 ) $ (0.15 )
LOSS PER EQUIVALENT ADS - AFTER THE ADS RATIO CHANGE
Basic and diluted $ (0.66 ) $ (1.04 ) $ (2.40 ) $ (3.68 )
Weighted-average number of ordinary shares in the computation of basic loss per ordinary share 348,028,867 348,723,365 325,684,272 348,723,365
Weighted-average number of equivalent ADS in the computation of basic loss per ADS – after the ADS Ratio Change 13,921,155 13,948,935 13,027,371 13,948,935


About ASLAN Pharmaceuticals

ASLAN Pharmaceuticals (Nasdaq: ASLN) is a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients. ASLAN is developing eblasakimab , a potential first-in-class antibody targeting the IL-13 receptor in moderate-to-severe atopic dermatitis (AD) with the potential to improve upon current biologics used to treat allergic disease. Eblasakimab is being investigated in a global Phase 2b trial of moderate-to-severe AD patients with topline readout expected in early July 2023. ASLAN is also developing farudodstat , a potent oral inhibitor of the enzyme DHODH, as a potential first-in-class treatment for alopecia areata (AA) and plans to initiate a proof-of-concept trial in 2Q 2023. ASLAN has teams in San Mateo, California, and in Singapore. For additional information please visit the website or follow ASLAN on LinkedIn .

Forward looking statements

This release contains forward-looking statements. These statements are based on the current beliefs and expectations of the management of ASLAN Pharmaceuticals Limited and/or its affiliates (the "Company"). These forward-looking statements may include, but are not limited to statements regarding the Company's business strategy and clinical development plans; the Company's plans to develop and commercialize eblasakimab and farudodstat ; the safety and efficacy of eblasakimab and farudodstat ; the Company's plans and expected timing with respect to clinical trials, clinical trial enrolment and clinical trial results for eblasakimab and farudodstat ; the potential of eblasakimab as a first-in-class treatment for atopic dermatitis and of farudodstat as a first-in-class treatment for alopecia areata; the Company's cash runway; and the potential to receive up an additional $80 million if all purchase warrants being issued in connection with the Purchase Agreement are fully exercised. The Company's estimates, projections and other forward-looking statements are based on management's current assumptions and expectations of future events and trends, which affect or may affect the Company's business, strategy, operations, or financial performance, and inherently involve significant known and unknown risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of many risks and uncertainties, which include, unexpected safety or efficacy data observed during preclinical or clinical studies; clinical site activation rates or clinical trial enrolment rates that are lower than expected; the impact of the COVID-19 pandemic or the ongoing conflict between Ukraine and Russia and bank failures on the Company's business and the global economy; general market conditions; changes in the competitive landscape; and the Company's ability to obtain sufficient financing to fund its strategic and clinical development plans. Other factors that may cause actual results to differ from those expressed or implied in such forward-looking statements are described in the Company's US Securities and Exchange Commission filings and reports (Commission File No. 001- 38475), including the Company's Annual Report on Form 20-F filed with the US Securities and Exchange Commission on March 24, 2023. All statements other than statements of historical fact are forward-looking statements. The words "believe," "may," "might," "could," "will," "aim," "estimate," "continue," "anticipate," "intend," "expect," "plan," or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify estimates, projections, and other forward-looking statements. Estimates, projections, and other forward-looking statements speak only as of the date they were made, and, except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement.

ASLAN Media and IR contacts

Emma Thompson
Spurwing Communications
Tel: +65 6206 7350
Email: ASLAN@spurwingcomms.com
Ashley R. Robinson
LifeSci Advisors, LLC
Tel: +1 (617) 430-7577
Email: arr@lifesciadvisors.com

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CSE:VGW

Valens GroWorks Highlighted by AltaCorp Capital Executive Discussing Flourishing Cannabis Pharma Space

With the launch of a legal recreational cannabis market in Canada, as well as an established medical market, players in the financial and investment spaces have started to look favorably upon cannabis companies leading the industry. In a recent interview on MidasLetter Live, AltaCorp Capital Inc.’s Managing Director David Kideckel spoke about the launch of his company’s cannabis sector coverage, which includes recognizable names in Canada like Auxly Cannabis Group Inc. (TSXV:XLY) and Valens GroWorks Corp. (CSE:VGW).

Speaking of Valens, a Kelowna, BC-based, research-driven, vertically-integrated Canadian cannabis company focusing on cannabis extraction, distillation as well as cannabinoid isolation and purification, Kideckel highlighted the steps the company has taken to deploy its business model. 

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Cannabis Investing

Valens Groworks Announces Strategic Collaboration

Valens GroWorks (CSE:VGW)(CSE:VGW.CN) (the “Company” or “Valens“) and its wholly-owned subsidiary Supra THC Services Inc. (“Supra“) are pleased to announce a collaboration between Supra and Thermo Fisher Scientific (Mississauga) Inc. to develop a “Centre of Excellence in Plant Based Medicine Analytics” centered in Kelowna, British Columbia. This agreement is the first of its kind between a Canadian cannabis company and a world leader in Health Science services, with an ability to deliver innovative technologies, purchasing convenience and comprehensive services to this emerging market.
Supra’s operations are located in the Company’s state-of-the-art 17,000 sq ft Kelowna facility, currently undergoing modifications ahead of a significant expansion. Supra will utilize a suite of Thermo Fisher Scientific sector-leading advanced analytical instrumentation to provide analytical services, research and development, forensic analysis and support for clinical trials as well as being a demonstration and training site for Thermo Fisher Scientific clients and third parties involved in this rapidly evolving sector. It will also be used as a regional resource center for universities and companies.
Dr. Rob O’Brien, CEO and Chief Science Officer of Supra THC Services Inc. stated; “There are many plants such as Cannabis that contain active ingredients which could be effective treatments for disease or provide critical health improvements. However, conducting proper clinical trials with materials that contain many active ingredients is challenging, particularly if the effective absorbed dose can vary significantly depending on how the material is consumed. For example, the effectiveness of absorption of active ingredients contained in an oil carrier is much different if that oil is placed under the patients tongue, then if the oil, or edible, is swallowedTo measure the amount of active ingredients and metabolites in blood, urine, hair and saliva, advanced instrumentation and a team of highly qualified personal is essential. With the Supra THC Services team and advanced instrumentation from Thermo Fisher Scientific, many significant advances are expected.”
Luc Dionne, Canadian Sales Manager with Thermo Fisher Scientific (Mississauga) Inc., states We welcome the opportunity to work with Dr. Rob O’Brien and the Supra THC Services team, an organization that conducts testing activities in plant based medicine. Dr. O’Brien has an extensive background in analytical chemistry and is a recognized authority in scientific circles. Dr. O’Brien has worked closely with Thermo Fisher Scientific in the past using several of our market leading technologies to successfully perform testing on natural products, pharmaceutical formulations and environmental samples. We are delighted that his team has selected Thermo Fisher Scientific‘s cost effective analytical testing solutions to promote the advancement of testing protocols to meet the rigorous and regulatory requirements of this market segment.
About Valens GroWorks Corp.
Valens GroWorks Corp. is a CSE-listed company with an aggressive buildout strategy in progress. The Company seeks to capture a broad spectrum of medical cannabis users and adult recreational users once legalized, as well as clinical trial and R&D clients, in pursuit of its ambitious seed-to-sale and farm-to-pharma objectives. The Company also provides management, consulting, testing and support services to domestic and international licensees, as well as financing and managing buildouts of fully-licensed 3rd party operations.
The Company has two wholly-owned subsidiaries based in the Okanagan Valley of British Columbia: 1) Valens Agritech Ltd. (“VAL”) which holds a Health Canada Dealer’s License, and 2) Supra THC Services Inc., a Health Canada licensed cannabis testing lab providing sector-leading analytical and proprietary services to Licensed Producers and ACMPR patients. For more information, please visit https:/valensgroworks.comhttps://www.valensagritech.com and https://www.suprathc.ca.
About Thermo Fisher Scientific (Mississauga) Inc.
Thermo Fisher Scientific (Mississauga) Inc. is a wholly owned subsidiary of Thermo Fisher Scientific Inc. (NYSE: TMO) the world leader in serving science, with revenues of more than US$20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands — Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services — we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. For more information, please visit www.thermofisher.com.
On behalf of the Board of Directors,
VALENS GROWORKS CORP.
(signed) Tyler Robson
Chief Executive Officer
For further information, please contact:
Greg Patchell
Telephone: +1.250.860.8634
Notice regarding Forward Looking Statements
This news release contains certain “forward-looking statements” within the meaning of such statements under applicable securities law. Forward-looking statements are frequently characterized by words such as “plan”, “continue”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur. These statements are only predictions. Various assumptions were used in drawing the conclusions or making the projections contained in the forward-looking statements throughout this news release. Forward-looking statements are based on the opinions and estimates of management at the date the statements are made, and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. The Corporation is under no obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by applicable law.
The CSE or other regulatory authority has not reviewed, approved or disapproved the contents of this press release. We seek Safe Harbour.
Click here to connect with Valens GroWorks (CSNX:VGW) to receive an Investor Presentation.

Thermo Fisher Scientific Expands Global Footprint to Support Cell and Gene Therapy Clinical Trials in Japan

To help meet increasing demand for cell and gene therapy clinical trial support around the globe, Thermo Fisher Scientific, the world leader in serving science, today announced the expansion of its Fisher BioServices cryogenic service capabilities in Japan.
This expansion enables its customers to seamlessly conduct clinical trials across multiple
geographies and provides patients around the world with access to life
changing therapies. As a leading service provider to the cell and gene
therapy community, Fisher BioServices is uniquely positioned with the
experience, resources, and global expertise to support its customers on
their path towards commercialization.
The facility in Tokyo was expanded to include cryogenic storage and
logistics by utilizing a combination of proven components and validated
procedures developed with years of experience in the cell and gene
therapy business. The new modules within this facility allow Fisher
BioServices to configure and replicate each site to meet the specific
requirements of individual clinical trials with minimal variation,
regardless of volume or geographic location. The facility is also
supported by a global comprehensive and integrated Quality System based
on regulatory requirements, industry best practices and trained
personnel.
“Japan is an increasingly important market for cell and gene therapy
companies conducting clinical trials,” said Dennis Barger, Fisher
BioServices vice president and general manager. “The addition of
cryogenic services to this facility in Japan, combined with our existing
capabilities in Europe and the US, enables us to seamlessly support our
customers’ global trials as they develop and commercialize their
therapies.”
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc.
(NYSE: TMO) is the world leader in serving science, with revenues of $17
billion and more than 50,000 employees in 50 countries. Our mission is
to enable our customers to make the world healthier, cleaner and safer.
We help our customers accelerate life sciences research, solve complex
analytical challenges, improve patient diagnostics and increase
laboratory productivity. Through our premier brands – Thermo Scientific,
Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services
– we offer an unmatched combination of innovative technologies,
purchasing convenience and comprehensive support. For more information,
please visit www.thermofisher.com.

MyDx Provides Positive Mid-Year Update as Part of Special Letter to Shareholders

Highlights:

  • MyDx experiencing double-digit quarterly revenue growth following commercialization of first of four patented technologies
  • Company’s increasing revenues and continued narrowing of losses clears path towards achieving profitability by year-end
  • Enters into first major distribution agreement valued at approximately $4 million for its CannaDx chemical sensor instrument
  • Expects to launch two new sensors by year-end, creating two entire new revenue channels
  • Focusing on substantially decreasing long-term debt and strengthening balance sheet
  • Seeking to aggressively expand sales and marketing initiatives for new products

LA JOLLA, Calif., June 07, 2016 (GLOBE NEWSWIRE) — MyDx, Inc. (OTCQB:MYDX), one of the fastest growing companies in the chemical detection industry and the producer of the patented MyDx™ (My Diagnostic) product line, the first battery operated, handheld, chemical analyzer for consumers, today issued the following Special Letter to Shareholders from its Chairman and Chief Executive Officer Daniel Yazbeck.
“Dear Fellow Shareholders,
2016 is off to a strong start, and as we approach the mid-year mark I thought it would be helpful to summarize our progress since launching our multi-use MyDx chemical analyzer with the CannaDx sensor and App.  I will also cover the highlights of our newly accelerated goals for the balance of the year as well as an analysis of the chemical detection marketplace in whose context I believe the MyDx Analyzer can clearly shown to be a market leader.
Before I discuss our goals and strategies looking ahead, I think it is important and prudent for a management team to look back at our accomplishments over the past four years.  Rather than summarizing our many achievements, we thought it would be better communicated via a short video clip we compiled for our investors.  Please click the following link for a quick video summary of the many successes we have had over the past four years that has enabled us to get to where we are today: a much nimbler, stronger and, by far, one of the fastest growing companies in the chemical detection market.
Please click here: MYDX 4 Year Business Plan Accomplishments Video (https://www.globenewswire.com/NewsRoom/AttachmentNg/ba458e62-5a32-4900-8b8e-29aadd1f6b86)
MyDx Second Half 2016 Key Goals: New Product Launches, Continued Market Penetration and Profitable Growth
Company Prepares for New Products to Enter into Commercialization
On the R&D front, with the recent launch of the next-generation CannaDx SmartPhone App, which expanded our features and updated our database, we are now focusing our effort on the next MyDx Product to enter into commercialization: OrganaDxTM. This application is slated for commercial release by the fourth quarter of this year.
The OrganaDx sensor will help you Trust and Verify™ the safety of your fruits and vegetables. Specifically, OrganaDx will enable you to measure the pesticide levels in your food, ensuring that you and your family do not unknowingly consume any potentially cancer-causing pesticides. It will empower you to verify, on the spot, whether or not produce is safe for consumption. This is particularly important when buying non-organic produce that are known to be notoriously high in pesticides, commonly referred to as the “Dirty Dozen.”
The Company expects future sales of OrganaDx should be at a substantially higher margin than our initial product line, which means a strong and growing contribution to our bottom line earnings growth.
Continued Market Penetration
In April 2016, we announced the first of what we expect to be many major retail distribution deals for our leading technology.  Our initial agreement was with Nanolux Technology, Inc. (“Nanolux”), valued at over $4 million. Nanolux produces one of the world’s leading brands of horticultural lighting ballasts. With over 1,000 retail shops in its distribution network, it has an extensive footprint throughout the U.S. indoor agriculture and hydroponic marketplace concentrated in states with cannabis sales legalized in some form — especially California as the nation’s largest legal cannabis market.
We are beginning to actively roll-out our MyDx Analyzers with CannaDx sensors, sales and marketing collateral along with product and sales training to those 1,000 retail shops. Those sales will begin to kick in during the current quarter and are expected to ramp-up steeply throughout the second half of the year, which will provide us with clear visibility of what the remainder of 2016 and even parts of 2017 will look like from a financial and operational perspective.
Increasing Demand for our Initial Product to Enter into Commercialization:  CannaDx
We see the market for CannaDx divided into three segments: consumer direct (primarily our online sales), and growers and dispensaries — both of which we consider prosumers. With online sales strong and growing, and even at high rates globally, that leaves the dispensary market segment still untapped and on which we are aggressively working to sign one or more regional or national distribution deals similar in nature to that of Nanolux.
MyDx is Clearly Positioned for Profitable Growth
Financially, just since its launch in the third quarter of 2015, CannaDx sales have topped well over $500,000, nearly all of which has come through direct-to-consumer sales with minimal marketing effort or expense.
Our net loss has narrowed by approximately $1.6 million year-over-year from ($2.1 million) to ($544,000) in the first quarter ended March 31, 2016. Additionally, we are actively working to reconfigure our manufacturing and supply chain management to scale up for far higher volumes and to reduce unit costs.
Based on these factors, and with the expected new applications in the final stages of development and commercialization, as well as an anticipated jump in CannaDx revenues in the weeks and months ahead driven by retail distribution, we believe we can reach profitability by year end — a significant milestone for MyDx.
Chemical Analyzer Marketplace: MyDx’s Growing Leadership Position
Bringing laboratory-based testing and analysis capability out of the lab and placing it in the palm of users’ hands is a common goal throughout the medical device (point of care) and many other industries.
In our industry, it is instructive to consider the hand-held chemical analyzer made by Thermo Fisher Scientific (“TMO”). TMO bills itself as the “world leader in serving science,” with revenues of $17 billion and more than 50,000 employees in 50 countries.
TMO developed and launched TruNarcTM, and while not identical in functionality to our CannaDx, it is fairly close, except that TruNarc is priced at close to $20,000 and has cost $400 million in R&D to develop.  Our CannaDx carries a $699 price tag while our multi-use MyDx Chemical Analyzer cost us under $7 million to develop, patent and deploy to market.  TMO’s move into the space validates the marketplace’s value, and we applaud however many millions of dollars it spends on sales and marketing since it serves to educate and build the market for both its products as well as our MyDx Analyzer.
MYDX Stock:  Significantly Undervalued
However, we understand we are one of the new entrants into the chemical detection space which is why we trade at such a low valuation compared to heavyweights such as Thermo Fisher.  However, if our past is any indication of what lies ahead for our Company and our shareholders, the Board of Directors and I, personally, strongly believe our stock price will adjust accordingly to our future achievements.  Once we achieve profitability and continue to grow at the pace we expect to, we believe our valuation should be closer to our competitors.  Thermo Fisher, for example, today trades at nearly 30 times 2017 earnings.  Once we provide our 2017 earnings expectations, we think you, as a long-term investor in MyDx, will be very pleasantly rewarded with the patience, confidence and support you have given our Company from the onset.  In fact, we believe the stock is so undervalued here that we are currently contemplating utilizing our excess cash flow to launch our first ever stock buyback program.  We will keep you updated on our Board’s decision on that initiative as soon as it is voted on.
In Summary
I trust this letter enables you to understand the sense of excitement and anticipation we at MyDx have on the outlook for the rest of 2016, and why we eagerly look forward to 2017.
If any of our investors will be in Southern California on Wednesday, June 8, please join us when I present the MyDx investment story and take questions at the 6th Annual LD Micro Invitational Investor Conference at 2:00 pm PDT / 5:00 pm EDT. The conference will be held at the Luxe Sunset Bel Air Hotel in Los Angeles and will feature nearly 200 companies in the small-cap universe. The presentation will be broadcast live, as well as archived on our website for 90 days. Hope to see you there.
Sincerely,
/s/ Daniel R. Yazbeck
Chairman and Chief Executive Officer
MyDx, Inc.
About MyDx
MyDx, Inc. (OTCQB:MYDX) is a chemical detection and sensor technology company based in San Diego, California whose mission is to help people Trust & Verify™ what they put into their minds and bodies. The Company has developed MyDx, a patented, affordable portable analyzer that provides real-time chemical analysis and fits in the palm of consumers’ hands. The multi-use MyDx leverages over a decade of established electronic nose technology to measure chemicals of interest. It owns a substantial and growing intellectual property portfolio of patents covering its technology. With its Canna sensor commercialized, it has four other sensors being developed in its lab that are compatible with the MyDx Analyzer and App. For more information, please visit www.cdxlife.com.
Forward-Looking Statements
This news release contains “forward-looking statements” as that term is defined in Section 27(a) of the Securities Act of 1933, as amended, and Section 21(e) of the Securities Exchange Act of 1934, as amended. Statements may contain certain forward-looking statements pertaining to future anticipated or projected plans, performance and developments, as well as other statements relating to future operations and results. Any statements in this press release that are not statements of historical fact may be considered to be forward-looking statements. Words such as “may,” “will,” “expect,” “believe,” “anticipate,” “estimate,” “intends,” “goal,” “objective,” “seek,” “attempt,” or variations of these or similar words, identify forward-looking statements. These forward-looking statements by their nature are estimates of future results only and involve substantial risks and uncertainties, including but not limited to risks associated with the uncertainty of future financial results, additional financing requirements, development of new products, our ability to complete our product testing and launch our product commercially, the acceptance of our product in the marketplace, the uncertainty of the laws and regulations relating to cannabis, the impact of competitive products or pricing, technological changes, the effect of economic conditions and other uncertainties detailed from time to time in our reports filed with the Securities and Exchange Commission, available at www.sec.gov.

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