IGC Reports Financial Results for the Quarter Ended June 30, 2022

IGC Reports Financial Results for the Quarter Ended June 30, 2022




IGC Reports Financial Results for the Quarter Ended June 30, 2022

POTOMAC, Md.–(BUSINESS WIRE)–#IGC–India Globalization Capital, Inc. (“IGC” or the “Company”) (NYSE American: IGC) announces its financial results for the three months ended June 30, 2022, which is the first quarter of the Company’s 2023 fiscal year.

The highlights for the quarter are:

  • The Company has submitted a protocol to the U.S. Food and Drug Administration (FDA) titled “A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-controlled, trial of the safety and efficacy of IGC-AD1 on agitation in participants with dementia due to Alzheimer’s disease.” The protocol is powered at 146 Alzheimer’s patients with half receiving placebo and is a superiority, parallel group study. The primary end point is agitation in dementia due to Alzheimer’s disease as rated by the Cohen-Mansfield Agitation Inventory (CMAI) over a six-week period. The Company has signed agreements with trial sites for conducting the trial, pending FDA approval.
  • On June 7, 2022, the USPTO issued a patent (#11,351,152) to the Company titled “Method and Composition for Treating Seizure Disorders.” The patent relates to compositions and methods for treating multiple types of seizure disorders and epilepsy in humans and animals using a combination of the CBD with other compounds. Subject to further research and study, the combination is intended to reduce side effects caused by hydantoin anticonvulsant drugs such as phenobarbital, by reducing the dosing of anticonvulsant drugs in humans, dogs, and cats.
  • On May 10, 2022, Hamsa Biopharma India Pvt. Ltd. (“Hamsa Biopharma”), a directly owned subsidiary of the Company, completed outstanding items in the agreement executed with the Jawaharlal Nehru Centre for Advanced Scientific Research (“JNCASR”). The agreement was signed on March 28, 2022, and the Company obtained exclusive global rights to certain molecules, technology, patent, and patent filings.

Revenue was approximately $212 thousand and $77 thousand for the three months ended June 30, 2022, and June 30, 2021, respectively. Revenue in both quarters was primarily derived from our Life Sciences segment, which involved sales of products such as lotion, gummies, and alcohol-based hand sanitizers, among others.

Selling, general, and administrative (“SG&A”) expenses were approximately $1.5 million for the three months ended June 30, 2022, and approximately $1.8 million for the three months ended June 30, 2021, a decrease of approximately $226 thousand or 13% stemming mostly from a decrease in marketing and legal expenses. SG&A expenses consist primarily of employee-related expenses, sales and marketing, professional and legal fees, other corporate expenses, allocated general overhead and provisions, depreciation and write-offs relating to doubtful accounts and advances, if any.

Research and Development (“R&D”) expenses were $1.4 million during the three months ended June 30, 2022, and approximately $444 thousand for the three-month ended June 30, 2021. The increase of approximately $950 thousand or 214% is primarily attributable to the progression of Phase 2 trials on IGC-AD1 and pre-clinical studies on TGR-63. We anticipate additional increases in R&D expenses as the Phase 2 trials on IGC-AD1 commence.

Net loss for the three months ended June 30, 2022, was approximately $2.8 million or ($0.05) per share, compared to approximately $1.8 million or ($0.04) per share for the three months ended June 30, 2021.

About IGC:

IGC has two segments: Life Sciences and Infrastructure. The company is based in Maryland, U.S.A.

Forward-looking Statements: This press release contains forward-looking statements. These forward-looking statements are based largely on IGC’s expectations and are subject to several risks and uncertainties, certain of which are beyond IGC’s control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company’s failure or inability to commercialize one or more of the Company’s products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required; general economic conditions that are less favorable than expected, including as a result of the ongoing COVID-19 pandemic; the FDA’s general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC’s SEC filings. IGC incorporates by reference the human trial disclosures and Risk Factors identified in its Annual Report on Form 10-K filed with the SEC on June 23, 2022, as if fully incorporated and restated herein. In light of these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur.

< Financial Tables to Follow>

India Globalization Capital, Inc.

CONSOLIDATED BALANCE SHEETS

(in thousands, except share data)

(Unaudited)

 

 

 

June 30,

2022

($)

 

 

March 31,

2022

($)

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

 

8,053

 

 

 

 

10,460

 

Accounts receivable, net

 

 

147

 

 

 

 

125

 

Inventory

 

 

3,622

 

 

 

 

3,548

 

Deposits and advances

 

 

905

 

 

 

 

978

 

Total current assets

 

 

12,727

 

 

 

 

15,111

 

 

 

 

 

 

 

 

 

 

Intangible assets, net

 

 

937

 

 

 

 

917

 

Property, plant and equipment, net

 

 

9,161

 

 

 

 

9,419

 

Claims and advances

 

 

922

 

 

 

 

937

 

Operating lease asset

 

 

419

 

 

 

 

450

 

Total long-term assets

 

 

11,439

 

 

 

 

11,723

 

Total assets

 

 

24,166

 

 

 

 

26,834

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

 

456

 

 

 

 

981

 

Accrued liabilities and others

 

 

1,200

 

 

 

 

1,457

 

Short-term loans

 

 

3

 

 

 

 

3

 

Total current liabilities

 

 

1,659

 

 

 

 

2,441

 

 

 

 

 

 

 

 

 

 

Long-term loans

 

 

143

 

 

 

 

144

 

Other liabilities

 

 

16

 

 

 

 

16

 

Operating lease liability

 

 

308

 

 

 

 

341

 

Total non-current liabilities

 

 

467

 

 

 

 

501

 

Total liabilities

 

 

2,126

 

 

 

 

2,942

 

 

 

 

 

 

 

 

 

 

Commitments and Contingencies See Note 12

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value: authorized 1,000,000 shares, no shares

issued or outstanding as of June 30, 2022, and March 31, 2022.

 

 

 

 

 

 

 

 

Common stock and additional paid-in capital, $0.0001 par value: 150,000,000

shares authorized; 51,840,603 and 51,054,017 shares issued and outstanding

as of June 30, 2022 and March 31, 2022, respectively.

 

 

117,171

 

 

 

 

116,019

 

Accumulated other comprehensive loss

 

 

(3,187

)

 

 

 

(2,968

)

Accumulated deficit

 

 

(91,944

)

 

 

 

(89,159

)

Total stockholders’ equity

 

 

22,040

 

 

 

 

23,892

 

Total liabilities and stockholders’ equity

 

 

24,166

 

 

 

 

26,834

 

These financial statements should be read in connection with the accompanying notes on Form 10-Q for the quarter ended June 30, 2022, filed with the SEC on August 5, 2022.

India Globalization Capital, Inc.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except loss per share and share data)

(Unaudited)

 

 

 

Three months ended June 30,

 

 

 

2022

($)

 

 

2021

($)

 

Revenue

 

 

212

 

 

 

 

77

 

Cost of revenue

 

 

(70

)

 

 

 

(51

)

Gross profit

 

 

142

 

 

 

 

26

 

Selling, general and administrative expenses

 

 

(1,550

)

 

 

 

(1,776

)

Research and development expenses

 

 

(1,394

)

 

 

 

(444

)

Operating loss

 

 

(2,802

)

 

 

 

(2,194

)

Impairment of investment

 

 

 

 

 

 

(37

)

Other income, net

 

 

17

 

 

 

 

443

 

Loss before income taxes

 

 

(2,785

)

 

 

 

(1,788

)

Income tax expense/benefit

 

 

 

 

 

 

 

Net loss attributable to common stockholders

 

 

(2,785

)

 

 

 

(1,788

)

Foreign currency translation adjustments

 

 

(219

)

 

 

 

(86

)

Comprehensive loss

 

 

(3,004

)

 

 

 

(1,874

)

 

 

 

 

 

 

 

 

Loss per share attributable to common stockholders:

 

 

 

 

 

 

 

 

Basic & diluted

 

$

(0.05

)

 

 

$

(0.04

)

Weighted-average number of shares used in computing loss per share

amounts:

 

 

 

51,616,598

 

 

 

 

 

47,910,866

 

These financial statements should be read in connection with the accompanying notes on Form 10-Q for the quarter ended June 30, 2022, filed with the SEC on August 05, 2022.

Contacts

Claudia Grimaldi

301-983-0998

Global Pharmerging Market to Reach $2.20 Billion by 2027 – ResearchAndMarkets.com

Global Pharmerging Market to Reach $2.20 Billion by 2027 – ResearchAndMarkets.com




Global Pharmerging Market to Reach $2.20 Billion by 2027 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Pharmerging Market Research Report by Product (OTC Drugs and Pharmaceuticals), Indication, Distribution, Region (Americas, Asia-Pacific, and Europe, Middle East & Africa) – Global Forecast to 2027 – Cumulative Impact of COVID-19” report has been added to ResearchAndMarkets.com’s offering.

The Global Pharmerging Market size was estimated at USD 1,291.23 million in 2021, USD 1,408.34 million in 2022, and is projected to grow at a CAGR 9.32% to reach USD 2,204.54 million by 2027.

Market Statistics:

The report provides market sizing and forecast across 7 major currencies – USD, EUR, JPY, GBP, AUD, CAD, and CHF. It helps organization leaders make better decisions when currency exchange data is readily available. In this report, the years 2019 and 2020 are considered as historical years, 2021 as the base year, 2022 as the estimated year, and years from 2023 to 2027 are considered as the forecast period.

Market Segmentation & Coverage:

This research report categorizes the Pharmerging to forecast the revenues and analyze the trends in each of the following sub-markets:

  • Based on Product, the market was studied across OTC Drugs and Pharmaceuticals. The Pharmaceuticals is further studied across Branded Prescription Drugs and Generic Drugs.
  • Based on Indication, the market was studied across Cancer and Autoimmune Diseases and Lifestyle Diseases.
  • Based on Distribution, the market was studied across Clinics, Drug Stores Expenditure, E-commerce, and Hospitals.
  • Based on Region, the market was studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, and Thailand. The Europe, Middle East & Africa is further studied across France, Germany, Italy, Netherlands, Qatar, Russia, Saudi Arabia, South Africa, Spain, United Arab Emirates, and United Kingdom.

Competitive Strategic Window:

The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies to help the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. It describes the optimal or favorable fit for the vendors to adopt successive merger and acquisition strategies, geography expansion, research & development, and new product introduction strategies to execute further business expansion and growth during a forecast period.

FPNV Positioning Matrix:

The FPNV Positioning Matrix evaluates and categorizes the vendors in the Pharmerging Market based on Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) that aids businesses in better decision making and understanding the competitive landscape.

Market Share Analysis:

The Market Share Analysis offers the analysis of vendors considering their contribution to the overall market. It provides the idea of its revenue generation into the overall market compared to other vendors in the space. It provides insights into how vendors are performing in terms of revenue generation and customer base compared to others. Knowing market share offers an idea of the size and competitiveness of the vendors for the base year. It reveals the market characteristics in terms of accumulation, fragmentation, dominance, and amalgamation traits.

Market Dynamics

Drivers

  • Growing elderly population and rising burden of chronic diseases worldwide
  • Rising number of private hospitals and healthcare institutes
  • Extensive spending on healthcare globally and growing life expectancy among people

Restraints

  • High cost of research and development and strict price control

Opportunities

  • Potential demand from targeted therapeutics or personalized medicines
  • Emerging adoption of pharmerging in developing economies

Challenges

  • Concerns over IP protection and socio-politics with complex government approval process

Key Topics Covered:

1. Preface

2. Research Methodology

3. Executive Summary

4. Market Overview

5. Market Insights

6. Pharmerging Market, by Product

7. Pharmerging Market, by Indication

8. Pharmerging Market, by Distribution

9. Americas Pharmerging Market

10. Asia-Pacific Pharmerging Market

11. Europe, Middle East & Africa Pharmerging Market

12. Competitive Landscape

13. Company Usability Profiles

14. Appendix

Companies Mentioned

  • Abbott Laboratories Inc.
  • AstraZeneca PLC
  • Bayer AG
  • Beckman Coulter, Inc.
  • Bikal Ltd.
  • CSL Behring LLC
  • Eli Lilly and Company
  • Farmson Pharmaceutical Gujarat Pvt. Ltd
  • GlaxoSmithKline PLC
  • Glenmark Pharmaceuticals Ltd
  • Johnson and Johnson
  • Lonza Group AG
  • Novartis AG
  • Pfizer, Inc.
  • Rhombus Pharma Private Limited
  • Rochling Group
  • SCHOTT AG
  • Sun Pharmaceutical Industries Ltd.
  • The RSA Group
  • ZIM Laboratories Limited

For more information about this report visit https://www.researchandmarkets.com/r/ez1tal

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Revitalist Announces Release of Three Proprietary Service Lines Advancing Their Comprehensive Footprint in the Mental Health and Psychedelic Wellness Space

Revitalist Announces Release of Three Proprietary Service Lines Advancing Their Comprehensive Footprint in the Mental Health and Psychedelic Wellness Space




Revitalist Announces Release of Three Proprietary Service Lines Advancing Their Comprehensive Footprint in the Mental Health and Psychedelic Wellness Space

VANCOUVER, British Columbia–(BUSINESS WIRE)–#education–REVITALIST LIFESTYLE AND WELLNESS LTD. (“Revitalist” or the “Company”) (CSE: CALM) (OTCQB: RVLWF) (FSE: 4DO), one of the largest publicly listed US based ketamine wellness clinics, is pleased to report continued expansion of service lines offering an online vitamin supplement line, an online global curriculum, and an onsite and virtual training program for providers and therapists creating a quality ecosystem for everyone entering the psychedelic wellness space.

Vital+® is a proprietary supplement line that has been created to optimally complement the nutritional needs of individuals for improved mental wellness. The combination of vitamins and adaptogenic ingredients complement the body and brain’s needs with a morning and evening supplement. These products will be available at each Revitalist location. They will also be able to be purchased online as a one time purchase or as a monthly subscription. More information can be found at VitalPlusSupplements.com or RevitalistClinic.com/Vitamins

Comprehensive Consciousness® is an online mental wellness program created through partnership with “global guru” Richard Barrett and the Barrett Values Centre. This six month, self-paced course has been designed to allow focus and continued improvement in mental wellness and psychological development for all individuals above 15 years of age. This curriculum will be available worldwide improving access to mental health resources and will be available to purchase in Fall 2022. For more information, please email corporate@Revitalist.com

Reset and Revolutionize® is Revitalist’s training program for practitioners seeking to advance competency in the psychedelic and ketamine wellness space. Training will be conducted by Revitalist Subject Matter Experts (SMEs), and will include teaching basic through advanced skills for all practitioners working with clients in medical and therapeutic capacities. Led by Dr. Cara Fisk, training will be available virtually as well as face-to-face at the premier training facility in Chattanooga, Tennessee.

The cost of training is $2400 USD. The premier course will be September 22, 23, and 24, 2022. Inaugural Instructors will be SMEs, Kathryn Walker, Matthew Dolan, and Dr. Denise Hopkins-Chadwick.

To learn more, or to sign up for the training, please email us at corporate@Revitalist.com

Revitalist CEO Kathryn Walker states, “The growth of our company continually amazes me. We are exactly what the world needs. The empathy, compassion, expertise, kindness, and advocacy that Revitalist provides is everything we have been missing in healthcare. The disruption we are causing is boundless.

The release of our vitamin line, online curriculum, and training program show the unsurpassed involvement and passion our team continues to have blazing the trails for others with hopes the global mental health crisis will one day subside.”

ABOUT REVITALIST LIFESTYLE AND WELLNESS LTD.

Revitalist Lifestyle and Wellness Ltd. (CSE: CALM) (OTCQB: RVLWF) (FSE: 4DO) is one of the largest publicly listed, ketamine focused clinic operations operating in the United States. Each clinic enables access to psychedelic medicine, vitamin infusions and other lifestyle optimization services provided by medical and behavioral professionals. Since opening their first clinic in 2018, Revitalist has provided thousands of ketamine infusions through its network of 9 clinics operating in 6 states. Its founder and CEO, Kathryn Walker, works as a lead provider in the psychedelic space. For additional information and to be added to the Company’s mailing list, please click here, https://revitalist.com/investors

ABOUT RICHARD BARRETT

Richard Barrett is Founder and Chairman of the Board of the Barrett Values Centre, author, speaker and internationally recognized as one of the most influential thinkers on leadership and the evolution of human values in business and society. He is a Fellow of the World Business Academy, a member of the Wisdom Council of the Center for World Spirituality, an honorary counselor of the Spirit of Humanity Forum and a former member of the World Bank. Richard Barrett is the creator of the Cultural Transformation Tools (CTT) that have been used to support the transformation journey of more than 10,000 companies in 94 countries. Over the past ten years, Richard Barrett has been frequently called upon by large organizations in Australia, South Africa, Canada, the United Kingdom, the United States and Sweden to support leaders in improving the performance of their companies through the development of a values-based culture.

ABOUT KATHRYN WALKER, MSN-Anesthesia, MSN-Psychiatry, CRNA, PMHNP

Kathryn Walker is the CEO of Revitalist Lifestyle and Wellness (CSE: CALM) (OTCQB: RVLWF) (FSE: 4DO) which serves as a leading mental health and wellness company lead by a comprehensive team of speciality providers. Kathryn worked at a Level 1 Trauma Center in Tennessee for 9 years before attending anesthesia school at the University of North Carolina-Charlotte. She practiced anesthesia of all specialties for 8 years before opening the first Revitalist location in Knoxville, TN in 2018. Today Kathryn operates as a leading advocate for psychedelic medicine as she continues to advance her comprehensive skill set recently graduating with her second Master’s degree in Psychiatric Nursing as a Psychiatric Mental Health Nurse Practitioner.

Recognizing the need for community access, Kathryn founded the national mental health 501c3 nonprofit, Community Change Foundation (CommunityChangeFoundation.org). This nonprofit foundation focuses on providing financial assistance to veterans, frontline workers, and the financially disadvantaged seeking help with psychedelic therapies. Kathryn incorporated Community Change Foundation in 2019.

Recognizing the need for education and training advancements, Kathryn founded the American Association of Psychedelics (AAPsychedelics.org). This education non-profit 501c3 aims to continually bring high quality education and training to all disciplines of providers. Kathryn incorporated the American Association of Psychedelics in 2021.

ABOUT MATTHEW DOLAN, MSN-Anesthesia, MSN-Psychiatry, CRNA, PMHNPS

Matthew Dolan is a Certified Registered Nurse Anesthesiologist that served in the US Army and is currently advancing his speciality skillset by obtaining an additional advanced degree as a Psychiatric Mental Health Nurse Practitioner. This degree allows additional speciality as a behavioral provider as well as a therapeutic provider making him comprehensively able to act as a medical, behavioral, and therapeutic provider.

ABOUT DR. DENISE HOPKINS-CHADWICK

Denise Hopkins-Chadwick received her PhD from the Ohio State University in Columbus, Ohio and has over 35 years of experience writing grants and working with patients, research participants, families, and faculty. Denise is a 30-year active-duty veteran Commissioned Officer in the Nurse Corps with clinical background experience spanning adults to neonatal ICUs, Emergency departments and patient transport. She serves on multiple boards including the Military Medicine Journal and the Tri-Service Nursing Research Interest Group: Women’s Health. Throughout her career, she has received dozens of awards in healthcare research and has secured research funding of over $50 million. She is Co-Inventor of the Precision Health Insight Tool which integrates data from multiple sources including behavioral health and pharmaceuticals into a unified system. Denise is also the founder of HC Research Associates, a company providing professional R&D as well as academic activities.

ABOUT DR. CARA FISK

Cara joined Revitalist in May of 2021 as Chattanooga’s Lead CRNA. Cara is extremely passionate about having this opportunity to help treat patients with mood/pain disorders after witnessing the amazing transformation ketamine had on one of her loved ones several years ago. She believes her anesthesia background and passion for preventative health and wellness are perfectly aligned with Revitalist’s unique array of collaborative treatment and care.

Cara comes to Revitalist with 26+ years of healthcare experience. She obtained her BSN with Honors from the University of Virginia. She practiced as a Critical Care RN in various settings throughout the United States while her husband served in the Marine Corps. Her passion was Trauma ICU and she earned her CCRN and TCRN Certification.

Cara attended the University of Tennessee Health Science Center where she earned her MSN in Anesthesia. She then earned her Doctor of Nurse Anesthesia Practice degree from Virginia Commonwealth University. Cara has 10+ years of practicing anesthesia in various settings from outpatient ambulatory surgery centers to a Level 1 Trauma hospital working high risk OB. She is currently working on her advanced degree as a Psychiatric Mental Health Nurse Practitioner.

Twitter:

@RevitalistCorp

Facebook:

@RevitalistLifestyleandWellnessLtd.

Instagram:

@RevitalistCorp

LinkedIn:

@RevitalistLifestyleAndWellnessLtd

On Behalf of the Board

Kathryn Walker

Chief Executive Officer

Forward Looking Statements

This news release contains forward-looking statements and information within the meaning of applicable securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Revitalist to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this news release.

Risks, uncertainties, and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information. The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Contacts

For further information please contact:

Revitalist Lifestyle and Wellness Ltd.

Email: Info@Revitalist.com
Tel: (865) 585-8414

SpectrumX Confirms Scientific Advice Meeting With MHRA, Proposed Timeline for Human Clinical Trials for Ground-Breaking Medicine SPX-001

SpectrumX Confirms Scientific Advice Meeting With MHRA, Proposed Timeline for Human Clinical Trials for Ground-Breaking Medicine SPX-001




SpectrumX Confirms Scientific Advice Meeting With MHRA, Proposed Timeline for Human Clinical Trials for Ground-Breaking Medicine SPX-001

The Company identifies critical milestones required to commence clinical trial programme

LONDON–(BUSINESS WIRE)–SpectrumX, a UK-based healthcare and pharmaceutical company, is pleased to announce that is has a date for a scientific advice meeting with the UK Medicines and Healthcare products Regulatory Agency (MHRA) to discuss its human clinical trial programme.

SpectrumX has confirmed the scientific advice meeting with the MHRA will take place in Q4 2022, and will discuss the available data supporting the commencement of human trials with SPX-001 and the protocol for the Phase Ib human volunteer study, prior to submission of the Clinical Trial Application (CTA) submission. The MHRA meeting provides an opportunity for the Company to receive further guidance on SPX-001, the broad-spectrum anti-pathogenic medicine produced using the SPC-069 drug substance.

Following completion of the scientific advice meeting, SpectrumX anticipates it will submit a CTA to the MHRA in which formal authorisation will be sought from the MHRA and UK ethics committee to conduct the proposed clinical trial. This will be conditional upon satisfactory review and evaluation of the information submitted by SpectrumX in the CTA. Submission of the CTA application is planned for early 2023.

Contingent upon MHRA approval of the CTA, SpectrumX expects to conduct its first human clinical trial in Q1 2023. This will be the first trial to use SPX-001 via a nebuliser to test its efficacy versus placebo treatment in subjects with Influenza A respiratory infection. Following successful completion of the trial, SpectrumX plans to move forward with trials in patients with respiratory infection to gather data necessary for market authorisation.

SpectrumX has already begun the production process of SPX-001 for clinical trials, working with a leading GMP-certified partner, to create vials of SPX-001 suitable for use by nebulisation. This is a critical step toward trial-readiness and will allow the Company to move quickly into clinical testing once the programme is approved by MHRA.

Dr Donna Lockhart, Consulting Head of Medicines at SpectrumX, said: “I am pleased to initiate formal discussions of our clinical trial plans with the MHRA to progress our ground-breaking solution, SPX-001, to market. I look forward to a productive discussion with the MHRA, and to relaying our current lab-driven data, supporting evidence and proposed clinical trial protocol, as well as the important features of SPX-001 to combat respiratory infection caused by viruses. From that point and incorporating guidance from the MHRA, the Company will be well-positioned to advance to its clinical trial programme and the subsequent processes that are essential to market authorisation.”

– ENDS –

About SpectrumX

SpectrumX is a UK-based healthcare and pharmaceuticals company focused on bringing to market a ground-breaking respiratory infection therapy and the roll-out of the most powerful hand sanitiser in the world to the NHS and other healthcare clients. Both products utilise unique patent pending HOCl formulations. HOCl is naturally occurring in human white blood cells and is a key contributor in the immune response to infection. It is well-tolerated in humans while also being the most effective disinfectant known to mankind when used on surfaces. For more on SpectrumX visit www.spectrumx.com.

Contacts

Media Contacts

Gracechurch Group
Jeff Segvich/Amy Stupavsky

SpectrumX@gracechurchpr.com
+44 (0)203 488 7510

Pharma Tech Holdings SA Obtains a Capital Commitment Agreement of CHF 30 million from Global Investor LDA Capital

Pharma Tech Holdings SA Obtains a Capital Commitment Agreement of CHF 30 million from Global Investor LDA Capital




Pharma Tech Holdings SA Obtains a Capital Commitment Agreement of CHF 30 million from Global Investor LDA Capital

LUGANO, Switzerland–(BUSINESS WIRE)–Pharma Tech Holding SA (“PTH”) announced today it has secured a CHF 30 million investment to support its portfolio investments from LDA Capital Ltd, a global investment group with expertise in cross border transactions including the agriculture, Agri-tech, and CBD industries.

Established in 2019, PTH is a Swiss based holding company, which invests into innovative businesses with high technological value and scalability potential, mainly in Switzerland and Europe, with a focus on the health-tech, Agri-tech, and functional food.

This investment will allow PTH to mainly invest and support its portfolio company Blue Sky Swisse SA (“BSS”) a JV between PTH and listed company IGEA PHARMA NV (“Igea”), IGPH – ISIN NL0012768675. BSS focuses on the extraction of natural active principles from vegetable matrices, vegetable waste, and renewable sources to deliver B2B products under the form of CBD oil, Terpenes and Waxes. The factory located in Biasca, will be built to the state of art of extraction technology by super critical CO2 and will be energy self-sufficient through the use of solar photovoltaic panels and district heating. BSS will grant for highest CBD quality also due to a proprietary extraction process, starting from the farming performed under strict control and culminating with the immediate freezing of the flowers after harvest, with the target to also sell “all natural” formulations to increase bioavailability thus enhancing the possible applications. Last, but not least, BSS will invest in the agricultural raw material chain and will create an aeroponic green house in Ticino, to deliver a high quality GMP Pharmaceutical CBD oil.

LDA Capital agreed to commit an amount of up to CHF 30 million (the “Capital Commitment”) in cash within a maximum of three years. This Capital Commitment will be released based on drawdowns by PTH, that PTH has the right to exercise at its sole discretion.

“We’re thrilled with this partnership and are so glad that LDA Capital recognizes the value of PTH and its portfolio company, with the aim of creating one of the most innovative hub for health-tech, agri-tech and functional food,” said Sabina Del Nigro, CEO at PTH.

About Pharma Tech Holding: Pharma Tech Holding SA (PTH) is a holding company based in Lugano, Switzerland, which invests into innovative businesses with high technological value and scalability potential, mainly in Switzerland and Europe, with a focus on the health-tech, Agri-tech, and functional food.

About LDA Capital: LDA Capital is a global alternative investment group with expertise in cross border transactions worldwide. Our team has dedicated their careers to international & cross border opportunities having collectively executed over 250 transactions in both the public and private middle markets across 43 countries with aggregate transaction values of over US$11 billion. For more information please visit: www.ldacap.com; for inquiries please email: info@ldacap.com.

Contacts

Sabina Del Nigro

Pharma Tech Holding SA

info@pharmatechholding.com

LDA Capital Ltd

info@ldacap.com

Poxel Provides Corporate Update and Reports Cash and Revenue for the Second Quarter and First Half 2022

Poxel Provides Corporate Update and Reports Cash and Revenue for the Second Quarter and First Half 2022




Poxel Provides Corporate Update and Reports Cash and Revenue for the Second Quarter and First Half 2022

  • Cash runway extended through at least February 2023 based upon debt restructuring agreement with IPF Partners (IPF) and equity-linked financing facility with Iris Capital Investment (IRIS)
  • As of June 30, 2022, cash and cash equivalents were EUR 16.1 million (USD 16.8 million)
  • Fast Track and Orphan Drug Designation for PXL065 and PXL770 in adrenoleukodystrophy (ALD) granted by the Food and Drug Administration (FDA)
  • New Solid Form Patent for PXL065 issued by the U.S. Patent and Trademark Office (PTO), providing additional protection through 2041
  • Phase 2 study results for PXL065 (DESTINY-1) in NASH expected in Q3 2022

LYON, France–(BUSINESS WIRE)–POXEL SA (Euronext : POXEL – FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today provided a corporate update and announced its cash position and revenue for the second quarter and first half of 2022.

“The next major milestone for Poxel will be the results of our Phase 2 DESTINY-1 study for PXL065 in NASH, which are expected later this quarter. One of our key objectives these past months has been to extend our cash runway to leverage this opportunity and independently finance our strategy in rare diseases. The two agreements announced today, the debt restructuring along with the equity-linked financing facility, provide further flexibility to finalize additional financing initiatives, including ongoing active partnership discussions related to our programs. In addition, we will continue our work to initiate our Phase 2 proof-of-concept studies in adrenoleukodystrophy which represent the foundation of our rare disease strategy,” said Thomas Kuhn, Chief Executive Officer of Poxel. “We have also had key regulatory achievements this year, including Fast Track Designation and Orphan Drug Designation granted by the FDA for PXL065 and PXL770 in ALD. In addition, the recent patent approval of a new solid form of PXL065 is an important addition to the protection of this compound and significantly extends its exclusivity.”

Commercial Update

TWYMEEG® (Imeglimin)

  • As of June 30, 2022, royalty revenue to Poxel based on TWYMEEG net sales in Japan under the Sumitomo Pharma license agreement has been limited following TWYMEEG’s commercial launch on September 16, 2021. TWYMEEG’s initial commercial uptake has been affected by restrictions in Japan on prescribing any new drug in its first year of commercialization, and conditions related to COVID-19, which have reduced the frequency of physician visits and limited the extensive prescriber education efforts required for any launch of an innovative drug with a new mechanism of action. However, as a result of Sumitomo Pharma’s promotional activities and efforts since launch, TWYMEEG is very well known among prescribers.

Clinical Updates

NASH

  • PXL065 (deuterium-stabilised R-pioglitazone) is in a Phase 2 study (DESTINY-1). Results from this 36-week, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study designed to assess efficacy and safety are anticipated, as planned, in Q3 2022. The goal of DESTINY-1 is to identify the optimal dose or doses of PXL065 to advance into a Phase 3 registration trial for the treatment of noncirrhotic biopsy-proven NASH patients.

Rare metabolic diseases

  • In ALD, two Phase 2a biomarker proof-of-concept (POC) clinical trials of PXL065 and PXL770 are expected to initiate as soon as possible, subject to additional financing. These two identical studies will enroll adult male patients with adrenomyeloneuropathy (AMN), the most common ALD subtype. The POC studies will evaluate the pharmacokinetics, safety and efficacy of PXL065 and PXL770 after 12 weeks of treatment based on relevant disease biomarkers, such as the effect on very long chain fatty acids (VLCFA), the characteristic plasma marker of the disease.
  • In February and April, the FDA awarded Fast Track Designation (FTD) to PXL065 and PXL770 respectively, for ALD. The FDA grants FTD to investigational drugs which treat a serious or life-threatening condition, and which fill an unmet medical need. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy. The key benefits of FTD comprise enhanced access to the FDA, with regular and more frequent opportunities for consultation and discussion.
  • In May, the FDA granted Orphan Drug Designation (ODD)1 to PXL065 and PXL770 for ALD. ODD confers a company a potential seven-year window of exclusive marketing rights following FDA approval, along with a reduction in certain application fees, and tax credits for expenses related to qualified clinical trials conducted after orphan designation is received.
  • Two preclinical articles on X-Linked Adrenoleukodystrophy (ALD) for PXL065 and PXL770 were published:

    • The article on PXL065 was published in The Journal of Inherited Metabolic Disease (“JIMD”) and is entitled “Therapeutic potential of deuterium-stabilized (R)-pioglitazone – PXL065 – for X-linked adrenoleukodystrophy”. It is available here: https://pubmed.ncbi.nlm.nih.gov/35510808/.
    • The article on PXL770 was published in The Journal of Pharmacology and Experimental Therapeutics (“JPET”), and is entitled “Beneficial effects of the direct AMP-Kinase activator PXL770 in in vitro and in vivo models of X-Linked Adrenoleukodystrophy”. It is available here: https://jpet.aspetjournals.org/content/early/2022/06/25/jpet.122.001208.

Corporate Update

  • In June, the U.S. Patent and Trademark Office (PTO) issued a new patent for PXL065 that describes a specific form of PXL065 with unique properties. Importantly, this recently issued patent provides additional protection through 2041 and could expand protection for PXL065 worldwide, with the potential for an additional 5 years through patent term extension.
  • On June 21, 2022, Poxel held its annual general meeting. The shareholders approved all the resolutions that were recommended by the Board of Directors. For further information, please visit: https://www.poxelpharma.com/en_us/investors/shareholder-information/annual-general-meeting-documents.
  • The mandates of Mrs. Janice Bourque and of Mr. Pierre Legault as members of the Board of Directors were renewed for three year terms. Effective July 1, 2022, Dr. John Kozarich transitioned off as a Board member due to the age limitation and will continue to assist the Board of Directors as a consultant and chair of the scientific committee of the Board.

Significant Events after the Period

The Company announced today that it has entered into an agreement with IPF to restructure its debt, resulting in the postponement of the Q3 2022 and Q4 2022 amortization payments under the existing debt facility, and lowering certain financial covenants until the end of January 2023.

Concurrently, the Company has entered into an equity-linked financing arrangement with IRIS for an initial gross amount of EUR 4 million, with the option, at the latest on December 31, 2022 and, at the Company’s sole discretion, to draw a second and third tranche of up to EUR 1 million each. As a result of these two agreements, the Company’s expects that its resources will be sufficient to fund its operations and capital expenditure requirements through at least February 2023.

For more information, please refer to the press release issued today.

Second Quarter and First Half 2022 Cash and Cash equivalents

As of June 30, 2022, cash and cash equivalents were EUR 16.1 million (USD 16.8 million), as compared to EUR 32.3 million (USD 36.6 million) as of December 31, 2021.

Net financial debt (excluding IFRS16 impacts and derivative debts) was EUR 17.3 million as of June 30, 2022, as compared to EUR 2.6 million as of December 31, 2021.

EUR (in thousands)

Q2 2022

Q4 2021

 

 

Cash

16,143

28,753

Cash equivalents

3,534

Total cash and cash equivalents*

16,143

32,287

Unaudited data

* Net financial debt (excluding IFRS 16 impacts and derivative debts) was EUR 17.3 million at the end of Q2 2022 as compared to EUR 2.6 million at the end of Q4 2021.

Based on:

  1. its cash position at June 30, 2022,
  2. the current development plan of the Company including 1) the completion of its ongoing Phase 2 NASH trial for PXL065 (DESTINY-1) but excluding 2) the two identical Phase 2a clinical proof-of-concept (POC) biomarker studies for PXL065 and PXL770 in adrenomyeloneuropathy (AMN),
  3. the cash forecast for the year 2022 approved by the Board of Directors of the Company, that does not include, as a conservative approach, any net royalties from Imeglimin in Japan,
  4. a strict control of its operating expenses, and
  5. the amendment to the IPF debt facility with the postponement of the Q3 2022 and Q4 2022 amortization payments until end of February 2023, as well as a full drawdown of all tranches of the equity-linked financing arrangement with IRIS for a total amount of EUR 6 million, before December 31, 2022,

the Company expects that its resources will be sufficient to fund its operations and capital expenditure requirements through at least February 2023.

The Company is actively pursuing additional financing options, prioritizing non-dilutive sources, including ongoing active partnership discussions related to its programs.

Second Quarter and First Half 2022 Revenue

Poxel reported revenues of EUR 83 thousand revenue for the six months ended June 30, 2022, as compared to EUR 13.3 million revenue during the corresponding period in 2021.

Revenue for the first half of 2022 reflects JPY 11 million (EUR 81 thousand) of royalty revenue from Sumitomo Pharma which represents 8% of TWYMEEG net sales in Japan. Based on the current forecast, Poxel expects to receive 8% royalties on TWYMEEG net sales in Japan through the Sumitomo Pharma fiscal year 2022 (April 2022 to March 2023). As part of the Merck Serono licensing agreement, Poxel will pay Merck Serono a fixed 8% royalty based on the net sales of Imeglimin, independent of the level of sales.

EUR (in thousands)

Q1

2022

Q2

2022

H1

2022

Q1

2021

Q2

2021

H1

2021

 

3 months

3 months

6 months

3 months

 

3 months

 

6 months

Sumitomo Pharma Agreement

32

51

83

13,274

13,274

Other

 

 

Total revenues

32

51

83

13,274

13,274

Unaudited data

Planned Presentations and Participation at the Following Upcoming Events

  • Keystone Symposia, Whistler, British Columbia, Canada, August 7-11
  • Paris NASH Meeting, Paris, France, September 8-9
  • Eurotox, International Congress of Toxicology, Maastricht, Netherlands, September 18-21

Next Financial Press Release : First Half 2022 financial results on September 21, 2022

About Poxel SA

Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare disorders. Poxel has clinical and earlier-stage programs from its adenosine monophosphate-activated protein kinase (AMPK) activator and deuterated thiazolidinedione (TZD) platforms targeting chronic and rare metabolic diseases. For the treatment of NASH, PXL065 (deuterium-stabilized R-pioglitazone) is in a streamlined Phase 2 trial (DESTINY-1). PXL770, a first-in-class direct AMPK activator, has successfully completed a Phase 2a proof-of-concept trial for the treatment of NASH, which met its objectives. For the rare inherited metabolic disorder, adrenoleukodystrophy (ALD), the company intends to initiate Phase 2a proof of concept studies with PXL065 and PXL770 in patients with adrenomyeloneuropathy (AMN). TWYMEEG® (Imeglimin), Poxel’s first-in-class lead product that targets mitochondrial dysfunction, has been approved and launched for the treatment of type 2 diabetes in Japan. Poxel expects to receive royalties and sales-based payments from Sumitomo Pharma. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries. The Company intends to generate further growth through strategic partnerships and pipeline development. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan.

For more information, please visit: www.poxelpharma.com

All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements. The Company does not endorse or is not otherwise responsible for the content of external hyperlinks referred to in this press release.

1 For more information on Orphan Drug Designation, see: https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-orphan-product-drugs-and-biological-products

Contacts

Contacts – Investor relations / Media

Aurélie Bozza

Investor Relations & Communication Senior Director

aurelie.bozza@poxelpharma.com
+33 6 99 81 08 36

Elizabeth Woo

Senior Vice President, Investor Relations & Communication

elizabeth.woo@poxelpharma.com

NewCap

Emmanuel Huynh or Arthur Rouillé

poxel@newcap.eu
+33 1 44 71 94 94

Number of Shares and Voting Rights of Innate Pharma as of August 1, 2022

Number of Shares and Voting Rights of Innate Pharma as of August 1, 2022




Number of Shares and Voting Rights of Innate Pharma as of August 1, 2022

MARSEILLE, France–(BUSINESS WIRE)–Regulatory News:

Pursuant to the article L. 233-8 II of the French “Code de Commerce” and the article 223-16 of the French stock-market authorities (Autorité des Marchés Financiers, or “AMF”) General Regulation, Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) releases its total number of shares outstanding as well as its voting rights as at August 1, 2022:

Total number of shares outstanding:

79,893,019 ordinary shares

6,514 Preferred Shares 2016

7,581 Preferred Shares 2017

Total number of theoretical voting rights (1):

Total number of exercisable voting rights (2):

80,650,859

80,632,284

(1) The total number of theoretical voting rights (or “gross” voting rights) is used as the basis for calculating the crossing of shareholding thresholds. In accordance with Article 223-11 of the AMF General Regulation, this number is calculated on the basis of all shares to which voting rights are attached, including shares whose voting rights have been suspended. The total number of theoretical voting rights includes (i) voting rights attached to AGAP 2016, i.e. 130 voting rights for the AGAP 2016-1 and 111 voting rights for the AGAP 2016-2 and (ii) no voting rights attached to AGAP 2017.

(2) The total number of exercisable voting rights (or “net” voting rights) is calculated without taking into account the shares held in treasury by the Company, with suspended voting rights. It is released so as to ensure that the market is adequately informed, in accordance with the recommendation made by the AMF on July 17, 2007.

About Innate Pharma:

Innate Pharma S.A. is a global, clinical-stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer.

Innate Pharma’s broad pipeline of antibodies includes several potentially first-in-class clinical and preclinical candidates in cancers with high unmet medical need.

Innate is a pioneer in the understanding of natural killer cell biology and has expanded its expertise in the tumor microenvironment and tumor-antigens, as well as antibody engineering. This innovative approach has resulted in a diversified proprietary portfolio and major alliances with leaders in the biopharmaceutical industry including Bristol-Myers Squibb, Novo Nordisk A/S, Sanofi, and a multi-products collaboration with AstraZeneca.

Headquartered in Marseille, France, with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com

Information about Innate Pharma shares:

ISIN code
Ticker code
LEI

FR0010331421

Euronext: IPH Nasdaq: IPHA

9695002Y8420ZB8HJE29

Disclaimer on forward-looking information and risk factors:

This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995.The use of certain words, including “believe,” “potential,” “expect” and “will” and similar expressions, is intended to identify forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s commercialization efforts, the Company’s continued ability to raise capital to fund its development and the overall impact of the COVID-19 outbreak on the global healthcare system as well as the Company’s business, financial condition and results of operations. For an additional discussion of risks and uncertainties which could cause the company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2021, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

Contacts

Investors and Media
Innate Pharma
Henry Wheeler

Tel.: +33 (0)4 84 90 32 88

Henry.wheeler@innate-pharma.fr

Poxel Announces Extended Cash Runway with Debt Restructuring Agreement and Equity-linked Financing Facility

Poxel Announces Extended Cash Runway with Debt Restructuring Agreement and Equity-linked Financing Facility




Poxel Announces Extended Cash Runway with Debt Restructuring Agreement and Equity-linked Financing Facility

  • Cash runway extended through at least February 2023 based upon debt restructuring agreement with IPF Partners (IPF) and equity-linked financing facility for up to EUR 6 million with Iris Capital Investment (IRIS)
  • Extended cash runway provides added flexibility to capitalize on upcoming Phase 2 DESTINY-1 results for PXL065 in NASH expected this quarter and independently pursue non-dilutive financing initiatives to fund and execute the Company’s rare disease strategy
  • As of June 30, 2022, cash and cash equivalents were EUR 16.1 million (USD 16.8 million)

LYON, France–(BUSINESS WIRE)–POXEL SA (Euronext: POXEL – FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for serious chronic diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, announced today that is has entered into (1) an agreement with IPF to restructure its existing debt facility and (2) an equity-linked financing for up to EUR 6 million with IRIS. On that basis, the Company expects that its resources will be sufficient to fund its operations and capital expenditure requirements through at least February 2023.

Thomas Kuhn, Chief Executive Officer of Poxel, stated: “We have an important milestone coming up this quarter with the topline results of the Phase 2 DESTINY-1 study for PXL065 in NASH. We have thus been working diligently these past months to extend our cash runway to capitalize on this opportunity and independently finance our strategy in rare diseases. Together, the successful completion of the debt restructuring and the equity-linked financing facility not only improves the Company’s balance sheet to support ongoing operations, but both agreements also provide further flexibility to finalize additional financing initiatives, including ongoing active partnership discussions related to our programs. We continue to work towards the initiation of our planned Phase 2a proof-of-concept clinical trials in adrenoleukodystrophy which represent the foundation of our rare disease strategy.

The Company has entered into an agreement with IPF to restructure its debt, resulting in the postponement of the Q3 2022 and Q4 2022 amortization payments under the existing debt facility, and lowering certain financial covenants until the end of January 2023.

Edouard Guillet, Partner at IPF Partners, commented: With this agreement to restructure the existing debt facility, we are pleased to provide Poxel with increased flexibility to complete its other financing initiatives which we strongly believe will be finalized in the near future and will allow Poxel to execute on its robust strategy in rare diseases.”

Concurrently, the Company has entered into an equity-linked financing arrangement with IRIS for an initial gross amount of EUR 4 million, with the option, at the latest on December 31, 2022 and at the Company’s sole discretion, to draw a second and third tranche of up to EUR 1 million each. Upon conversion of the equity-linked instruments, IRIS will be issued Poxel shares to be created from the Company’s authorized capital and is expected to sell these newly issued shares on the market or in block trades. The equity-linked financing is intended to provide additional liquidity in support of the Company’s ongoing regulatory and development activities as well as general corporate purposes.

Based on:

  1. its cash position at June 30, 2022,
  2. the current development plan of the Company including 1) the completion of its ongoing Phase 2 NASH trial for PXL065 (DESTINY-1) but excluding 2) the two identical Phase 2a clinical proof-of-concept (POC) biomarker studies for PXL065 and PXL770 in adrenomyeloneuropathy (AMN),
  3. the cash forecast for the year 2022 approved by the Board of Directors of the Company, that does not include, as a conservative approach, any net royalties from Imeglimin in Japan,
  4. a strict control of its operating expenses, and
  5. the amendment to the IPF debt facility with the postponement of the Q3 2022 and Q4 2022 amortization payments until end of February 2023, as well as a full drawdown of all tranches of the equity-linked financing arrangement with IRIS for a total amount of EUR 6 million, before December 31, 2022,

the Company expects that its resources will be sufficient to fund its operations and capital expenditure requirements through at least February 2023.

The Company is actively pursuing additional financing options, prioritizing non-dilutive sources, including ongoing active partnership discussions related to its programs.

Debt Restructuring with IPF

  • With the objective to extend its cash runway, the Company has entered into an agreement with IPF to restructure its existing debt, consisting of postponing repayment of EUR 3.2 million, corresponding to Q3 2022 and Q4 2022 amortizations, until February 2023.
  • In addition, IPF and the Company agreed to temporarily amend the financial covenants of the debt facility until 31 January 2023 so that no breach occurs before February 2023, independently of any other potential additional financing of the Company. Under the revised financial covenants, the Company shall maintain a minimum cash position between EUR 15 million and EUR 10 million through January 2023. After such date, the previously existing financial covenants will be reinstated1.
  • The amendment of the debt facility also includes an increase of 3% of the PIK margin (in addition to the existing 2% PIK). IPF shall also be entitled to a fee payable at the maturity date of each tranche and set at a total amount of approximately EUR 4 million.
  • Should the Company close a financing transaction of a minimum amount of EUR 15 million, and subject to the then applicable debt to market capitalization gearing ratio of the Company, Poxel will partially prepay IPF debt with an amount up to 20% of the proceeds of such transaction as a partial early debt repayment, which would reduce the Company’s indebtedness. Such early repayment shall consist in principal and shall not include any early repayment fee.
  • As part of the amendment agreement, IPF will be appointed as an observer to the Company’s Board of Directors. IPF will have the same right to information as the Directors and may participate in meetings of the Board of Directors of the Company in an advisory capacity but will not have any voting rights.
  • The terms of the existing warrants held by IPF which were attached to the Tranche 1, 2 and 3 bonds giving right to subscribe 630,804 shares at respectively €7.37, €7.14, €6.72 per warrant for each Tranche, remain unchanged and thus trigger no potential additional dilution.

Equity-linked financing with IRIS

Legal basis of issuance

Acting on the delegation of the Board of Directors and in accordance with the 17th resolution of the Annual General Meeting of Shareholders of June 21, 2022, the Company decided to implement this equity-linked financing, provided by IRIS, a venture capital firm specialized in providing financing solutions to listed companies.

Operation objectives

This funding aims to increase the Company’s cash position to support its operations. Proceeds shall be used mainly to support ongoing regulatory and development activities as well as general corporate purposes.

Operation arrangements

In accordance with the terms of the agreement, IRIS, acting as a specialized investor without a strategy to retain a stake in the Company’s share capital, has committed to subscribe to bonds convertible into new ordinary shares of the Company for an initial amount of EUR 4 million. At the Company’s sole discretion, two additional tranches of EUR 1 million each, may be drawn down in Q4 2022.

IRIS has the right to request the conversion of its bonds into new ordinary shares of the Company at any time in one or several occasions until full repayment of the bonds. The issuance of shares upon conversion of the bonds shall be made on each conversion date on the basis of the average volume weighted share price over the last trading day preceding each issue, less a discount of 8%, subject to a floor corresponding to the average volume weighted share price over the twenty trading days preceding each issue, less a discount of 20%.

During the term of the financing, IRIS is expected to sell the newly issued shares received upon conversion of the convertible bonds on the market or in block trades. In connection with the financing, Poxel will issue shares out of its authorized share capital in accordance with the 17th resolution of the Annual General Meeting of Shareholders of June 21, 2022 with excluded pre-emptive rights of the existing shareholders for the benefit of certain category of investors.

The new shares issued under the terms of this agreement shall be admitted to trading on Euronext Paris.

No application for admission to trading on any market whatsoever will be made for the convertible bonds.

Considering the anticipated number of shares to be issued upon conversion of the convertible bonds issued, based on the share price of the Company on the last trading day preceding the date of this press release, this operation does not give rise at this stage to publication of a prospectus to be submitted to the approval by the French securities regulator, the Autorité des marchés financiers (AMF). Should a prospectus be required in the future due to a potentially higher than expected issuance of shares, the Company and IRIS have agreed that the issuance program will be suspended for a maximum period of three months, until such prospectus has been approved by the AMF.

On the basis of the issuance of all three tranches of the financing facility with IRIS and the average price weighted by volumes of the Company’s share during the last trading day preceding the date of this press release, the stake of a shareholder with 1% of the Company’s share capital would decrease to 0.91%, i.e. a 9% dilution. As a reminder, based on the decisions of the general assembly meeting of the shareholders on June 21, 2022, the Company’s board on July 29, 2022, and the CEO decision dated August 5, 2022, the maximum number of shares to be issued on redemption of convertible bonds is currently set at 15,800,000 shares. Should this maximum amount apply, the stake of a shareholder holding 1% of the Company’s share capital would decrease to 0.65%, i.e. a 35% dilution.

To the Company’s knowledge, on the basis of the same assumptions, the distribution of its share capital before and after redemption of all the convertible bonds in newly issued shares will be as follows:

Shareholders

Before the transaction

After the transaction

 

(on the basis of the drawdown of all Tranches and the average price weighted by Company’s share volumes during the last trading day preceding the date of this press release)

After the transaction

 

(on the basis of the maximum potential dilution authorized by the general assembly meeting of the shareholders under the 17th resolution)

Number of

shares

% of

capital

Number of

shares

% of capital

Number of

shares

% of capital

Founders

2,778,947

9.6%

2,778,947

8.7%

2,778,947

6.2%

Bpifrance

5,753,662

19.9%

5,753,662

18.1%

5,753,662

12.9%

Free float

20,420,041

70.5%

23,318,311

73.2%

36,220,041

80.9%

Total

28,952,650

100.0%

31,850,920

100.0%

44,752,650

100.0%

The Company will make available to investors on its website an up-to-date summary chart of its outstanding convertible bonds and the number of shares in circulation.

The public’s attention is drawn to the risk factors relative to the Company and its business, presented in its universal registration document filed with the AMF on 4 May 2022, which is available on the Company’s website. The occurrence of all or some of these risks is likely to have an unfavourable effect on the Company’s business, financial situation, results, development or prospects.

In addition, the public’s attention is specifically drawn to the following main risks related to the IRIS financing and its implementation:

Risk of dilution of the Company’s shareholders: the Company’s shareholders who cannot participate in the operation will suffer dilution when new shares are issued to IRIS upon conversion of the convertible bonds;

Risk in the event of non-fulfillment of all the tranches: the Company may have to seek additional financings and to review accordingly its development strategy and its objectives if an event of default occurs or certain minimum share price prevent the drawdown of the Tranches II and/or III of the financing, respectively of EUR 1 million each.

Risk on the volatility, liquidity and share price of the Company’s shares: Given IRIS’ strategy, which is to sell newly issued shares shortly after conversion of the convertible bonds it holds, the share price and the volatility of the Company’s shares could fluctuate significantly after the issuance of the convertible bonds issued to IRIS.

This press release and the information it contains do not, and will not, constitute an offer to subscribe for or sell, nor the solicitation of an offer to subscribe for or buy, any securities of the Company in any jurisdiction.

Main Characteristics of the financing with IRIS:

Maturity Date

48 months

Total Commitment

EUR 6 million

Tranche I

EUR 4 million

  • IRIS has subscribed to the first tranche of EUR 4 million at signing

Tranche II

EUR 1 million maximum, at the option of Poxel

  • At the sole option of Poxel, IRIS will subscribe to a new tranche EUR 1 million on or before November 30, 2022

Tranche III

EUR 1 million maximum, at the option of Poxel

  • At the sole option of Poxel, IRIS will subscribe to a new tranche EUR 1 million on or before December 31, 2022

Nominal of Notes

EUR 2,500

Coupon

0%

Conversion

  • IRIS may request that the convertible bonds be converted into shares of the company at the prevailing conversion ratio at any time upon delivery of a conversion notice to the Company
  • The conversion of the convertible bonds into new or existing shares of the Company is mandatory at the latest at maturity of the convertible bonds

Conversion Price

  • The average volume weighted share price over the last trading day preceding each issue, less a discount of 8%, subject to a floor corresponding to the average volume weighted share price over the twenty trading days preceding each issue, less a discount of 20%

Conditions precedent of drawdown for Tranche II and III

  • Usual condition precedents for this type of financing including absence of event of default and minimum share price at the time of drawdown

Event of defaults

  • Usual event of defaults for this type of financing including the absence of timely delivery of shares in conversion of the convertible bonds (e.g. in case of insufficient authorizations from the general assembly meeting of the shareholders or in the absence of publication of a prospectus, as the case may be)

Subscription price

100% of par value

New Shares

  • New shares of the Company issued on redemption of the convertible bonds will bear current dividend rights. They will have the same rights as those attached to existing ordinary shares and be admitted for trading on the Euronext regulated market on Euronext Paris. The Company will keep on its website a chart for monitoring convertible bonds and the number of shares in circulation up to date.
  • Nominal value of the shares of the Company: EUR 0.02

Potential dilution – Maximum share number

  • Pursuant to the decisions of the general assembly meeting of the shareholders on June 21, 2022, the Company’s board on July 29, 2022 and the CEO decision on August 5, 2022, the maximum number of shares for issue on redemption of convertible bonds has been set at 15,800,000 shares. By way of illustration, assuming issuance of all the convertible bonds and the average price weighted by volumes of the Company’s share during the last trading day preceding the date of this press release, i.e.€2.07, the number of new Company shares for subscription by the Investor on redemption of the convertible bonds in new shares would be 2,898,270 shares, representing approximately 10.0% of the share capital (on a non-diluted basis). Based on the same assumptions, the number of new Company shares for subscription by the Investor on redemption of the convertible bonds in new shares for Tranche I only would be 1,932,180 shares representing approximately 6.7% of the share capital (on a non-diluted basis), and the number of new Company shares for subscription by the Investor on redemption of the convertible bonds in new shares for each of Tranche II and III only would be 483,045 shares representing approximately 1.7% of the share capital (on a non-diluted basis).
  • On the date of this press release, the Company has a share capital of €579,053 divided into 28,952,650 ordinary shares

Share Loan Agreement

  • As part of the equity-linked financing, certain shareholders of the Company have undertaken to loan part of their shares to IRIS. This loan will only be used to facilitate implementation of the financing and avoid potential delays related to the delivery-settlement of shares issued upon conversion of the bonds. Such loan agreement shall terminate at the latest on the date of full conversion of the bonds.

Structuring Fee

  • The Company will pay IRIS a structuring fee of 3% of the nominal amount of each tranche drawn, payable in cash on each drawdown

No Penalty clauses

  • No penalty clauses are included in the agreement including in case the conversion price would fall below the nominal value of the shares

About Poxel SA

Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare disorders. Poxel has clinical and earlier-stage programs from its adenosine monophosphate-activated protein kinase (AMPK) activator and deuterated thiazolidinedione (TZD) platforms targeting chronic and rare metabolic diseases. For the treatment of NASH, PXL065 (deuterium-stabilized R-pioglitazone) is in a streamlined Phase 2 trial (DESTINY-1). PXL770, a first-in-class direct AMPK activator, has successfully completed a Phase 2a proof-of-concept trial for the treatment of NASH, which met its objectives. For the rare inherited metabolic disorder, adrenoleukodystrophy (ALD), the company intends to initiate Phase 2a proof of concept studies with PXL065 and PXL770 in patients with adrenomyeloneuropathy (AMN). TWYMEEG® (Imeglimin), Poxel’s first-in-class lead product that targets mitochondrial dysfunction, has been approved and launched for the treatment of type 2 diabetes in Japan. Poxel expects to receive royalties and sales-based payments from Sumitomo Pharma. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries. The Company intends to generate further growth through strategic partnerships and pipeline development. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan.

For more information, please visit: www.poxelpharma.com

All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements. The Company does not endorse or is not otherwise responsible for the content of external hyperlinks referred to in this press release.

________________________

1 The Company shall then maintain minimum cash position of the higher of i) EUR 10 million and ii) the sum of the consolidated debt service of the Company plus the amount of cash required to be spent by the Company as part of its operations, in each case for the following 6-months period.

Contacts

Contacts – Investor relations / Media

Aurélie Bozza

Investor Relations & Communication Senior Director

aurelie.bozza@poxelpharma.com
+33 6 99 81 08 36

Elizabeth Woo

Senior Vice President, Investor Relations & Communication

elizabeth.woo@poxelpharma.com

NewCap

Emmanuel Huynh or Arthur Rouillé

poxel@newcap.eu
+33 1 44 71 94 94

BioDuro-Sundia and X-Chem Enter Partnership to Launch DEL Services in China for the Discovery of New Small Molecule Drugs

BioDuro-Sundia and X-Chem Enter Partnership to Launch DEL Services in China for the Discovery of New Small Molecule Drugs




BioDuro-Sundia and X-Chem Enter Partnership to Launch DEL Services in China for the Discovery of New Small Molecule Drugs

SHANGHAI–(BUSINESS WIRE)–#DEL–BioDuro-Sundia, an industry-leading drug discovery, development and commercial service CRDMO backed by Advent International, and X-Chem, a DEL technology pioneer in small molecule drug discovery, jointly announced the launch of DNA Encoded Compound Library (DEL) technology services in China to help more innovative pharmaceutical companies quickly discover small molecule drugs. X-Chem will leverage its powerful DEL technology platform and large collection of novel, diverse lead- and drug-like small molecule compounds to help customers significantly accelerate the discovery of hits and expand their target range. Combined with BioDuro-Sundia’s one-stop drug discovery platform, customers can access world-class discovery technologies and support, covering hit identification and optimization, evaluation of lead and candidate compounds, and quickly advance to preclinical development.

As a pioneer in DEL technology, X-Chem’s libraries contain over 250 billion small molecules. X-Chem has licensed more than 100 research projects to companies in the US, Europe and Japan, comprising over three hundred independent chemical series and more than one thousand validated hit compounds. BioDuro-Sundia will utilize its powerful protein screening platform to assist customers to complete the protein qualification, ensuring that its purity, concentration and degree of aggregation meet the requirements for compound library screening to ensure the best chances for hit identification.

“We are very pleased to collaborate with BioDuro-Sundia in China to explore more new and challenging, valuable therapeutic targets,” said X-Chem ‘s CBO, Steffen Helmling. “We believe that X-Chem’ s DEL platform technology, in strong association with BioDuro-Sundia’s one-stop new drug discovery development platform, can deliver promising drug leads and will bring higher value returns to our biopharma clients.”

BioDuro-Sundia is an integrated CRDMO providing drug discovery, development and manufacturing services. As an expert in drug discovery, the company has leveraged its more than 18 years of discovery chemistry services and has successfully delivered thousands of projects to date.

“We look forward to working with X-Chem to help our customers discover more novel small molecule leads through the application of DNA Encoded Compound Library (DEL),” said Dr. Xiang Li, Drug Discovery President of BioDuro-Sundia. “This collaboration will provide a cutting-edge platform for hit identification in early drug discovery and further expand BioDuro-Sundia’s one-stop new drug discovery and development capabilities. It will also empower innovative Chinese pharmaceutical companies with a more efficient drug discovery mechanism. We believe that through our collaboration with X-Chem scientists, new drug candidates will continue to be discovered and advanced, eventually moving towards the clinic and benefiting patients.”

About BioDuro-Sundia

BioDuro-Sundia, an Advent International portfolio company is a trusted, leading Contract Research, Development and Manufacturing Organization (CRDMO) for over 27 years. We provide our biotech and pharmaceutical partners with fully integrated services to support their efforts from target identification through to commercial drug product manufacturing. The company is based in the US and China with more than 2,500 employees and 10 global sites across 7 cities.

Core expertise includes small and large molecule discovery, development and scale up, support for IND submission, and unique technology platforms such as bioavailability enhancement of insoluble compounds. The one-stop-shop operation helps biotech and pharma partners across the globe to significantly accelerate discovery and de-risk development to create higher value outcomes. We adhere to one global highest standard of compliance and business operation code. Science-driven, customer-oriented, flexible, people focused culture enables us to provide top-tier integrated, fast and flexible tailored services to our customers to meet their unique needs and accelerate development timeline.

About X-Chem

X-Chem, Inc. is the leader in small molecule discovery science, providing pharmaceutical and biotech companies a complete, seamless solution for screening, hit validation and lead optimization. As pioneers of DNA-encoded chemical library (DEL) technology, the company leverages its market-leading DEL platform to discover novel small molecule leads against challenging, high-value therapeutic targets. In-house lead optimization services enable clients to progress their compounds directly for even higher quality outputs. Our expertise in medicinal chemistry, custom synthesis and scale-up process chemistry enables us to support all aspects of drug discovery, supporting lead optimization through candidate identification.

Contacts

Christina Coby

marketing@bioduro.com
christina.coby@bioduro-sundia.com

Biocom California Statement on New Drug Pricing Legislation

Biocom California Statement on New Drug Pricing Legislation




Biocom California Statement on New Drug Pricing Legislation

SOUTH SAN FRANCISCO, LOS ANGELES, SAN DIEGO & WASHINGTON–(BUSINESS WIRE)–Biocom California, the association representing the life science industry of California, issued the following statement regarding the drug pricing portion in the Inflation Reduction Act. The statement can be attributed to Joe Panetta, Biocom California’s president and CEO:

After a detailed review and consideration of the drug pricing provisions included in the Inflation Reduction Act, we at Biocom California have no other choice than to oppose this legislation, as it once again comes short of protecting innovation and making meaningful changes for patients.

While we wholeheartedly support the provisions in the bill that establish a much needed $2,000 cap on out-of-pocket patient spending and restructure of the Medicare Part D benefit program, we are deeply concerned that the bill ignores the tireless work of well-informed lawmakers who put forward alternatives that struck a delicate balance between promoting patient affordability and recognizing the role of the biomedical innovation community in bringing innovative medicines to market.

We appreciate that the bill does not include foreign price controls, but it still gives the federal government unilateral determination over the value of a medicine and, if a company does not agree with that valuation, it would be effectively barred from the entire Medicare market. This is pure government price setting, not negotiation.

The bill would impact not only the drugs selected for ‘negotiation,’ but also future medicines that rely on risk-averse investments to be developed. Price controls have been proven to destabilize innovation ecosystems by driving capital investments away, chilling research and development, and eliminating jobs. Ultimately, they reduce the number of medicines being developed and reaching patients.

A recent study by Vital Transformation has estimated that the bill would reduce innovators’ revenue by at least 55%, putting 104 out of 110 drugs or 95% of the pipeline at risk of cancelled development, and costing California over 100,000 jobs. California is the global leader in biomedical innovation and a vital contributor to the state’s economy, generating over $400 billion in annual economic activity and supporting almost 1.4 million jobs. As such, California companies and the state’s overall economy will be disproportionately harmed, especially small companies that create more than half of new medicines.

The bill also ignores repeated calls from more than 130 patient organizations to bar the federal government from using price setting methodologies that ration care and discriminate against seniors and individuals with disabilities.

Last but not least, the bill would take away almost $300 billion in industry revenue to reduce federal government prescription drug spending. Yet, there is absolutely nothing in the bill that requires the federal government to pass a penny of these ‘savings’ down to patients. Instead, they are intended to reduce the budgetary impact of unrelated provisions in the bill that paradoxically invest in other research and manufacturing industries, effectively picking winners and losers.

After years of debate and factual input from our industry, the patient community and legislators with deep technical knowledge of the innovation ecosystem, it is alarming that Congress is pursuing another drug pricing proposal that endorses price setting and fails to recognize the role of scientific discovery, despite our successful work to address the COVID-19 pandemic. As always, we stand ready to work with Congress to enact bipartisan proposals that meaningfully address inefficiencies within the health care system and bring all stakeholders to the table.”

About Biocom California

Biocom California is the leader and advocate for California’s life science sector. We work on behalf of more than 1,600 members to drive public policy, build an enviable network of industry leaders, create access to capital, introduce cutting-edge STEM education programs and create robust value-driven purchasing programs.

Founded in 1995 in San Diego, Biocom California provides the strongest public voice to research institutions and companies that fuel the local and state-wide economy. Our goal is simple: to help our members produce novel solutions that improve the human condition. In addition to our San Diego headquarters, Biocom California operates core offices in Los Angeles and the San Francisco Bay Area, with satellite offices in Sacramento, Washington, D.C. and Tokyo. Our broad membership benefits apply to biotechnology, pharmaceutical, medical device, genomics and diagnostics companies of all sizes, as well as to research universities and institutes, clinical research organizations, investors and service providers.

For more information on Biocom California, please visit our website at www.biocom.org. Connect with us on LinkedIn, Facebook, and Twitter (@BIOCOMCA).

Contacts

Biocom California Media Contact:
Katherine Smith

Evoke Canale

(619) 849-5382

Katherine.smith@evokegroup.com