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OUR NEW PROFILE IS: (NASDAQ: INM)
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INM HAS A FLOAT OF 3.3 MILLION WITH $9.6MILL IN CASH (MARCH, 21 2023) AND $2.3MILL IN Q4 REVENUES!! (UNAUDITED)
LAST 2 PERIODS SHOW A MASSIVE 123%(UNAUDITED) AND 120% QUARTER OVER QUARTER GROWTH
TOTAL REVENUES OF $4.1M (UNAUDITED) IN FISCAL YEAR 2023, REPRESENTING A 276% INCREASE OVER THE PREVIOUS FISCAL YEAR
A CLINICAL STAGE COMPANY WITH A ROBUST PIPELINE OF PHARMA PROGRAMS IN DERMATOLOGY, OCULAR AND ALZEIMERS
READ THE INVESTOR PRESENTATION HERE
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Hello Everyone,
Up next is an extremely unique hybrid clinical stage pharmaceutical company. They have several pharmaceutical programs supported by a revenue generating business. If this kind of growth continues then they have the possibility of being a self funded pharma company.
Pull up INM right away and start your research on it.
Recently we have witnessed a surge in MJ companies on the back of The Drug Enforcement Agency (DEA) considering reclassifying marijuana as a Schedule III drug, placing it alongside substances like ketamine, anabolic steroids, and testosterone. This classification implies a moderate to low potential for physical or psychological dependence. This recommendation does not entail complete removal from the controlled substances list however it will be a huge advantage for MJ companies and pharmaceutical companies like INM that are not MJ companies, however, they are aligned with the Cannabis markets. INM is already listed on the Nasdaq and does not have to navigate the tricky banking regulations often associated with these types of companies.
The new classification could benefit MJ companies in a few ways.
Marijuana businesses currently face restrictions under IRS code 280E, preventing them from deducting expenses on federal tax returns. Reclassification could alleviate this burden. Rescheduling could enable legal interstate commerce, addressing the challenge of transporting marijuana across state lines, opening up new lines of business. It would also open doors for increased research in the marijuana sector, potentially attracting investors and driving the MJ market higher.
InMed Pharmaceuticals is a global leader in the research, development and manufacturing of rare cannabinoids, including clinical and preclinical programs targeting the treatment of diseases with high unmet medical needs. They also have significant know-how in developing proprietary manufacturing approaches to produce cannabinoids for various market sectors.
Things appear to be heading in the right direction for INM if you look at the numbers. The company has had to optimize and scale up the manufacturing processes over the last 12 months to meet increasing demand. InMed’s BayMedica subsidiary delivered $4.1 Million in revenue in fiscal 2023 (unaudited) including $1.8 million in rare cannabinoid ingredient sales to distributors and manufacturers in the H&W sector in the first 9 months of the fiscal year, compared to $0.6 million in all of 2022. Q4 financial are expected to post in the coming weeks. If similar growth continues then we could potentially see INM become a self funded Pharma company.
Another major catalyst is the valuation gap. If you look at the current market cap it is a mere fraction of the cash position. We often see companies valued at multiples of current revenues. That is certainly not the case with INM. The market cap is below $3Mill with Q4 (Unaudited) revenues of 2.3 Mill and growing. All this without even taking into account the current pharmaceutical pipeline. These components could be major factors towards the growth of this company from it’s current levels.
According to a recent analyst report, rare cannabinoids in demand. After hitting some earlier speed bumps following its acquisition by InMed in October 2021, BayMedica’s revenue growth profile in the last three quarters offers evidence that select rare cannabinoids led by cannabichromene (CBC), BayMedica’s leading product, are starting to make their mark as ingredients of growing importance in health and wellness products. A better understanding and growing awareness of the health benefits of rare cannabinoids are evidenced by leading consumer health companies expanding their product lines to include new formats and formulations using rare cannabinoids. It is important to note that the health and wellness sector remains very much an under-penetrated market for rare cannabinoids. According to data and market intelligence firm Headset.io. While global CBC sales totaled $1.7M in 2022, sales for the more established rare cannabinoids such as CBN and CBG were $187M and $55M respectively, highlighting CBC’s growth. Global sales of major cannabinoid CBD are running at ~$5B (of which half are B2B sales) is perhaps an indicator of the potential market size for rare cannabinoids.
BayMedica’ positioning in the market is being wellexecuted. BayMedica is uniquely positioned to meet the fast-growing demand for rare cannabinoids. Its manufacturing processes and global supply chain allow it to cost-effectively scale up its supply of high-quality rare cannabinoids, as evidenced by its recent growth profile. BayMedica has the unparalleled ability to potentially scale production to metric tons as demand continues to rise.
RINMED PHARMACEUTICALS INC. ANNOUNCES RESULTS FROM A PHASE 2 CLINICAL TRIAL IN EPIDERMOLYSIS BULLOSA
- An exploratory clinical evaluation of the Phase 2 clinical trial data showed a positive indication of enhanced anti-itch activity for INM-755 cannabinol (“CBN”) cream versus the control cream alone.
- The results for non-wound itch were not statistically significant in favor of INM-755 CBN cream due, in part, to the clinically important anti-itch effect of the underlying control cream.
- INM-755 CBN cream demonstrated a favorable safety and tolerability profile.
- InMed will pursue strategic partnership opportunities for INM-755 in epidermolysis bullosa (“EB”) and other itch-related skin conditions.
Vancouver, BC – June 22, 2023 – InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM), a leader in the pharmaceutical research, development, manufacturing and commercialization of rare cannabinoids and cannabinoid analogs, today announced safety and efficacy results from its Phase 2 clinical trial, called 755-201-EB (the “Phase 2 Trial”), for the treatment of symptoms related to EB.
The purpose of the Phase 2 Trial was to evaluate the safety of INM-755 CBN cream, which consists of the control cream plus the active pharmaceutical ingredient CBN, and obtain preliminary evidence of efficacy in treating symptoms and healing wounds over a 28-day period in patients with EB. All four subtypes of inherited EB, including EB Simplex, Dystrophic EB, Junctional EB, and Kindler Syndrome were accepted into the Phase 2 Trial. The Phase 2 Trial used a within-patient, double-blind design whereby matched index areas were randomized to INM-755 CBN cream or control cream.
The Phase 2 Trial enrolled a total of 19 patients. Data from one patient were excluded from efficacy analyses due to a significant protocol deviation. Of the 18 remaining patients whose data were considered reliable for clinical review, 17 were treated for chronic non-wound itch and one patient was treated for wound-related itch. The remaining endpoints (pain, wound healing) could not be analyzed due to too few enrollees with such symptoms.
Of the 18 participants assessed, chronic itch improved by a clinically meaningful amount in 12 patients (66.7%), of whom:
- 6 patients (33.3%) had the same level of itch improvement with INM-755 cream as with control cream;
- 5 patients (27.8%) treated with INM-755 showed meaningful anti-itch activity beyond that of the control cream; and
- 1 patient (5.6%) showed better itch reduction with the control cream.
However, the protocol-specified statistical analyses for non-wound itch were not statistically significant in favor of INM-755 due in part to the clinically important anti-itch effect of the underlying control cream.
As expected based on a Phase 1 safety study (755-101-HV) undertaken by the Company, systemic exposure of CBN was measured at very low concentrations (picograms/mL in plasma). There were no serious drug-related adverse events (“AEs”) and there were no withdrawals from treatment. Moderate headaches in one study participant were the only systemic AEs deemed ‘possibly related’ to study drug. Very few local AEs were reported in the treatment areas; they were transient and resolved without cessation of treatment. The Phase 2 Trial indicated that INM-755 CBN cream was very well tolerated on sensitive EB skin.
“This is an important day for the Company, as we report that INM-755 CBN cream demonstrated sufficient clinically important anti-itch activity to warrant further development. We are very encouraged that INM-755 CBN cream could someday provide itch relief for patients with EB and possibly other diseases,” commented Alexandra Mancini, SVP of Clinical and Regulatory Affairs at InMed. “We are deeply grateful for all of the individuals with EB and their families who participated in the study and for the investigators and clinical team who conducted this trial.”
InMed’s CEO, Eric A. Adams, added, “Despite many challenges associated with conducting an international clinical trial in an orphan disease, compounded by COVID-related disruptions, the InMed and clinical research organization joint team, led by Ms. Mancini, persevered to see this trial through to conclusion. Based on the safety and efficacy data for treating non-wound itch in this EB study, as well as previous safety data from Phase 1 trials, InMed will now seek R&D and commercial partnership opportunities for any continued development of INM-755 CBN cream.”
Learn more about InMed’s INM-755 EB program: https://www.inmedpharma.com/pharmaceutical/inm-755-for-epidermolysis-bullosa/
MANUFACTURING & COMMERCIAL
INM is currently using modern manufacturing approaches to produce rare cannabinoids economically so they can be used in products for the health and wellness industry. Rare cannabinoids unlike CBD and THC are very difficult to grow and extract economically- InMed solve for that issue. They are well positioned once big consumer goods companies start entering the space and need pure, consistent, economic ingredients at scale.
INMED PROVIDES UPDATE ON BAYMEDICA RARE CANNABINOID BUSINESS
- $2.3M revenues (unaudited) in Q4 2023, representing 123% increase quarter over quarter (“QoQ”)
- Optimized and scaled up manufacturing processes over the last 12 months to meet increasing demand
- Third consecutive quarter with significant revenue growth
Vancouver, British Columbia–(Newsfile Corp. – July 20, 2023) – InMed Pharmaceuticals Inc. (NASDAQ: INM) (“InMed“), a leader in the pharmaceutical research, development, manufacturing and commercialization of rare cannabinoids and cannabinoid analogs, today provided a commercial and manufacturing update on its subsidiary BayMedica LLC (“BayMedica“), a leading supplier of bioidentical rare cannabinoids to the Health and Wellness (“H&W”) market.
“We are very encouraged to see another strong quarter with (unaudited) revenues in excess of $2.3M, representing our third consecutive quarter with significant revenue growth,” said Eric A. Adams, InMed’s President and CEO. He added, “As demand for minor cannabinoids continues to increase, we see a potential path for BayMedica to become a profitable standalone business subsidiary and contribute margin to the pharmaceutical R&D parent.”
BayMedica Growing Revenue (Unaudited)
- $2.3M in revenue for the three months ended June 30, 2023, a 123% increase QoQ.
- Third consecutive quarter of strong revenue growth and the second consecutive quarter with growth exceeding 100% QoQ.
- Total revenues of $4.1M in fiscal year 2023, representing a 276% increase over the previous fiscal year.
Supply Chain Optimization
As revenues have grown steadily over the past several months, BayMedica has been diligently working to ensure sufficient inventory to meet the increasing demand of its bioidentical rare cannabinoids. BayMedica has been focused on creating redundancy at both ends of the supply chain by securing more sources of raw materials as well as securing additional downstream purification partners. In addition, BayMedica has recently hired a director for manufacturing and logistics to oversee the supply chain function and manage third party vendors.
Increased Production
BayMedica, through its manufacturing partners, has steadily increased manufacturing throughput to maintain supply of finished goods to meet customer demand over the last 12 months. With completed and ongoing process improvements, BayMedica has the capability to potentially scale production to metric tonnes (thousands of kilograms) should demand continue to rise.
Product Portfolio
BayMedica is a leading high quality, low cost supplier of non-intoxicating bioidentical rare cannabinoids for the H&W sector: cannabichromene (CBC), delta-9 tetrahydrocannabivarin (THCV), cannabidivarin (CBDV) and cannabicitran (CBT). BayMedica continues to optimize its manufacturing processes and supply chain logistics to reduce the overall cost of goods, while also improving the already high quality and purity levels for all products in its portfolio.
“We have seen demand for rare cannabinoids surge over the past year, and we are pleased to have been able to increase production to meet the needs of our customers,” commented Shane Johnson, General Manager of BayMedica. “We attribute the increasing demand, in part, to better research of rare cannabinoids, companies and brands looking for product innovation and effects-based outcomes, and the ability of companies like ours to be able to reliably supply high quality rare cannabinoids with low batch-to-batch variations. We are pleased to have established ourselves as a leading supplier of rare cannabinoids in this fast-growing yet still nascent market.”
Although InMed experienced revenue growth for the fourth quarter in the BayMedica segment, management expects to report an overall net loss for the year ended June 30, 2023. InMed plans to file a 10-K with audited financial statements, including audited revenue figures, in the second half of September 2023.
INMED PHARMACEUTICALS REPORTS THIRD QUARTER FISCAL 2023 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
- Completed enrollment in Phase 2 Clinical Trial; data readout expected during calendar 3Q 2023
- 120% quarter-over-quarter revenue growth in the commercial BayMedica subsidiary
- Published a peer-reviewed study showing the anti-inflammatory potential of rare cannabinoids
Vancouver, British Columbia–(Newsfile Corp. – May 15, 2023) – InMed Pharmaceuticals Inc. (NASDAQ: INM) (“InMed” or the “Company“), a leader in the pharmaceutical research, development, manufacturing and commercialization of rare cannabinoids and cannabinoid analogs, today announced financial results for the third quarter of the fiscal year 2023 (“FY 3Q23”) which ended March 31, 2023.
The Company’s full financial statements and related MD&A for the third quarter ended March 31, 2023, are available at www.inmedpharma.com, www.sedar.com and at www.sec.gov.
“The third quarter of fiscal year 2023 was an important period for InMed, as we achieved several key milestones across our different business segments, including completing enrollment in our Phase 2 clinical trial for epidermolysis bullosa, marking the first time cannabinol (“CBN”) has completed a Phase 2 clinical trial. We look forward to the data read out during 3Q and will then be in a better position to evaluate our strategic opportunities for the program,” said Eric A. Adams, President and CEO of InMed. “We are increasingly excited about the data we are seeing in our preclinical ocular and neurodegenerative disease programs where we are researching proprietary cannabinoid analogs in the treatment of various indications.”
“We also hit another significant milestone in our commercial BayMedica subsidiary, surpassing $1M in quarterly revenues for the first time from the sales of rare cannabinoids to the Health and Wellness (“H&W”) sector, representing a 120% increase over 2Q sales.” Adams continued, “In the last few months we have seen a noticeable increase in awareness, understanding and adoption of rare cannabinoids in the H&W sector, evidenced by leading companies expanding their product lines to include new formats and formulations using rare cannabinoids such as the non-psychoactive ingredient cannabichromene (“CBC”). We are encouraged by two consecutive periods of significant quarter over quarter revenue growth. We will continue to support growth in a fiscally prudent manner in this relatively nascent market, where product demand can be unpredictable. The combination of a pharmaceutical drug development pipeline, together with a revenue generating commercial operation that will be contributing to extending our cash runway makes InMed a unique company within the rare cannabinoid space.”
Business update
Pharmaceutical Development Programs
INM-755 – Phase 2 Clinical Trial in EB
In March 2023, the Company concluded enrollment of 19 patients in its Phase 2 clinical trial, with the last patient completing treatment in April, using the investigational drug INM-755 CBN cream for the treatment of symptoms in persons with epidermolysis bullosa (“EB”), a rare genetic skin disease. The study used a within-patient, double-blind design in which matched index areas were randomized to INM-755 (cannabinol) cream or vehicle cream as a control. Selected matched index areas may have been wounds or non-wound areas. In this study, designed to measure safety and obtain preliminary evidence of efficacy, there is no single primary efficacy endpoint. Net benefit from INM-755 cream will be evaluated within each patient and based on their clinical needs at baseline. Based on their presenting symptoms, the majority of the enrolled and treated patients in the 755-201-EB study were treated for non-wound itch.
INM-088 – Glaucoma Program
The Company continues to conduct IND-enabling preclinical testing for the development of a CBN-based eye drop formulation in glaucoma and has planned GLP toxicology studies in Q4 2023.
As part of the Company’s proprietary cannabinoid analog program, InMed continues to screen a library of new compounds across a spectrum of therapeutic applications, including other ocular indications such as Age-related Macular Degeneration (“AMD”) and other similar ‘back-of-the-eye’ diseases.
INM-900 – Neurodegenerative Diseases Program
Two cannabinoid analogs are being assessed in in vivo models of neurodegenerative diseases and the Company expects these studies to be completed and a candidate selected for further development in calendar 2Q 2023. Our research demonstrated the neuroprotective effects of specific cannabinoid analogs and their potential to improve neuronal function in in vitro testing.
InMed recently filed a patent application covering a range of cannabinoids demonstrating neuroprotection and enhanced neuronal function for the potential treatment of neurodegenerative diseases such as Alzheimer’s Disease, Parkinson’s Disease, Huntington’s Disease and others.
Publications
In March 2023, the Company announced the publication of a peer-reviewed scientific study entitled “Rare phytocannabinoids exert anti-inflammatory effects on human keratinocytes via the endocannabinoid system and MAPK signaling pathway” in the International Journal of Molecular Sciences. The study, conducted in collaboration with Dr. Mauro Maccarrone at the Università degli Studi dell’Aquila, Italy, investigates the dermatological anti-inflammatory effects of certain rare cannabinoids. It is the second Company-sponsored study to demonstrate the anti-inflammatory effects of rare cannabinoids and their potential for the treatment of skin conditions such as atopic dermatitis, psoriasis, pruritus, and acne.
BayMedica Commercial Business
InMed’s BayMedica rare cannabinoids business, which serves the H&W sector, delivered its strongest revenue quarter since acquisition in late 2021. As a result of slower than anticipated product demand throughout 2022, in 2023, management took a conservative approach towards investment in inventory and new products while the sales and marketing function sought to develop commercial opportunities.
This approach has proven beneficial as, thus far in 2023, the H&W sector has experienced a significant increase in demand for rare cannabinoids, particularly CBC, where BayMedica has been well-positioned to be a key supplier to distributors and manufacturers. During the nine months ended March 31, 2023, revenues totaled more than $1.8 million, as sales surpassed $1 million in the third quarter alone, compared to $0.6 million for the nine months ended March 31, 2022.
While the medium- and long-term outlooks remain uncertain, sales and marketing efforts remain focused on products that have stable pricing, lower manufacturing costs, and where BayMedica holds a strong competitive position.
Financial and Operational Highlights:
For the nine months ended March 31, 2023, the Company recorded a net loss of $7.6 million, or $3.53 per share, compared with a net loss of $10.7 million, or $20.13 per share, for the nine months ended March 31, 2022.
Research and development and patents expenses decreased by $2.7 million for the nine months ended March 31, 2023 compared to the same period in 2022. The decrease was due to a combination of lower personnel expenses and high start-up costs associated with the multicenter Phase 2 clinical trial in our INM-755 program during fiscal 2022.
The Company incurred general and administrative expenses of $4.4 million for the nine months ended March 31, 2023 compared with $5.1 million for the nine months ended March 31, 2022. The decrease results primarily from a combination of changes including lower personnel expenses, insurance fees, investor relation expenses, accounting fees, legal fees and were offset by the inclusion of BayMedica operating results following its acquisition on October 13, 2021.
At March 31, 2023, the Company’s cash, cash equivalents and short-term investments were $9.6 million, which compares to $6.2 million at June 30, 2022. The increase in cash, cash equivalents and short-term investments during the nine months ended March 31, 2023, was primarily the result of both the September 13, 2022 and November 21, 2022 private placements partially offset by cash outflows from operating activities. With ongoing revenue from the BayMedica operations and depending on how we prioritize investment into our various development activities, InMed has a projected cash runway to the middle of fiscal 3Q 2024.
At March 31, 2023, the Company’s total issued and outstanding shares were 3,328,191. During the three and nine months ending March 31, 2023, the weighted average number of common shares was 3,328,191 and 2,156,283, which is used for the calculation of loss per share for the respective interim periods.
For the nine months ending March 31, 2023, InMed’s BayMedica subsidiary delivered $1.8 million in rare cannabinoid ingredient sales to distributors and manufacturers in the H&W sector, compared to $0.6 million in 2022, reflecting expanded marketing efforts and increased market demand. Gross profit margin was adversely affected by downward pricing pressure on certain products in the portfolio and a write-down of selected inventories to net realizable value of $0.6 million in the first quarter of 2023. We expect our overall gross profit and gross profit margins will improve over the coming quarters as sales and marketing efforts are focused on products with more stable pricing and lower manufacturing costs.
NEWS
INMED TO PRESENT AT H.C. WAINWRIGHT 25TH ANNUAL GLOBAL INVESTMENT CONFERENCE
September 7, 2023
INMED TO PARTICIPATE IN FIRESIDE CHAT WITH WATER TOWER RESEARCH ON JULY 25, 2023 AT 2PM ET
July 21, 2023
INMED PROVIDES UPDATE ON BAYMEDICA RARE CANNABINOID BUSINESS
July 20, 2023
INMED PHARMACEUTICALS INC. ANNOUNCES RESULTS FROM A PHASE 2 CLINICAL TRIAL IN EPIDERMOLYSIS BULLOSA
June 22, 2023
INMED’S NEURODEGENERATIVE DISEASE STUDY PRESENTED AT CANADIAN NEUROSCIENCE MEETING
June 1, 2023
INMED TO PARTICIPATE IN UPCOMING VIRTUAL INVESTOR EVENTS
May 24, 2023
INMED TO PARTICIPATE IN FIRESIDE CHAT WITH WATER TOWER RESEARCH ON MAY 23, 2023 AT 1PM ET
May 18, 2023
INMED PHARMACEUTICALS REPORTS THIRD QUARTER FISCAL 2023 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
May 15, 2023
INMED ANNOUNCES CONCLUSION OF PATIENT ENROLLMENT IN PHASE 2 CLINICAL TRIAL INVESTIGATING INM-755 CANNABINOL CREAM FOR EPIDERMOLYSIS BULLOSA
March 28, 2023
INMED ANNOUNCES PUBLICATION OF PEER-REVIEWED STUDY SHOWING THE ANTI-INFLAMMATORY POTENTIAL OF RARE CANNABINOIDS IN SKIN CONDITIONS
March 13, 2023
INMED TO PARTICIPATE IN UPCOMING INVESTOR EVENTS
March 7, 2023
INMED REPORTS SECOND QUARTER FISCAL 2023 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
February 17, 2023
INMED SUBMITS FORM 12B-25
February 9, 2023
INMED PROVIDES BUSINESS UPDATE AND MILESTONES FOR 2023
January 10, 2023
INMED ANNOUNCES RESULTS OF 2022 ANNUAL GENERAL MEETING
December 15, 2022
INMED ANNOUNCES APPOINTMENT OF INTERIM CHIEF FINANCIAL OFFICER AND CHANGE OF AUDITOR
December 12, 2022
INMED PHARMACEUTICALS ANNOUNCES CLOSING OF $6 MILLION PRIVATE PLACEMENT PRICED AT A PREMIUM TO MARKET
November 21, 2022
INMED PHARMACEUTICALS ANNOUNCES $6 MILLION PRIVATE PLACEMENT PRICED AT A PREMIUM TO MARKET
November 18, 2022
INMED PROVIDES UPDATE ON MANAGEMENT CHANGES
November 17, 2022
INMED PHARMACEUTICALS ADVANCES NEURODEGENERATIVE DISEASE PROGRAM WITH NATURAL SCIENCES AND ENGINEERING RESEARCH COUNCIL OF CANADA (“NSERC”) ALLIANCE GRANT FUNDING
November 16, 2022
INMED PHARMACEUTICALS REPORTS FIRST QUARTER FISCAL 2023 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
November 11, 2022
MANAGEMENT
ERIC A. ADAMS, MIBS
Chief Executive Officer & President
Eric A. Adams was appointed Chief Executive Officer, President and Director of InMed Pharmaceuticals, Inc. in June 2016. During his tenure at InMed, he has reconstituted the Board of Directors and the Executive management team and has raised more than $35M in
capital to fund operations. Mr. Adams is a seasoned biopharmaceutical executive with more than 25 years of experience in establishing corporate entities, capital formation, global market development, mergers & acquisitions, licensing and corporate governance.
Mr. Adams previously served as CEO at enGene Inc., where he oversaw its transformation from a nascent start-up into a venture capital-backed leader in gene therapy. Prior to enGene, Mr. Adams held senior positions in global market development with QLT Inc. (Vancouver), Advanced Tissue Sciences Inc. (La Jolla, CA), Abbott Laboratories (Chicago, IL), and Fresenius AG (Germany). As the previous Chairman of BIOTECanada’s Emerging Company Advisory Board, and for his extensive generosity in mentoring biotech entrepreneurs, Mr. Adams is well-respected within the Canadian biotech industry as a strategic advisor to a number of early-stage biotech companies.
He is a dual citizen of Canada and the United States, and holds a Masters of International Business from the University of South Carolina and a Bachelor’s Degree in Chemistry from the University of Southern Indiana.
MICHAEL WOUDENBERG, P.ENG.
Chief Operating Officer
Mr. Woudenberg joined InMed with more than 20 years of successful drug development, process engineering, GMP manufacturing and leadership experience. He brings valuable expertise in the development, technology transfer and commercialization of
active pharmaceutical ingredients (APIs) and drug products.
Prior to joining InMed in 2018, Mr. Woudenberg held various positions within 3M, Cardiome Pharma, Arbutus Biopharma and most recently as the Managing Director of Phyton Biotech, LLC. His experience includes process and formulation development from lab/pre-clinical products through the various stages of clinical development to validated and successfully approved and inspected commercial APIs and drug products. Additionally, he has extensive experience with regards to regulatory inspections (e.g. FDA, European, Australian, Korean, Japanese, Canadian) and their related chemistry, manufacturing and control requirements from clinical to commercial production of approved products.
Mr. Woudenberg received his Bachelor of Science, Chemistry and Bachelor of Engineering Science, Chemical at Western University of London, Ontario, Canada.
ALEXANDRA D.J. MANCINI, MSC
Senior Vice President, Clinical & Regulatory Affairs
Ms. Mancini has more than 30 years of global biopharmaceutical R&D experience, overseeing a wide range of drug development activities, with a particular emphasis on clinical development and regulatory affairs. She has been an executive with numerous biotech
companies, including Sr. V.P. of Clinical & Regulatory Affairs at Sirius Genomics, where her responsibilities included identifying and managing external resources for medical expertise in sepsis, clinical data management and statistical theory, programming and analyses.
Prior to joining Sirius Genomics, Ms. Mancini served as Sr. V.P. of Clinical & Regulatory Affairs at INEX Pharmaceuticals; and V.P. of Regulatory Affairs at QLT Inc., where she played a significant role in the development of VISUDYNE from the preclinical stage through to its approval as the first drug for age-related macular degeneration. While at QLT, Ms. Mancini also led the regulatory approval process for the anti-cancer drug PHOTOFRIN and its associated medical devices, the first drug-device combination product approved by the U.S. Food and Drug Administration.
Ms. Mancini holds a Master of Science degree from the University of Toronto.
ERIC C. HSU, PHD
Senior Vice President, Pre-Clinical Research & Development
Dr. Hsu joined InMed with more than 18 years of scientific leadership experience in the field of gene therapy. Prior to joining InMed, he held various positions within enGene Inc., including V.P. of Research and V.P. of Scientific Affairs and Operations.
Dr. Hsu’s experience includes a wide array of activities, including benchtop research, formulation development and manufacturing process development, as well as patent prosecution, vendor contract negotiations and execution, and research partnerships. He is also responsible for expanding product pipelines, and managing R&D budgets and timelines. Dr. Hsu is considered to be an expert in gene transfer and gene expression using vector systems.
Dr. Hsu received his Doctorate from the Department of Medical Biophysics at the University of Toronto and his Bachelor’s degree from McGill University.
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