3 unchanged sentences
(in thousands, except share data)
−Removed: December 31, 2023
+Added: June 30, 2024
March 31, 2024
2 unchanged sentences
Accounts receivable, net
−Removed: Short term investments
+Added: Asset held for sale
Deposits and advances
20 unchanged sentences
Preferred stock, $ 0.0001 par value:
−Removed: authorized 1,000,000 shares, no shares issued or outstanding as of December 31, 2023, and March 31, 2023.
+Added: authorized 1,000,000 shares, no shares issued or outstanding as of June 30, 2024, and March 31, 2024.
Common stock and additional paid-in capital, $ 0.0001 par value:
150,000,000 shares authorized;
−Removed: 63,734,439 and 53,077,436 shares issued and outstanding as of December 31, 2023, and March 31, 2023, respectively.
+Added: 75,636,419 and 66,691,195 shares issued and outstanding as of June 30, 2024, and March 31, 2024, respectively.
Accumulated other comprehensive loss
3 unchanged sentences
The accompanying notes should be read in connection with these Condensed Consolidated Financial Statements.
−Removed: | December 31, 2023, Form 10-Q
+Added: | June 30, 2024, Form 10-Q
IGC Pharma, Inc.
1 unchanged sentence
(in thousands, except loss per share and share data)
−Removed: Three months ended
−Removed: Nine months ended
+Added: Three months ended June 30,
Cost of revenue
2 unchanged sentences
Operating loss
−Removed: Impairment Loss on PPE
Other income, net
4 unchanged sentences
Comprehensive loss
−Removed: Net loss per share attributable to common stockholders:
+Added: Loss per share attributable to common stockholders:
Basic and diluted
−Removed: Weighted-average number of shares used in computing net loss per share amounts:
+Added: Weighted-average number of shares used in computing loss per share amounts:
The accompanying notes should be read in connection with these Condensed Consolidated Financial Statements.
−Removed: | December 31, 2023, Form 10-Q
+Added: | June 30, 2024, Form 10-Q
IGC Pharma, Inc.
1 unchanged sentence
(in thousands)
−Removed: Three months ended December 31, 2022
Common Shares
4 unchanged sentences
Total Stockholders’
−Removed: Balances as of September 30, 2022
−Removed: Common stock-based compensation & expenses, net
−Removed: Issuance of common stock through offering (net of expenses)
−Removed: Cancellation/forfeiture of shares
−Removed: Foreign currency translation adjustments
−Removed: Balances as of December 31, 2022
−Removed: Three months ended December 31, 2023
−Removed: Balances as of September 30, 2023
−Removed: Common stock-based compensation & expenses, net
−Removed: Issuance of common stock through offering (net of expenses)
−Removed: Cancellation/forfeiture of shares
−Removed: Foreign currency translation adjustments
−Removed: Balances as of December 31, 2023
−Removed: Nine months ended December 31, 2022
−Removed: Common Shares
−Removed: Common Stock and
−Removed: Additional Paid in
−Removed: Accumulated Other
−Removed: Comprehensive Loss
−Removed: Total Stockholders’
Balances as of March 31, 2023
2 unchanged sentences
Cancellation/forfeiture of shares
−Removed: Foreign currency translation adjustments
−Removed: Balances as of December 31, 2022
−Removed: Nine months ended December 31, 2023
+Added: Common stock subscribed
+Added: Foreign currency translation
+Added: Balances as of June 30, 2023
Balances as of March 31, 2024
2 unchanged sentences
Cancellation/forfeiture of shares
−Removed: Foreign currency translation adjustments
−Removed: Balances as of December 31, 2023
+Added: Common stock subscribed
+Added: Foreign currency translation
+Added: Balances as of June 30, 2024
The accompanying notes should be read in connection with these Condensed Consolidated Financial Statements.
−Removed: | December 31, 2023, Form 10-Q
+Added: | June 30, 2024, Form 10-Q
IGC Pharma, Inc.
1 unchanged sentence
(in thousands)
−Removed: Nine months Ended
+Added: Three months Ended
Cash flows from operating activities:
2 unchanged sentences
Common stock-based compensation and expenses, net
−Removed: Impairment of assets
Other non-cash items
10 unchanged sentences
Sale of property, plant, and equipment
−Removed: Investment in short term investments
−Removed: Acquisition and filing cost of patents and rights
−Removed: Net cash provided by investing activities
+Added: Acquisition and development of intangible assets
+Added: Net cash used in investing activities
Cash flows from financing activities:
1 unchanged sentence
Repayment of long-term loan
−Removed: Net cash provided by financing activities
+Added: Net cash provided by (used in) financing activities
Effects of exchange rate changes on cash and cash equivalents
−Removed: Net decrease in cash and cash equivalents
+Added: Net increase (decrease) in cash and cash equivalents
Cash and cash equivalents at the beginning of the period
4 unchanged sentences
The accompanying notes should be read in connection with these Condensed Consolidated Financial Statements.
−Removed: | December 31, 2023, Form 10-Q
+Added: | June 30, 2024, Form 10-Q
IGC Pharma, Inc.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: THREE MONTHS AND NINE MONTHS ENDED DECEMBER 31, 2023
+Added: THREE MONTHS ENDED JUNE 30, 2024
(in thousands, except for share data and loss per share, unaudited)
4 unchanged sentences
NOTE 1 – BUSINESS DESCRIPTION
−Removed: IGC Pharma is a clinical-stage pharmaceutical company developing novel therapies for Alzheimer’s disease and conditions related to the central nervous system.
−Removed: The company is pursuing five assets:
−Removed: IGC-AD1, TGR-63, LMP, IGC-1C, and IGC-M3, all of which target Alzheimer’s disease and are at various stages of development.
−Removed: Our most clinically advanced investigational new drug for Alzheimer’s, IGC-AD1, has shown significant promise in preclinical studies.
−Removed: In Alzheimer’s cell lines, IGC-AD1 has demonstrated the potential to effectively suppress or ameliorate two key hallmarks of Alzheimer’s disease:
−Removed: plaques and tangles.
−Removed: In animal models, it has shown effectiveness in improving memory.
−Removed: Furthermore, in a Phase 1 multiple ascending dose (“MAD”) trial, it exhibited potential efficacy in reducing neuropsychiatric symptoms, including agitation, anxiety, and depression.
−Removed: IGC-AD1 is currently in a Phase 2B, multi-center, randomized, double-blind, placebo-controlled trial, specifically designed to address agitation in dementia from Alzheimer’s disease (clinicaltrials.gov, NCT05543681).
−Removed: Alzheimer’s impacts more than 15 million individuals in North America and Europe.
−Removed: The Company has 13 trial sites under contract in the US and Canada for its Phase 2B trial.
−Removed: Our portfolio includes four other small molecule assets, each at distinct stages of development, all with a singular mission — to transform the landscape of Alzheimer’s treatment.
−Removed: LMP targets neuroinflammation, Aβ plaques, and neurofibrillary tangles, TGR-63 targets Aβ plaque, where we seek to disrupt the progression of Alzheimer’s disease.
−Removed: IGC-M3 targets the inhibition of Aβ plaque aggregation with the potential to create a profound impact on early-stage Alzheimer’s.
−Removed: IGC-1C targets tau and neurofibrillary tangles, IGC-1C represents a forward-thinking approach to Alzheimer’s therapy.
−Removed: Furthermore, IGC controls a total of 21 patent filings.
−Removed: IGC maintains a state-of-the-art manufacturing facility in Washington State, which is poised for potential use in a Phase 3 trial and commercialization of IGC-AD1.
−Removed: In Bogota, Colombia, we also operate an R&D laboratory and an internal Contract Research Organization (“CRO”) that provides clinical trial services.
−Removed: We are actively expanding our technological capabilities with a primary focus on Generative Artificial Intelligence (“AI”) to enhance various aspects of clinical trial operations and data analysis.
−Removed: Our Company is investing in and pursuing AI development with an immediate focus on clinical trial processes, and analysis.
−Removed: Our AI initiatives are centered on informing clinical trials, developing a methodology for early detection of Alzheimer’s, and investigating the interaction of our molecules with cannabinoids.
+Added: IGC Pharma, a clinical-stage company developing treatments for Alzheimer’s disease, is committed to transforming patient care by striving to offer faster-acting and more effective solutions.
+Added: Our leading drug candidate, IGC-AD1, embodies this vision by tackling a critical challenge – managing agitation in Alzheimer’s dementia.
+Added: Early results from our Phase 2 trial are promising:
+Added: IGC-AD1 effectively reduced agitation in patients compared to a placebo, and crucially, it did so much faster than traditional medications.
+Added: While existing anti-psychotics can take a long 6 to 12 weeks to show effects, IGC-AD1 has the potential to act within two weeks.
+Added: This significantly faster onset of action could significantly improve patient care and represents a potential breakthrough in managing Alzheimer’s-related agitation, although there can be no assurance thereof.
+Added: We currently have five platforms, each with a core molecule that can be modified.
+Added: For example, the TGR family consists of many molecules, such as TGR-60, TGR-61, and TGR-63.
+Added: TGR-63 targets plaques in Alzheimer’s.
+Added: Similarly, the IGC-C and IGC-M platforms consist of many molecules.
+Added: The Alzheimer’s targeting molecule from each of our platforms is set forth below:
+Added: Our lead investigational drug tackles agitation, a major burden for patients and caregivers.
+Added: By addressing neuroinflammation, it has the potential to offer a faster-acting solution compared to traditional medications.
+Added: Through pre-clinical studies, TGR-63 has demonstrated its potential to disrupt the progression of Alzheimer’s by targeting Aβ plaques, a key disease hallmark.
+Added: At the preclinical stage, IGC-1C represents a potential breakthrough by targeting tau protein and neurofibrillary tangles, aiming to modify the disease course.
+Added: Also in preclinical development, IGC-M3 focuses on early intervention by inhibiting Aβ plaque formation, potentially slowing cognitive decline.
+Added: In preclinical development, LMP is designed to target multiple hallmarks of Alzheimer’s disease, including Aβ plaques and neurofibrillary tangles, for a comprehensive therapeutic effect.
+Added: We are also developing Artificial Intelligence (“AI”) models for predicting early Alzheimer’s detection biomarkers, optimizing clinical trials, and to help us explore new disease applications for our molecules.
+Added: For example, our AI models are being developed to predict the probability that our molecules can work on other receptors, such as GLP1 (neurological disorders, weight loss), CB1 (neuropsychiatric conditions), among others.
+Added: Additionally, our 26 patent filings, including for IGC-AD1, demonstrate our commitment to innovation and protecting our intellectual property.
Collectively, these core assets and initiatives underscore our commitment to advancing the field of pharmaceuticals, delivering groundbreaking treatments, and creating lasting value for our investors.
We remain steadfast in our pursuit of excellence and our mission to improve the lives of those affected by Alzheimer’s and related conditions.
−Removed: Our manufacturing facility is also utilized to produce women’s wellness products under the brand “Holief.” IGC Pharma is a Maryland corporation established in 2005 with a fiscal year ending on March 31, spanning a 52- or 53-week period.
−Removed: The Company operates in two primary business segments:
−Removed: Life Sciences and Infrastructure.
−Removed: Life Sciences Segment
−Removed: Pharmaceutical :
−Removed: Since 2014, the Company has focused primarily on the potential uses of phytocannabinoids, in combination with other compounds, to treat multiple diseases, such as Alzheimer’s disease.
−Removed: As a company engaged in the clinical-stage pharmaceutical industry, we focus our research and development efforts, subject to results of future clinical trials, on seeking pharmaceutical solutions that may a) alleviate neuropsychiatric symptoms such as agitation, anxiety, and depression associated with dementia in Alzheimer’s disease; and b) halt the onset, progression, or cure Alzheimer’s disease.
−Removed: | December 31, 2023, Form 10-Q
−Removed: Over-the-Counter Products :
−Removed: We have created a women’s wellness brand, Holief™, available through online channels that are compliant with relevant federal, state, and local laws and regulations.
−Removed: Holief™ is an all-natural, non-GMO, vegan, line of over-the-counter (“OTC”) products aimed at treating menstrual cramps (“dysmenorrhea”) and premenstrual syndrome (“PMS”).
−Removed: The products are available online and through Amazon and other online channels.
−Removed: In addition, we white label our product formulations to other companies that market them under their brand.
−Removed: Phase 2 Clinical Trial Update
−Removed: In this document, we use the terms Phase 2 and Phase 2B interchangeably, though typically, a Phase 2 trial is divided into a Phase 2A and a Phase 2B trial.
−Removed: Phase 2A is designed to assess dosing requirements, while Phase 2B is intended to establish efficacy.
−Removed: Our company has started a Phase 2B protocol called “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 trial is powered at 146 Alzheimer’s patients, with half receiving a placebo, and is a superior, parallel-group study.
−Removed: 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.
−Removed: The Phase 2 trial will also look at eleven exploratory objectives, including changes in anxiety, changes in cognitive processes such as attention, orientation, language, and visual spatial skills as well as memory, changes in depression, delusions, hallucinations, euphoria/elation, apathy, disinhibition, irritability, aberrant motor behavior, sleep disorder, appetite, quality of life, and caregiver burden.
−Removed: In addition, the trial will evaluate the impact of CYP450 polymorphisms and specifically CYP2C9 on each of the NPS and assess any reductions in psychotropic drugs, among others.
−Removed: CYP2C9 ranks amongst the most important drug metabolizing enzymes in humans, as it breaks down over 100 drugs, including nonsteroidal anti-inflammatory drugs.
−Removed: We seek to understand how various versions of the enzyme act on IGC-AD1.
−Removed: Each participant will receive two doses of IGC-AD1 (“b.i.d.”) or two doses of placebo per day for six weeks.
−Removed: Infrastructure Segment
−Removed: The Company’s infrastructure business has been operating since 2008.
−Removed: It includes (i) execution of construction contracts and (ii) rental of heavy construction equipment.
+Added: IGC is a Maryland corporation established in 2005 with a fiscal year ending on March 31, spanning a 52- or 53-week period.
+Added: IGC has two business segments:
+Added: Life Sciences Segment and Infrastructure Segment.
+Added: For more information on the business segments, please refer to Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations”.
+Added: | June 30, 2024, Form 10-Q
+Added: Phase 2 Clinical Trial
+Added: IGC Pharma launched a Phase 2 trial with a protocol 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” (clinicaltrials.gov, Identifier:
+Added: The study is powered to include 146 Alzheimer’s patients; as a superiority trial with parallel groups;
+Added: half of the participants will receive a placebo, and the other half will receive IGC-AD1.
+Added: The primary and secondary endpoints are the mean change in agitation scores from baseline, compared to placebo, as assessed by the Cohen-Mansfield Agitation Inventory (“CMAI”) in Alzheimer’s patients after 6 weeks of treatment and the mean change in CMAI scores after 2 weeks of treatment, respectively.
+Added: Agitation is rated at the trial site, at baseline, week 2, and week 6, by a trained practitioner using the CMAI, a scale designed and widely used to measure agitation in Alzheimer’s dementia (“AAD”) in clinical trials.
+Added: The IGC-AD1 Phase 2 is an ongoing clinical trial that continues to enroll.
+Added: IGC-AD1 is an oral liquid formulation administered twice daily (“bid”) for six weeks with no placebo run-in and titration to full dose over two days.
+Added: To date over 1,000 oral doses have been administered, with no dose-limiting adverse events observed, highlighting the safety profile of IGC-AD1.
+Added: The investigational product potentially targets different pathways implicated in agitation in Alzheimer’s dementia (“AAD”), including CB1 receptor dysfunction, neuroinflammation, and neurotransmitter imbalance.
+Added: AI / Machine Learning ( “ ML ” )
+Added: In our pursuit of innovation, we leverage AI and ML.
+Added: AI refers to the development of intelligent systems that can learn and act autonomously.
+Added: ML is a branch of AI that allows computers to learn from data without the need for explicit programming.
+Added: This technology plays a vital role in our efforts and could allow companies our size to do what previously was the domain of much larger pharmaceutical companies.
+Added: For instance, we are utilizing ML by training transformers, a powerful neural network architecture, to analyze vast datasets from our Phase 1 and unblinded Phase 2 interim clinical trial to identify patterns and optimize the clinical trial protocol for a potential Phase 3 trial.
+Added: The AI model, for example, can tell us if a particular neuropsychiatric scale that we used in Phase 1 and Phase 2 added valuable information to the trial, and if it did not, we could remove that scale from a future Phase 3 trial, thus saving money and time in the overall trial management.
+Added: In the long term, with more data, the trained AI model could allow us to consider incoming patient signatures and predict outcomes for our drug, including adverse effects, thus personalizing the delivery of IGC-AD1.
+Added: Additionally, we are developing AI models that help us explore potential applications of molecules from our platforms beyond their initial Alzheimer’s targets;
+Added: we know that TGR-63 and IGC-M3 target plaques in Alzheimer’s, however, AI models could help us consider applications of TGR-60, TGR-61, IGC-M1, IGC-M2, and many others.
+Added: For example, we are investigating whether our molecules might interact with other receptors, like GLP-1.
+Added: GLP-1 is a receptor linked to regulating blood sugar and is increasingly being studied for its potential role in neurological disorders, in addition to its established role in weight management.
+Added: A successful link between our molecules and other targets potentially expands our opportunities, as some of these other markets, such as the weight loss market, are considerably larger than the Alzheimer’s market.
+Added: These applications could potentially lead, if proven in future clinical trials, to new treatment avenues and broader market reach for our molecules.
+Added: This analysis also potentially allows us to prioritize work on our molecules and optimize our resources.
Business Organization
−Removed: As of December 31, 2023, the Company had the following operating subsidiaries:
−Removed: Techni Bharathi Private Limited (TBL), IGCare LLC, HH Processors, LLC (formerly Holi Hemp LLC), IGC Pharma LLC, SAN Holdings LLC, Sunday Seltzer LLC, Hamsa Biopharma India Pvt.
−Removed: Ltd., Colombia-based beneficially-owned subsidiary IGC Pharma SAS (formerly Hamsa Biopharma Colombia SAS) and IGC Pharma IP LLC.
+Added: As of June 30, 2024, the Company had the following operating subsidiaries:
+Added: IGCare LLC, HH Processors, LLC, IGC Pharma, LLC, IGC Pharma IP, LLC, SAN Holdings, LLC, Sunday Seltzer, LLC, Hamsa Biopharma India Pvt.
+Added: Ltd., Techni Bharathi Private Limited (TBL), and Colombia-based beneficially-owned subsidiary IGC Pharma SAS.
The Company’s fiscal year is the 52- or 53-week period that ends on March 31.
−Removed: The Company’s principal office is in Maryland.
−Removed: Additionally, the Company has offices in Washington state, Colombia, and India.
+Added: The Company’s principal office is in Maryland, established in 2005.
+Added: Additionally, the Company has offices in Washington state, Colombia, South America, and India.
The Company’s filings are available on www.sec.gov .
−Removed: IGC Pharma, Inc.
−Removed: was incorporated in 2005.
+Added: | June 30, 2024, Form 10-Q
NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of presentation
−Removed: The accompanying condensed consolidated Balance Sheet as of December 31, 2023, and March 31, 2023, condensed consolidated statements of operations for the three months and nine months ended December 31, 2023, and 2022, and condensed consolidated statements of cash flows for the nine months ended December 31, 2023, and 2022, are unaudited.
−Removed: The consolidated balance sheet as of March 31, 2023, has been derived from audited financial statements, and the accompanying as of December 31, 2023 unaudited condensed consolidated financial statements (“interim statements”) of the Company have been prepared in accordance with accounting principles generally accepted in the U.S.
+Added: The accompanying condensed consolidated Balance Sheet as of June 30, 2024, and March 31, 2024, condensed consolidated statements of operations for the three months ended June 30, 2024, and 2023, and condensed consolidated statements of cash flows for the three months ended June 30, 2024, and 2023, are unaudited.
+Added: The consolidated balance sheet as of March 31, 2024, has been derived from audited financial statements, and the accompanying as of June 30, 2024 unaudited condensed consolidated financial statements (“interim statements”) of the Company have been prepared in accordance with accounting principles generally accepted in the U.S.
GAAP”) as determined by the Financial Accounting Standards Board (the “FASB”) within its Accounting Standards Codification (“ASC”) and under the rules and regulations of the SEC.
3 unchanged sentences
The results reported in these interim statements are not necessarily indicative of the results that may be reported for the entire year.
−Removed: These interim statements should be read in conjunction with the Company’s audited consolidated financial statements for the fiscal year ended March 31, 2023 (“Fiscal 2023”) contained in the Company’s Form 10-K for Fiscal 2023, filed with the SEC on July 7, 2023, specifically in Note 2 to the consolidated financial statements.
−Removed: | December 31, 2023, Form 10-Q
+Added: These interim statements should be read in conjunction with the Company’s audited consolidated financial statements for the fiscal year ended March 31, 2024 (“Fiscal 2024”) contained in the Company’s Form 10-K for Fiscal 2024, filed with the SEC on June 24, 2024, specifically in Note 2 to the consolidated financial statements.
Principles of consolidation
1 unchanged sentence
Intercompany accounts and transactions have been eliminated.
−Removed: In the opinion of Management, the interim statements reflect all adjustments, which are normal and recurring in nature, necessary for fair financial statement presentation.
+Added: In the opinion of the Company’s management, the interim statements reflect all adjustments, which are normal and recurring in nature, necessary for fair financial statement presentation.
Transactions between the Company and its subsidiaries are eliminated in the consolidated financial statements.
Presentation and functional currencies
−Removed: The Company operates in India, the U.S., Colombia, and Hong Kong, and a portion of the Company’s financials are denominated in the Indian Rupee (“INR”), the Hong Kong Dollar (“HKD”), or the Colombian Peso (“COP”).
+Added: The Company operates in the U.S., Colombia, and India and a portion of the Company’s financials are denominated in the Indian Rupee (“INR”), or the Colombian Peso (“COP”).
As a result, changes in the relative values of the U.S.
−Removed: Dollar (“USD”), the INR, the HKD, or the COP affect our financial statements.
+Added: Dollar (“USD”), the INR, or the COP affect our financial statements.
The accompanying financial statements are reported in USD.
−Removed: INR, HKD, and COP are the functional currencies for certain subsidiaries of the Company.
+Added: INR and COP are the functional currencies for certain subsidiaries of the Company.
The translation of the functional currencies into USD is performed for assets and liabilities using the exchange rates in effect at the balance sheet date and for revenues and expenses using average exchange rates prevailing during the reporting periods.
6 unchanged sentences
The Company expects to continue to incur significant operating and net losses and negative cash flows from operations in the near future.
−Removed: The Company estimates that its current cash and cash equivalents balance with working capital credit facility is sufficient to support operations beyond the twelve months following the date these consolidated financial statements and footnotes were issued.
+Added: The Company estimates that its current cash and cash equivalents balance with the working capital and equity investment is sufficient to support operations beyond the twelve months following the date these consolidated financial statements and footnotes were issued.
These estimates are based on assumptions that may prove to be wrong, and the Company could use its available capital resources sooner than it currently expects.
+Added: | June 30, 2024, Form 10-Q
Accounts receivable
1 unchanged sentence
If the financial condition of a customer deteriorates, additional allowances may be required.
−Removed: We had $ 92 thousand of accounts receivable, net of provision for the doubtful debt of $ 12 thousand as of December 31, 2023, as compared to $ 107 thousand of accounts receivable, net of provision for the doubtful debt of $ 17 thousand as of March 31, 2023.
+Added: We had $ 28 thousand of accounts receivable, net of provision for the doubtful debt of $ 24 thousand as of June 30, 2024, as compared to $ 39 thousand of accounts receivable, net of provision for the doubtful debt of $ 24 thousand as of March 31, 2024.
Loss per share
−Removed: The computation of basic loss per share for the nine months ended December 31, 2023, excludes potentially dilutive securities of approximately 9 million shares, which includes share options, unvested shares such as restricted shares and restricted share units, granted to employees, non-employees, and advisors, and shares from the conversion of outstanding units, if any because their inclusion would be anti-dilutive.
−Removed: The weighted average number of shares outstanding for the nine months ended December 31, 2023, and 2022, used for the computation of basic earnings per share (“EPS”) is 57,039,035 and 52,412,830 , respectively, as compared to 63,725,084 and 53,074,123 for the three months ended December 31, 2023, and 2022, respectively.
−Removed: Due to the loss incurred by the Company during the nine months ended December 31, 2023, and 2022, all the potential equity shares are anti-dilutive, and accordingly, the fully diluted EPS is equal to the basic EPS.
−Removed: | December 31, 2023, Form 10-Q
+Added: The computation of basic loss per share for the three months ended June 30, 2024, excludes potentially dilutive securities of approximately 11 million shares, which includes share options, unvested shares such as restricted shares and restricted share units, granted to employees, non-employees, and advisors, and shares from the conversion of outstanding units, if any because their inclusion would be anti-dilutive.
+Added: The weighted average number of shares outstanding for the three months ended June 30, 2024, and 2023, used for the computation of basic earnings per share (“EPS”) is 72,813,538 and 53,077,436 , respectively.
+Added: Due to the loss incurred by the Company during the three months ended June 30, 2024, and 2023, all the potential equity shares are anti-dilutive, and accordingly, the fully diluted EPS is equal to the basic EPS.
Cybersecurity
We have a cybersecurity policy in place and have taken cybersecurity measures to safeguard against hackers, however, there can be no assurance thereof.
−Removed: During the nine months ended December 31, 2023, there were no impactful breaches in cybersecurity.
+Added: During the three months ended June 30, 2024, there were no impactful breaches in cybersecurity.
Revenue Recognition
16 unchanged sentences
Revenue from white label services is recognized when the performance obligation has been completed, and output material has been transferred to the customer.
−Removed: Net sales disaggregated by significant products and services for the three months and nine months ended December 31, 2023, and 2022 are as follows:
−Removed: (in thousands)
−Removed: Three months ended
−Removed: December 31, 2023
−Removed: (in thousands)
−Removed: Three months ended
−Removed: December 31, 2022
−Removed: (in thousands)
−Removed: Nine months ended
−Removed: December 31, 2023
+Added: | June 30, 2024, Form 10-Q
+Added: Net sales disaggregated by significant products and services for the three months ended June 30, 2024, and 2023 are as follows:
(in thousands)
−Removed: Nine months ended
−Removed: December 31, 2022
+Added: Three months ended June 30,
Infrastructure segment (1)
3 unchanged sentences
(1) Infrastructure segment consists of income from the rental of heavy construction equipment and construction contracts.
−Removed: (2) Revenue from wellness and lifestyle consists of the sale of products such as gummies, hand sanitizers, bath bombs, lotions, beverages, hemp crude extract, hemp isolate, and hemp distillate.
+Added: (2) Revenue from wellness and lifestyle consists of the sale of products such as gummies, hand sanitizers, bath bombs, lotions, hemp crude extract, hemp isolate, and hemp distillate.
(3) Revenue from white label services consists of rebranding our formulations or the customer’s products as per the customer’s requirement.
4 unchanged sentences
Newly issued ASUs not listed are expected to have no impact on the Company’s consolidated financial position and results of operations, because either the ASU is not applicable, or the impact is expected to be immaterial.
−Removed: | December 31, 2023, Form 10-Q
NOTE 3 – INVENTORY
(in thousands)
−Removed: December 31, 2023
+Added: June 30, 2024
March 31, 2024
2 unchanged sentences
Finished goods
−Removed: During the nine months ended December 31, 2023, and 2022, the Company wrote off approximately $ 746 thousand and $ 110 thousand of inventory due to abnormal loss due to the product expiration, idle facility expense, freight, handling costs, scrap, and wasted material (spoilage).
+Added: During the three months ended June 30, 2024, and 2023, the Company wrote off approximately $ 26 and $ 20 thousand of inventory due to abnormal loss due to the product expiration, idle facility expense, freight, handling costs, scrap, and wasted material (spoilage).
This charge was recorded in Selling, general, and administrative Expenses.
We capitalize inventory costs related to our investigational drug, provided that management determines there is a potential alternative use for the inventory in future research and development projects or other purposes.
−Removed: As of December 31, 2023, and March 31, 2023, our consolidated balance sheet reported approximately $ 397 thousand and $ 407 thousand clinical trial-related inventory, respectively.
+Added: As of June 30, 2024, and March 31, 2024, our consolidated balance sheet reported approximately $ 392 thousand clinical trial-related inventory, respectively.
NOTE 4 – DEPOSITS AND ADVANCES
(in thousands)
−Removed: December 31, 2023
+Added: June 30, 2024
March 31, 2024
2 unchanged sentences
Prepaid expenses and other current assets
+Added: | June 30, 2024, Form 10-Q
The Advances to suppliers and consultants primarily relate to advances to vendors.
−Removed: Prepaid expenses and other current assets include approximately $ 27 thousand of statutory advances as of December 31, 2023, and approximately $ 25 thousand as of March 31, 2023, respectively.
+Added: Prepaid expenses and other current assets include approximately $ 34 thousand statutory advances as of June 30, 2024, and approximately $ 39 thousand as of March 31, 2024, respectively.
NOTE 5 – INTANGIBLE ASSETS
(in thousands)
−Removed: December 31, 2023
+Added: June 30, 2024
March 31, 2024
4 unchanged sentences
Other intangible assets
−Removed: Other intangibles
+Added: Software development cost
Total unamortized intangible assets
Total intangible assets
−Removed: | December 31, 2023, Form 10-Q
−Removed: The value of intangible assets includes the cost of acquiring patent rights, supporting data, and the expense associated with filing of patent applications.
+Added: The value of intangible assets includes the cost of acquiring patent rights, supporting data, and the expense associated with filing various patent applications in different countries along with granted patents.
It also includes acquisition costs related to domains and licenses.
−Removed: The intangible with finite life is up to 20 years are amortized on straight-line basis, commencing from the date of grant or acquisition.
−Removed: The amortization expense in the three months ended December 31, 2023, and 2022, amounted to approximately $ 19 thousand and $ 14 thousand, respectively, whereas the amortization expense in the nine months ended December 31, 2023, and 2022 amounted to approximately $ 55 thousand and $ 38 thousand, respectively.
−Removed: The Company regularly reviews its intangible assets to determine if any intangible asset is other-than-temporarily impaired, which would require the Company to record an impairment charge in the period and concluded that, as of December 31, 2023, there was no impairment.
+Added: The amortization of patent and patent rights with finite life is up to 20 years, commencing from the date of grant or acquisition.
+Added: The amortization expense in the three months ended June 30, 2024, and 2023, amounted to approximately $ 20 thousand and $ 18 thousand, respectively.
+Added: The Company regularly reviews its intangible assets to determine if any intangible asset is other-than-temporarily impaired, which would require the Company to record an impairment charge in the period and concluded that, as of June 30, 2024, there was no impairment.
Estimated annual amortization expense
8 unchanged sentences
Useful Life (years)
−Removed: December 31, 2023
+Added: June 30, 2024
March 31, 2024
7 unchanged sentences
Total property, plant, and equipment, net
−Removed: The depreciation expense in the three months ended December 31, 2023, and 2022 amounted to approximately $ 140 thousand and $ 158 thousand, respectively.
−Removed: The depreciation expense in the nine months ended December 31, 2023, and 2022 amounted to approximately $ 417 thousand and $ 466 thousand, respectively.
−Removed: The net decrease in Total property, plant, and equipment is primarily due to the impairment of land by approximately $ 2.6 million.
−Removed: During the nine months ended December 2023, the Company sold a fully depreciated property in India for net proceeds of approximately $ 43 thousand and accounted the same in other income.
−Removed: During the quarter ended December 31, 2023, the Company considered multiple alternatives to generate revenue from the land situated in Nagpur, India, and did a preliminary evaluation of the Nagpur real estate market.
−Removed: As a result, the Company impaired the said land comprised in the infrastructure segment by approximately $ 2.6 million to $ 1.4 million from $ 4.1 million to bring it closer to the fair value.
+Added: | June 30, 2024, Form 10-Q
+Added: The depreciation expense in the three months ended June 30, 2024, and 2023 amounted to approximately $ 142 thousand and $ 137 thousand, respectively.
For more information, please refer to Note 16 – “Segment Information” for the non-current assets other than financial instruments held in the country of domicile and foreign countries.
+Added: Asset Held For Sale
+Added: During Fiscal 2024, the Company focused on liquidating all non-operating assets to reduce costs and generate cash.
+Added: As a result, the Company impaired the land situated in Nagpur, India, by approximately $ 3.3 million to $ 720 thousand from $ 4.1 million to bring it closer to the fair market value.
+Added: The Company believes it can sell the above-said non-operating land as it is without any improvement.
+Added: Selling this land will give immediate cash, which the Company can use in its operating segments.
+Added: During the three months ended June 30, 2024, the Company started negotiating with an interested buyer and received approximately $ 180 thousand as a deposit.
+Added: In the month of July 2024, the Company entered into an agreement with the buyer to sell the said land for a net realizable value of approximately $ 717 thousand.
+Added: The agreement is subject to the final registration and execution.
+Added: As of June 30, 2024, the Company holds the ownership and possession of the said land.
NOTE 7 – LEFT BLANK INTENTIONALLY
−Removed: | December 31, 2023, Form 10-Q
NOTE 8 – CLAIMS AND ADVANCES
(in thousands)
−Removed: December 31, 2023
+Added: June 30, 2024
March 31, 2024
1 unchanged sentence
Non-current deposits
−Removed: Non-current advances
The claims receivable is due from different vendors.
While the Company has initiated collection proceedings internally or with the appropriate authorities, it believes receiving the amount in the next 12 months will be challenging because of the time required for collection proceedings.
−Removed: It includes $ 166 thousand owed to the company by one of our manufacturers for the equipment purchase.
NOTE 9 – LEFT BLANK INTENTIONALLY
1 unchanged sentence
(in thousands)
−Removed: December 31, 2023
+Added: June 30, 2024
March 31, 2024
5 unchanged sentences
In addition, provision for expenses includes provision for legal, professional, and marketing expenses.
−Removed: Other current liability also includes statutory payables of approximately $ 41 thousand and $ 31 thousand as of December 31, 2023, and March 31, 2023, respectively, and approximately $ 3 thousand of short-term loans as of December 31, 2023, and March 31, 2023, respectively.
+Added: Other current liability also includes statutory payables of approximately $ 23 thousand and $ 25 thousand as of June 30, 2024, and March 31, 2024, respectively, and approximately $ 3 thousand of short-term loans as of June 30, 2024, and March 31, 2024, respectively.
+Added: | June 30, 2024, Form 10-Q
NOTE 11 – LOANS AND OTHER LIABILITIES
−Removed: Loan as of December 31, 2023:
+Added: Loan as of June 30, 2024:
On June 11, 2020, the Company received an Economic Injury Disaster Loan (“EIDL”) for approximately $ 150 thousand at an annual interest rate of 3.75 %.
2 unchanged sentences
All remaining principal and accrued interest is due and payable 30 years from the date of the loan.
−Removed: For the nine months ended December 31, 2023, the interest expense and principal payment for the EIDL were approximately $ 4 thousand and $ 2 thousand, respectively.
−Removed: For the nine months ended December 31, 2022, the interest expense and principal payment for the EIDL were approximately $ 4.1 thousand and $ 2 thousand, respectively.
−Removed: As of December 31, 2023, approximately $ 138 thousand of the loan is classified as Long-term loans and approximately $ 3 thousand as Short-term loans.
−Removed: | December 31, 2023, Form 10-Q
−Removed: On June 30, 2023, the Company entered into a Master Loan and Security Agreement with O-Bank, CO., LTD.
−Removed: (the “Credit Agreement”), pursuant to which the Company may borrow up to $ 12 million, which will be used to fulfill liquidity requirements and ensure the Company’s ability to sustain its operations.
−Removed: The Credit Agreement matures June 30, 2024, with an option to renew.
−Removed: Interest on borrowings will be calculated according to the interest rate stated in the Certificate of Deposit (as defined in the Credit Agreement), plus an applicable margin of 1 %, and the Company will bear the tax.
−Removed: The Company must pay the interest in full on the last business day of each interest period.
−Removed: As of December 31, 2023, the Company has not yet used any of the $ 12 million available under the Credit Agreement.
+Added: For the three months ended June 30, 2024, the interest expense and principal payment for the EIDL were approximately $ 1 thousand and 1 thousand, respectively.
+Added: For the three months ended June 30, 2023, the interest expense and principal payment for the EIDL were approximately $ 1 thousand and $ 1 thousand, respectively.
+Added: As of June 30, 2024, approximately $ 136 thousand of the loan is classified as Long-term loans and approximately $ 3 thousand as Short-term loans.
Other Liability:
(in thousands)
−Removed: December 31, 2023
+Added: June 30, 2024
March 31, 2024
4 unchanged sentences
Such matters are subject to many uncertainties, and outcomes are not predictable with assurance.
−Removed: There are no such matters that are deemed material to the condensed consolidated financial statements as of December 31, 2023, except as disclosed in the legal proceedings section below.
+Added: There are no such matters that are deemed material to the condensed consolidated financial statements as of June 30, 2024, except as disclosed in the legal proceedings section below.
In the U.S., we provide health insurance, life insurance, and a 401(k) plan wherein the Company matches up to 6 % of the employee’s pre-tax contribution up to a maximum annual amount determined by the IRS.
5 unchanged sentences
NOTE 13 – SECURITIES
−Removed: As of December 31, 2023, the Company was authorized to issue up to 150,000,000 shares of common stock, par value $ 0.0001 per share, and 63,734,439 shares of common stock were issued and outstanding.
−Removed: The Company is also authorized to issue up to 1,000,000 shares of preferred stock, par value $ 0.0001 per share, and no preferred shares were issued and outstanding as of December 31, 2023.
+Added: As of June 30, 2024, the Company was authorized to issue up to 150,000,000 shares of common stock, par value $ 0.0001 per share, and 75,636,419 shares of common stock were issued and outstanding.
+Added: The Company is also authorized to issue up to 1,000,000 shares of preferred stock, par value $ 0.0001 per share, and no preferred shares were issued and outstanding as of June 30, 2024.
Our common stock is listed on the NYSE American (ticker symbol:
3 unchanged sentences
The unit holders are requested to contact the Company or our transfer agent, Continental Stock Transfer and Trust, to separate their units into common stock.
−Removed: In November 2023, Apogee and the Company participated in a mediation and IGC paid Apogee $100,000 as part of a mutual release and settlement of all claims against each other.
−Removed: For more information, kindly refer to Item 1 – Legal Proceedings for more information.
−Removed: | December 31, 2023, Form 10-Q
−Removed: On October 27, 2023, the Company entered into a Sales Agreement (the “Agreement”) with A.G.P./Alliance Global Partners (the “Agent”) pursuant to which the Company may offer and sell, from time to time, through the Agent, as sales agent and/or principal shares of its common stock having an aggregate offering price of up to $ 60 million (“Shares”), subject to certain limitations on the amount of common stock that may be offered and sold by the Company set forth in the Sales Agreement (the “Offering”).
−Removed: Prior to entering into the Sales Agreement with A.G.P./Alliance Global Partners, the Company terminated the Sales Agreement dated January 13, 2021, with The Benchmark Company.
+Added: On March 22, 2024, the Company entered into a Share Purchase Agreement (the “March 2024 SPA”) with Bradbury Strategic Investment Fund A, resulting in approximately $ 3 million in gross proceeds.
+Added: During the quarter ended June 30, 2024, the Company issued approximately 8.8 million shares of unregistered common stock at a price of $ 0.34 per share.
+Added: Shares are intended to be exempt from registration under the Securities Act of 1933, as amended (the “Securities Act”), by virtue of the provisions of Section 4(a)(2) of the Securities Act and Regulation D and/or Regulation S adopted thereunder.
+Added: During fiscal 2024, the Company had received $ 500 thousand of the total $ 3 million due under the March 2024 SPA, while the remaining $ 2.5 million was received in April 2024.
+Added: | June 30, 2024, Form 10-Q
NOTE 14 – STOCK-BASED COMPENSATION
−Removed: As of December 31, 2023, 9 million restricted share units (“RSUs”), fair valued at $ 5.6 million with a weighted average value of $ 0.64 per share, have been granted but not yet issued from different Incentive Plans and Grants.
−Removed: This includes 4.7 million RSUs granted to employees and directors, which consists of a vesting schedule based entirely on the attainment of both operational milestones and market conditions, assuming continued employment either as an employee or director with the Company.
−Removed: The performance-based RSUs are accounted upon certification by Management, confirming the probability of achievement of milestones.
−Removed: As of December 31, 2023, Management confirmed three of the milestones had been achieved, and the rest were considered probable to be achieved by March 31, 2028.
−Removed: Additionally, options held by advisors and directors to purchase 150 thousand shares of common stock fair valued at $ 69 thousand with a weighted average of $ 0.46 per share have been granted but are to be exercised over a service period ending in Fiscal 2031.
−Removed: Options exercised before the service period are expensed when exercised.
+Added: As of June 30, 2024, under both the Company’s previous 2008 and current 2018 Omnibus Incentive Plans approximately 9.1 million shares of common stock have been issued to employees, non-employees, and advisors.
+Added: In addition, 7.6 million restricted share units (“RSUs”) fair valued at $ 4.6 million with a weighted average value of $ 0.61 per share, have been granted but not yet issued from different Incentive Plans and Grants.
+Added: This includes 4.9 million RSUs granted to employees and directors, which consists of a vesting schedule based entirely on the attainment of either operational milestones (performance conditions) or market conditions, assuming continued employment either as an employee, or director with the Company.
+Added: The performance-based RSUs are accounted for upon certification by the management, confirming the probability of achievement of milestones.
+Added: As of June 30, 2024, the management confirmed that five milestones had been achieved, and the rest were probable to be achieved by March 31, 2028.
+Added: Additionally, options held by advisors and directors to purchase 3.7 million shares of common stock fair valued at $ 925 thousand with a weighted average of $ 0.25 per share, which have been granted but are to be issued over a vesting period between Fiscal 2022 and Fiscal 2027.
+Added: Options granted and issued before the vesting period are expensed when issued.
The options are valued using a Black-Scholes Pricing Model, and Market-based RSUs are valued based on a lattice model, with the following assumptions:
4 unchanged sentences
Risk-free interest rate
+Added: 4.15 % 5.24 %
Expected volatility
1 unchanged sentence
The expense associated with share-based payments to employees, directors, advisors, and contractors is allocated over the vesting or service period and recognized in the Selling, general, and administrative expenses (including research and development).
−Removed: For the nine months ended December 31, 2023, the Company’s share-based expense and option-based expense shown in Selling, General and Administrative expenses (including research and development) were $ 1.4 million and $ 9 thousand, respectively, and for the nine months ended December 31, 2022, the Company’s share-based expense and option-based expense was $ 2.2 million and $ 23 thousand, respectively.
+Added: For the three months ended June 30, 2024, the Company’s share-based expense and option-based expense shown in Selling, general, and administrative expenses (including research and development) were $ 268 thousand and $ 165 thousand, respectively, and for the three months ended June 30, 2023, the Company’s share-based expense and option-based expense was $ 354 thousand and $ 4 thousand, respectively.
Non-vested shares
4 unchanged sentences
Cancelled/forfeited
−Removed: Non-vested shares as of December 31, 2023
+Added: Non-vested shares as of June 30, 2024
(in thousands)
5 unchanged sentences
Cancelled/forfeited
−Removed: Options outstanding as of December 31, 2023
−Removed: | December 31, 2023, Form 10-Q
−Removed: There was a combined unrecognized expense of $ 2.1 million related to non-vested shares and share options that the Company expects to be recognized over the weighted average life of 5 years.
+Added: Options outstanding as of June 30, 2024
+Added: | June 30, 2024, Form 10-Q
+Added: There was a combined unrecognized expense of $ 2.7 million related to non-vested shares and share options that the Company expects to be recognized over a life of up to 4 (four) years.
NOTE 15 – FAIR VALUE OF FINANCIAL INSTRUMENTS
−Removed: As of December 31, 2023, the Company’s investments may consist of money market funds, debt and equity funds, and other marketable securities, among others, which have been classified as Level 1 of the fair value hierarchy because they have been valued using quoted prices in active markets.
+Added: As of June 30, 2024, the Company’s investments may consist of money market funds, debt and equity funds, and other marketable securities, among others, which have been classified as Level 1 of the fair value hierarchy because they have been valued using quoted prices in active markets.
The Company’s cash and cash equivalents have also been classified as Level 1 on the same principle.
3 unchanged sentences
Level 3 investments are valued using the cost method.
−Removed: The following table presents information about the Company’s assets that are measured at fair value on a recurring basis as of December 31, 2023, and March 31, 2023, and indicates the fair value hierarchy of the valuation techniques the Company used to determine such fair value:
+Added: The following table presents information about the Company’s assets that are measured at fair value on a recurring basis as of June 30, 2024, and March 31, 2024, and indicates the fair value hierarchy of the valuation techniques the Company used to determine such fair value:
(in thousands)
−Removed: As of December 31, 2023
+Added: As of June 30, 2024
Adjusted Cost
7 unchanged sentences
Certificates of Deposit
−Removed: | December 31, 2023, Form 10-Q
+Added: | June 30, 2024, Form 10-Q
NOTE 16 – SEGMENT INFORMATION
11 unchanged sentences
(in thousands)
−Removed: Three months ended
−Removed: December 31, 2023
−Removed: (in thousands)
−Removed: December 31, 2022
−Removed: (in thousands)
−Removed: Nine months ended
−Removed: December 31, 2023
−Removed: (in thousands)
−Removed: Nine months ended
−Removed: December 31, 2022
+Added: Three months ended June 30,
Infrastructure segment
7 unchanged sentences
Three months ended
−Removed: December 31, 2023
−Removed: Nine months ended
−Removed: December 31, 2023
+Added: June 30, 2024
+Added: Percentage of
+Added: Total Revenue
(in thousands)
Three months ended
−Removed: December 31, 2022
−Removed: Nine months ended
−Removed: December 31, 2022
−Removed: | December 31, 2023, Form 10-Q
+Added: June 30, 2023
+Added: Percentage of
+Added: Total Revenue
+Added: | June 30, 2024, Form 10-Q
3) The table below shows the non-current assets other than financial instruments held in the country of domicile (U.S.) and foreign countries.
3 unchanged sentences
Foreign Countries
−Removed: (India, Hong Kong, and Colombia)
−Removed: December 31, 2023
+Added: (India and Colombia)
+Added: June 30, 2024
Intangible assets, net
7 unchanged sentences
Foreign Countries
−Removed: (India, Hong Kong, and Colombia)
+Added: (India and Colombia)
March 31, 2024
4 unchanged sentences
Total non-current assets
−Removed: NOTE 17 – LEFT BLANK INTENTIONALLY
−Removed: | December 31, 2023, Form 10-Q
+Added: NOTE 17 – SUBSEQUENT EVENT
+Added: In the month of July 2024, the Company entered into an Agreement to Sell (“Agreement”) to sell the land situated in Nagpur for a net realizable value of approximately $ 717 thousand.
+Added: The above-said agreement is subject to the final registration and execution.
+Added: The Company holds the ownership and possession of the said land.
+Added: On July 08, 2024, the Company successfully renewed the working capital credit facility from O- Bank, totaling $ 12 million for one year.
+Added: This credit facility serves to minimize ongoing liquidity requirements and ensure the Company’s ability to sustain its operations.
+Added: | June 30, 2024, Form 10-Q
Management ’ s Discussion and Analysis of Financial Condition and Results of Operations
The purpose of this Management’s Discussion and Analysis (“MD&A”) is to provide an understanding of IGC Pharma, Inc.’s (“IGC,” the “Company,” “we,” “our,” and/or “us”) consolidated financial condition and results of operations and cash flows.
−Removed: The MD&A should be read in conjunction with our unaudited condensed financial statements and related notes that appear elsewhere in this Quarterly Report on Form 10-Q for the three months and nine months ended December 31, 2023, and the Annual Report on Form 10-K for the fiscal year ended March 31, 2023, filed with the SEC on July 7, 2023 (the “2023 Form 10-K”).
+Added: The MD&A should be read in conjunction with our unaudited condensed financial statements and related notes that appear elsewhere in this Quarterly Report on Form 10-Q for the three months ended June 30, 2024, and the Annual Report on Form 10-K for the fiscal year ended March 31, 2024, filed with the SEC on June 24, 2024 (the “2024 Form 10-K”).
The Company’s actual results could differ materially from those discussed here.
3 unchanged sentences
We disclaim any obligation, except as expressly required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those outlined in the forward-looking statements.
−Removed: IGC Pharma is a clinical-stage pharmaceutical company developing novel therapies for Alzheimer’s disease and conditions related to the central nervous system.
−Removed: The company is pursuing five assets:
−Removed: IGC-AD1, TGR-63, LMP, IGC-1C, and IGC-M3, all of which target Alzheimer’s disease and are at various stages of development.
−Removed: Our most clinically advanced investigational new drug for Alzheimer’s, IGC-AD1, has shown significant promise in preclinical studies.
−Removed: In Alzheimer’s cell lines, IGC-AD1 has demonstrated the potential to effectively suppress or ameliorate two key hallmarks of Alzheimer’s disease:
−Removed: plaques and tangles.
−Removed: In animal models, it has shown effectiveness in improving memory.
−Removed: Furthermore, in a Phase 1 multiple ascending dose (MAD) trial, it exhibited potential efficacy in reducing neuropsychiatric symptoms, including agitation, anxiety, and depression.
−Removed: IGC-AD1 is currently in a Phase 2B, multi-center, randomized, double-blind, placebo-controlled trial, specifically designed to address agitation in dementia from Alzheimer’s disease (clinicaltrials.gov, NCT05543681).
−Removed: Alzheimer’s affects more than 15 million individuals in North America and Europe.
−Removed: The Phase 2 trial is being conducted at 13 sites in the US and Canada.
−Removed: Our portfolio includes four other small molecule assets, each at distinct stages of development, all with a singular mission — to transform the landscape of Alzheimer's treatment.
−Removed: LMP targets neuroinflammation, Aβ plaques, and neurofibrillary tangles, TGR-63 targets Aβ plaque, where we seek to disrupt the progression of Alzheimer's disease.
−Removed: IGC-M3 targets the inhibition of Aβ plaque aggregation with the potential to create a profound impact on early-stage Alzheimer’s.
−Removed: IGC-1C targets tau and neurofibrillary tangles, IGC-1C represents a forward-thinking approach to Alzheimer's therapy.
−Removed: Furthermore, IGC controls a total of 21 patent filings.
−Removed: IGC maintains a state-of-the-art manufacturing facility in Washington State, which is poised for potential use in a Phase 3 trial and commercialization of IGC-AD1.
−Removed: In Bogota, Colombia, we also operate an R&D laboratory and an internal Contract Research Organization (“CRO”) that provides clinical trial services.
−Removed: The Company is actively expanding its technological capabilities with a primary focus on Generative Artificial Intelligence (“AI”) to enhance various aspects of operations, including clinical research and clinical trials.
−Removed: Our company is investing in and driving AI development with a strong focus on transforming our approach, gaining insights, and increasing cost efficiencies.
−Removed: Our AI initiatives are centered on informing clinical trials, developing a methodology for early detection of Alzheimer’s, and investigating the interaction of pharmaceuticals with cannabinoids.
−Removed: Collectively, these core assets and initiatives underscore our commitment to advancing the field of pharmaceuticals, delivering groundbreaking treatments, and creating lasting value for our investors.
−Removed: We remain steadfast in our pursuit of excellence and our mission to improve the lives of those affected by Alzheimer’s and related conditions.
−Removed: Our manufacturing facility is also utilized to produce women’s wellness products under the brand “Holief.” IGC Pharma is a Maryland corporation established in 2005 with a fiscal year ending on March 31, spanning a 52- or 53-week period.
−Removed: The company operates in two primary business segments:
−Removed: Life Sciences and Infrastructure.
+Added: IGC Pharma is on a mission to transform Alzheimer’s treatment.
+Added: We are attempting to build a robust pipeline comprising five assets, each targeting different facets of Alzheimer’s disease at various stages of development.
+Added: Our primary drug candidate, currently undergoing a Phase 2 clinical trial (clinicaltrials.gov, CT05543681), IGC-AD1 holds significant potential in alleviating the burden of agitation in this vulnerable population.
+Added: This CB1 partial agonist is specifically designed to address neuroinflammation associated with agitation in Alzheimer’s patients.
+Added: Through pre-clinical studies, TGR-63 has demonstrated its potential to disrupt the progression of Alzheimer’s by targeting Aβ plaques, a hallmark feature of the disease.
+Added: This approach offers new avenues for intervening in the underlying pathology of Alzheimer’s.
+Added: At the preclinical stage, we believe IGC-1C represents a forward-thinking approach to Alzheimer’s therapy by targeting tau protein and neurofibrillary tangles, crucial contributors to the neurodegenerative process.
+Added: By addressing these pathological mechanisms, IGC-1C holds potential for disease-modifying interventions.
+Added: Also in preclinical development, IGC-M3 aims to inhibit the aggregation of Aβ plaques, offering potential therapeutic benefits in early stage Alzheimer’s by targeting the underlying pathology responsible for cognitive decline.
+Added: Designed to target multiple hallmarks of Alzheimer’s disease, including Aβ plaques and neurofibrillary tangles, LMP potentially represents a comprehensive therapeutic approach to addressing the complex pathophysiology of the disease.
+Added: In addition to our pipeline of therapeutic candidates, IGC Pharma is attempting to leverage Artificial Intelligence (“AI”) to develop models for the early detection of Alzheimer’s and to optimize clinical trial design.
+Added: By integrating cutting-edge technology with innovative drug development, we are striving to make significant steps in the fight against Alzheimer’s disease.
+Added: Furthermore, IGC controls a total of 26 patent filings reflecting our commitment to innovation and intellectual property protection, including for IGC-AD1.
+Added: Our patent portfolio underscores our dedication to safeguarding our competitive advantage in the market.
+Added: IGC Pharma Inc., is a Maryland corporation established in 2005 with a fiscal year ending on March 31, spanning a 52- or 53-week period.
+Added: IGC has two segments:
+Added: Life Sciences Segment and Infrastructure Segment.
+Added: | June 30, 2024, Form 10-Q
Life Sciences Segment
−Removed: Pharmaceutical :
−Removed: Since 2014, the Company has focused primarily on the potential uses of phytocannabinoids, in combination with other compounds, to treat multiple diseases, such as Alzheimer’s disease.
−Removed: As a company engaged in the clinical-stage pharmaceutical industry, we focus our research and development efforts, subject to results of future clinical trials, on seeking pharmaceutical solutions that may a) alleviate neuropsychiatric symptoms such as agitation, anxiety, and depression associated with dementia in Alzheimer’s disease; and b) halt the onset, progression, or cure Alzheimer’s disease.
−Removed: | December 31, 2023, Form 10-Q
−Removed: Currently, IGC-AD1 is in a Phase 2B safety and efficacy clinical trial for agitation in dementia from Alzheimer’s (clinicaltrials.gov, NCT05543681).
−Removed: The progress we are making in the clinical trial, gives us confidence in the potential of IGC-AD1 as a potentially groundbreaking therapy, with the potential to treat Alzheimer’s and to manage devastating symptoms that separate families, increase admissions to nursing homes, and drive the cost of Alzheimer’s care, although there can be no assurance.
−Removed: Although there can be no assurance, we believe that additional investment in clinical trials, research, and development (“R&D”), facilities, marketing, advertising, AI and acquisition of complementary products and businesses supporting our Life Sciences segment will be critical to the development and delivery of innovative products and positive patient and customer experiences.
−Removed: We hope to leverage our R&D and intellectual property to develop ground-breaking, science-based products that are proven effective through planned pre-clinical and clinical trials.
−Removed: Although there can be no assurance, we believe this strategy has the potential to improve existing products and lead to the creation of new products, which, based on scientific study and research, may offer positive results for the management of certain conditions, symptoms, and side effects.
−Removed: While the bulk of our medium and longer-term focus is on clinical trials and getting IGC-AD1 into an FDA-approved drug, our shorter-term strategy is to use our resources to provide white-label services and market Holief™.
−Removed: We believe this may provide us with several profit opportunities, although there can be no assurance of such profit opportunities.
−Removed: Over-the-Counter Products :
−Removed: We have created a women’s wellness brand, Holief™, available through online channels that are compliant with relevant federal, state, and local laws and regulations.
−Removed: Holief™ is an all-natural, non-GMO, vegan, line of over-the-counter (“OTC”) products aimed at treating menstrual cramps (“dysmenorrhea”) and premenstrual syndrome (“PMS”).
−Removed: The products are available online and through Amazon and other online channels.
−Removed: In addition, we sell our product formulations to other companies that market them under their brand.
−Removed: This is the white label part of the OTC business.
−Removed: Contract Research Organization (CRO) and Clinical Trial Software:
−Removed: The IGC-Pharma Electronic Data Capture system (“IGC-EDC”) is a secure and user-friendly data management software designed to collect clinical trial data in electronic format.
−Removed: The software incorporates rigorous security measures that help IGC to protect data and ensure compliance with regulatory requirements and industry standards.
−Removed: This format is designed for our clinical trials, especially our Phase 2 trial.
−Removed: The EDC system is designed to store and organize handwritten source documents, including medical history, concomitant medications, laboratory results, neuropsychiatric scales scores, adverse events, vital signs, safety calls, demographics, among others.
−Removed: The system allows users to generate data reports that will be used for data analysis and generate computational models to simulate the effects of our investigational drug IGC-AD1 on participants’ outcomes.
−Removed: At IGC Pharma, we recognize the significance of operational excellence and cost management in clinical trials.
−Removed: One major cost driver in conducting trials is the expense associated with engaging CROs.
−Removed: These costs can significantly impact on the overall budget of a trial.
−Removed: To address this challenge and optimize trial costs, we have established an internal CRO, including proprietary software that we believe sets us apart from the traditional approach of outsourcing.
−Removed: We believe this strategic move will enable us to reduce the costs associated with clinical trials compared to relying on external CROs, although there can be no assurance.
−Removed: On July 21, 2023, IGC Pharma and the University of Los Andes (“Faculty of Engineering”) signed a Master Cooperation Agreement, to conduct innovative research in AI applied to the pharmaceutical industry and to join efforts to create academic spaces that allow for generating research and development projects and innovation.
−Removed: This agreement will enable us to work closely with some of the brightest minds in the field and develop innovative projects.
−Removed: We are excited to collaborate with the University of Los Andes and are committed to advancing the frontiers of science and technology together.
−Removed: We believe this overlay of AI will help us simulate trial scenarios, generate new insights to facilitate improved decision-making, efficiently design our Phase 3 trial, provide advanced data analysis, and ultimately enhance the effectiveness and efficiency of our clinical trials, although there can be no assurance thereof.
−Removed: Our AI initiatives are centered on enhancing clinical trials, developing a methodology for early detection of Alzheimer’s, and investigating the interaction of pharmaceuticals with cannabinoids.
−Removed: By leveraging AI technology, we aim to accelerate progress in Alzheimer’s drug development and revolutionize the way we approach treatment.
−Removed: We believe that our commitment to advancing the field of AI in medicine creates a strategic advantage in the industry, although there can be no assurance thereof.
−Removed: | December 31, 2023, Form 10-Q
+Added: IGC Pharma, a clinical-stage company developing treatments for Alzheimer’s disease, is committed to transforming patient care by striving to offer faster acting and more effective solutions.
+Added: Our lead drug, IGC-AD1, embodies this vision by tackling a critical challenge – managing agitation in Alzheimer’s dementia.
+Added: Early results from our Phase 2 trial are promising:
+Added: IGC-AD1 effectively reduced agitation in patients compared to a placebo, and crucially, it did so much faster than traditional medications.
+Added: While existing anti-psychotics can take a long 6 to 12 weeks to show effects, IGC-AD1 has the potential to act within two weeks.
+Added: This significantly faster onset of action could significantly improve patient care and represents a potential breakthrough in managing Alzheimer’s-related agitation, although there can be no assurance thereof.
+Added: In addition, we have created in-house wellness brands, available through online channels that are compliant with relevant federal, state, and local laws and regulations.
+Added: We derive revenue from our in-house wellness non-pharmaceutical formulations that are manufactured as non-GMO, vegan, products at our facility and are sold over-the-counter (“OTC”).
Infrastructure Segment
−Removed: The Company’s infrastructure business has been operating since 2008.
−Removed: It includes (i) execution of construction contracts and (ii) rental of heavy construction equipment.
−Removed: Company Highlights for the Quarter ended December 31, 2023
−Removed: On October 25, 2023, Divisional Direction of Patents, Mexico, issued a Granting Office Action (GOA) to the Company titled “METHOD AND COMPOSITION FOR TREATING CNS DISORDER”, for the treatment of Alzheimer’s disease.
−Removed: On October 18, 2023, the European Patent Office (“EPO”) issued a patent (#3193862) to the Company titled “CANNABINOID COMPOSITION AND METHOD FOR TREATING PAIN”.
−Removed: The patent introduces a method for treating pain in humans.
−Removed: Utilizing a cream base infused with a unique blend of cannabinoids, including THC and CBD, alongside other compounds, this revolutionary cream or gel is designed for transdermal absorption.
−Removed: It interacts harmoniously with the peripheral nervous and immune systems, delivering effective pain relief without psychotropic or adverse side effects..
−Removed: Business Strategy
−Removed: The Life Sciences business strategy includes:
−Removed: Subject to FDA approval, developing IGC-AD1 as a drug for treating agitation in dementia due to Alzheimer’s and investigating and developing TGR-63, LMP, IGC-1C and IGC -M3 for the potential treatment of Alzheimer’s disease.
−Removed: Marketing Holief TM and formulations.
+Added: The Company’s infrastructure business has been operating since 2008, it includes (i) Execution of Construction Contracts and (ii) Rental of Heavy Construction Equipment.
+Added: Contract Research Organization (CRO) and Clinical Trial Software
+Added: The IGC-Pharma Electronic Data Capture system (“IGC-EDC”) is a secure and user-friendly data management software designed to collect electronic clinical trial data.
+Added: It includes rigorous security measures to protect data and ensure compliance with regulations.
+Added: The system is designed for our Phase 2 trial and can store and organize various handwritten source documents.
+Added: This allows users to generate data reports for analysis and computational models to simulate the effects of our investigational drug IGC-AD1.
+Added: Recognizing the importance of operational excellence and cost management in clinical trials, we have established an internal CRO with proprietary software to reduce trial costs compared to using external CROs.
+Added: Additionally, we are integrating machine learning and AI into the software framework for improved decision-making, data entry, computational models, trial design (Phase 3), and data analysis.
+Added: Our Business Strategy
+Added: The business strategy includes:
+Added: ● Subject to FDA approval and clinical trials, developing IGC-AD1 as a drug for treating agitation in dementia due to Alzheimer’s.
+Added: ● Subject to FDA approval, developing IGC-AD1 as a drug for treating Alzheimer’s disease.
+Added: ● Developing TGR-63 for the potential treatment of Alzheimer’s disease.
+Added: ● Driving revenue from in-house OTC brands and formulations.
+Added: ● Allocate capital to enhance shareholder value.
We believe developing a drug for both symptom and disease-modifying agents has less risk due to the need for expensive multi-year trials.
5 unchanged sentences
Although there can be no assurance, we believe this strategy can improve our existing products and lead to the creation of new products that can provide treatment options for multiple conditions, symptoms, and side effects.
−Removed: | December 31, 2023, Form 10-Q
−Removed: Results of Operations for the Three Months Ended
−Removed: December 31, 2023, and December 31, 2022
+Added: | June 30, 2024, Form 10-Q
+Added: Company Highlights for the Quarter ended June 30, 2024
+Added: On June 25, 2024, the Company shared positive pre-clinical results for TGR-63, showing its potential in combating Alzheimer’s disease in an Alzheimer’s mouse model.
+Added: On May 28, 2024, the Company announced patient enrollment at Neurostudies, Inc.
+Added: in Port Charlotte, Florida, for its Phase 2 clinical trial investigating IGC-AD1, the lead investigational drug, as a potential treatment for agitation in Alzheimer’s disease.
+Added: On April 16, 2024, the Company announced that interim data from its Phase 2 clinical trial demonstrates a clinically significant reduction, approaching statistical significance, in agitation in Alzheimer’s at week two compared to placebo.
+Added: On April 9, 2024, the Company welcomed Pablo Arbelaez, Ph.D., a renowned AI expert and researcher, to support the development of the Phase 2 clinical trial of IGC-AD1, the lead therapeutic candidate addressing agitation in Alzheimer’s disease.
+Added: | June 30, 2024, Form 10-Q
+Added: Results of Operations for the Three Months Ended June 30, 2024, and June 30, 2023
The historical results presented below are not necessarily indicative of the results that may be expected for any future period.
−Removed: The following table presents an overview of our results of operations for the three months ended December 31, 2023, and December 31, 2022:
+Added: The following table presents an overview of our results of operations for the three months ended June 30, 2024, and June 30, 2023:
Statement of Operations (in thousands, unaudited)
7 unchanged sentences
Income tax expense/benefit
−Removed: Revenue – During the three months ended December 31, 2023, the Company generated approximately $204 thousand in revenue, representing a decrease of approximately $128 thousand, or 38%, compared to the approximately $332 thousand recorded during the three months ended December 31, 2022.
−Removed: The primary source of revenue in both quarters was from the Life Sciences segment, encompassing the sales of our formulations as white-labeled manufactured products and sales of branded holistic women’s health care products, among others.
−Removed: Cost of revenue – Cost of revenue amounted to approximately $71 thousand for the three months ended December 31, 2023, compared to $230 thousand in the three months ended December 31, 2022, this represents gross margins of 65% and 31%, respectively.
−Removed: The cost of revenue is primarily attributable to the cost of raw materials, labor, and other direct overheads required to produce our products in the Life Science segment.
−Removed: Typically, the gross margin in the Life Sciences business will fluctuate from one quarter to another based on the mix within the Life Sciences business between white label, private label, and branded products.
−Removed: There is insufficient revenue to model or project gross margins.
−Removed: Selling, General and Administrative expenses (“SG&A”) – SG&A expenses primarily encompass various costs such as employee-related expenses, sales commissions, professional fees, legal fees, marketing expenses, other corporate expenses, allocated general overhead, provisions, depreciation, and write-offs related to doubtful accounts and advances.
−Removed: During the three months ended December 31, 2023, SG&A expenses increased by approximately $654 thousand or 42% to approximately $2.2 million, from approximately $1.5 million recorded for the three months ended December 31, 2022.
−Removed: The increase in SG&A expenses is primarily attributed to an increase in the one-time non-cash expenses.
−Removed: Research and Development expenses – R&D expenses were attributed to our Life Sciences segment.
−Removed: The R&D expenses increased by approximately $97 thousand or 12% to $903 thousand during the three months ended December 31, 2023, from approximately $806 thousand for the three months ended December 31, 2022.
−Removed: The increase is primarily attributable to the progression of Phase 2 trials on IGC-AD1 and pre-clinical studies on the other small molecule assets.
−Removed: Although there can be no assurance, we anticipate increased R&D expenses as the development of our other small molecule assets targeting Alzheimer’s and the Phase 2B trial on Alzheimer’s expand.
−Removed: Impairment Loss – During the three months ended December 31, 2023, the Company impaired the land situated in Nagpur, India, by approximately $2.6 million to $1.4 million from $4.1 million to bring it closer to the fair value.
−Removed: Other income, net – Other net income increased by approximately $3 thousand or 10% during the three months ended December 31, 2023.
−Removed: The total other income for the three months ended December 30, 2023, and 2022, is approximately $32 thousand and $29 thousand, respectively.
−Removed: The component of other income typically includes interest and rental income, dividend income, profits from the sale of assets, unrealized gains from non-debt investments, net income, and income from the sale of scraps.
−Removed: These sources contribute to the overall other income generated by the Company.
−Removed: | December 31, 2023, Form 10-Q
−Removed: Results of Operations for the Nine Months Ended December 30, 2023, and December 30, 2022
−Removed: The historical results presented below are not necessarily indicative of the results that may be expected for any future period.
−Removed: The following table presents an overview of our results of operations for the nine months ended December 31, 2023, and December 31, 2022:
−Removed: Statement of Operations (in thousands, unaudited)
−Removed: Nine months ended
−Removed: Cost of revenue
−Removed: Selling, General and Administrative expenses
−Removed: Research and development expenses
−Removed: Operating loss
−Removed: Other income, net
−Removed: Loss before income taxes
−Removed: Income tax expense/benefit
−Removed: Revenue – Revenue was approximately $1 million and $745 thousand for the nine months ended December 31, 2023, and December 31, 2022, respectively.
−Removed: Revenue in both quarters was primarily derived from our Life Sciences segment, which involved providing white-label manufactured products and sales of holistic women’s health care products, among others.
−Removed: The Infrastructure segment revenue was approximately $161 thousand and $59 thousand for the nine months ended December 31, 2023, and December 31, 2022, respectively.
−Removed: The increase in revenue derived from the Company’s commitment to its current strategy of driving sales in formulations both as branded and white-labeled products in the Life Science segment.
−Removed: Cost of revenue – Cost of revenue amounted to approximately $488 thousand for the nine months ended December 31, 2023, compared to $366 thousand in the nine months ended December 31, 2022, this represents gross margins of 54% and 51%, respectively.
+Added: Revenue – Revenue was approximately $272 thousand and $555 thousand for the three months ended June 30, 2024, and June 30, 2023, respectively.
+Added: Revenue in both quarters was primarily derived from our Life Sciences segment, which involved providing white-label manufactured products and sales of holistic health care products, among others.
+Added: The decrease in revenue is attributed to the completion of our Infrastructure project in India as well as the white-label project in the U.S., both of which comprise approximately 50% of June 2023 revenue.
+Added: The Company is committed to its current strategy of driving sales in formulations both as branded and white-labeled products in the Life Science segment.
+Added: Cost of revenue – Cost of revenue amounted to approximately $109 thousand for the three months ended June 30, 2024, compared to $300 thousand in the three months ended June 30, 2023, this represents gross margins of 60% and 46%, respectively.
The cost of revenue is primarily attributable to the cost of raw materials, labor, and other direct overheads required to produce our products in the Life Science segment.
1 unchanged sentence
There is insufficient revenue to model or project gross margins.
−Removed: Selling, General and Administrative expenses – SG&A expenses were approximately $5.3 million and $5 million for the nine months ended December 31, 2023, and December 31, 2022, respectively.
−Removed: The increase of $329 thousand is primarily attributed to one-time non-cash expenses.
−Removed: SG&A expenses consist primarily of employee-related expenses, sales commission, professional fees, legal fees, marketing, other corporate expenses, allocated general overhead and provisions, depreciation, and write-offs relating to doubtful accounts, and advance, if any.
−Removed: Research and Development expenses – R&D expenses were attributed to our Life Sciences segment.
−Removed: The R&D expenses decreased by approximately $50 thousand or 2% to $2.9 million during the nine months ended December 31, 2023, from approximately $2.9.
+Added: Selling, General and Administrative expenses ( “ SG&A ” ) – SG&A expenses primarily encompass various costs such as employee-related expenses, sales commissions, professional fees, legal fees, marketing expenses, other corporate expenses, allocated general overhead, provisions, depreciation, and write-offs related to doubtful accounts and advances.
+Added: During the three months ended June 30, 2024, SG&A expenses increased by approximately $23 thousand or 1% to approximately $1.7 million as compared to the three months ended June 30, 2023.
+Added: Research and Development expenses ( “ R&D ” ) – R&D expenses were attributed to our Life Sciences segment.
+Added: The R&D expenses increased by approximately $142 thousand or 19% to approximately $889 thousand during the three months ended June 30, 2024, from approximately $747 thousand.
It is primarily attributable to the progression of Phase 2 trials on IGC-AD1 and pre-clinical studies on the other small molecule assets.
−Removed: We anticipate increased R&D expenses as the development of our other small molecule assets targeting Alzheimer’s and the Phase 2B trial on Alzheimer’s expand.
−Removed: Impairment Loss – During the nine months ended December 31, 2023, the Company impaired the land situated in Nagpur, India, by approximately $2.6 million to $1.5 million from $4.1 million to bring it closer to the fair value.
−Removed: Other income, net – Other net income increased by approximately $80 thousand or 143% during the nine months ended December 31, 2023.
−Removed: As a result, the total other income for the nine months ended December 31, 2023, and 2022 is approximately $136 thousand and $56 thousand, respectively.
−Removed: The increase in other income for the nine months ended December 31, 2023, is attributable to profit from the sale of assets.
+Added: We anticipate increased R&D expenses as the development of our other small molecule assets targeting Alzheimer’s and the Phase 2 trial on Alzheimer’s expand.
+Added: Other income, net – Other net income decreased by approximately $46 thousand or 72% during the thousand months ended June 30, 2024.
+Added: As a result, the total other income for the three months ended June 30, 2024, and 2023 is approximately $18 thousand and $64 thousand, respectively.
+Added: The other income for the three months ended June 30, 2023, is attributable to profit from the sale of assets.
Other income includes interest and rental income, dividend income, profit from the sale of assets, unrealized gains from investments, net income, and income from scrap sales.
−Removed: | December 31, 2023, Form 10-Q
+Added: | June 30, 2024, Form 10-Q
Liquidity and Capital Resources
3 unchanged sentences
Please refer to Note 12, “Commitments and Contingencies,” and Note 11, “Loans and Other Liabilities,” in Item 1 of this report for further information on Company commitments and contractual obligations.
−Removed: On June 30, 2023, the Company signed the Master Loan and Security Agreement (the “Credit Agreement”) with O-Bank, CO., LTD.
−Removed: pursuant to which the Company may borrow up to $12 million.
−Removed: Additionally, the Company sold 10 million shares of common stock for $3 million pursuant to an SPA with Bradbury Asset Management and three unrelated investors.
−Removed: These measures have been taken to address ongoing liquidity requirements and ensure the Company’s ability to sustain its operations.
−Removed: Moreover, the Company plans to raise additional funds through private placement and ATM offerings, subject to market conditions, although there can be no assurance that such financing efforts will be successful.
−Removed: The Credit Agreement matures on June 30, 2024, with an option to renew.
−Removed: Borrowings under the Credit Agreement will bear interest, calculated according to the interest rate mentioned in the Certificate of Deposit (as defined in the Credit Agreement), as the case may be, plus an applicable margin of 1%, and the Company shall bear the tax.
−Removed: Interest is due and payable in full by the Company on the last business day of each interest period.
−Removed: As of September 30, 2023, the entire amount of $12 million remains unused.
+Added: Pursuant to the signed Master Loan and Security Agreement (the “Credit Agreement”) with O-Bank, CO., LTD., the Company successfully obtained a working capital credit facility totaling $12 million and, in addition, signed two SPAs to raise $6 million in exchange for approximately 18.8 million shares.
+Added: Out of $6 million, the Company received $2.5 million during the quarter ended June 30, 2024.
+Added: The equity and the credit facility serve to minimize ongoing liquidity requirements and ensure the Company’s ability to sustain its operations.
+Added: Furthermore, the Company intends to raise additional funds through private placement and ATM offerings, subject to market conditions, although there can be no assurance that such financing efforts will be successful.
+Added: Please refer to Note 13 – “Securities”, for more information.
On October 27, 2023, the Company entered into a Sales Agreement (the “Agreement”) with A.G.P./Alliance Global Partners (the “Agent”) pursuant to which the Company may offer and sell, from time to time, through the Agent, as sales agent and/or principal, shares of its common stock, par value $0.0001 per share (the “Common Stock”), having an aggregate offering price of up to $60 million (“Shares”), subject to certain limitations on the amount of Common Stock that may be offered and sold by the Company set forth in the Sales Agreement (the “Offering”).
−Removed: Prior to entering into the Sales Agreement with A.G.P./Alliance Global Partners, the Company terminated the Sales Agreement dated January 13, 2021, with The Benchmark Company.
The Company expects to raise further capital for its research and development initiatives as and when it is able to do so, but there can be no assurance thereof.
3 unchanged sentences
(in thousands, unaudited)
−Removed: December 31, 2023
+Added: June 30 31, 2024
March 31, 2024
3 unchanged sentences
Cash and cash equivalents
−Removed: Cash and cash equivalents decreased by approximately $1.8 million to $1.4 million in the nine months ended December 31, 2023, from $3.2 million as of March 31, 2023, a decrease of approximately 57%.
−Removed: | December 31, 2023, Form 10-Q
+Added: Cash and cash equivalents increased by approximately $626 thousand to $1.8 million in the three months ended June 30, 2024, from $1.2 million as of March 31, 2024, an increase of approximately 52%.
+Added: | June 30, 2024, Form 10-Q
Summary of Cash flows
(in thousands, unaudited)
−Removed: Nine months ended
+Added: Three months ended
Cash used in operating activities
−Removed: Cash provided by investing activities
−Removed: Cash provided by financing activities
+Added: Cash used in investing activities
+Added: Cash provided by (used in) financing activities
Effects of exchange rate changes on cash and cash equivalents
3 unchanged sentences
Operating Activities
−Removed: Net cash used in operating activities for the nine months ended December 31, 2023, was approximately $4.6 million.
−Removed: It consists of a net loss of approximately $10.1 million, a positive impact on cash due to non-cash expenses of approximately $5.2 million, and a positive change in operating assets and liabilities of approximately $220 thousand.
−Removed: Non-cash expenses consist of an amortization and depreciation charge of approximately $473 thousand, stock-based expenses of approximately $1.4 million, impairment loss of approximately $3.3 million and an approximately $42 thousand decrease in other non-cash items.
−Removed: In addition, changes in operating assets and liabilities had a positive impact of approximately $220 thousand on cash, of which approximately $169 thousand is due to a decrease in deposits and advances, approximately $117 thousand increase in accounts payable, approximately $83 thousand decrease in accrued and other liabilities and approximately $20 thousand increase in other net current assets and liabilities.
−Removed: Net cash used in operating activities for the nine months ended December 31, 2022, was approximately $5.5 million.
−Removed: It consists of a net loss of approximately $7.5 million, a positive impact on cash due to non-cash expenses of approximately $2.8 million, and a negative change in operating assets and liabilities of approximately $856 thousand.
−Removed: Non-cash expenses consist of an amortization and depreciation charge of approximately $504 thousand, stock-based expenses of approximately $2.3 million, and net loss on the sale of a property, plant, and equipment of approximately $39 thousand.
−Removed: In addition, changes in operating assets and liabilities had a negative impact of approximately $856 thousand on cash, of which approximately $127 thousand is due to a decrease in accounts receivables, approximately $572 thousand decrease in accrued and other liabilities, and approximately $157 thousand decrease in other net current assets and liabilities.
+Added: Net cash used in operating activities for the three months ended June 30, 2024, was approximately $1.8 million.
+Added: It consists of a net loss of approximately $2.4 million, a positive impact on cash due to non-cash expenses of approximately $564 thousand, and a positive change in operating assets and liabilities of approximately $62 thousand.
+Added: Non-cash expenses consist of an amortization and depreciation charge of approximately $162 thousand and stock-based expenses of approximately $402 thousand.
+Added: In addition, changes in operating assets and liabilities had a positive impact of approximately $62 thousand on cash, of which a net negative impact of approximately $118 thousand is due to an increase in deposits and advances, and a positive impact of approximately $151 thousand is due to increase in accrued and other liabilities, and net other current assets and liabilities of approximately $29 thousand.
+Added: Net cash used in operating activities for the three months ended June 30, 2023, was approximately $1.5 million.
+Added: It consists of a net loss of approximately $2.1 million, a positive impact on cash due to non-cash expenses of approximately $459 thousand, and a positive change in operating assets and liabilities of approximately $148 thousand.
+Added: Non-cash expenses consist of an amortization and depreciation charge of approximately $155 thousand, stock-based expenses of approximately $357 thousand, and an approximately $53 thousand decrease in other non-cash items.
+Added: In addition, changes in operating assets and liabilities had a positive impact of approximately $148 thousand on cash, of which a net negative impact of approximately $118 thousand is due to an increase in accounts receivables, a positive impact of approximately $142 thousand is due to increase in accounts payable, a positive impact of approximately $91 thousand is due to increase in accrued and other liabilities and net other current assets and liabilities of approximately $33 thousand.
Investing Activities
−Removed: Net cash provided by investing activities for the nine months ended December 31, 2023, was approximately $6 thousand, which comprised of expenses of approximately $67 thousand for the acquisition filing expenses related to intellectual property, approximately $81 thousand for the net purchase of property, plant, and equipment and approximately $154 thousand of investment in marketable securities.
−Removed: Net cash provided by investing activities for the nine months ended December 31, 2022, was approximately $7 thousand, which comprised net proceeds from the sale of property, plant, and equipment of approximately $239 thousand, adjusted with cash expenses of approximately $144 thousand for the acquisition and filing expenses related to patents and approximately $88 thousand of a short-term investment.
+Added: Net cash used in investing activities for the three months ended June 30, 2024, was approximately $131 thousand, which comprised of expenses of approximately $93 thousand for the acquisition and development of intangible assets, and approximately $38 thousand for the net purchase of property, plant, and equipment.
+Added: Net cash used in investing activities for the three months ended June 30, 2023, was approximately $5 thousand, which comprised of expenses of approximately $28 thousand for the acquisition and filing expenses related to intellectual property, approximately $23 thousand for the purchase of property, plant, and equipment.
Financing Activities
−Removed: Net cash provided by financing activities was approximately $2.9 million for the nine months ended December 31, 2023, which is comprised of net proceeds from issuance of equity stock of approximately $2.8 million and re-payment of the loan of approximately $3 thousand.
−Removed: Net cash provided by financing activities from the issuance of equity stock through our ATM offering, net of all expenses related to the issuance of stock, was approximately $101 thousand for the nine months ended December 31, 2022.
−Removed: | December 31, 2023, Form 10-Q
+Added: Net cash provided by financing activities was approximately $2.5 million for the three months ended June 30, 2024, which is comprised of net proceeds from issuance of equity stock of approximately $2.5 million and re-payment of the loan of approximately $1 thousand.
+Added: Please refer to Note 13 – “Securities”, for more information.
+Added: Net cash used in financing activities was approximately $1 thousand for the three months ended June 30, 2023, which is comprised of re-payment of loan.
+Added: | June 30, 2024, Form 10-Q
Off-Balance Sheet Arrangements
13 unchanged sentences
Recent accounting pronouncements that may apply to us are described in Note 2, “Significant Accounting Policies” to the Notes to the Unaudited Condensed Consolidated Financial Statements in this report and in the Notes to the Audited Consolidated Financial Statements in Part II of our 2024 Form 10-K.
−Removed: | December 31, 2023, Form 10-Q
+Added: | June 30, 2024, Form 10-Q
Quantitative and Qualitative Disclosures about Market Risk
1 unchanged sentence
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.