10-Q 1 igcpharma20231231_10q.htm FORM 10-Q igcpharma20231231_10q.htm


UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 10-Q

 


 

Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

For the quarterly period ended December 31, 2023

 

 

Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Commission file number: 001-32830

igcpharma_001.jpg

IGC PHARMA, INC.

(Exact name of registrant as specified in its charter)

 

Maryland

(State or other jurisdiction of incorporation or organization)

20-2760393

(I.R.S. Employer Identification No.)

 

 

10224 Falls Road, Potomac, Maryland

(Address of principal executive offices)

20854 

(Zip Code)

 

(301) 983-0998

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

IGC

 

NYSE American LLC

 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☑ Yes ☐ No

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☑ Yes ☐ No

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer ☐

 

Accelerated filer ☐

Non-accelerated filer

 

Smaller reporting company

 

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes No

 

63,734,439 shares of our common stock were outstanding as of February 12, 2024.

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

 

 

IGC PHARMA, INC.

FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED DECEMBER 31, 2023

 

Table of Contents

 

 

 

Page

PART I. FINANCIAL INFORMATION

 

 

 

Item 1.

Financial Statements

4

 

Condensed Consolidated Balance Sheets

4

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

5

 

Condensed Consolidated Statements of Changes in Shareholder’s Equity

6

 

Condensed Consolidated Statements of Cash Flows

7

 

Notes to Condensed Consolidated Financial Statements

8

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

20

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

28

Item 4.

Controls and Procedures

28

 

 

 

PART II. OTHER INFORMATION

 

 

 

Item 1.

Legal Proceedings

29

Item 1A.

Risk Factors

29

Item 2.

Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities

30

Item 3.

Defaults Upon Senior Securities

30

Item 4.

Mine Safety Disclosures

30

Item 5.

Other Information

31

Item 6.

Exhibits

31

 

 

 

SIGNATURES

32

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

 

 

FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q and the documents incorporated herein by reference contain forward-looking statements. Additionally, we, or our representatives, may, from time to time, make other written or verbal forward-looking statements and discuss plans, expectations, and objectives regarding our business, financial condition, and results of operations. Without limiting the foregoing, statements that are in the future tense, and all statements accompanied by terms such as believe, project, expect, trend, estimate, forecast, assume, intend, plan, target, anticipate, outlook, preliminary, will likely result, will continue, and variations of them and similar terms are intended to be forward-looking statements as defined by federal securities laws. Such statements are based on currently available information, which management has assessed but which is dynamic and subject to rapid change due to risks and uncertainties that affect our business.

 

For the next several years, we believe our success is highly correlated with the outcome of our clinical trials and secondarily with the sale of our products and services. The Company may not be able to complete human trials on our investigational drug candidates, or, once conducted, the results of human trials may not be favorable or as anticipated or may reflect a lack of efficacy in humans or animals. Precautions, including social distancing and travel restrictions, among others could lead to delays or expenses greater than anticipated or projected. Failure or delay with respect to any of the above factors could have a material adverse effect on our business, future results of operations, stock price, and financial condition.

 

Our projections and investments anticipate certain regulatory changes and stable pricing, which may not hold out over the next several years. We may not be able to protect our intellectual property adequately or receive patents. We may not receive regulatory approval for our products or trials. The patent applications we have licensed may not be granted by the United States Patent and Trademark Office (USPTO), even if the Company is in full compliance with USPTO requirements. We may not have adequate resources, including financial resources, to successfully conduct all requisite clinical trials, to bring a product based on the above-referenced patented formulations to market, or to pay applicable maintenance fees over time. We may not be able to successfully commercialize our products even if they are successful and receive regulatory approval, including, but not limited to, based on the Food and Drug Administrations (FDA) current position on hemp and hemp-based products. Failure or delay with respect to any of the factors above could have a material adverse effect on our business, future results of operations, stock price, and financial condition.

 

This document also contains statements that are not approved by the FDA, including statements on hemp and hemp extracts and their potential efficacy on humans and animals. While these statements and claims are intended to be in compliance with federal and state laws, we cannot guarantee such compliance.

 

We caution you not to place undue reliance on forward-looking statements, which are based upon assumptions, expectations, plans, and projections subject to risks and uncertainties, including those, if any, identified in the Risk Factors set forth in this report or in our annual report on Form 10-K for the fiscal year ended March 31, 2023, filed with the Securities and Exchange Commission (SEC) on July 7, 2023, this Form 10-Q for the fiscal quarter ended December 31, 2023 and other documents that we subsequently file with the SEC that update, supplement or supersede such information, which may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Forward-looking statements speak only as of the date when they are made. Except as required by federal securities law, we do not undertake any obligation to update forward-looking statements to reflect events, circumstances, changes in expectations, or the occurrence of unanticipated events after the date of those statements.

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

PART I FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

IGC Pharma, Inc.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share data)

(Unaudited)

 

   

December 31, 2023

($)

   

March 31, 2023
($)

 

ASSETS

               

Current assets:

               

Cash and cash equivalents

    1,378       3,196  

Accounts receivable, net

    92       107  

Short term investments

    -       154  

Inventory

    1,925       2,651  

Deposits and advances

    188       358  

Total current assets

    3,583       6,466  
                 

Non-current assets:

               

Intangible assets, net

    1,182       1,170  

Property, plant, and equipment, net

    5,268       8,213  

Claims and advances

    999       1,003  

Operating lease asset

    227       326  

Total non-current assets

    7,676       10,712  

Total assets

    11,259       17,178  

LIABILITIES AND STOCKHOLDERS EQUITY

               

Current liabilities:

               

Accounts payable

    648       530  

Accrued liabilities and others

    1,288       1,368  

Total current liabilities

    1,936       1,898  
                 

Non-current liabilities:

               

Long-term loans

    138       141  

Other liabilities

    17       21  

Operating lease liability

    115       207  

Total non-current liabilities

    270       369  

Total liabilities

    2,206       2,267  
                 

Commitments and Contingencies See Note 12

   
 
     
 
 
                 

Stockholders equity:

               

Preferred stock, $0.0001 par value: authorized 1,000,000 shares, no shares issued or outstanding as of December 31, 2023, and March 31, 2023.

               

Common stock and additional paid-in capital, $0.0001 par value: 150,000,000 shares authorized; 63,734,439 and 53,077,436 shares issued and outstanding as of December 31, 2023, and March 31, 2023, respectively.

    123,258       118,965  

Accumulated other comprehensive loss

    (3,425 )     (3,389 )

Accumulated deficit

    (110,780 )     (100,665 )

Total stockholders equity

    9,053       14,911  

Total liabilities and stockholders equity

    11,259       17,178  

 

The accompanying notes should be read in connection with these Condensed Consolidated Financial Statements.

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

IGC Pharma, Inc.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

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

(Unaudited)

 

   

Three months ended

December 31,

   

Nine months ended

December 31,

 
   

2023

   

2022

   

2023

   

2022

 
    ($)     ($)     ($)    

($)

 
                                 

Revenue

    204       332       1,050       745  

Cost of revenue

    (71 )     (230 )     (488 )     (366 )

Gross profit

    133       102       562       379  

Selling, General and Administrative expenses

    (2,228 )     (1,574 )     (5,272 )     (4,943 )

Research and development expenses

    (903 )     (806 )     (2,918 )     (2,968 )

Operating loss

    (2,998 )     (2,278 )     (7,628 )     (7,532 )

Impairment Loss on PPE

    (2,623 )     -       (2,623 )     -  

Other income, net

    32       29       136       56  

Loss before income taxes

    (5,589 )     (2,249 )     (10,115 )     (7,476 )

Income tax expense/benefit

    -       -       -       -  

Net loss attributable to common stockholders

    (5,589 )     (2,249 )     (10,115 )     (7,476 )

Foreign currency translation adjustments

    18       (61 )     (36 )     (462 )

Comprehensive loss

    (5,571 )     (2,310 )     (10,151 )     (7,938 )
                                 

Net loss per share attributable to common stockholders:

                               

Basic and diluted

  $ (0.09 )     (0.04 )     (0.18 )     (0.14 )

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

    63,725,084       53,063,473       57,039,035       52,412,830  

 

The accompanying notes should be read in connection with these Condensed Consolidated Financial Statements.

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

IGC Pharma, Inc.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY

(in thousands)

(Unaudited)

 

Three months ended December 31, 2022

 

Number of

Common Shares

   

Common Stock and

Additional Paid in

Capital

($)

   

Accumulated

Deficit

($)

   

Accumulated Other

Comprehensive Loss

($)

   

Total Stockholders’

Equity

($)

 

Balances as of September 30, 2022

    53,058       117,899       (94,386 )     (3,369 )     20,144  

Common stock-based compensation & expenses, net

    19       483       -       -       483  

Issuance of common stock through offering (net of expenses)

    -       -       -       -       -  

Cancellation/forfeiture of shares

    -       -       -       -       -  

Net loss

    -       -       (2,249 )     -       (2,249 )

Foreign currency translation adjustments

    -       -       -       (61 )     (61 )

Balances as of December 31, 2022

    53,077       118,382       (96,635 )     (3,430 )     18,317  
                                         

Three months ended December 31, 2023

                                       

Balances as of September 30, 2023

    63,707       122,732       (105,191 )     (3,443 )     14,098  

Common stock-based compensation & expenses, net

    27       526       -       -       526  

Issuance of common stock through offering (net of expenses)

    -       -       -       -       -  

Cancellation/forfeiture of shares

    -       -       -       -       -  

Net loss

    -       -       (5,589 )     -       (5,589 )

Foreign currency translation adjustments

    -       -       -       18       18  

Balances as of December 31, 2023

    63,734       123,258       (110,780 )     (3,425 )     9,053  

 

Nine months ended December 31, 2022

 

Number of

Common Shares

   

Common Stock and

Additional Paid in

Capital

($)

   

Accumulated

Deficit

($)

   

Accumulated Other

Comprehensive Loss

($)

   

Total Stockholders’

Equity

($)

 

Balances as of March 31, 2022

    51,054       116,019       (89,159 )     (2,968 )     23,892  

Common stock-based compensation & expenses, net

    1,815       2,260       -       -       2,260  

Issuance of common stock through offering (net of expenses)

    208       103       -       -       103  

Cancellation/forfeiture of shares

    -       -       -       -       -  

Net loss

    -       -       (7,476 )     -       (7,476 )

Foreign currency translation adjustments

    -       -       -       (462 )     (462 )

Balances as of December 31, 2022

    53,077       118,382       (96,635 )     (3,430 )     18,317  
                                         

Nine months ended December 31, 2023

                                       

Balances as of March 31, 2023

    53,077       118,965       (100,665 )     (3,389 )     14,911  

Common stock-based compensation & expenses, net

    1,157       1,433       -       -       1,433  

Issuance of common stock through offering (net of expenses)

    10,000       2,860       -       -       2,860  

Cancellation/forfeiture of shares

    (500 )     -       -       -       -  

Net loss

    -       -       (10,115 )     -       (10,115 )

Foreign currency translation adjustments

    -       -       -       (36 )     (36 )

Balances as of December 31, 2023

    63,734       123,258       (110,780 )     (3,425 )     9,053  

 

The accompanying notes should be read in connection with these Condensed Consolidated Financial Statements.

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

IGC Pharma, Inc.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)

 

   

Nine months Ended

December 31,

 
   

2023

($)
   

2022

($)
 

Cash flows from operating activities:

               

Net loss

    (10,115 )     (7,476 )

Adjustment to reconcile net loss to net cash:

               

Depreciation and amortization

    473       504  

Common stock-based compensation and expenses, net

    1,433       2,260  

Impairment of assets

    3,358       -  

Other non-cash items

    (42 )     39  
                 

Changes in:

               

Accounts receivables, net

    14       (127 )

Inventory

    (8 )     (200 )

Deposits and advances

    169       656  

Claims and advances

    4       (91 )

Accounts payable

    117       (516 )

Accrued and other liabilities

    (83 )     (572 )

Operating lease asset

    99       93  

Operating lease liability

    (92 )     (100 )

Net cash used in operating activities

    (4,673 )     (5,530 )
                 

Cash flow from investing activities:

               

Purchase of property, plant, and equipment

    (123 )     (305 )

Sale of property, plant, and equipment

    42       544  

Investment in short term investments

    154       (88 )

Acquisition and filing cost of patents and rights

    (67 )     (144 )

Net cash provided by investing activities

    6       7  
                 

Cash flows from financing activities:

               

Net proceeds from the issuance of common stock

    2,860       103  

Repayment of long-term loan

    (3 )     (2 )

Net cash provided by financing activities

    2,857       101  
                 

Effects of exchange rate changes on cash and cash equivalents

    (8 )     (93 )

Net decrease in cash and cash equivalents

    (1,818 )     (5,515 )

Cash and cash equivalents at the beginning of the period

    3,196       10,460  

Cash and cash equivalents at the end of the period

    1,378       4,945  
                 

Supplementary information:

               

Non-cash items:

               

Common stock issued/granted for stock-based compensation, including patent acquisition

    1,433       2,260  

 

The accompanying notes should be read in connection with these Condensed Consolidated Financial Statements.

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

IGC Pharma, Inc.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

THREE MONTHS AND NINE MONTHS ENDED DECEMBER 31, 2023

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

 

Unless the context requires otherwise, all references in this report to IGC, the Company, we, our and/or us refer to IGC Pharma, Inc., together with our subsidiaries and beneficially owned subsidiary. Our public filings with the Securities and Exchange Commission, the SEC,” are available on www.sec.gov. The information contained on our various websites, including www.igcinc.us, is not incorporated by reference in this report, and you should not consider such information to be a part of this report. We exclude our investments and minority non-controlling interests, and any information provided by them is not incorporated by reference in this report, and you should not consider such information to be a part of this report.

 

NOTE 1 BUSINESS DESCRIPTION

 

Overview

 

IGC Pharma is a clinical-stage pharmaceutical company developing novel therapies for Alzheimer’s disease and conditions related to the central nervous system. The company is pursuing five assets: IGC-AD1, TGR-63, LMP, IGC-1C, and IGC-M3, all of which target Alzheimer’s disease and are at various stages of development.

 

Our most clinically advanced investigational new drug for Alzheimer’s, IGC-AD1, has shown significant promise in preclinical studies. In Alzheimer’s cell lines, IGC-AD1 has demonstrated the potential to effectively suppress or ameliorate two key hallmarks of Alzheimer’s disease: plaques and tangles. In animal models, it has shown effectiveness in improving memory. Furthermore, in a Phase 1 multiple ascending dose (“MAD”) trial, it exhibited potential efficacy in reducing neuropsychiatric symptoms, including agitation, anxiety, and depression. 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). Alzheimer’s impacts more than 15 million individuals in North America and Europe. The Company has 13 trial sites under contract in the US and Canada for its Phase 2B trial.

 

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. LMP targets neuroinflammation, Aβ plaques, and neurofibrillary tangles, TGR-63 targets Aβ plaque, where we seek to disrupt the progression of Alzheimer’s disease. IGC-M3 targets the inhibition of Aβ plaque aggregation with the potential to create a profound impact on early-stage Alzheimer’s. IGC-1C targets tau and neurofibrillary tangles, IGC-1C represents a forward-thinking approach to Alzheimer’s therapy.

 

Furthermore, IGC controls a total of 21 patent filings. 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. In Bogota, Colombia, we also operate an R&D laboratory and an internal Contract Research Organization (“CRO”) that provides clinical trial services. 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. Our Company is investing in and pursuing AI development with an immediate focus on clinical trial processes, and analysis. 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.

 

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.

 

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. The Company operates in two primary business segments: Life Sciences and Infrastructure.

 

Life Sciences Segment

 

Pharmaceutical: 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. 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.

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

Over-the-Counter Products: 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. 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”). The products are available online and through Amazon and other online channels. In addition, we white label our product formulations to other companies that market them under their brand.

 

Phase 2 Clinical Trial Update

 

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. Phase 2A is designed to assess dosing requirements, while Phase 2B is intended to establish efficacy. 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.

 

The primary end point is agitation in dementia due to Alzheimer’s disease, as rated by the Cohen-Mansfield Agitation Inventory (“CMAI”) over a six-week period. The 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. 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. CYP2C9 ranks amongst the most important drug metabolizing enzymes in humans, as it breaks down over 100 drugs, including nonsteroidal anti-inflammatory drugs. We seek to understand how various versions of the enzyme act on IGC-AD1. Each participant will receive two doses of IGC-AD1 (“b.i.d.”) or two doses of placebo per day for six weeks.

 

Infrastructure Segment

 

The Company’s infrastructure business has been operating since 2008. It includes (i) execution of construction contracts and (ii) rental of heavy construction equipment.

 

Business Organization

 

As of December 31, 2023, the Company had the following operating subsidiaries: 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. Ltd., Colombia-based beneficially-owned subsidiary IGC Pharma SAS (formerly Hamsa Biopharma Colombia SAS) and IGC Pharma IP LLC. The Company’s fiscal year is the 52- or 53-week period that ends on March 31. The Company’s principal office is in Maryland. Additionally, the Company has offices in Washington state, Colombia, and India. The Company’s filings are available on www.sec.gov. IGC Pharma, Inc. was incorporated in 2005.

 

NOTE 2 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Basis of presentation

 

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. 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. (“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.

 

Accordingly, they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments and disclosures necessary for a fair presentation of these interim statements have been included. The results reported in these interim statements are not necessarily indicative of the results that may be reported for the entire year. 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.

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

Principles of consolidation

 

The interim statements include the consolidated accounts of the Company and its subsidiaries. Intercompany accounts and transactions have been eliminated. In the opinion of 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

 

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”). As a result, changes in the relative values of the U.S. Dollar (“USD”), the INR, the HKD, or the COP affect our financial statements.

 

The accompanying financial statements are reported in USD. INR, HKD, 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. Adjustments resulting from the translation of functional currency financial statements to reporting currency are accumulated and reported as other comprehensive (loss), a separate component of shareholders’ equity. Transactions in currencies other than the functional currency during the year are converted into the functional currency at the applicable rates of exchange prevailing when the transactions occurred. Transaction gains and losses are recognized in the consolidated statements of operations.

 

Going Concern

 

The Company assesses and determines its ability to continue as a going concern in accordance with the provisions of ASC Subtopic 205-40, “Presentation of Financial StatementsGoing Concern”, which requires the Company to evaluate whether there are conditions or events that raise substantial doubt about its ability to continue as a going concern.

 

The Company is currently in a clinical trial stage and, thus, has not yet achieved profitability. The Company expects to continue to incur significant operating and net losses and negative cash flows from operations in the near future.

 

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. 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.

 

Accounts receivable

 

We make estimates of the collectability of our accounts receivable by analyzing historical payment patterns, customer concentrations, customer creditworthiness, and current economic trends. If the financial condition of a customer deteriorates, additional allowances may be required. 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.

 

Loss per share

 

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.

 

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. 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.

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

Cybersecurity

 

We have a cybersecurity policy in place and have taken cybersecurity measures to safeguard against hackers, however, there can be no assurance thereof. During the nine months ended December 31, 2023, there were no impactful breaches in cybersecurity.

 

Revenue Recognition

 

The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers (ASC 606). The core principle of this standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services.

 

ASC 606 prescribes a 5-step process to achieve its core principle. The Company recognizes revenue from trading, rental, or product sales as follows:

I. Identify the contract with the customer.

II. Identify the contractual performance obligations.

III. Determine the amount of consideration/price for the transaction.

IV. Allocate the determined amount of consideration/price to the performance obligations.

V. Recognize revenue when or as the performing party satisfies performance obligations.

 

The consideration/price for the transaction (performance obligation(s)) is determined as per the agreement or invoice (contract) for the services and products in the Infrastructure and Life Sciences segment.

 

Revenue in the Infrastructure segment is recognized for the renting business when the equipment is rented, and the terms of the agreement have been fulfilled during the period. Revenue from the execution of infrastructure contracts is recognized based on the output method as and when part of the performance obligation has been completed, and approval from the contracting agency has been obtained after survey of the performance completion as of that date. In the Life Sciences segment, the revenue from the wellness and lifestyle business is recognized once goods have been sold to the customer and the performance obligation has been completed. In retail sales, we offer consumer products through our online stores. Revenue is recognized when control of the goods is transferred to the customer. This generally occurs upon our delivery to a third-party carrier or to the customer directly. Revenue from white label services is recognized when the performance obligation has been completed, and output material has been transferred to the customer.

 

Net sales disaggregated by significant products and services for the three months and nine months ended December 31, 2023, and 2022 are as follows:

 

   

(in thousands)

Three months ended

December 31, 2023

($)

   

(in thousands)

Three months ended

December 31, 2022

($)

   

(in thousands)

Nine months ended

December 31, 2023

($)

   

(in thousands)

Nine months ended

December 31, 2022

($)

 

Infrastructure segment (1)

    -       42       161       59  
                                 

Life Sciences segment

                               

Wellness and lifestyle (2)

    47       105       165       334  

White labeling services (3)

    157       185       724       352  

Total

    204       332       1,050       745  

 

(1) Infrastructure segment consists of income from the rental of heavy construction equipment and construction contracts.

(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.

(3) Revenue from white label services consists of rebranding our formulations or the customer’s products as per the customer’s requirement.

 

Recently issued accounting pronouncements

 

Changes to U.S. GAAP are established by the FASB in the form of accounting standards updates (“ASUs”) to the FASB’s ASC. The Company considers the applicability and impact of all ASUs. 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.

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

NOTE 3 INVENTORY

 

   

(in thousands)

 
   

As of

December 31, 2023

($)

   

As of

March 31, 2023

($)

 

Raw materials

    1,414       2,100  

Work-in-Progress

    -       18  

Finished goods

    511       533  

Total

    1,925       2,651  

 

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). 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. 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.

 

NOTE 4 DEPOSITS AND ADVANCES

 

   

(in thousands)

 
   

As of

December 31, 2023

($)

   

As of

March 31, 2023

($)

 

Advances to suppliers and consultants

    48       72  

Other receivables and deposits

    16       24  

Prepaid expenses and other current assets

    124       262  

Total

    188       358  

 

The Advances to suppliers and consultants primarily relate to advances to vendors. 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.

 

NOTE 5 INTANGIBLE ASSETS

 

   

(in thousands)

 
   

As of

December 31, 2023

($)

   

As of

March 31, 2023

($)

 

Amortized intangible assets

               

Patents

    735       709  

Other intangibles

    34       34  

Accumulated amortization

    (162 )     (107 )

Total amortized intangible assets

    607       636  
                 

Other intangible assets

               

Patents

    575       534  

Other intangibles

    -       -  

Total unamortized intangible assets

    575       534  

Total intangible assets

    1,182       1,170  

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

The value of intangible assets includes the cost of acquiring patent rights, supporting data, and the expense associated with filing of patent applications. It also includes acquisition costs related to domains and licenses.

 

The intangible with finite life is up to 20 years are amortized on straight-line basis, commencing from the date of grant or acquisition. 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.

 

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.

 

Estimated annual amortization expense

 

(in thousands)

($)

 

For the year ended 2025

    81  

For the year ended 2026

    89  

For the year ended 2027

    98  

For the year ended 2028

    108  

For the year ended 2029

    119  

 

NOTE 6 PROPERTY, PLANT, AND EQUIPMENT

 

   

(in thousands, except useful life)

 
   

Useful Life (years)

   

As of

December 31, 2023

($)

   

As of

March 31, 2023

($)

 

Land

  N/A       1,442       4,100  

Buildings and facilities

  25       2,310       2,298  

Plant and machinery

  5-20       3,352       3,335  

Computer equipment

  3       158       138  

Office equipment

  3-5       139       84  

Furniture and fixtures

  5       93       92  

Vehicles

  5       101       102  

Total gross value

          7,595       10,149  

Less: Accumulated depreciation

          (2,327 )     (1,936 )

Total property, plant, and equipment, net

          5,268       8,213  

 

The depreciation expense in the three months ended December 31, 2023, and 2022 amounted to approximately $140 thousand and $158 thousand, respectively. The depreciation expense in the nine months ended December 31, 2023, and 2022 amounted to approximately $417 thousand and $466 thousand, respectively. The net decrease in Total property, plant, and equipment is primarily due to the impairment of land by approximately $2.6 million. 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. 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. 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. 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.

 

NOTE 7 LEFT BLANK INTENTIONALLY

 

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

NOTE 8 CLAIMS AND ADVANCES

 

   

(in thousands)

 
   

As of

December 31, 2023

($)

   

As of

March 31, 2023

($)

 

Claims receivable (1)

    946       951  

Non-current deposits

    27       27  

Non-current advances

    26       25  

Total

    999       1,003  

 

(1)

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. It includes $166 thousand owed to the company by one of our manufacturers for the equipment purchase.

 

NOTE 9 LEFT BLANK INTENTIONALLY

 

NOTE 10 ACCRUED AND OTHER LIABILITIES

 

   

(in thousands)

 
   

As of

December 31, 2023

($)

   

As of

March 31, 2023

($)

 

Compensation and other contributions

    745       619  

Provision for expenses

    209       258  

Short-term lease liability

    124       133  

Other current liability

    210       358  

Total

    1,288       1,368  

 

Compensation and other contribution-related liabilities consist of accrued salaries to employees. In addition, provision for expenses includes provision for legal, professional, and marketing expenses. 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.

 

NOTE 11 LOANS AND OTHER LIABILITIES

 

Loan as of December 31, 2023:

 

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%. The Company must pay principal and interest payments of $731 every month beginning June 5, 2021. The SBA will apply each installment payment first to pay interest accrued to the day the SBA receives the payment and will then apply any remaining balance to reduce the principal. All remaining principal and accrued interest is due and payable 30 years from the date of the loan. 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. 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. 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.

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

On June 30, 2023, the Company entered into a Master Loan and Security Agreement with O-Bank, CO., LTD. (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. The Credit Agreement matures June 30, 2024, with an option to renew. 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. The Company must pay the interest in full on the last business day of each interest period. As of December 31, 2023, the Company has not yet used any of the $12 million available under the Credit Agreement.

 

Other Liability:

 

   

(in thousands)

 
   

As of

 
   

December 31, 2023

($)

   

March 31, 2023

($)

 

Statutory reserve

    17       21  

Total

    17       21  

 

The statutory reserve is a gratuity reserve for employees in our subsidiaries in India.

 

NOTE 12 COMMITMENTS AND CONTINGENCIES

 

The Company may be involved in legal proceedings, claims, and assessments arising in the ordinary course of business. Such matters are subject to many uncertainties, and outcomes are not predictable with assurance. 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.

 

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. In accordance with applicable laws of foreign countries, the Company provides for gratuity, a defined benefit retirement plan (“Gratuity Plan”) covering certain categories of employees. The Gratuity Plan provides a lump sum payment to vested employees, at retirement or termination of employment, an amount based on the respective employee’s last drawn salary and the years of employment with the Company. In addition, employees receive benefits from a provident fund, a defined contribution plan. The employee and employer each make monthly contributions to the plan as required by the law. The contribution is made to the Foreign Government’s funds.

 

NOTE 13 SECURITIES

 

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. 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.

 

Our common stock is listed on the NYSE American (ticker symbol: IGC). This security also trades on the Frankfurt, Stuttgart, and Berlin stock exchanges (ticker symbol: IGS1). The Company also has 91,472 units outstanding that can be separated into common stock. Ten units may be separated into one share of common stock. 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.

 

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. For more information, kindly refer to Item 1 – Legal Proceedings for more information.

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

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”). 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.

 

NOTE 14 STOCK-BASED COMPENSATION

 

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. 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. The performance-based RSUs are accounted upon certification by Management, confirming the probability of achievement of milestones. 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.

 

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. Options exercised before the service period are expensed when exercised.

 

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:

 

   

Granted in Fiscal 2024

   

Granted in Fiscal 2023

 

Expected life of options

 

5 years

   

5 years

 

Vested options

    100 %     100 %

Risk-free interest rate

    4.15 %     2.64 %

Expected volatility

    262 %     285 %

Expected dividend yield

 

Nil

   

Nil

 

 

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). 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.

 

Non-vested shares

 

Shares

(in thousands)

(#)

   

Weighted average

grant date fair value

($)

 

Non-vested shares as of March 31, 2023

    4,429       1.01  

Granted

    4,300       0.26  

Vested

    (197 )     0.30  

Cancelled/forfeited

    -       -  

Non-vested shares as of December 31, 2023

    8,532       0.65  

 

Options

 

Shares

(in thousands)

(#)

   

Weighted average

grant date fair value

($)

   

Weighted average

exercise price

($)

 

Options outstanding as of March 31, 2023

    150       1.39       0.30  

Granted

    -       -       -  

Exercised

    -       -       -  

Cancelled/forfeited

    -       -       -  

Options outstanding as of December 31, 2023

    150       1.39       0.30  

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

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.

 

NOTE 15 FAIR VALUE OF FINANCIAL INSTRUMENTS

 

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. The Company’s cash and cash equivalents have also been classified as Level 1 on the same principle. Financial instruments are classified as current if they are expected to be liquidated within the next twelve months. The Certificates of Deposit are classified as Level 2 as they do not have regular market pricing, but their fair value can be determined based on other data values or market prices. The Company’s remaining investments have been classified as Level 3 instruments as there is little or no market data. Level 3 investments are valued using the cost method.

 

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:

 

(in thousands)

As of December 31, 2023

 

Particular

 

Adjusted Cost

($)

   

Gain

($)

   

Loss

($)

   

Fair Value

($)

   

Cash &

Cash Equivalents

($)

   

Short Term

Investments

($)

 

Level 1

                                               

Cash

    676       -       -       676       676       -  

Money Market Fund

    432       -       -       432       432       -  

Debt Funds

    13       -       -       13       13       -  

Mutual Fund

    71       -       -       71       71       -  

Level 2

                                               

Certificates of Deposit

    186       -       -       186       186       -  

Level 3

    -       -       -       -       -       -  

TOTAL

    1,378       -       -       1,378       1,378       -  

 

As of March 31, 2023

 

Particular

 

Adjusted Cost

($)

   

Gain

($)

   

Loss

($)

   

Fair Value

($)

   

Cash &

Cash Equivalents

($)

   

Short Term

Investments

($)

 

Level 1

                                               

Cash

    1,156       -       -       1,156       1,156       -  

Money Market Fund

    2,000       -       -       2,000       2,000       -  

Debt Funds

    40       -       -       40       40       -  

Mutual Fund

    152       2       -       154       -       154  

Level 2

                                               

Certificates of Deposit

    -       -       -       -       -       -  

Level 3

    -       -       -       -       -       -  

TOTAL

    3,348       2       -       3,350       3,196       154  

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

NOTE 16 SEGMENT INFORMATION

 

FASB ASC 280, “Segment Reporting,” establishes standards for reporting information about reportable segments. Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the chief operating decision maker, or decision-making group (“CODM”), in deciding how to allocate resources and in assessing performance. The CODM evaluates revenues and gross profits based on product lines and routes to market. Based on our integration and Management strategies, we operate in two reportable segments, the (i) Infrastructure segment and (ii) Life Sciences segment.

 

The Company’s CODM is the Company’s Chief Executive Officer (“CEO”). The CEO reviews financial information presented on an operating segment basis for purposes of making operating decisions and assessing financial performance. Therefore, and before our Life Sciences segment started, the Company determined that it operated in a single operating and reportable segment. As of the date of this report and in preparation for the new and different source of revenue, the Company has determined that it operates in two operating and reportable segments, the (a) Infrastructure segment and (b) Life Sciences segment. The Company does not include intercompany transfers between segments for Management reporting purposes.

 

The following provides information required by ASC 280-10-50-38 “Entity-wide Information”:

 

 

1)

The table below shows revenue reported by segment:

 

   

(in thousands)

Three months ended

December 31, 2023

($)

   

(in thousands)

Three months

ended

December 31, 2022

($)

   

(in thousands)

Nine months ended

December 31, 2023

($)

   

(in thousands)

Nine months ended

December 31, 2022

($)

 

Infrastructure segment

    -       42       161       59  
                                 

Life Sciences segment

                               

Wellness and lifestyle

    47       105       165       334  

White labeling services

    157       185       724       352  

Total

    204       332       1,050       745  

 

For information on revenue by product and service, refer to Note 2, “Summary of Significant Accounting Policies”.

 

2) The table below shows the revenue attributed to the country of domicile (U.S.) and foreign countries. Revenue is generally attributed to the geographic location of customers:

 

       

(in thousands)

 

Segments

 

Country

 

Three months ended

December 31, 2023

($)

   

Nine months ended

December 31, 2023

($)

 
                     

Asia

 

India

    -       161  

America

 

U.S.

    204       889  

Total

    204       1,050  

 

       

(in thousands)

 

Segments

 

Country

 

Three months ended

December 31, 2022

($)

   

Nine months ended

December 31, 2022

($)

 
                     

Asia

 

India

    42       59  

America

 

U.S.

    290       673  
   

Colombia

    -       13  

Total

    332       745  

 

igcpharma_002.jpg | December 31, 2023, 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.

 

   

(in thousands)

 

Nature of assets

 

USA

(Country of Domicile)

($)

   

Foreign Countries

(India, Hong Kong, and Colombia)

($)

   

Total as of

December 31, 2023

($)

 

Intangible assets, net

    1,182       -       1,182  

Property, plant, and equipment, net

    3,749       1,519       5,268  

Claims and advances

    588       411       999  

Operating lease asset

    220       7       227  

Total non-current assets

    5,739       1,937       7,676  

 

   

(in thousands)

 

Nature of assets

 

USA

(Country of Domicile)

($)

   

Foreign Countries

(India, Hong Kong, and Colombia)

($)

   

Total as of

March 31, 2023

($)

 

Intangible assets, net

    1,170       -       1,170  

Property, plant, and equipment, net

    4,074       4,139       8,213  

Claims and advances

    585       418       1,003  

Operating lease asset

    298       28       326  

Total non-current assets

    6,127       4,585       10,712  

 

NOTE 17 LEFT BLANK INTENTIONALLY

 

         

 

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

Item 2. Managements 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. 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”). The Company’s actual results could differ materially from those discussed here. Factors that could cause differences include those discussed in the “Forward-Looking Statements” and “Risk Factors” sections and discussed elsewhere in this report. The risks and uncertainties can cause actual results to differ significantly from those in our forward-looking statements or implied in historical results and trends. Accordingly, we caution readers not to place undue reliance on any forward-looking statements made by us, which speak only as of the date they are made. 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.

 

Overview

 

IGC Pharma is a clinical-stage pharmaceutical company developing novel therapies for Alzheimer’s disease and conditions related to the central nervous system. The company is pursuing five assets: IGC-AD1, TGR-63, LMP, IGC-1C, and IGC-M3, all of which target Alzheimer’s disease and are at various stages of development.

 

Our most clinically advanced investigational new drug for Alzheimer’s, IGC-AD1, has shown significant promise in preclinical studies. In Alzheimer’s cell lines, IGC-AD1 has demonstrated the potential to effectively suppress or ameliorate two key hallmarks of Alzheimer’s disease: plaques and tangles. In animal models, it has shown effectiveness in improving memory. Furthermore, in a Phase 1 multiple ascending dose (MAD) trial, it exhibited potential efficacy in reducing neuropsychiatric symptoms, including agitation, anxiety, and depression. 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). Alzheimer’s affects more than 15 million individuals in North America and Europe. The Phase 2 trial is being conducted at 13 sites in the US and Canada.

 

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. LMP targets neuroinflammation, Aβ plaques, and neurofibrillary tangles, TGR-63 targets Aβ plaque, where we seek to disrupt the progression of Alzheimer's disease. IGC-M3 targets the inhibition of Aβ plaque aggregation with the potential to create a profound impact on early-stage Alzheimer’s. IGC-1C targets tau and neurofibrillary tangles, IGC-1C represents a forward-thinking approach to Alzheimer's therapy.

 

Furthermore, IGC controls a total of 21 patent filings. 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. In Bogota, Colombia, we also operate an R&D laboratory and an internal Contract Research Organization (“CRO”) that provides clinical trial services. 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. Our company is investing in and driving AI development with a strong focus on transforming our approach, gaining insights, and increasing cost efficiencies. 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.

 

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.

 

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. The company operates in two primary business segments: Life Sciences and Infrastructure.

 

Life Sciences Segment

 

Pharmaceutical: 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. 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.

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

Currently, IGC-AD1 is in a Phase 2B safety and efficacy clinical trial for agitation in dementia from Alzheimer’s (clinicaltrials.gov, NCT05543681). 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.

 

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. 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. 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.

 

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™. We believe this may provide us with several profit opportunities, although there can be no assurance of such profit opportunities.

 

Over-the-Counter Products:

 

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. 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”). The products are available online and through Amazon and other online channels. In addition, we sell our product formulations to other companies that market them under their brand. This is the white label part of the OTC business.

 

Contract Research Organization (CRO) and Clinical Trial Software:

 

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. The software incorporates rigorous security measures that help IGC to protect data and ensure compliance with regulatory requirements and industry standards. This format is designed for our clinical trials, especially our Phase 2 trial. 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. 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. At IGC Pharma, we recognize the significance of operational excellence and cost management in clinical trials. One major cost driver in conducting trials is the expense associated with engaging CROs. These costs can significantly impact on the overall budget of a trial. 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. 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.

 

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. This agreement will enable us to work closely with some of the brightest minds in the field and develop innovative projects. We are excited to collaborate with the University of Los Andes and are committed to advancing the frontiers of science and technology together. 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. 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. By leveraging AI technology, we aim to accelerate progress in Alzheimer’s drug development and revolutionize the way we approach treatment. 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.

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

Infrastructure Segment

 

The Company’s infrastructure business has been operating since 2008. It includes (i) execution of construction contracts and (ii) rental of heavy construction equipment.

 

Company Highlights for the Quarter ended December 31, 2023

 

 

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.

 

 

On October 18, 2023, the European Patent Office (“EPO”) issued a patent (#3193862) to the Company titled “CANNABINOID COMPOSITION AND METHOD FOR TREATING PAIN”. The patent introduces a method for treating pain in humans. 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. It interacts harmoniously with the peripheral nervous and immune systems, delivering effective pain relief without psychotropic or adverse side effects..

 

Business Strategy

 

The Life Sciences business strategy includes:

 

 

1.

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.

 

 

2.

Marketing HoliefTM and formulations.

 

We believe developing a drug for both symptom and disease-modifying agents has less risk due to the need for expensive multi-year trials. However, there is considerable upside and significant value creation to the extent we obtain a first-in-class advantage, of which there can be no assurance. If we were to obtain a first-in-class advantage, such an advantage could result in significant growth if and when an approved drug such as IGC-AD1 launches.

 

We believe that additional investment in clinical trials, AI, R&D, facilities, marketing, advertising, and acquisition of complementary products and businesses will be critical to the ongoing growth of the Life Sciences segment. Although there can be no assurance, we believe these investments will fuel the development and delivery of innovative products that drive positive patient and customer experiences. We hope to leverage our R&D and intellectual property to develop ground-breaking, science-based products that are proven effective through clinical trials, subject to FDA approval. 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.

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

Results of Operations for the Three Months Ended

 

December 31, 2023, and December 31, 2022

 

The historical results presented below are not necessarily indicative of the results that may be expected for any future period. The following table presents an overview of our results of operations for the three months ended December 31, 2023, and December 31, 2022:

 

Statement of Operations (in thousands, unaudited)

 

   

Three months ended

December 31,

                 
   

2023

($)
   

2022

($)
   

Change

($)
   

Percent

Change

 

Revenue

    204       332       (128 )     (38 )%

Cost of revenue

    (71 )     (230 )     159       (69 )%

Gross profit

    133       102       31       30 %

Selling, General and Administrative expenses

    (2,228 )     (1,574 )     (654 )     42 %

Research and development expenses

    (903 )     (806 )     (97 )     12 %

Operating loss

    (2,998 )     (2,278 )     (720 )     32 %

Impairment

    (2,623 )     -       (2,623 )     -  

Other income, net

    32       29       3       10 %

Loss before income taxes

    (5,589 )     (2,249 )     (3,340 )     149 %

Income tax expense/benefit

    -       -       -       -  

Net loss

    (5,589 )     (2,249 )     (3,340 )     149 %

 

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. 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.

 

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. 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. 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. There is insufficient revenue to model or project gross margins.

 

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. 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. The increase in SG&A expenses is primarily attributed to an increase in the one-time non-cash expenses.

 

Research and Development expenses – R&D expenses were attributed to our Life Sciences segment. 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. 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. 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.

 

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.

 

Other income, net – Other net income increased by approximately $3 thousand or 10% during the three months ended December 31, 2023. The total other income for the three months ended December 30, 2023, and 2022, is approximately $32 thousand and $29 thousand, respectively. 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. These sources contribute to the overall other income generated by the Company.

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

Results of Operations for the Nine Months Ended December 30, 2023, and December 30, 2022

 

The historical results presented below are not necessarily indicative of the results that may be expected for any future period. The following table presents an overview of our results of operations for the nine months ended December 31, 2023, and December 31, 2022:

 

Statement of Operations (in thousands, unaudited)

 

   

Nine months ended

December 31,

                 
   

2023

($)
   

2022

($)
   

Change

($)
   

Percent

Change

 

Revenue

    1,050       745       305       41 %

Cost of revenue

    (488 )     (366 )     (122 )     33 %

Gross profit

    562       379       183       48 %

Selling, General and Administrative expenses

    (5,272 )     (4,943 )     (329 )     7 %

Research and development expenses

    (2,918 )     (2,968 )     50       (2 )%

Operating loss

    (7,628 )     (7,532 )     (96 )     1 %

Impairment

    (2,623 )     -       (2,623 )     -  

Other income, net

    136       56       80       143 %

Loss before income taxes

    (10,115 )     (7,476 )     (2,639 )     35 %

Income tax expense/benefit

    -       -       -       -  

Net loss

    (10,115 )     (7,476 )     (2,639 )     35 %

 

Revenue – Revenue was approximately $1 million and $745 thousand for the nine months ended December 31, 2023, and December 31, 2022, respectively. 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. The Infrastructure segment revenue was approximately $161 thousand and $59 thousand for the nine months ended December 31, 2023, and December 31, 2022, respectively. 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.

 

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. 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. Typically, the gross margin in the Life Sciences business will fluctuate from one quarter to another based on the mix within the Life Science business between white label, private label, and branded products. There is insufficient revenue to model or project gross margins.

 

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. The increase of $329 thousand is primarily attributed to one-time non-cash expenses. 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.

 

Research and Development expenses – R&D expenses were attributed to our Life Sciences segment. 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. It is primarily attributable to the progression of Phase 2 trials on IGC-AD1 and pre-clinical studies on the other small molecule assets. 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.

 

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.

 

Other income, net – Other net income increased by approximately $80 thousand or 143% during the nine months ended December 31, 2023. 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. The increase in other income for the nine months ended December 31, 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.

         

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

Liquidity and Capital Resources

 

Our sources of liquidity are cash and cash equivalents, funds raised through the ATM offering, cash flows from operations, short-term and long-term borrowings, and short-term liquidity arrangements. The Company continues to evaluate various financing sources and options to raise working capital to help fund current research and development programs and operations. The Company does not have any material long-term debt, capital lease obligations, or other long-term liabilities except as disclosed in this report. 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.

 

On June 30, 2023, the Company signed the Master Loan and Security Agreement (the “Credit Agreement”) with O-Bank, CO., LTD. pursuant to which the Company may borrow up to $12 million. 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. These measures have been taken to address ongoing liquidity requirements and ensure the Company’s ability to sustain its operations. 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.

 

The Credit Agreement matures on June 30, 2024, with an option to renew. 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. Interest is due and payable in full by the Company on the last business day of each interest period. As of September 30, 2023, the entire amount of $12 million remains unused.

 

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”). 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. In addition, there can be no assurance of the terms thereof, and any subsequent equity financing sought may have dilutive effects on our current shareholders. While there is no guarantee that we will be successful, we are applying to non-dilutive funding opportunities such as Small Business Research and Development programs. In addition, subject to limitations on the amount of capital that can be raised, the Company expects to utilize its shelf registration on a statement on Form S- 3 to raise capital through at-the-market offerings or otherwise.

 

   

(in thousands, unaudited)

                 
   

As of

December 31, 2023

($)
   

As of

March 31, 2023

($)
   

Change

   

Percent Change

 

Cash and cash equivalents

    1,378       3,196       (1,818 )     (57 )%

Working capital

    1,647       4,568       (2,921 )     (64 )%

 

Cash and cash equivalents

 

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%.

 

igcpharma_002.jpg | December 31, 2023, Form 10-Q

 

Summary of Cash flows

 

   

(in thousands, unaudited)

                 
   

Nine months ended

December 31,

           

Percent

 
   

2023

   

2022

   

Change

   

Change

 

Cash used in operating activities

    (4,673 )     (5,530 )     857       (15 )%

Cash provided by investing activities

    6       7       (1 )     (11 )%

Cash provided by financing activities

    2,857       101       2,756       2,731 %

Effects of exchange rate changes on cash and cash equivalents

    (8 )     (93 )     85       (92 )%

Net decrease in cash and cash equivalents

    (1,818 )     (5,515 )     3,697       (67