UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of August, 2022

Commission File Number: 001-38480

IMV Inc.
(Name of registrant)

130 Eileen Stubbs Avenue, Suite 19
Dartmouth, Nova Scotia
B3B 2C4, Canada

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

[   ] Form 20-F [ X ] Form 40-F

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): [   ]

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): [   ]






SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

  IMV Inc.
 
Date: August 11, 2022 By: /s/ Brittany Davison
  Name: Brittany Davison
  Title: Senior VP Finance

 





Form 6-K Exhibit Index

Exhibit
Number
Document Description
99.1 Interim Financial Statements for the period ended June 30, 2022
99.2 Management Discussion and Analysis for the period ended June 30, 2022
99.3 CEO Certification
99.4 CFO Certification

 




Exhibit 99.1

Exhibit 99.1

 

 

 

Unaudited Interim Condensed Consolidated

Financial Statements

June 30, 2022

  

 

 

August 10, 2022

 

Management’s Responsibility for Financial Reporting

 

The accompanying unaudited interim condensed consolidated financial statements of IMV Inc. (the “Corporation”) are the responsibility of management and have been approved by the Board of Directors. The unaudited interim condensed consolidated financial statements have been prepared by management in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board. The unaudited interim condensed consolidated financial statements include some amounts and assumptions based on management’s best estimates which have been derived with careful judgment.

 

In fulfilling its responsibilities, management has developed and maintains a system of internal accounting controls. These controls are designed to ensure that the financial records are reliable for preparation of the unaudited interim condensed consolidated financial statements. The Audit Committee of the Board of Directors reviewed and approved the Corporation’s unaudited interim condensed consolidated financial statements and recommended their approval by the Board of Directors.

 

(signed) Andrew Hall (signed) “Brittany Davison”
  Chief Executive Officer   Senior Vice President of Finance

 

Approved on behalf of the Board of Directors

 

(signed) “Michael Bailey”, (signed) “Kyle Kuvalanka”,
  Director   Director

 

 

 

IMV Inc.

Unaudited Interim Condensed Consolidated Statements of Financial Position

As at June 30, 2022 and December 31, 2021

(Expressed in thousands of United States dollars except for share and per share amounts)

 

  

June 30,

2022

$

  

December 31,

2021

$

 
Assets        
         
Current assets        
Cash and cash equivalents   31,134    38,616 
Amounts receivable   926    602 
Prepaid expenses   3,380    6,037 
Investment tax credits receivable   1,012    1,135 
    36,452    46,390 
Property and equipment   4,041    3,731 
    40,493    50,121 
Liabilities          
           
Current liabilities          
Accounts payable, accrued and other liabilities   8,255    8,607 
Current portion of long-term debt (note 4)   74    73 
Current portion of lease obligation   284    265 
Warrant liabilities (note 5)   94    318 
    8,707    9,263 
Lease obligation   1,233    1,387 
Long-term debt (note 4)   28,138    17,929 
      38,078       28,579  
Equity   2,415    21,542 
    40,493    50,121 
Going concern (note 1)          

 

The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.

 

 

 

IMV Inc.

Unaudited Interim Condensed Consolidated Statements of Equity

For the periods ended June 30, 2022 and June 30, 2021

(Expressed in thousands of United States dollars except for share and per share amounts)

 

  

Share

capital

$

(note 6)

  

Contributed

surplus

$

(note 7)

  

Warrants

$

(note 8)

  

Deficit

$

  

Accumulated

other

comprehensive

income

$

  

Total

$

 
                         
Balance, January 1, 2021   137,262    7,652    2,112    (118,331)   2,107    30,802 
Net loss and comprehensive loss for the period               (14,319)       (14,319)
Issuance of shares in a public equity offering   2,304                    2,304 
Share issuance costs in a public equity offering   (104)                   (104)
Redemption of DSU's, net of applicable taxes   239    (235)               4 
DSUs:                              
Value of services recognized       281                281 
Employee share options:                              
Value of services recognized       669                669 
Exercise of options   217    (171)               46 
Balance, June 30, 2021   139,918    8,196    2,112    (132,650)   2,107    19,683 
                               
Balance, December 31, 2021   156,236    9,370    8,196    (154,920)   2,660    21,542 
                               
Net loss and comprehensive loss for the period               (20,415)       (20,415)
Issuance of shares in a public equity offering   142                    142 
Share issuance costs in a public equity offering   (49)                   (49)
Expiry of Warrants       2,350    (2,350)            
DSUs:                              
Value of services recognized       215                215 
Employee share options:                              
Value of services recognized       980                980 
Balance, June 30, 2022   156,329    12,915    5,846    (175,335)   2,660    2,415 

 

The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.

 

 

 

IMV Inc.

Unaudited Interim Condensed Consolidated Statements of Loss and Comprehensive Loss

For the three and six months ended June 30, 2022 and 2021

(Expressed in thousands of United States dollars except for share and per share amounts)

 

  

Three months ended

June 30,

  

Six months ended

June 30,

 
  

2022

$

  

2021

$

  

2022

$

  

2021

$

 
Income                
Interest income   34    42    59    112 
                     
Expenses                    
Research and development   6,048    5,219    12,678    9,961 
General and administrative   4,620    3,416    8,602    6,499 
Government assistance   (689)   (1,169)   (1,070)   (2,404)
Accreted interest and valuation adjustments (note 4)   (38)   15    264    375 
    9,941    7,481    20,474    14,431 
                     
Net loss and comprehensive loss for the period   (9,907)   (7,439)   (20,415)   (14,319)
Basic and diluted loss per share   (0.12)   (0.11)   (0.25)   (0.21)
Weighted-average shares outstanding   82,265,209    67,781,940    82,236,788    67,629,392 

 

The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.

 

 

 

IMV Inc.

Unaudited Interim Condensed Consolidated Statements of Cash Flows

For the six months ended June 30, 2022 and 2021

(Expressed in thousands of United States dollars except for share and per share amounts)

 

  

Six months

ended

June 30,

2022

$

  

Six months ended

June 30,

2021

$

 
Cash provided by (used in)        
Operating activities        
Net loss for the period   (20,415)   (14,319)
Charges to operations not involving cash          
Depreciation of property and equipment   392    209 
Accreted interest and valuation adjustments   264    375 
Fair value adjustment on government loan       (420)
Loss on disposal   2    5 
Deferred share unit compensation   215    281 
Stock-based compensation   980    669 
Fair value adjustment on warrant liabilities   20     
    (18,542)   (13,200)
Net change in non-cash working capital balances related to operations          
(Increase) decrease in amounts receivable   (324)   880 
Decrease in prepaid expenses   2,313    340 
Decrease (increase) in investment tax credits receivable   123    (376)
Decrease in accounts payable, accrued and other liabilities   (455)   (2,542)
    (16,885)   (14,898)
Financing activities          
Proceeds from public equity offering   142    2,304 
Share issuance costs in a public equity offering   (49)   (104)
Proceeds from the exercise of stock options       46 
Proceeds from long term borrowings   10,000     
Repayment of long-term debt   (37)   (436)
Repayment of lease obligation   (129)   (55)
    9,927    1,755 
Investing activities          
Acquisition of property and equipment   (636)   (504)
Net change in cash and cash equivalents during the period   (7,594)   (13,647)
           
Cash and cash equivalents – Beginning of period   38,616    36,268 
Effect of foreign exchange on cash and cash equivalents   112    205 
Cash and cash equivalents – End of period   31,134    22,826 
           
Supplementary cash flow          
Interest received   34    112 
Interest paid   (339)   (65)

 

The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.

 

 

 

IMV Inc.

Notes to the Unaudited Interim Condensed Consolidated Financial Statements

As at June 30, 2022 and December 31, 2021

(Expressed in thousands of United States dollars except for share and per share amounts)

 

1Nature of operations and going concern

 

IMV Inc. (the “Corporation” or “IMV”) is, through its 100% owned subsidiaries, a clinical-stage immuno-oncology company advancing a portfolio of therapies based on the Company’s immune-educating platform, DPX®. Through a differentiated mechanism of action, the DPX platform delivers instruction to the immune system to generate a specific, robust, and persistent immune response. IMV’s lead candidate, maveropepimut-S (MVP-S), delivers antigenic peptides from survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers. MVP-S treatment has been well tolerated and has demonstrated defined clinical benefit in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response. MVP-S is currently being evaluated in clinical trials for hematologic and solid cancers, including Diffuse Large B Cell Lymphoma as well as ovarian, bladder and breast cancers. The Corporation has one reportable and geographic segment. Incorporated under the Canada Business Corporations Act and domiciled in Dartmouth, Nova Scotia, Canada the shares of the Corporation are listed on the Nasdaq Stock Market and the Toronto Stock Exchange under the symbol “IMV”. The Corporation’s principal place of business is 130 Eileen Stubbs Avenue, Suite 19, Dartmouth, Nova Scotia, Canada and it also has corporate offices in Cambridge, MA and Quebec, QC.

 

These financial statements have been prepared using International Financial Reporting Standards applicable to a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business as they come due. Since the Corporation’s inception, the Corporation’s operations have been financed through the sale of shares, issuance of debt, revenue from subcontracts, interest income on funds available for investment, government assistance and income tax credits. The Corporation has incurred significant operating losses and negative cash flows from operations since inception and has an accumulated deficit of $175,335 as at June 30, 2022.

 

The ability of the Corporation to continue as a going concern is dependent upon raising additional financing through equity and non-dilutive funding and partnerships. There can be no assurance that the Corporation will have sufficient capital to fund its ongoing operations, develop or commercialize any products without future financings. These material uncertainties cast substantial doubt as to the Corporation’s ability to meet its obligations as they come due and, accordingly, the appropriateness of the use of accounting principles applicable to a going concern. The Corporation is currently pursuing financing alternatives that may include equity, debt, and non-dilutive financing alternatives including co-development through potential collaborations, strategic partnerships or other transactions with third parties, and merger and acquisition opportunities. There can be no assurance that additional financing will be available on acceptable terms or at all. If the Corporation is unable to obtain additional financing when required, the Corporation may have to substantially reduce or eliminate planned expenditures or the Corporation may be unable to continue operations.

 

The Corporation’s ability to continue as a going concern is dependent upon its ability to fund its research and development programs and defend its patent rights. These unaudited interim condensed consolidated financial statements do not reflect the adjustments to the carrying values of assets and liabilities and the reported expenses and statements of financial position classifications that would be necessary if the Corporation were unable to realize its assets and settle its liabilities as a going concern in the normal course of operations. Such adjustments could be material.

 

(1)

 

 

IMV Inc.

Notes to the Unaudited Interim Condensed Consolidated Financial Statements

As at June 30, 2022 and December 31, 2021

(Expressed in thousands of United States dollars except for share and per share amounts)

 

1Nature of operations and going concern (continued)

 

An outbreak of a novel strain of coronavirus, identified as “COVID-19”, was declared a global pandemic by the World Health Organization on March 11, 2020. To date, COVID-19 has not had a material impact on the Corporation’s financial condition, liquidity or longer-term strategic development and commercialization plans. The extent to which COVID-19 may cause more significant disruptions to IMV’s business and greater impacts to results of operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration and severity of outbreaks, including potential future waves or cycles, and the effectiveness of actions to contain and treat COVID-19. The Corporation cannot predict the duration, scope and severity of any potential business shutdowns or disruptions, including to ongoing and planned clinical studies and regulatory approval prospects. Further prolonged shutdowns or other business interruptions could result in material and negative effects to the Corporation’s ability to conduct its business in the manner and on the timelines currently planned, which could have a material adverse impact on IMV’s business, results of operations, and financial condition. The COVID-19 pandemic continues to evolve, and the Corporation will continue to monitor the effects of COVID-19 on its business.

 

2Basis of presentation

 

The Corporation prepares its unaudited interim condensed consolidated financial statements in accordance with International Acounting Standards (IAS) 34 – Interim Financial Reporting as set out in the Chartered Professional Accountants of Canada Handbook – Accounting Part I, which incorporates International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board.

 

These interim unaudited condensed consolidated financial statements were approved by the Board of Directors on August 10, 2022.

 

Functional and presentation currency 

 

Items included in the unaudited interim condensed consolidated financial statements of the Corporation are measured using the currency of the primary economic environment in which the entity operates (the “functional currency”). Effective January 1, 2021 these financial statements are presented in United States dollars, which is the Corporation’s functional currency

 

3Significant accounting policies, judgments and estimation uncertainty

 

These unaudited interim condensed consolidated financial statements have been prepared using the same policies and methods as the annual audited consolidated financial statements of the Corporation for the year ended December 31, 2021. Refer to note 4 of the Corporation’s annual audited consolidated financial statements for the year ended December 31, 2021 for more information on accounting policies and methods applied.

 

(2)

 

 

IMV Inc.

Notes to the Unaudited Interim Condensed Consolidated Financial Statements

As at June 30, 2022 and December 31, 2021

(Expressed in thousands of United States dollars except for share and per share amounts)

 

4Long-term debt

 

     

June 30,

2022

$

   

December 31,

2021

$

 
  ACOA Atlantic Innovation Fund (“AIF”), interest-free loan1 with a maximum contribution of CAD$3,786. Annual repayments, commencing December 1, 2008, are calculated as a percentage of gross revenue for the preceding fiscal year, at 2% when gross revenues are less than CAD$5,000 and 5% when gross revenues are greater than CAD$5,000. As at June 30, 2022, the amount drawn down on the loan, net of repayments, is $2,927 (2021 - $2,927).     1,268       1,088  
  ACOA AIF, interest-free loan1 with a maximum contribution of CAD$3,000. Annual repayments, commencing December 1, 2011, are calculated as a percentage of gross revenue for the preceding fiscal year, at 2% when gross revenues are less than CAD$5,000 and 5% when gross revenues are greater than CAD$5,000. As at June 30, 2022, the amount drawn down on the loan is $2,341 (2021 - $2,341).     1,063       911  
  ACOA Business Development Program, interest-free loan with a maximum contribution of CAD$395, repayable in monthly payments commencing October 2015 of CAD$3 until October 2017 and CAD$6 until June 2023. As at June 30, 2022, the amount drawn down on the loan, net of repayments, is $52 (2021 - $78).     51       76  
  ACOA AIF, interest-free loan1 with a maximum contribution of CAD$2,944, annual repayments commencing September 1, 2014, are calculated as a percentage of gross revenue from specific product(s) for the preceding fiscal year, at 5% for the first 5 years and 10%, thereafter. As at June 30, 2022, the amount drawn down on the loan is $2,303 (2021 - $2,303).     1,092       937  
  TNC 120-140 Eileen Stubbs Ltd. (the Landlord) loan, with an original balance of CAD$300, bearing interest at 8% per annum, is repayable in monthly payments of $4 beginning February 1, 2019 until May 1, 2028. As at June 30, 2022, the balance on the loan is $167 (2021 - $179).     167       179  
  ACOA Regional Economic Growth through Innovation1 – Business Scale-Up and Productivity Program, interest-free loan with a maximum contribution of CAD$1,000. Annual repayments, commencing September 1, 2022, are calculated as a percentage of gross revenue from DPX-COVID-19 product(s) for the preceding fiscal year, at 5% when gross revenues are less than CAD$5,000 and 10% when gross revenues are greater than CAD$5,000. Subsequent to September 1, 2024, any outstanding balance is payable in full on December 31, 2024 from DPX-COVID-19 gross revenues. As at June 30, 2022, the amount drawn down on the loan is $704 (2021 - $704).       190       192  

 

(3)

 

 

IMV Inc.

Notes to the Unaudited Interim Condensed Consolidated Financial Statements

As at June 30, 2022 and December 31, 2021

(Expressed in thousands of United States dollars except for share and per share amounts)

 

4Long-term debt (continued)

 

 

Venture loan with Horizon Technology Finance Corporation and Powerscourt investments XXV, LP (“Venture Loan”) bearing interest at The Wall Street Journal prime rate plus 5.75%, compounded annually and payable monthly, maturity on July 1, 2025, with effective interest rate of 13.06%. As at June 30, 2022, the amount drawn down on the loan is $25,000 (2021 - $15,000).

   24,381    14,619 
      28,212    18,002 
  Less: current portion   74    73 
      28,138    17,929 

 

1 These loans are repayable based on a percentage of gross revenue, if any. The carrying amount of these loans is reviewed each reporting period and adjusted as required to reflect management’s best estimate of future cash flows, based on a number of assumptions, discounted at the original effective interest rate.

 

    

June 30,

2022

$

  

December 31,

2021

$

 
  Balance – Beginning of period   18,002    6,906 
  Borrowings   10,000    14,520 
  Accreted interest and valuation adjustments   264    907 
  Revaluation of long-term debt   15    (367)
  Repayment of debt   (37)   (4,069)
  Currency translation adjustment (note 2)   (32)   105 
  Balance – End of period   28,212    18,002 
  Less: Current portion   74    73 
  Non-current portion   28,138    17,929 

 

Total contributions received, less amounts repaid as at June 30, 2022, is $33,494 (2021 - $23,532).

 

Certain ACOA loans require approval by ACOA before the Corporation can pay management fees, bonuses, dividends or other distributions, or before there is any change of ownership of the Corporation.

 

On December 17, 2021, the Corporation was issued a $15,000 Venture Loan at a variable annual rate of prime rate, as published in The Wall Street Journal, plus 5.75% with an interest rate floor at 3.25% on the prime rate (effective interest rate of 13.06%).

 

Interest is compounded annually and payable monthly on the first day of the month commencing January 1st , 2022. The Venture Loan maturity date is set 42 months from the first day of the month next following the month in which the loan was issued. In addition, a final payment of $750 is required by the contract. Concurrent to the Venture Loan issuance, six warrants were issued to the lender at an initial fair value of $318. Combined, these warrants allow the holder to purchase 454,544 shares at an exercise price of $1.32.

 

(4)

 

 

IMV Inc.

Notes to the Unaudited Interim Condensed Consolidated Financial Statements

As at June 30, 2022 and December 31, 2021

(Expressed in thousands of United States dollars except for share and per share amounts)

 

4Long-term debt (continued)

 

On June 22, 2022, following the achievement of a pre-determined milestone; activation of it’s phase 2B AVALON trial in plantinum-resistant ovarian cancer, the Corporation borrowed the remaining $10,000 under the Venture

 

Loan, and the number of shares for which the attached warrants are exercisable increased by 113,636, to a total of 568,180.

 

Upon the achievement of a second pre-determined milestone, the start date for the repayment of principal can be deferred for 6 months, with no extension of maturity. Transaction costs associated with the venture loan were $377 of which, $224 has been allocated to the debt component, $4 to the warrants and $149 to the loan commitment at inception.

 

Monthly pro rata principal repayments start after 24 months from loan inception.

 

The Corporation may, at its option, at any time, prepay all the outstanding Venture Loan by simultaneously paying to the lenders an amount equal to any accrued and unpaid interest, the outstanding principal balance and the final payments of the Venture Loan plus an amount equal to:

 

a)3% in the 18 first months of the loan;
b)2% in the months 19 to 30 of the loan;
c)1% in the last 12 months of the loan (31 to 42).

 

The prepayment option is an embedded derivative, but has insignificant value on the issuance date and as at June 30, 2022.

 

The Venture Loan has a priority security interest in all assets of IMV, excluding intellectual property. IMV has entered into a negative pledge agreement regarding intellectual property with the lenders.

 

The Corporation is in compliance with its debt covenants.

 

5Warrant Liabilities

 

In conjunction with the Venture Loan with Horizon Technology Finance Corporation and Powerscourt Investments XXV, on December 17, 2021, six warrants have been issued to the lenders. These warrants allowed the holder to purchase 454,544 common shares at an exercise price of $1.32. On June 22, 2022, in connection with the draw down of the remaining of $10,000 under the Venture Loan, the number of shares for which these warrants are exerciseable increased to 568,180 with no change in exercise price. The warrants can be exercised at any moment from grant date to the 10 year anniversary and will be automatically exercised on expiration date. The holder can choose to exercise the warrant with a payment to the Corporation or exercise on a net issuance basis (cashless). This last feature breaches the fixed-for-fixed criterion, therefore the warrants are classified as financial liability and will be remeasured at FVTPL at each reporting period.

  

(5)

 

 

IMV Inc.

Notes to the Unaudited Interim Condensed Consolidated Financial Statements

As at June 30, 2022 and December 31, 2021

(Expressed in thousands of United States dollars except for share and per share amounts)

 

5Warrant liabilities (continued)

 

The fair values of warrants are estimated using the Black-Scholes option pricing model. The weighted average assumptions used in the Black-Scholes valuation model for the periods presented were as follows:

 

    

June 30,

2022

  

December 31,

2021

 
  Risk-free interest rate   3.10%   0.94%
  Market price  $0.68   $1.28 
  Expected volatility   78.53%   94.44%
  Expected dividend yield        
  Expected life (years)   2    2.5 

 

6Share capital

 

Authorized

 

Unlimited number of common shares and preferred shares, issuable in series, all without par value.

 

    

Common shares

#

  

Amount

$

 
  Issued and outstanding        
  Balance – January 1, 2021   67,093,547    136,705 
  Issued for cash, net of issuance costs   14,842,408    18,983 
  DSUs redeemed   145,870    331 
  Stock options exercised   83,504    217 
  Balance – December 31, 2021   82,165,329    156,236 
  Issued for cash, net of issuance costs   104,133    93 
  Balance – June 30, 2022   82,269,462    156,329 

 

As at June 30, 2022, a total of 17,198,195 shares (December 31, 2021 – 16,837,872) are reserved to meet outstanding stock options, warrants and deferred share units (“DSUs”).

 

On July 20, 2021, the Corporation completed the July 2021 Public Offering, issuing an aggregate of 14,285,714 units at a price of $1.75 per unit, for aggregated proceeds of $25 million. Each unit consisted of one common share and 0.75 of one common share purchase warrant, with each whole warrant entitling the holder to acquire one common share of the Corporation at an exercise price of $2.10 for a period of 60 months expiring on July 20, 2026. The value allocated to the common shares issued was $18,557 and the value allocated to the warrants was $6,443. Total costs associated with the offering were $2,121, including cash costs for professional and regulatory fees.

 

On October 16, 2020, the Corporation entered into an Equity Distribution Agreement (“October 2020 ATM”) with Piper Sandler & Co. (“Piper Sandler”) authorizing the Corporation to offer and sell common shares from time-totime up to an aggregate offering amount of $50,000 through Piper Sandler, as agent. The total expenses associated with the ATM Distribution, excluding compensation and reimbursements payable to Piper Sandler under the terms of the Equity Distribution Agreement, were approximately $295. For the six month period ended June 30, 2022, 104,133 (2021 – 556,694) common shares were sold for gross proceeds of $142 (2021 - $2,168).

 

(6)

 

 

IMV Inc.

Notes to the Unaudited Interim Condensed Consolidated Financial Statements

As at June 30, 2022 and December 31, 2021

(Expressed in thousands of United States dollars except for share and per share amounts)

 

7Contributed surplus

 

Deferred share units

 

The maximum number of common shares which the Corporation is entitled to issue from Treasury in connection with the redemption of DSUs granted under the DSU Plan is 2,000,000 common shares.

 

DSU activity for the six months ended June 30, 2022 and year ended December 31, 2021 are as follows:

 

    

June 30

2022

  

December 31

2021

 
     #   # 
  Opening balance   537,203    429,530 
  Granted   174,532    325,263 
  Redeemed       (217,590)
  Closing balance   711,735    537,203 

 

The compensation expense for the six months ended June 30, 2022 was $215 (2021 – $583) recognized over the vesting period. Vested DSUs cannot be redeemed until the holder is no longer a member of the Board.

 

Stock options

 

The fair values of stock options are estimated using the Black-Scholes option pricing model. As at June 30, 2022, 3,134,710 stock options (2021 – 1,430,635) with a weighted average exercise price of CAD$1.46 (2021 – CAD$3.30) and a term of ten years (2021 – ten years), were granted to employees and consultants. The expected volatility of these stock options was determined using historical volatility rates and the expected life was determined using the weighted average life of past options issued. The value of these stock options has been estimated at $2,540 (2021 - $2,683), which is a weighted average grant date value per option of CAD$1.03 (2021 - CAD$2.35), using the Black-Scholes valuation model and the following weighted average assumptions:

 

     2022   2021 
  Risk-free interest rate   1.68%   0.82%
  Exercise price   CAD$1.46    CAD$3.30 
  Market price   CAD$1.46         CAD$3.30 
  Expected volatility   77%   79%
  Expected dividend yield        
  Expected life (years)   7.0    7.0 
  Forfeiture rate   6%   4%
             

 

(7)

 

 

IMV Inc.

Notes to the Unaudited Interim Condensed Consolidated Financial Statements

As at June 30, 2022 and December 31, 2021

(Expressed in thousands of United States dollars except for share and per share amounts)

 

7Contributed surplus (continued)

 

Option activity for the six months ended June 30, 2022 and year December 31, 2021 was as follows:

 

     June 30, 2022   December 31, 2021 
    

Number

#

  

Weighted

average

exercise

price

$CAD

  

Number

#

  

Weighted

average

exercise

price

$CAD

 
                   
  Outstanding - Beginning of period   2,674,227    4.28    1,636,236    4.93 
                       
  Granted   3,134,710    1.46    1,430,635    3.30 
  Exercised    1           (150,438 )1    2.37  
  Forfeited   (449,505)   1.88    (109,218)   4.46 
  Cancelled   (10,125)   5.05    (124,238)   3.84 
  Expired   (145,312)   2.40    (8,750)   2.37 
                       
  Outstanding - End of period   5,203,995    2.84    2,674,227    4.28 

   

1 Of the 150,438 options exercised in 2021, 125,812 elected the cashless exercise, under which 58,787 shares were issued. These options would have otherwise been exercisable for proceeds of $235 on the exercise date. There have been no options exercised to date in 2022.

 

The number and weighted average exercise price of options exercisable as at June 30, 2022 is 1,457,694 and $CAD5.25, respectively (2021 – 1,301,048 and CAD$5.14).

 

8Warrants

 

Warrant activity for the six months ended June 30, 2022 and year ended December 31, 2021, was as follows

 

     June 30, 2022   December 31, 2021 
     Number  

Weighted

average

exercise

price

   Amount   Number  

Weighted

average

exercise

price

   Amount 
     #   $CAD   $   #   $CAD   $ 
  Opening balance   13,171,898    2.87    8,196    2,457,613    3.72    2,116 
  Granted               10,714,285    2.67    6,080 
  Expired   (2,457,613)   3.72    (2,350)            
                                 
  Closing balance   10,714,285    2.67    5,846    13,171,898    2.87    8,196 

 

The fair values of warrants are estimated using the Black-Scholes option pricing model. There have been no warrants issued in 2022.

 

(8)

 

 

IMV Inc.

Notes to the Unaudited Interim Condensed Consolidated Financial Statements

As at June 30, 2022 and December 31, 2021

(Expressed in thousands of United States dollars except for share and per share amounts)

 

8Warrants (continued)

 

The weighted average assumptions used in the Black-Scholes valuation model for the periods presented were as follows:

 

     2021 
  Risk-free interest rate   0.51%
  Market price   CAD$2.67 
  Expected volatility   92%
  Expected dividend yield    
  Expected life (years)   2.5 

 

9Financial instruments

 

Fair value of financial instruments

 

Financial instruments are defined as a contractual right or obligation to receive or deliver cash on another financial asset. The following table sets out the approximate fair values of financial instruments as at the consolidated statements of financial position date with relevant comparatives:

 

     June 30, 2022   December 31, 2021 
    

Carrying

value

$

  

Fair value

$

  

Carrying

value

$

  

Fair value

$

 
                   
  Cash and cash equivalents   31,134    31,134    38,616    38,616 
  Amounts receivable   520    520    10    10 
  Accounts payable, accrued and other liabilities   8,228    8,228    8,589    8,589 
  Warrant liabilities   94    94    318    318 
  Long-term debt   28,212    28,212    18,002    18,002 

 

Assets and liabilities, such as commodity taxes, that are not contractual and that arise as a result of statutory requirements imposed by governments, do not meet the definition of financial assets or financial liabilities and are, therefore, excluded from amounts receivable and accounts payable.

 

Fair value of items, which are short-term in nature, have been deemed to approximate their carrying value. The above noted fair values, presented for information only, reflect conditions that existed only as at June 30, 2022, and do not necessarily reflect future value or amounts which the Corporation might receive if it were to sell some or all of its assets to a willing buyer in a free and open market.

 

The fair value of long-term debt is estimated based on the expected interest rates for similar borrowings by the Corporation at the consolidated statements of financial position dates. For the periods presented, the fair value is estimated to be equal to the carrying amount.

 

(9)

 

 

IMV Inc.

Notes to the Unaudited Interim Condensed Consolidated Financial Statements

As at June 30, 2022 and December 31, 2021

(Expressed in thousands of United States dollars except for share and per share amounts)

 

10Subsequent events

 

On July 7, 2022, the Corporation received a letter from the Listing Qualifications Department of the Nasdaq indicating that, based upon the closing bid price of the Corporation’s common shares for the 30 consecutive business day period between May 23, 2022, through July 6, 2022, the Corporation did not meet the minimum bid price of US$1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2). The Corporation will be provided with a compliance period of 180 calendar days, or until January 3, 2023, in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A) and may be eligible for an additional 180 calendar days to regain compliance, if certain requirements are met. The letter has no immediate impact on the Corporation’s business operations or listing of its common shares, which will continue to be listed and traded on The Nasdaq Capital Market, subject to the Corporation’s continued compliance with the other listing requirements of The Nasdaq Capital Market, as well as on the TSX.

 

On August 4, 2022, the Corporation re-established its existing at-the-market facility (“August 2022 ATM Distribution”) initially announced on October 16, 2020 under a renewed base shelf prospectus, which is effective for a period of 25 months from July 25, 2022. Pursuant to this August 2022 ATM Distribution, the Corporation may, from time to time, sell common shares up to an aggregate amout of US$50,000. The total expenses associated with the ATM Distribution, excluding compensation and reimbursements payable to Piper Sandler under the terms of the Equity Distribution Agreement, are estimated to be $100. As at August 10, 2022, there have been no common shares have been sold under the August 2022 ATM Distribution.

 

 

(10)


 


Exhibit 99.2

Exhibit 99.2

 

 

 

Management’s Report on Financial Position and Operating Results

 

For the three and six months ended June 30, 2022

 

 

 

MANAGEMENT DISCUSSION AND ANALYSIS (“MD&A”)

 

The following analysis provides a review of the unaudited interim condensed consolidated results of operations, financial condition, and cash flows for the three and six months ended June 30, 2022 (“Q2 2022”), with information compared to the three and six months ended June 30, 2021 (“Q2 2021”), for IMV Inc. (“IMV”, “us”, “our”, “we” or the “Corporation”). This analysis should also be read in conjunction with the information contained in the audited annual consolidated financial statements and related notes for the years ended December 31, 2021 and December 31, 2020.

 

The Corporation prepares its unaudited interim condensed consolidated financial statements in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (IASB). Management is responsible for the preparation of the consolidated financial statements and other financial information relating to the Corporation included in this report. The Board of Directors is responsible for ensuring that management fulfills its responsibilities for financial reporting. In furtherance of the foregoing, the Board of Directors has appointed an Audit Committee comprised of independent directors. The Audit Committee meets with management and the auditors in order to discuss the results of operations and the financial condition of the Corporation prior to making recommendations and submitting the consolidated financial statements to the Board of Directors for its consideration and approval for issuance to shareholders. The information included in this MD&A is as of August 10, 2022, the date when the Board of Directors approved the Corporation’s unaudited interim condensed consolidated financial statements for the three and six months ended June 30, 2022, on the recommendation of the Audit Committee.

 

Amounts presented in this MD&A are approximate and have been rounded to the nearest thousand except for share and per share data. All currency figures reported in the unaudited interim condensed consolidated financial statements and in this document are in United States dollars (“USD”), unless otherwise specified.

 

Additional information regarding the business of the Corporation, including the Annual Information Form of the Corporation for the year ended December 31, 2021 (the “AIF”) and included in the Corporation’s Form 40-F filed with the U.S. Securities and Exchange Commission, is available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.

 

FORWARD-LOOKING STATEMENTS

 

Certain statements in this MD&A may constitute “forward-looking” statements which involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance, or achievements of the Corporation, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. When used in this MD&A, such statements use such words as “will”, “may”, “could”, “intends”, “potential”, “plans”, “believes”, “expects”, “projects”, “estimates”, “anticipates”, “continues”, “potential”, “predicts” or “should” and other similar terminology. These statements reflect current expectations of management regarding future events and operating performance and speak only as of the date of this MD&A. Forward-looking statements include, among others:

 

·the Corporation’s business strategy;

·statements with respect to the sufficiency of the Corporation’s financial resources to support its activities;

·potential sources of funding;

·the Corporation’s ability to obtain necessary funding on favorable terms or at all;

·the Corporation’s expected expenditures and accumulated deficit level;

·the Corporation’s ability to obtain necessary regulatory approvals for its product candidates;

·the expected outcomes from the Corporation’s preclinical assays, studies and clinical trials and the anticipated timing of release of any results therefrom;

·the Corporation’s expectations about the timing of achieving milestones and the cost of preclinical assays, studies and clinical trials;

·the Corporation’s expected outcomes from its ongoing and future research and research collaborations;

·the Corporation’s exploration of opportunities to maximize shareholder value as part of the ordinary course of its business through collaborations, strategic partnerships, and other transactions with third parties;

·the potential impact of partnerships on the Corporation’s manufacturing capabilities;

 

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·the Corporation’s plans for the research and development of certain product candidates;

·the Corporation’s strategy for protecting its intellectual property;

·the Corporation’s ability to identify licensable products or research suitable for licensing and commercialization;

·the Corporation’s ability to obtain licences on commercially reasonable terms;

·the Corporation’s plans for generating revenue;

·the Corporation’s plans for future clinical trials; and

·the Corporation’s hiring and retention of skilled staff.

 

Forward-looking statements involve significant risks and uncertainties, should not be read as guarantees of future performance or results and will not necessarily be accurate indications of whether or not such results will be achieved. IMV Inc. assumes no responsibility to update forward-looking statements in this MD&A except as required by law. A number of factors could cause actual results to differ materially from the results discussed in the forward-looking statements, including, but not limited to, the factors discussed in the AIF, under the heading “Risk Factors and Uncertainties”. Although the forward-looking statements contained in this MD&A are based upon what management of the Corporation believes are reasonable assumptions, the Corporation cannot provide any assurance to investors that actual results will be consistent with these forward-looking statements and should not be unduly relied upon by investors.

 

Actual results, performance and achievements are likely to differ, and may differ materially, from those expressed or implied by the forward-looking statements contained in this MD&A. Such statements are based on a number of assumptions which may prove to be incorrect, including, but not limited to, assumptions about:

 

·the Corporation’s ability to raise sufficient capital and obtain additional funding on reasonable terms when necessary;

·positive results of preclinical assays, studies and clinical trials;

·the Corporation’s ability to successfully develop existing and new product candidates;

·the Corporation’s ability to hire and retain skilled staff;

·the products and technology offered by the Corporation’s competitors;

·general business and economic conditions, including as a result of the ongoing COVID-19 pandemic, as well as political crisis, such as terrorism, war, political instability or other conflict;

·adverse macroeconomic conditions including inflation, disrupting in global market conditions and the increase in labour costs;

·the Corporation’s ability to accurately assess and anticipate the impact of COVID-19 on the Corporation’s clinical studies and trials and operations generally;

·the Corporation’s ability to protect its intellectual property;

·the coverage and applicability of the Corporation’s intellectual property rights to any of its product candidates;

·the expectation that the Common Shares will continue to be listed on the Toronto Stock Exchange ("TSX") and the Nasdaq Stock Market LLC ("Nasdaq"), including as it relates to the Corporation regaining compliance with the Nasdaq listing requirements, such as the Minimum Bid Price Requirement

·the Corporation’s ability to manufacture its product candidates, if approved, and to meet demand;

·the general regulatory environment in which the Corporation operates;

·the Corporation’s ability to collaborate with governmental authorities with respect to the clinical development of its product candidates; and

·obtaining necessary regulatory approvals for its product candidates and the timing in respect thereof.

 

These statements reflect management’s current views and beliefs and are based on estimates, assumptions and information currently available to, and considered reasonable by, management. The forward-looking information in this MD&A does not include a full assessment or reflection of the unprecedented impacts of the COVID-19 pandemic and the resulting global and regional economic impacts. The Corporation has experienced uncertainty related to the COVID-19 situation. Uncertainties include the scope, severity and duration of the pandemic, the actions taken to contain or mitigate its impact and the direct and indirect effect of the pandemic and containment measures, among others. It is anticipated that the COVID-19 pandemic and global measures to contain it will continue to have an impact on the Corporation, including its clinical trials and collection and analysis of data, however it is challenging to quantify the potential magnitude of such impact at this time. The Corporation is regularly assessing the situation and remains in contact with its partners, clinical sites and investigators and suppliers to assess any impacts and risks.

 

3

 

 

The information contained herein is dated as of August 10, 2022, the date of the Board of Directors’ approval of the Q2 2022 unaudited interim condensed consolidated financial statements and of the MD&A. For additional information on risks, uncertainties and assumptions, including a more detailed assessment of the risks that could cause actual results to materially differ from current expectations, please refer to the AIF of IMV filed on SEDAR at www.sedar.com and included in the registration statement on Form 40-F filed on EDGAR at www.sec.gov.

 

COVID-19 IMPACT

 

COVID-19 has impacted the Corporation’s research and development activities but has not caused significant disruptions to its business operations to date. In April 2020, IMV was designated as an essential business by the Nova Scotia Department of Business and Nova Scotia Public Health which allowed for essential lab employees to continue operations in its Dartmouth laboratories. Following the outbreak of the Omnicron variant, IMV adopted a rotating on site work schedule and required that all employees working on site provide either proof of vaccination status or submit bi-weekly negative COVID-19 test results. IMV required all employees working on site, regardless of vaccination status, to complete a rapid COVID-19 test once every three working days. Effective March 1st, 2022, employees no longer are required to test and a hybrid working model has been adopted.

 

To date, COVID-19 has not had a material impact on the Corporation’s financial condition, liquidity or longer-term strategic development and commercialization plans. While certain clinical trial activities, including patient enrollment and site activations were delayed or otherwise impacted by the COVID-19 pandemic, the extent to which the ongoing pandemic may cause more significant disruptions to IMV’s business and greater impacts to results of operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration and severity of outbreaks, including potential future waves or cycles, the variants and the effectiveness of actions to contain and treat COVID-19. The Corporation cannot predict the duration, scope and severity of any potential business shutdowns or disruptions, including impacts to ongoing and planned clinical studies and regulatory approval prospects. Further prolonged shutdowns or other business interruptions could result in material and negative effects to the Corporation’s ability to conduct its business in the manner and on the timelines currently planned, which could have a material adverse impact on IMV’s business, results of operations and financial condition.

 

The COVID-19 pandemic continues to evolve, and the Corporation will continue to monitor the effects of COVID-19 on its business.

 

CORPORATE OVERVIEW

 

We are a clinical-stage immuno-oncology company developing a portfolio of therapies based on DPX®, our novel immune-educating technology platform (“DPX Platform” or “DPX”), that is designed to inform a specific, robust and persistent anti-tumor immune response, offering long-lasting benefit to patients with solid or hematological cancers.

 

Our lead product candidate, maveropepimut-S (or “MVP-S”, previously known as “DPX-Survivac”) is a DPX-based immunotherapy that delivers antigenic peptides of survivin to eliminate survivin-expressing cells by educated, cytotoxic T cells. Survivin is overexpressed in most solid and liquid tumors and survivin expression is highly correlated with aggressive tumors and poor prognosis in multiple cancers. We believe results of preclinical and clinical studies support the benefit of MVP-S in human cancers and suggest that the anti-tumor activity of MVP-S in some tumor types may be further enhanced through use with immune modulators and/or anti-cancer drugs. MVP-S is currently being evaluated in clinical trials for hematologic and solid cancers, including relapsed/refractory Diffuse Large B Cell Lymphoma (“r/r DLBCL”) as well as ovarian, bladder and breast cancers.

 

4

 

 

Recent clinical progress with our DPX-based immunotherapeutic candidates:

 

· We have activated new sites in North America, Europe, Australia and New Zealand in the VITALIZE phase 2b study in r/r DLBCL, with lead principal investigator Dr. Matthew J. Matasar, Section Head for Aggressive B-cell Lymphoma at Memorial Sloan Kettering Cancer Center (NYC). The goal of this study is to further evaluate the promising Objective Response Rate (“ORR”) observed in Program Death Ligand 1 (“PD-L1+”) positive patients in the now completed SpiReL phase 2 study which evaluated the combination of MVP-S, intermittent, low-dose cyclophosphamide (“CPA”), and Merck’s checkpoint inhibitor, pembrolizumab (Keytruda®). Early data from the follow-on, open label VITALIZE study are expected in Q3 2022.

· We have dosed the first patient in our AVALON phase 2b study. The goal of this study is to further evaluate the clinical benefit observed in our phase 2 DeCidE1 study which evaluated patients with recurrent ovarian cancer receiving MVP-S and intermittent, low-dose CPA. In the now completed DeCidE1 study, median overall survival was 19.9 months and nearly half of the patients survived for at least 2 years. Treatment-related adverse events (“AEs”) were tolerable, reflecting mostly grade 1 and grade 2 site injection reactions. Enrollment of stage one of the AVALON phase 2b study (approximately 40 patients) is expected to be completed in Summer 2023.

·We have engaged in discussions with experts in the field to determine the best clinical pathway for MVP-S in bladder cancer following the promising results obtained in the phase 2 “basket” study evaluating MVP-S and intermittent, low-dose CPA in combination with pembrolizumab (Keytruda®) in different solid tumor cancer indications. Clinical benefit was observed most prominently in metastatic bladder cancer patients and patients with turmors shown to be positive for the microsatellite instability high (“MSI-H”) biomarker. Details on the data observed in the bladder cancer cohort were presented in a late-breaking oral symposium at the American Association for Cancer Research (“AACR”) annual meeting in April 2022. Data showed that five out of 17 patients showed response (2 confirmed responses (“CRs”) and 3 partial responses (“PRs”) per RECIST v1.1, including patients who were previously treated with immune checkpoint inhibitors). The combination treatment was well-tolerated, with the majority of adverse events being grade 1 or grade 2 and no severe adverse events attributed to MVP-S.

·We have also made progress in the enrollment of two investigator-led neoadjuvant studies; a phase 1b clinical study in women with non-metastatic HR+/HER2- evaluating MVP-S with an aromatase inhibitor and a phase 1 study in non-muscle invasive bladder cancer (“NMIBC”) which will evaluate MVP-S and our second DPX-based product candidate, DPX-SurMAGE. A clinical update on early patients from each of these studies is expected in Q4 2022.

 

In 2022, our goal is to move MVP-S forward on the path to registration trials in r/r DLBCL and ovarian cancer, while leveraging our versatile DPX platform to build a diversified portfolio of cancer immunotherapies.

 

IMV Inc. is headquartered in Dartmouth, NS and has corporate offices in Cambridge, MA and Quebec, QC. The common shares of the Corporation (the “Common Shares”) are currently listed on the Nasdaq and on the TSX under the symbol “IMV”.

 

OUR DPX® PLATFORM GIVES US UNIQUE ADVANTAGES

 

Our DPX technology is a unique and patented delivery platform that can incorporate a range of bioactive molecules and is designed to produce targeted, long-lasting immune responses enabled by various formulated components. We believe our versatile, immune-educating technology can be developed for application in a variety of therapeutic areas where generation of a target-specific immune response is expected to mitigate disease.

 

The DPX delivery platform has a differentiated mechanism of action (“MOA”) and multiple advantages

 

DPX is a versatile technology for delivery of single or multiple bioactive molecules, including peptides, proteins, small molecules, nucleic acids, whole viruses and virus-like particles (“VLPs”).

 

When formulated with tumor-associated antigens, DPX-based immunotherapies are designed to maintain antigens at the injection site for prolonged interaction with the immune system, inducing a robust expansion of antigen-specific cytotoxic T cells and an inhibition of tumor growth in tumor-bearing models. In clinical trials, DPX-based immunotherapies (administered alone and in combination with other agents) have achieved robust, sustained immune responses with infrequent, low-volume injections that have been well tolerated (i.e. most commonly Grade 1 or 2 injection site reactions). In the clinic, our lead compound has been shown to elicit and increase both T and B cell infiltration into tumors. Recently, we presented results from clinical/translational studies and preclinical models suggesting a distinct role for NK cells, in addition to the previously recognized role for T and B cells, in DPX-mediated immunotherapeutic anti-tumor activity efficacy. The poster presented at AACR 2022 is available for viewing on our website4.

5

 

 

 

We believe our non-aqueous, lipid-based DPX technology can confer numerous practical advantages to our DPX-based immunotherapies, including ease and low cost of manufacturing as well as the ability to incorporate both hydrophilic and hydrophobic molecules without the need for cold-chain shipping or storage and with long-term shelf stability and simple subcutaneous administration in an office setting.

 

OUR BUSINESS STRATEGY

 

Cancer is considered one of the most widespread and prevalent diseases globally. According to the 2022 Cancer Facts & Figures released by the American Cancer Society, it is predicted that the global cancer burden will rise to 28 million and the number of cancer deaths to 16.2 million by 2040 solely due to the growth of the aging population. However, these projections may be underestimated, given the adoption of unhealthy behaviors and lifestyles associated with rapid income growth and changes in reproductive patterns in economically transitioning countries.

 

Conventional cancer treatment involves surgery to remove the tumor whenever possible, as well as chemotherapy and radiation. Chemotherapies are widely used, despite their associated toxicities, because they interfere with the ability of cancer cells to proliferate. However, studies have shown that older patients often receive little or no treatment because the benefit of prolonged survival does not outweigh potential adverse effects and impact on quality of life. Also, in all groups of patients, tumors often develop resistance to chemotherapies, thus limiting their efficacy in preventing tumor recurrence.

 

 

4 https://www.imv-inc.com/the-dpx-platform/scientific-publications-posters

 

6

 

 

Despite recent advances in some cancer indications, independent sources5 note a high unmet medical need in cancer therapy, noting the median survival rate remains poor.

 

Even though the immune system can prevent or slow cancer growth, cancer cells have numerous mechanisms to evade immune detection and destruction. Cancer immunotherapy is a type of treatment that is designed to activate and leverage a patient’s immune system to control and eradicate cancer cells. The National Cancer Institute describes several types of immunotherapies, including Immune Checkpoint Inhibitors (“CPIs”) like Merck’s pembrolizumab (KEYTRUDA®), activated T-cell transfer therapies, monoclonal antibodies, treatment vaccines and immune modulators. Although immunotherapy has revolutionized cancer treatment in the last decade, these treatments can cause serious side effects, including organ-specific and systemic inflammation. Unfortunately, even patients who initially respond to immunotherapy may relapse and succumb to their disease.

 

We are leveraging the unique mechanism of action of the DPX platform to build a portfolio of novel immune-educating cancer immunotherapies, which are designed to instruct a robust, persistent immune response against a specific target. Through the expertise of our teams, the quality of our science and emerging strategic partnerships, our mission is to push the boundaries of our novel immunotherapeutic platform to offer better treatments for solid and hematological cancers. The favourable safety outcomes shown by our lead product candidate in clinical trials to date encourages us to seek opportunities for combination with other immunotherapies to induce a synergistic activation of a patient’s immune systems against cancer. We are exploring a variety of avenues, including co-development through potential collaborations, strategic partnerships or other transactions with third parties to continue developing new DPX-based immune-educating therapies.

 

We are also evaluating potential licencing opportunities for our programs outside of immuno-oncology and for other applications of the DPX technology. We may seek additional equity and non-dilutive funding to advance the development of our immune-oncology product candidates and potential new programs.

 

A FOCUS ON IMMUNO-ONCOLOGY

 

 

IMV owns or is the exclusive licensee of all DPX-based product candidates.

 

Results of research with DPX-based immunotherapies have shown robust and sustained antigen-specific T-cell activity in preclinical tumor models and in humans with advanced cancers. Notably, preclinical and early clinical research indicates that DPX-based immunotherapies can also enlist other immune cell types, including B cells, and NK cells, in the anti-cancer response. IMV’s immune-educating therapies are well tolerated and can readily be combined with other immunotherapeutic approaches, including CPIs.

 

 

5 Cancer Facts and Figures 2022. American Cancer Society

7

 

 

OUR DPX®-BASED IMMUNOTHERAPIES

 

Our Lead Cancer Immunotherapy: Maveropepimut-S

 

MVP-S is our first DPX-based immunotherapy designed to instigate a specific immune response to survivin; a protein commonly overexpressed in many advanced cancers. MVP-S is comprised of peptides from the survivin protein, a peptide to activate CD4 T “helper” cells, and an activator of innate immune cells (polydIdC). The inclusion of each of these components together elicits a robust, persistent induction of survivin-specific CD8 “killer” T cells that patrol the body to seek out and specifically eradicate survivin-expressing cancer cells.

 

Survivin is a well-known tumor-associated antigen (“TAA”) and is overexpressed in most solid and liquid tumors, but rarely in normal, terminally differentiated, adult tissues. Survivin supports tumor growth and metastasis by protecting tumor cells from apoptosis, conferring resistance to chemotherapy and radiotherapy. Survivin expression is correlated with tumor aggressiveness and poor prognosis in multiple cancers6.

 

MVP-S has been shown to enhance and prolong survivin-specific immune responses in preclinical tumor models when compared with these same survivin-specific peptides administered in an emulsion-based formulation. In the clinic, MVP-S has shown promising clinical activity in different cancer indications whereas Lennerz et al. (2014) described that these same survivin peptides formulated in a conventional emulsion demonstrated limited clinical benefit with no objective responses. These results were presented at the last AACR-NCI-EORTC meeting in September 2021. The presentation is available for viewing on our website7.

 

Ongoing clinical programs are evaluating MVP-S alone and in combination with intermittent, low dose cyclophosphamide and anti-cancer drugs in patients with advanced DLBCL, ovarian cancer, breast cancer, and other solid tumors.

 

In certain clinical trials, IMV is exploring the activity of MVP-S, with and without intermittent oral, low-dose CPA used as an immune-modulator. Conventional chemotherapeutic drugs are traditionally used for their cytotoxic effect on tumors, but CPA can also be used at lower doses to potentiate the activity of other immunotherapies without inducing significant cytotoxicity. Several studies have demonstrated that low-dose regimens of CPA can have multiple beneficial effects for T cell therapies, including reduction of T regulatory cell numbers and increase in effector T cells (Hugues et al, Immunology. 2018). In phase 1 clinical studies, IMV has demonstrated that patients receiving intermittent low-dose oral CPA and MVP-S show increased polyfunctional, survivin-specific T cells when compared to patients treated only with MVP-S (Weir et Al, AACR, 2016).

 

Orphan Drug Status

 

The Corporation announced, in November 2016, that the European Medicines Agency (“EMA”) had granted orphan drug designation status to IMV’s MVP-S in ovarian cancer. In July 2015, the FDA also granted orphan drug status to MVP-S for the treatment of ovarian cancer. This designation is valid for all applications of MVP-S in ovarian cancer without restriction to a specific stage of disease.

 

Clinical programs with MVP-S

 

The clinical development of our lead compound, MVP-S, is focused on exploring its therapeutic potential in stage-gated clinical trials, with the goal of advancing MVP-S toward registration trials based on observed clinical signals in each stage.

 

DLBCL – VITALIZE phase 2b clinical trial (IMV-sponsored)

 

According to GlobalData: DLBCL, Competitive Landscape 2021, Diffuse Large B Cell Lymphoma is the most common and aggressive form of Non-Hodgkin Lymphoma (“NHL”) accounting for 30%-40% of all cases of adult NHL and, with 27,000 new cases per year in the United States, this blood cancer represents a high unmet medical need. Patients with aggressive NHLs such as DLBCL can generally expect low median survival rates (median overall survival is 4.4 months for patients who fail salvage regimens). The prognosis of patients with r/r DLBCL is poor, and clinical, economic, and logistical barriers limit access to potentially curative therapies. Only about 50% of r/r DLBCL patients respond to salvage chemotherapy and are thus eligible for autologous stem cell transplant (“ASCT”) in the 2nd line setting8. Utilization of CAR T-cell therapies is limited by high cost, payer denials, cumbersome logistics, toxicity, and patient proximity to a specialized center9 and is only available to patients in certain countries.

 

 

6 Virrey JJ et al. Increased survivin expression confers chemoresistance to tumor-associated endothelial cells. The American journal of pathology. 2008;173(2):575-585.

7 https://www.imv-inc.com/the-dpx-platform/scientific-publications-posters

8 Vardhana SA et al. Outcomes of primary refractory diffuse large B-cell lymphoma (DLBCL) treated with salvage chemotherapy and intention to transplant in the rituximab era. British journal of haematology. 2017;176(4):591-599.

9 Gajra A. et al. Perceptions of community hematologists/oncologists on barriers to chimeric antigen receptor T-cell therapy for the treatment of diffuse large B-cell lymphoma. Immunotherapy. 2020;12(10):725-732.

 

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Survivin overexpression is common in DLBCL and is associated with advanced clinical stage, high-risk International Prognostic Index scores, bone marrow involvement, and short overall survival, suggesting that immunotherapy incorporating MVP-S may fill unmet medical needs in DLBCL10.

 

In our clinical trials, we evaluate r/r DLBCL patients who have received at least two prior lines of systemic therapy and who are ineligible or have failed ASCT or CAR-T therapy. Based on 2024 projections from the 2019 Data Monitor Syndicated Report, it is estimated that there are 9,500 patients in the US eligible for a third line of treatment or are not eligible for stem cell transplantation or cell therapy.

 

The now completed SpiReL phase 2 study, evaluated a combination of MVP-S with pembrolizumab (KEYTRUDA®11) and intermittent, low-dose CPA in r/r DLBCL (ClinicalTrials.gov Identifier: NCT03349450). The treatment regimen was well-tolerated (population median age: 75 years) and demonstrated impressive clinical benefit, particularly in patients whose tumors express the Program Death Ligand 1 (“PD-L1”). Among the 8 patients with tumor PD-L1 expression, the ORR was 75% (compared with PD-L1-negative patients [n=11], 0%) suggesting that PD-L1 positivity may identify patients most likely to respond to this combination immunotherapy. Presence of immune cells observed in the tumor before and during treatment was associated with tumor response. Survivin-specific T cells responses were observed during treatment and also associated with tumor response. More details can be found on the Scientific Publications & Posters section of our website (SITC November 2020 and ASH December 2020) for presentations given by Dr. Neil Berinstein, Hematologist at the Sunnybrook Health Science Center in Toronto and principal investigator of the SpiReL study.

 

In 2021, to further evaluate the results observed in the SpiReL study, we initiated the VITALIZE study, a company-sponsored, multi-centre phase 2b trial in patients with r/r DLBCL. The VITALIZE phase 2b trial is an open-label, randomized, parallel group, Simon two-stage study designed to assess the combination of MVP-S and pembrolizumab with or without intermittent, low-dose CPA. In the first stage of this study, our lead compound is being evaluated in approximately 30 subjects, with r/r DLBCL who have received at least two prior lines of systemic therapy and who are ineligible or have failed ASCT or CAR-T therapy (ClinicalTrials.gov Identifier: NCT04920617).

 

The primary endpoint is ORR, centrally evaluated per Lugano (2014) and measured by the number of subjects per arm achieving a best response of Partial or Complete Response (“PR” or “CR”) during the 2-year treatment period. All subjects will be evaluated for their baseline PD-L1 expression with the goal to validate the SpiReL data that highlighted PD-L1 as a possible predictive biomarker for the combination therapy.

 

Dr. Matthew J. Matasar, Section Head for Aggressive B-cell Lymphoma at Memorial Sloan Kettering Cancer Center is the lead principal investigator of the VITALIZE study.

 

In January 2022, we announced that a first patient with r/r DLBCL received treatment with MVP-S in combination with pembrolizumab, in the VITALIZE phase 2B clinical trial, advancing our lead compound on the path to a registration trial. Exploratory endpoints include cell mediated immune response, tumor immune cell infiltration, and biomarker analyses. Global site activation is ongoing and a clinical update on early patients is expected in Q3 2022.

 

During the six months ended June 30, 2022, IMV has spent $3.4 million related to this phase 2b study. We anticipate that, in addition to general clinical department expenses, which are distributed amongst the various clinical projects, the costs to complete the first stage of this trial (approximately 30 patients) are estimated at $10 million, of which $6 million is estimated to be spent in 2022.

 

 

10 Zhang Y, Wang J, Sui X, et al. Prognostic and Clinicopathological Value of Survivin in Diffuse Large B-cell Lymphoma: A Meta-Analysis. Medicine. 2015;94(36):e1432.

11 KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Pembrolizumab is a highly selective humanized monoclonal IgG4 antibody directed against the PD-1 receptor on the cell surface. The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells, which is complementary to MVP-S’ mechanism of action.

 

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Ovarian Cancer – AVALON phase 2B in patients with platinum-resistant ovarian cancer (IMV-sponsored)

 

Globally, ovarian cancer is the seventh most diagnosed cancer among women and a leading cause of mortality among all gynecological cancers (Global Data: Ovarian Cancer Opportunity Analysis and Forecast to 2028). According to Globocan 2020, on a worldwide basis, 314,000 women are diagnosed and there are 207,000 ovarian cancer related deaths each year with a median age of 63 at diagnosis. Almost all patients eventually become resistant to platinum-based therapy and 70% of patients relapse within three years. The standard of care for recurrent platinum resistant ovarian cancer is single agent chemotherapy (doxorubicin, paclitaxel or topotecan). These treatments have a 10-15% objective response rate and a three-to-four-month progression free survival rate with a median overall survival of 10-12 months. Accordingly, the overall prognosis for ovarian cancer still remains poor with multiple areas of high unmet need. No immunotherapy has been approved yet in this indication.

 

Survivin is overexpressed in about 50% of stage I/II and up to 100% of stage III/IV ovarian cancers but is not expressed in normal ovarian tissue. Survivin positivity increases with histological Grade (Grade 1/2, 50% vs Grade 3, 76%) and is associated with reduced overall survival12.

 

In 2021, we completed the DeCidE1 phase 2 trial which evaluated safety and effectiveness of MVP-S, with intermittent, low-dose CPA. This trial enrolled patients with advanced platinum-sensitive and –resistant ovarian cancer. All patients treated had advanced and recurrent disease and 12 patients had received 3 or more lines of prior therapy.

 

In patients with advanced ovarian cancer that were post first or second line of treatment, robust, dose-dependant survivin-specific T-cell responses that were durable over time were observed in patients treated with MVP-S. In this trial, we observed a median overall survival of 19.9 months, with a 45% overall survival rate at 23.8 months. Long-term clinical benefit was observed among those with platinum-sensitive, resistant and refractory disease. Survivin-specific T-cell responses were observed in 87% of patients.

 

Translational analyses revealed an increase from baseline in unique, survivin-specific T-cell clones in on-treatment tumor samples. Pre-treatment T-cell infiltration was associated with tumor regression. Enriched B-cell infiltration was also detected in on-treatment tumor samples, especially in patients who showed tumor reduction. Furthermore, antibodies to all 5 survivin-derived peptides were detected in plasma samples and were more prominent in patients with tumor shrinkage.

 

Treatment with MVP-S and low-dose CPA was well-tolerated. Consistent with a previous study, treatment-related AEs were common in DeCidE1 and were predominantly Grade 1/2 injection site reactions. The most common treatment-related systemic AE was Grade 1 fatigue.

 

Earlier this year, we initiated the AVALON phase 2b study to further evaluate the clinical benefit observed in the DeCidE1 trial. The AVALON study is an open label, company-sponsored phase 2b, single arm trial evaluating the efficacy and safety of MVP-S and intermittent low-dose CPA in subjects with platinum-resistant ovarian cancer. The study has a Simon two-stage design where 30-40 subjects will be evaluated in stage one, with the option to expand to up to a total of 73 patients. Patients participating in the trial will receive two doses of subcutaneous MVP-S once every three weeks, followed by an MVP-S dose once every eight weeks, plus low-dose oral CPA on a repeating cycle of one week on/one week off. (ClinicalTrials.gov Identifier: NCT05243524). The primary endpoint is ORR, evaluated per RECIST v1.1 criteria. Secondary outcome measures include ORR per iRECIST criteria, duration of response (DOR), disease control rate (DCR), time to progression (TTP), progression free survival (PFS), overall survival (OS) and safety exploratory endpoints include analyses of PBMC/plasma samples and biopsies.

 

Oliver Dorigo, M.D., Ph.D., Associate Professor of Obstetrics and Gynecology, Stanford University is the lead principal investigator of the AVALON study.

 

IMV estimates that, in addition to general clinical department expenses, which are distributed amongst the various clinical projects, the total cost to complete the first stage of the AVALON phase 2b ovarian study will be $3.0 million, of which $1.2 million is expected to be spent in 2022. During the six months ended June 30, 2022, IMV has spent $0.1 million in start-up costs related to the AVALON trial.

 

12 Gąsowska-Bajger B, Gąsowska-Bodnar A, Knapp P, Bodnar L. Prognostic Significance of Survivin Expression in Patients with Ovarian Carcinoma: A Meta-Analysis. Journal of clinical medicine. 2021;10(4).

 

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Phase 2 basket trial in multiple solid tumor indications (IMV-sponsored)

 

In December 2021, IMV announced the completion of enrollment in the phase 2 basket trial in collaboration with Merck.

 

Top line data from both the bladder and MSI-H cohorts showed promising results. Clinical benefit (complete responses, partial responses, and stable disease) was observed in advanced or metastatic bladder cancer patients, including in patients who had received prior immune checkpoint inhibitor therapy. In April 2022, in a mini-symposium at the annual meeting of the AACR, Dr. Jeremy Graff presented results from seventeen patients with advanced, metastatic bladder cancer, who on average had received two prior lines of therapy and treated with the combination of MVP-S, intermittent, low-dose CPA and pembrolizumab. Key findings in this cohort included:

 

Treatment with MVP-S/CPA and pembrolizumab was well tolerated with mostly grade 1-2 injection site reactions, and no severe adverse events attributed to MVP-S;

 

·Of the 17 treated patients, 5 showed response: 2 confirmed CRs and 3 PRs per RECIST v1.1,
  
·CRs and PRs were observed in some patients previously treated with checkpoint inhibitors, and
  
·Survivin-specific T cells were most evident in patients with the greatest clinical benefit.

 

This study was designed to identify and select the best solid tumor opportunities for the combination of IMV’s MVP-S/CPA with Merck’s anti PD-1 checkpoint inhibitor pembrolizumab (Keytruda®).

 

The basket study was an open-label, multicenter study to evaluate the safety and efficacy of the immunotherapeutic combination in patients with bladder, liver (hepatocellular carcinoma), ovarian, or non-small cell lung (“NSCLC”) cancers, as well as tumors shown to be positive for the MSI-H biomarker. Recruitment in the five indications followed a Simon two-stage design and each indication had prespecified success thresholds defined by the expected effect of pembrolizumab as a monotherapy agent in that indication. Based on the observed clinical benefit in the bladder cohort, the Corporation is currently conducting discussions with experts in the field to determine the optimal clinical pathway for MVP-S in bladder cancer.

 

During the six months ended June 30, 2022, IMV spent $1.1 million on the phase 2 basket trial. We anticipate that, in addition to general clinical department expenses, which are distributed amongst the various clinical projects, costs to complete this trial are estimated at $18 million, of which $15.3 million has been spent to date and a total of $2.4 million is estimated to be spent in 2022.

 

Hormone receptor positive/HER2-negative (HR+/HER2-) Breast Cancer (investigator-sponsored)

 

Our lead compound, MVP-S is being investigated in patients with HR+/HER2- breast cancer. HR+/HER2- tumors represent an unmet clinical need with relatively poor responses to neoadjuvant endocrine treatment13. According to the National Cancer Institute, Hormone Receptive (HR+) and HER2 negative (HER2-) is the most common form of breast cancer representing approximately 70% of all cases. Investigators at the Providence Cancer Institute have identified ki67 as a prognostic marker of resistance to treatment that is associated with upregulated survivin expression. Targeting survivin with MVP-S in this population represents a promising approach that will be tested in the study. This investigator-initiated phase 1B clinical study is being conducted at the Providence Cancer Institute in Oregon, recruitment is ongoing, and patients have started to receive treatment with MVP-S.

 

This three-arm phase 1b trial is designed to assess the combination of MVP-S plus standard-of-care aromatase inhibitor with/without radiotherapy or intermittent, low-dose CPA prior to surgery. Across the three arms of this study, our lead compound will be evaluated for the first time as a neoadjuvant in 18 subjects with resectable, non-metastatic HR+/HER2- breast cancer.

 

 

13 Schettini, Francesco et al. “Endocrine-Based Treatments in Clinically-Relevant Subgroups of Hormone Receptor-Positive/HER2-Negative Metastatic Breast Cancer: Systematic Review and Meta-Analysis.” Cancers vol. 13,6 1458. 22 Mar. 2021.

 

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The primary objective is to evaluate the safety and immunogenicity of the neoadjuvant combination of MVP-S with the aromatase inhibitor, with/without radiation, or low-dose CPA in each arm. Survivin-specific T cells in the resected tumor will be evaluated as a secondary objective. Translational studies will be conducted as exploratory analyses to characterize the MVP-S mechanism of action in the tumor and the tumor microenvironment. All intellectual rights from this study will remain the property of the Corporation. Enrollment is ongoing and a clinical update with first results is expected at a scientific conference in Q4 2022.

 

IMV anticipates that, in addition to general clinical department expenses, which are distributed amongst the various clinical projects, $0.6 million is currently estimated to be spent by IMV for our share of the trial, of which $0.1 million has been spent to date in 2022.

 

Ovarian Cancer phase 2 PESCO clinical trial (investigator-sponsored)

 

University Health Network’s (“UHN”) Princess Margaret Cancer Centre is conducting a phase 2 non-randomized, open-label trial designed to evaluate the potential anti-tumor activity of the combination of Merck’s Keytruda® (pembrolizumab), MVP-S and intermittent, low-dose CPA in patients with advanced, epithelial ovarian cancer. The study’s primary objective is to assess overall response rate. Secondary study objectives include progression free survival rate, overall survival rate, and potential side effects, over a five-year period. Results were presented by the investigator on the dose escalation and expansion cohorts at the annual ASCO meeting in June 2022.

 

The Corporation will assess next steps with the UHN based on results provided by the investigators.

 

During the first six months of 2022, IMV has spent $0.08 million on this study, which represents payment of the final milestone due to investigators for this trial. There are no other material costs anticipated for this study.

 

Our Next Cancer Immunotherapy: DPX-SurMAGE

 

Our second DPX-based immunotherapy, DPX-SurMAGE formulates, within the DPX platform, antigens to two distinct cancer associated proteins, survivin and MAGE-A9. MAGE protein family member, A9 (MAGE-A9) is frequently expressed in various human cancers including bladder, lung, and kidney. MAGE-A9 peptides will be combined with selected immunogenic peptides from the survivin protein (also in MVP-S) to form a dual targeted immune-educating therapy. We believe that MAGE-A9 and survivin peptides presented on the surface of cancer cells may represent complementary targets for an enhanced DPX-based cancer immunotherapy.

 

 

 

IMV began a phase 1 clinical study to evaluate MVP-S and DPX-SurMAGE in separate cohorts of patients with NMIBC in 2022. The first patient was dosed with MVP-S in April 2022 and the DPX-SurMAGE cohort is anticipated to begin enrollment in Q3 2022. Early results with the MVP-S cohort are expected in late 2022.

 

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Despite the entry of immunotherapy agents into the bladder cancer market, including the promising checkpoint inhibitors, there remains significant unmet need across bladder cancer settings14,15. There are abundant opportunities for drug development for early-stage disease, as well as for patients who do not respond to or relapse following, treatment with an immune checkpoint inhibitor. Bladder cancer is a common cancer worldwide that occurs when there is uncontrolled cell growth in the bladder lining, most commonly in urothelial cells (Antoni et al., 2017; ASCO, 2019).

 

This research is conducted in collaboration with CQDM, a Canadian bioresearch consortium, that awarded a grant for a collaboration among IMV, Centre de recherche du CHU de Quebec-Universite Laval (“CHU”) and La Fondation du CHU de Quebec (“FCHUQc”). The collaboration is receiving a grant from the CQDM and from the FCHUQc, to develop this novel dual target T cell therapy for an initial clinical application in bladder cancer. During the six months ended June 30, 2022, IMV spent $0.7 million on the DPX-SurMAGE program. We anticipate that, in addition to general clinical department expenses, which are distributed amongst the various projects, IMV’s share of costs to complete this trial estimated at $1.8 million, of which $1.1 million is estimated to be spent in 2022.

 

Other collaborations in oncology

 

From time to time, IMV enters into collaborations with partners to evaluate the use of the DPX platform with other products in oncology.

 

COVID-19 Impact on Clinical Programs

 

The COVID-19 pandemic crisis is still impacting clinical activities across the industry due to the pressure placed on the healthcare systems as well as governmental and institutional restrictions. IMV’s clinical team continues to work closely with each clinical site and its CRO’s on contingency plans to ensure that patient safety and the integrity of data is maintained. IMV is following the guidance issued by the FDA: “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic Guidance for Industry, Investigators, and Institutional Review Boards”. Additionally, the IMV team continues to monitor updated institutional, regional and national guidance to fully comply with applicable guidelines as they are issued. It is noted that many clinical sites are experiencing staffing shortages and as a result, have decreased clinical trial activities, while other, less impacted sites, have continued activities as planned. Patients are encouraged to comply with directives from public health officials and, subject to such compliance, attend visits as planned or to discuss alternatives with their physician. The current activities performed at central labs to assess the eligibility of patients and the management of clinical samples has not been impacted to date, and IMV is working with its vendors to ensure continuity of activities. Drug supply has not been impacted to date and IMV has been developing contingency plans to address supply of drugs to all clinical sites in the event of future transportation or other constraints.

 

EXPLORING THE BOUNDARIES OF OUR DPX PLATFORM

 

We leveraged the unique mechanism of action of our DPX delivery platform to create peptide vaccine candidates that are designed to generate a sustained and targeted B cell immune response (antibodies) with the potential to prevent infections by viruses. We have previously demonstrated the flexibility of DPX through the development of two DPX-based therapies against infectious diseases, DPX-RSV and DPX-COVID-19, that have shown generation of a targeted and sustained B cell response in a phase 1 trial and preclinical studies, respectively.

 

We are continuously exploring the boundaries of our DPX delivery platform, and we are testing different bioactive molecules beyond peptide antigens. In 2021, we entered into a collaboration with Medicago Inc., a biopharmaceutical company that develops VLPs against infectious diseases. The collaboration will evaluate Medicago’s VLPs encapsulated in IMV’s DPX technology. This agreement reflects IMV’s strategic shift in focus to seek licensing opportunities for its DPX platform in indications outside of immuno -oncology. These collaborations are exploratory in nature and the Corporation expects to disclose evaluations or other results only when those are made available to IMV by each of its collaborators.

 

 

14 Fisher et al. Treatment patterns and outcomes in metastatic bladder cancer in community oncology settings. J Clin Oncol. 2017;35, no. 6_suppl:396-396

15 Campi et al. Unmet Clinical Needs and Future Perspectives in Non–muscle-invasive Bladder Cancer. Eur Urol Focus. 2018:4:472-480.

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INTELLECTUAL PROPERTY

 

The Corporation strives to protect its intellectual property in established and emerging markets around the world. The Corporation’s intellectual property portfolio relating to its vaccine platform technology includes 22 patent families containing 60 issued patents and 85 pending patent applications in 12 jurisdictions (including applications filed and/or patents granted in the United States, Europe, Canada, Australia, Japan, India, Israel, Singapore, Brazil, Taiwan, China and separately Hong Kong).

 

The Corporation’s patents and applications cover specific DPX compositions with broad utility for infectious diseases and cancer applications, as well as methods of manufacture and other applications of the platform technology. These patents, together with the pending applications if allowed, extend patent protection for some or all DPX-based compositions and/or uses thereof approximately up to the year 2041. More details on the Corporation’s intellectual property strategy and patents can be found in the AIF filed on SEDAR at www.sedar.com.

 

Trademark protection for the platform name DPX has been registered in the United States and Canada.

 

RECENT AND QUARTERLY DEVELOPMENTS

 

The Corporation announced:

 

·On August 5, 2022, that in order to maintain the remainder of its at-the-market (“October 2020 ATM”) facility, the Corporation re-entered into an equity-distribution agreement dated August 4, 2022 with Piper Sandler pursuant to which the Corporation may from time to time sell through “at-the-market” offerings, with Piper Sandler acting as sales agent, on the Nasdaq such number of common shares that have an aggregate offering price of up to US$50 million under the ATM Prospectus Supplement. This was filed as a result of the underlying Canadian final base shelf prospectus expiring on July 25, 2022.


·On July 8, 2022, the Corporation received a letter from the Listing Qualifications Department of the Nasdaq indicating that, based upon the closing bid price of the Common Shares for the 30 consecutive business day period between May 23, 2022, through July 6, 2022, IMV did not meet the minimum bid price of US$1.00 per share required for continued listing on Nasdaq (the “Minimum Bid Price Requirement”). This notice has no immediate effect on the Corporation’s business operations or listing of the Common Shares on the Nasdaq. However, in the event the Corporation does not regain compliance with the Minimum Bid Price Requirement within a period of 180 calendar days (which can be extended, in certain circumstances, by an additional 180 calendar days), the Common Shares may be subject to delisting.


·On June 22, 2022, the drawdown of the remaining US$10 million available under the Corporation’s existing US$25 million debt facility with Horizon Technology Finance Corporation (“Horizon”). This drawdown was made available as the Corporation achieved a predetermined milestone following site activation in its phase 2b AVALON trial. AVALON is a phase 2B, single arm trial evaluating MVP-S and intermittent, low-dose CPA in subjects with platinum-resistant ovarian cancer. The goal of this trial is to further evaluate the data observed in our phase 2 DeCidE trial. This study is now open for enrollment and dosed its first patient in August 2022.


·On April 22, 2022, the appointment of existing director, Michael P. Bailey to Chairman of the Board, effective May 1, 2022. Mr. Bailey has more than 30 years of pharmaceutical industry experience, having been instrumental in the commercial planning and launch of several new medicines across multiple oncology indications. 


·On April 8, 2022, safety and preliminary efficacy data of the combination of the Corporation’s lead product candidate, MVP-S, with pembrolizumab from a phase 2 basket study of patients with advanced, metastatic bladder cancer. Data was presented at a late-breaking oral symposium at AACR on April 12, 2022. The preliminary results suggest that IMV’s therapy may provide a well-tolerated therapeutic alternative for advanced, metastatic bladder cancer patients in need of new treatment options:

 

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oFive out of 17 subjects showed response (2 confirmed CRs and 3 PRs per RECIST v1.1);

oThree of these, including both confirmed CRs, had progressed on prior anti-PD-1/L1 therapy;

oLong-term clinical benefit was observed in several subjects, as was an increase in detectable survivin-specific T cells in peripheral blood; one patient remains on treatment after 18 months; and

oThe combination treatment was well-tolerated, with the majority of adverse events being grade 1 or grade 2.


·On January 12, 2022, the first patient dosed in the VITALIZE phase 2B clinical trial. VITALIZE will further evaluate the therapeutic potential of IMV’s lead compound, MVP-S, in combination with Merck’s anti-PD-1 therapy, pembrolizumab and intermittent, low-dose CPA, in patients with r/r DLBCL.

 

SELECTED FINANCIAL INFORMATION

 

The selected statements of loss and comprehensive loss data for the periods presented, and the selected statement of financial position data as of the dates presented are derived from the unaudited interim and audited annual consolidated financial statements. The selected historical financial data below should be read in conjunction with the financial statements and related notes and the sections titled “Components of Operations Overview” and “Results of Operations” appearing elsewhere in this report.

 

    As of,  
    June 30, 2022     December 31, 2021  
Statements of financial position data:   (in thousands of US dollars)  
Cash and cash equivalents $ 31,134     $ 38,616  
Working capital (1)   27,745       37,127  
Total assets   40,493       50,121  
Total liabilities   38,078       28,579  
Accumulated deficit   (175,335 )     (154,920 )
Total shareholder’s equity   2,415       21,542  

 

(1) Working capital is defined as current assets less current liabilities. See financial statements for further details regarding current assets and current liabilities.

 

    Three months ended June 30,       Six months ended June 30,  
    2022       2021       2022       2021  
  (in thousands of US dollars, except share and per share amounts)  
Statements of loss and comprehensive loss data:      
Revenue                              
Interest income   34       42       59       112  
Total revenue                              
Operating Expenses                              
Research and development   6,048       5,219       12,678       9,961  
General and administrative   4,620       3,416       8,602       6,499  
Government assistance   (689 )     (1,169 )     (1,070 )     (2,404 )
Accreted interest and valuation adjustments   (38 )     15       264       375  
Total operating expenses   9,941       7,481       20,474       14,431  
Total comprehensive loss for the period $ (9,907 )   $ (7,439 )   $ (20,415 )   $ (14,319 )
Basic and diluted loss per share   (0.12 )     (0.11 )      (0.25 )     (0.21 )
Weighted-average shares outstanding   82,265,209       67,781,940       82,236,788       67,629,392  

 

COMPONENTS OF OPERATIONS OVERVIEW

 

Revenue

 

The Corporation has no products approved for commercial sale and has not generated any revenue from product sales. Revenue in all periods presented consists primarily of income earned on cash balances held at a commercial bank.

 

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Operating Expenses

 

Research and development expenses

 

To date, the Corporation’s research and development expenses have related primarily to discovery efforts and preclinical manufacturing and clinical development of its product candidates. The most significant research and development expenses for the year relate to costs incurred for the development of the Corporation’s most advanced product candidates, MVP-S

 

·Expenses incurred under agreements with CROs, as well as investigative sites and consultants that conduct clinical trials, preclinical studies and other scientific development services;

·Costs related to the production and scale-up of clinical materials, including fees paid to contract manufacturers;

·Employee-related expenses, including salaries, related benefits, travel and share-based compensation expense for employees engaged in research and development functions;

·Expenses incurred for outsourced professional scientific and regulatory development services;

·Laboratory materials and supplies used to support research activities; and

·Facilities and other expenses, which includes depreciation on laboratory equipment.

 

The Corporation expenses all research and development costs in the periods in which they are incurred. The Corporation accrues for costs incurred as the services are being provided by monitoring the status of projects and the invoices received from its external service providers. Accruals are adjusted as actual costs become known. Where contingent milestone payments are due to third parties under research and development arrangements or license agreements, the milestone payment obligations are expensed when the milestone results are achieved.

 

Research and development activities are central to IMV’s business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-staged clinical trials. The Corporation expects that research and development expenses will increase substantially over the next few years as it increases personnel, advances manufacturing processes, initiates and conducts additional clinical trials and prepares regulatory filings related to its product candidates. The Corporation also expects to incur increased research and development expenses as it selectively identifies and develops additional product candidates. However, it is difficult to determine with certainty the duration and completion costs of current or future preclinical programs and clinical trials of product candidates.

 

The duration and timing of clinical trials and development of the Corporation’s product candidates will depend on a variety of factors that include, but are not limited to, the following:

 

·The scope, progress, outcome and costs of clinical trials and other research and development activities, including establishing an appropriate safety profile with IND-directed studies;

·Patient enrollment, discontinuation rates, per patient trial costs and number and location of clinical trial sites in clinical trials;

·The ability of the Corporation’s clinical partners and sponsors for investigator-sponsored trials to manage clinical trials;

·Establishing commercial manufacturing capabilities or making arrangements with third party manufacturers;

·Timing, receipt and terms of any marketing approvals from applicable regulatory authorities;

·Obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights;

·Significant and changing government regulation; and

·Significant competition and rapidly changing technologies within the biopharmaceutical industry.

 

The probability of success for each product candidate is highly uncertain. The Corporation will determine which programs to pursue and what resources to allocate to each program in response to the scientific and clinical success of each product candidate as well as an assessment of each product candidate’s commercial potential. Further, because IMV’s product candidates are still in clinical development, the Corporation cannot estimate the actual amounts necessary to successfully complete the development and commercialization of product candidates or whether, or when, it may achieve profitability.

 

General and administrative

 

General and administrative expenses consist primarily of salaries and other staff-related costs, including share-based compensation expense for personnel in executive, finance, human resources, project management, business development, investor relations and administrative functions. General and administrative expenses also include, but are not limited to, facilities and overhead costs, legal fees related to corporate, securities and patent matters, investor relations costs, insurance and professional fees for assurance, taxation, information technology communications and human resources matters. General and administrative costs are expensed as incurred and the Corporation accrues for services provided by third parties related to the above expenses by monitoring the status of services provided and receiving estimates from its service providers, adjusting accruals as actual costs become known.

 

16

 

 

The Corporation expects that its general and administration expenses will increase in the future as it increases personnel to support the continued development of its product candidates. The Corporation has experienced and expects to continue to experience, increased expense associated with being a Nasdaq listed company including increased accounting, audit, legal, regulatory and compliance costs, director and officer insurance premiums, as well as higher investor relations and public relations costs.

 

Government assistance

 

Government assistance consists primarily of research and development investment tax credits awarded through the Canada Revenue Agency’s Scientific Research and Economic Development (“SR&ED”) program for research expenditures incurred in Canada. Government assistance also contains other government funding for research projects and employment funding as well as fair market value adjustments to interest-free and low-interest government loans.

 

Accreted interest

 

Accreted interest relates entirely to the valuation of interest-free and low interest-bearing government loans, most of which are repayable based on a percentage of future gross revenue.

 

RESULTS OF OPERATIONS

 

Comparison of the Three Months Ended June 30, 2022 and 2021

 

The following table summarizes the Corporations results of operations for the three months ended June 30, 2022 and 2021:

 

    Three months ended June 30,          
    2022       2021       Change ($)  
  (In thousands of US dollars)          
Income                      
Interest income $ 34     $ 42     $ (8 )
                       
Operating Expenses                      
Research and development   6,048       5,219       829  
General and administrative   4,620       3,416       1,204  
Government assistance   (689 )     (1,169 )     480  
Accreted interest and adjustments   (38 )     15       (53 )
Total operating expenses   9,941       7,481       2,460  
Net loss $ (9,907 )   $ (7,439 )   $ (2,468 )

 

Revenue

 

Interest income consists primarily of income earned on cash balances held at a commercial bank and did not significantly fluctuate period over period.

 

Research and development expenses

 

Research and development expenses increased to $6.0 million for the three months ended June 30, 2022, from $5.2 million for the three months ended June 30, 2021. The increase of $0.8 million compared to Q2 2021 is mainly attributable to $1.3 million in costs for the DLBCL VITALIZE phase 2B trial and $0.2 million increase in personnel costs as a result of increased headcount. This increase is partly offset by a $0.4 million decrease in basket trial costs, following the completion of enrollment in 2021 and a $0.3 million decrease in DPX-COVID-19 development costs, following a shift in strategic focus.

 

17

 

 

General and administrative expenses

 

General and administrative expenses increased to $4.6 million for the three months ended June 30, 2022, compared to $3.4 million for the three months ended June 30, 2021. This $1.2 million increase is mainly attributable to an increase of $0.4 million in loan interest, related to the Horizon venture debt facility, an increase of $0.3 million in salaries and non-cash stock-based compensation, related to planned hiring and executive leadership changes, an increase of $0.2 million in employee related expenses and an increase of $0.2 million in legal fees mainly related to intellectual property portfolio maintenance.

 

Government Assistance

 

The decrease in government assistance for the period ending June 30, 2022, compared with June 30, 2021, is mainly attributable to a decline in government funding related to the development of DPX-COVID-19, which is received as project expenses are incurred.

 

Comparison of the Six Months Ended June 30, 2022 and 2021

 

The following table summarizes the Corporations results of operations for the six months ended June 30, 2022 and 2021 (in thousands of US dollars):

 

    Six months ended June 30,          
    2022       2021       Change ($)  
    (In thousands of US dollars)          
Income                      
Interest income $ 59     $ 112     $ (53 )
                       
Operating Expenses                      
Research and development   12,678       9,961       2,717  
General and administrative   8,602       6,499       2,103  
Government assistance   (1,070 )     (2,404 )     1,334  
Accreted interest and adjustments   264       375       (111 )
Total operating expenses   20,474       14,431       6,043  
Net loss $ (20,415 )   $ (14,319 )   $ (6,096 )

 

Revenue

 

Interest income consists primarily of income earned on cash balances held at a commercial bank and did not significantly fluctuate period over period.

 

Research and development expenses

 

Research and development expenses increased to $12.7 million for the six months ended June 30, 2022, from $10 million for the six months ended June 30, 2021. The increase of $2.7 million compared to Q2 2022 is mainly attributable to a $2.6 million increase in costs for the DLBCL VITALIZE phase 2B trial, a $1.0 million increase in manufacturing and development costs for maveropepimut-S, a $0.8 million increase in personnel costs as a result of increased headcount and executive leadership changes, and a $0.4 million increase in costs for DPX-SurMAGE program. This increase is partly offset by a $1.5 million decrease in DPX-COVID-19 development costs, following a shift in strategic focus and a $0.9 million decrease in basket trial costs, following the completion of enrollment in 2021.

 

18

 

 

    Six months ended June 30,          
    2022       2021       Change ($)  
    (In thousands of US Dollars)          
Direct research and development expenses by program:                      
DPX-Survivac                      
DLBCL (incl Vitalize and SPiReL) $ 3,575     $ 907     $ 2,668  
Ovarian   269       343       (74 )
Basket Trial   1,087       1,982       (895 )
Breast (HR+/HER2-)   140       7       133  
Other (incl. MVP-S manufacturing activities)   2,090       1,115       975  
DPX-SurMAGE   732       354       378  
DPX-COVID-191   10       1,466       (1,456 )
Other programs   281       336       (55 )
Total direct R&D expense   8,184       6,510       1,674  
Unallocated research and development expenses:                      
Personnel (including stock-based compensation)   3,882       3,135       747  
Indirect research and development expense2   612       316       296  
Total research and development expenses $ 12,678     $ 9,961     $ 2,717  

 

1 DPX-COVID-19 development is government funded

2 Indirect research and development expense includes non-cash amortization of lab equipment, travel and general laboratory utilities and consumables.

 

General and administrative expenses

 

General and administrative expenses increased to $8.6 million for the six months ended June 30, 2022, compared to $6.5 million for the six months ended June 30, 2021. This $2.1 million increase is mainly attributable to an increase of $0.7 million in salaries and non-cash stock-based compensation, as a result of planned hiring and executive leadership changes, an increase of $0.7 million in loan interest, related to the Horizon venture debt facility, an increase of $0.3 million in employee related expenses, and an increase of $0.2 million in legal fees mainly related to intellectual property portfolio maintenance.

 

Government Assistance

 

The decrease in government assistance for the six months ending June 30, 2022, compared with the six months ending June 30, 2021, is mainly attributable to a decline in government funding related to the development of DPX-COVID-19, which is received as project expenses are incurred.

 

CASHFLOWS, LIQUIDITY AND CAPITAL RESOURCES

 

Liquidity and Capital Resources

 

Sources of liquidity

 

IMV is publicly traded and as a result has funded its operations primarily through public and private equity offerings, as well as from upfront and milestone payments, and research support payments generated from collaborations.

 

As of August 10, 2022, IMV has issued 660,827 shares under its October 2020 ATM (as defined and further described below) for total gross process of $2.5 million and net proceeds of $2.2 million. On December 17, 2021, the Corporation secured a $25 million long-term debt facility lead by Horizon Technology Finance Corporation (“Horizon”), which has been fully drawn down. In addition, on July 20, 2021, the Corporation completed the July 2021 Offering (as defined and further described below) of 14,285,714 Units for gross proceeds of $25 million and net proceeds of $23 million. In 2020, IMV completed a private placement of 8,770,005 units of the Corporation for gross proceeds of $17.8 million and net proceeds of $17.7 million. The Corporation also issued 6,841,773 shares under two ATM distribution agreements for total gross proceeds of $30 million and net proceeds of $28.5 million.

 

19

 

 

Funding requirements

 

The Corporation has not generated any revenue from approved product sales to date and does not expect to do so until such time as IMV obtains regulatory approval and commercializes one or more of its product candidates. As the Corporation is currently in the preclinical and clinical stages development, it is uncertain when or if it will achieve commercialization. IMV expects that operating expenses will continue to increase in connection with ongoing and new, later-staged clinical trials, expanded preclinical activities and the development of product candidates in the pipeline. The Corporation expects to continue and expand its current collaborations and will look for additional collaborations. For the purposes of assessing the Corporation as a going concern, although it is difficult to predict funding requirements, based on the current operating plan, it is anticipated that existing cash and cash equivalents and identified potential sources of cash, will fund operations and capital expenditure requirements into the second quarter of 2023. These estimates are based on assumptions and plans which may change and which could impact the magnitude and/or timing of operating expenses, capital expenditures and the Corporation’s cash runway. The successful development of product candidates is uncertain, and therefore IMV is unable to estimate the actual funds required to complete the research, development and commercialization of product candidates. The ability of the Corporation to continue as a going concern is dependent upon raising additional financing through equity and non-dilutive funding and partnerships. There can be no assurance that the Corporation will have sufficient capital to fund its ongoing operations, develop or commercialize any products without future financings. There can be no assurance that additional financing will be available on acceptable terms or at all. The Corporation is currently pursuing financing alternatives that may include equity, debt, and non-dilutive financing alternatives including co-development through potential collaborations, strategic partnerships or other transactions with third parties, that may or may not include merger and acquisitions activities. If the Corporation is unable to obtain additional financing when required, the Corporation may have to substantially reduce or eliminate planned expenditures, or the Corporation may be unable to continue operations. These material uncertainties cast substantial doubt as to the Corporation’s ability to meet its obligations as they come due and, accordingly, the appropriateness of the use of accounting principles applicable to a going concern.

 

At June 30, 2022, the Corporation had approximately $33 million of existing and identified potential sources of cash including:

 

  · cash and equivalents of $31.1 million; and

·amounts receivable and investment tax credits receivable of $1.9 million.

 

In addition, the Corporation re-established its ATM under its renewed base shelf prospectus allowing the Corporation to offer and sell common shares from time-to-time up to an aggregate offering amount of $50 million through Piper Sandler & Co, as agent (remaining available as of August 10, 2022 is $50 million). The Corporation continually reassesses the adequacy of its cash resources, evaluating existing clinical trials, research projects and/or potential collaboration opportunities, to determine when and how much additional funding is required.

 

The Corporation continuously monitors its cash position, the status of its development programs including those of its partners, cash forecasts for completing various stages of development and the potential to license or co-develop each product candidate and continues to actively pursue alternatives to raise capital, including equity offerings, debt and non-dilutive funding.

 

Cash Flows

 

The following table summarizes the Corporation’s cash flows for the periods indicated (in thousands of US dollars):

 

  Six Months Ended June 30,  
  2022       2021  
  (In thousands of US Dollars)  
Net cash (used in) provided by:            
Operating activities (16,885 )     (14,898 )
Financing activities 9,927       1,755  
Investing activities (636 )     (504 )
Net increase (decrease) in cash and cash equivalents (7,594 )     (13,647 )

 

20

 

 

Cash flows from operating activities

 

During the first half of 2022, $16.9 million was used in operating activities. This included the reported net loss of $20.4 million prior to being decreased by $1.9 million for non-cash expenses including deferred share unit (“DSU”) compensation, depreciation, accretion of long-term debt, loss on disposal of assets, revaluation of long-term debt and stock-based compensation. The Corporation had a net increase of cash of $1.6 million as a result of changes in working capital balances, which included a $2.3 million decrease in prepaid expenses and a $0.1 million in investment tax credits receivable, partly offset by a $0.3 million increase in amounts receivable and a $0.5 million decrease in accounts payable, accrued and other liabilities.

 

During the first half of 2021, $14.9 million was used in operating activities. This included the reported net loss of $14.3 million prior to being decreased by $1.1 million for non-cash expenses including DSU compensation, depreciation, accretion of long-term debt, revaluation of long-term debt, and stock-based compensation. The Corporation had a net decrease of cash of $1.7 million as a result of changes in working capital balances, which included a $2.5 million decrease in accounts payable, accrued and other liabilities and a $0.4 million increase in SR&ED investment tax credits receivable partly offset by a $0.9 million decrease in amounts receivable and $0.3 million in prepaid expenses.

 

Cash flows from financing activities

 

During the first half of 2022, sources of cash from financing activities included: $10 million in proceeds from the second disbursement under the Horizon Venture Debt Facility and $0.1 million in net proceeds from the October 2020 ATM. The Corporation used $0.2 million to repay long-term debt and lease obligations during the period.

 

During the first half of 2021, sources of cash from financing activities included: $2.3 million in proceeds raised from the October 2020 ATM offering less cash issuance costs of $0.1 million and $0.05 million through the exercise of stock options. The Corporation used $0.5 million to repay long-term debt and lease obligations during the period.

 

Cash flows from investing activities

 

During the first half of 2022, IMV used $0.6 million of cash in investing activities, consisting mainly of planned purchases of capital expenditures for ongoing research and operating activities.

 

During the first half of 2021, IMV used $0.5 million of cash in investing activities, consisting mainly of purchases of capital expenditures for ongoing research and operating activities

 

JULY 2021 EQUITY OFFERING AND USE OF PROCEEDS

 

On July 20, 2021, the Corporation completed a public offering (“July 2021 Offering”), issuing 14,285,714 Units at a price of $1.75 per Unit for aggregate proceeds of $25 million and net proceeds of $23 million. Each Unit comprised one common share and three-quarters of one common share purchase warrant. The Corporation intends to use the net proceeds of the July 2021 Offering to continue the clinical development of maveropepimut-S in DLBCL, breast cancer, ovarian cancer, bladder cancer and microsatellite instability high (MSI-H), start the clinical development of a new product candidate, DPX-SurMAGE, in bladder cancer, continue the development of its proprietary drug delivery platform (DPX) and for general corporate purposes. The table below provides the amount used to date and any variances in thousands of United States dollars (except for working capital and general corporate purposes).

 

Intended Use of Proceeds Estimated Amount Variances
(in thousands of US dollars) amount to date  
  $ $  
Clinical development of maveropepimut-S 16,680 12,984 No variances anticipated

 

MARCH 2019 EQUITY OFFERING AND USE OF PROCEEDS

 

On March 6, 2019, the Corporation completed a public offering, issuing 5,404,855 Common Shares (including 504,855 Common Shares upon the exercise of the underwriters’ over-allotment option on March 11, 2019) at a price of CAD$5.45 per share for aggregate proceeds of $22.1 million. The Corporation intends to use the net proceeds of this offering to accelerate the development of MVP-S in combination with pembrolizumab as part of the basket trial in selected advanced or recurrent solid tumors in bladder, liver (hepatocellular carcinoma), ovarian and non-small-cell lung cancers, as well as tumors shown to be positive for the microsatellite instability high biomarker and for general corporate purposes. The table below provides the amount used to date and any variances in thousands of United States dollars (except for working capital and general corporate purposes).

 

21

 

 

Intended Use of Proceeds Estimated Amount Variances
(in thousands of US dollars) amount to date  
  $ $  
Phase 2 clinical trial for multiple indications 12,000 10,076 No variances anticipated

 

OCTOBER 2020 ATM DISTRIBUTION

 

On October 16, 2020, the Corporation entered into an equity distribution agreement (“October 2020 ATM”) with Piper Sandler authorizing the Corporation to offer and sell, through “at-the-market” offerings, Common Shares from time to time up to an aggregate offering price of $50 million through Piper Sandler, as agent. The Corporation intends to use the net proceeds from the October 2020 ATM for research and development expenditures, clinical trial expenditures, including expenditures related to a COVID-19 vaccine candidate and general corporate purposes. As of June 30, 2022, 660,827 common shares have been sold under the October 2020 ATM for total gross proceeds of $2.5 million. In order to maintain the ATM Distribution facility under its new Canadian base shelf prospectus filed in July 2022, IMV re-entered into an ATM Distribution dated August 4, 2022, with Piper Sandler, to offer and sell common shares from time-to-time up to an aggregate offering amount of US$50 million. As of August 10, 2022, no common shares have been sold under the August 2022 ATM.

 

SUMMARY OF QUARTERLY RESULTS

 

The selected quarterly financial information(1) for the past eight financial quarters is outlined below:

 

(in thousands of dollars, except for per share amounts)

 

  Q2 -
2022
Q1 -
2022
Q4 -
2021
Q3 -
2021
Q2 -
2021
Q1 -
2021
Q4 -
2020
Q3 -
2020
Total Revenue 34 24 35 41 42 69 69 66
Total Expenses 9,941 10,547 11,731 10,480 7,481 7,026 7,435 6,318
Loss (9,907) (10,523) (11,696) (10,439) (7,439) (6,957) (7,366) (6,252)
Basic and Diluted Loss per Share (0.12) (0.13) (0.14) (0.13) (0.11) (0.10) (0.11) (0.09)

 

(1)Unless otherwise noted, financial information in thousands of US dollars and prepared in accordance with IFRS.

 

Revenues from quarter-to-quarter may vary significantly. Revenues are generated mainly from interest on cash balances as well as from non-recurring contract research agreements. It is also important to note that historical patterns of expenses cannot be taken as an indication of future expenses. The amount and timing of expenses and availability of capital resources vary substantially from quarter-to-quarter, depending on the level of R&D activities being undertaken at any time and the availability of funding from investors or collaboration partners.

 

22

 

 

ONCOLOGY OUTLOOK

 

 

The exact timing could differ from expectations but are currently management’s best estimate.

 

RELATED PARTY TRANSACTIONS

 

For the period ending June 30, 2022, there were no related party transactions (2021 - $nil).

 

CONTRACTUAL OBLIGATIONS

 

There is no material change in the contractual obligations of the Corporation since the beginning of the 2022 fiscal year. Details on the contractual obligations of the Corporation can be found in the annual audited consolidated financial statements and related notes for the year ended December 31, 2021.

 

OFF-BALANCE SHEET ARRANGEMENTS

 

The Corporation was not party to any off-balance sheet arrangements as of June 30, 2022.

 

OUTSTANDING SECURITIES

 

As at August 10, 2022, the number of issued and outstanding Common Shares was 82,452,187 and a total of 16,101,369 shares are reserved for the issuance of outstanding stock options, warrants and deferred share units.

 

RISKS AND UNCERTAINTIES

 

The Corporation is a clinical-stage company that operates in an industry that is dependent on a number of factors that include the Corporation’s capacity to raise additional funding on reasonable terms when necessary, obtain positive results of pre-clinical studies and clinical, successfully develop existing and new products, hire and retain skilled staff, protect its intellectual property, manufacture its products and meet demand, and obtain necessary regulatory approvals and the timing in respect thereof, etc. An investment in the Common Shares is subject to a number of risks and uncertainties. An investor should carefully consider the risks described in the Corporation’s AIF and the registration statement on Form 40-F filed with the U.S. Securities and Exchange Commission, as well as the other information filed with the securities regulators before investing in the Common Shares. If any of such described risks occur, or if others occur, the Corporation’s business, operating results and financial condition could be seriously harmed and investors may lose a significant proportion of their investment.

 

There are important risks which management believes could impact the Corporation’s business. For information on risks and uncertainties, please also refer to the “Risk Factors” section of the Corporation’s most recent AIF filed on SEDAR at www.sedar.com and included in the registration statement on Form 40-F filed on EDGAR at www.sec.gov.

 

23

 

 

DISCLOSURE CONTROLS AND PROCEDURES AND INTERNAL CONTROLS OVER FINANCIAL REPORTING

 

Disclosure Controls and Procedures

 

The Chief Executive Officer (the “CEO”) and the Senior Vice President of Finance (the “SVP, Finance”) of the Corporation are responsible for establishing and maintaining the Corporation’s disclosure controls and procedures (“DCP”) including adherence to the Disclosure Policy adopted by the Corporation. The Disclosure Policy requires all staff to keep senior management fully apprised of all material information affecting the Corporation so that they may evaluate and discuss this information and determine the appropriateness and timing for public disclosure.

 

The Corporation maintains DCP designed to ensure that information required to be disclosed in reports filed under applicable securities laws, is recorded, processed, summarized and reported within the appropriate time periods and that such information is accumulated and communicated to the Corporation’s management, including the CEO and SVP, Finance, to allow for timely decisions regarding required disclosure.

 

The CEO and SVP, Finance have evaluated whether there were changes to the DCP during the period ended June 30, 2022 that have materially affected, or are reasonably likely to materially affect, the DCP. No such changes were identified through their evaluation.

 

In designing and evaluating DCP, the Corporation recognizes that any disclosure controls and procedures, no matter how well conceived or operated, can only provide reasonable, not absolute, assurance that the objectives of the control system are met, and management is required to exercise its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

 

Internal Control over Financial Reporting

 

The Corporation’s management, including the CEO and the SVP, Finance, are responsible for establishing and maintaining adequate internal control over financial reporting (“ICFR”) for the Corporation to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with IFRS. The fundamental issue is ensuring all transactions are properly authorized and identified and entered into a well-designed, robust and clearly understood accounting system on a timely basis to minimize risk of inaccuracy, failure to fairly reflect transactions, failure to fairly record transactions necessary to present financial statements in accordance with IFRS, unauthorized receipts and expenditures, or the inability to provide assurance that unauthorized acquisitions or dispositions of assets can be detected.

 

The CEO and SVP, Finance have evaluated whether there were changes to ICFR during the period ended June 30, 2022 that have materially affected, or are reasonably likely to materially affect, ICFR. No such changes were identified through their evaluation. In response to the COVID-19 pandemic, the Corporation asked its employees to work from home to the extent possible. This change requires certain processes and controls that were previously done or documented manually to be completed and retained in electronic form. Despite the changes required by the current environment, there have been no significant changes in the Corporation’s internal controls during the period ended June 30, 2022 that have materially affected, or are reasonably likely to materially affect, ICFR.

 

The Corporation’s ICFR may not prevent or detect all misstatements because of inherent limitations. Additionally, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because changes in conditions or deterioration in the degree of compliance with the Corporation’s policies and procedures.

 

BASIS OF PRESENTATION OF CONSOLIDATED FINANCIAL STATEMENTS AND SIGNIFICANT ACCOUNTING POLICIES AND CHANGES IN ACCOUNTING POLICIES

 

The consolidated financial statements have been prepared in accordance with the IFRS as issued by the IASB. The accounting policies, methods of computation and presentation applied in the unaudited interim condensed consolidated financial statements are consistent with those of previous financial year except for the change in accounting policies described hereunder. The significant accounting policies of IMV are detailed in the notes to the annual audited consolidated financial statements for the year ended December 31, 2021 filed on SEDAR www.sedar.com and included in the registration statement on Form 40-F filed on EDGAR at www.sec.gov/edgar.

24

 

 

 

CRITICAL ACCOUNTING ESTIMATES AND JUDGEMENTS

 

Estimates and assumptions are continually evaluated and are based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. The determination of estimates requires the exercise of judgement based on various assumptions and other factors such as historical experience and current and expected economic conditions. Actual results could differ from those estimates.

 

While the Corporation’s significant accounting policies and critical judgements in applying the Corporation’s accounting policies are detailed in the audited annual consolidated financial statements for the year ended December 31, 2021 filed on SEDAR www.sedar.com and included in the registration statement on Form 40-F filed on EDGAR at www.sec.gov/edgar, the Corporation believes that the following critical accounting policies, estimates and judgements are most important to understanding and evaluating its financial results.

 

FINANCIAL INSTRUMENTS

 

Financial instruments are defined as a contractual right or obligation to receive or deliver cash on another financial asset. The Corporation recognizes financial instruments based on their classification. Depending on the financial instrument’s classification, changes in subsequent measurements are recognized in net loss or other comprehensive loss.

 

A description of the financial instruments, their fair value and risk management is included in the Corporation’s annual audited consolidated financial statements for the year ended December 31, 2021, filed on SEDAR www.sedar.com and included in the annual report on Form 40-F filed on EDGAR at www.sec.gov.

 

(Signed) Andrew Hall (Signed) Brittany Davison
Andrew Hall Brittany Davison
Chief Executive Officer Senior Vice President of Finance

 

August 10, 2022

 

 

25


 


Exhibit 99.3

Exhibit 99.3

FORM 52-109F2
CERTIFICATION OF INTERIM FILINGS
FULL CERTIFICATE

I, Andrew Hall, Chief Executive Officer of IMV Inc., certify the following:

1.     

Review: I have reviewed the interim financial report and interim MD&A (together, the “interim filings”) of IMV Inc. (the “issuer”) for the interim period ended June 30, 2022.

 

 
2.     

No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings.

 

 
3.     

Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the interim filings.

 

 
4.     

Responsibility: The issuer’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification of Disclosure in Issuers’ Annual and Interim Filings, for the issuer.

 

 
5.     

Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s other certifying officer(s) and I have, as at the end of the period covered by the interim filings:

 

 
  (a)     

designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that:

   

 
  (i)     

material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and

   

 
  (ii)     

information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and

   

 
  (b)     

designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuer’s GAAP.

   

 
5.1     

Control framework: The control framework the issuer’s other certifying officer(s) and I used to design the issuer’s ICFR is Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission.





- 2 -

5.2     

ICFR - material weakness relating to design: N/A

 

 
5.3     

Limitation on scope of design: N/A

 

 
6.     

Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuer’s ICFR that occurred during the period beginning on April 1, 2022 and ended on June 30, 2022 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR.

Date: August 11, 2022

(signed) Andrew Hall
Andrew Hall
Chief Executive Officer




Exhibit 99.4

Exhibit 99.4

FORM 52-109F2
CERTIFICATION OF INTERIM FILINGS
FULL CERTIFICATE

I, Brittany Davison, Snr. VP Finance acting as Chief Financial Officer of IMV Inc., certify the following:

1.     

Review: I have reviewed the interim financial report and interim MD&A (together, the “interim filings”) of IMV Inc. (the “issuer”) for the interim period ended June 30, 2022.

 

 
2.     

No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings.

 

 
3.     

Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the interim filings.

 

 
4.     

Responsibility: The issuer’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification of Disclosure in Issuers’ Annual and Interim Filings, for the issuer.

 

 
5.     

Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s other certifying officer(s) and I have, as at the end of the period covered by the interim filings:

 

 
  (a)     

designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that:

   

 
  (i)     

material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and

   

 
  (ii)     

information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and

   

 
  (b)     

designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuer’s GAAP.

   

 
5.1     

Control framework: The control framework the issuer’s other certifying officer(s) and I used to design the issuer’s ICFR is Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission.





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5.2     

ICFR - material weakness relating to design: N/A

 

 
5.3     

Limitation on scope of design: N/A

 

 
6.     

Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuer’s ICFR that occurred during the period beginning on April 1, 2022 and ended on June 30, 2022 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR.

Date: August 11, 2022

(signed) Brittany Davison
Brittany Davison
Snr. VP Finance acting as Chief Financial Officer