Amended and Restated Offering Document
Under the Listed Issuer Financing Exemption
October 26, 2023
| | Theralase® Technologies Inc. |
| | ("Company" or "Theralase®" or "Issuer") |
| | Summary of Offering |
What are we offering? | |
| | |
Securities: | | Up to 24,090,910 units of the Company ("Units"), with each Unit consisting of one common |
| | share of the Company ("Common Share") and one Common Share purchase warrant |
| | ("Warrant"). Each Warrant is exercisable for a Common Share at a price of C$0.28 for a |
| | period of sixty (60) months from the Closing Date (as defined herein). |
| | In addition, the Company will use commercial reasonable efforts to obtain the necessary |
| | approvals to list the Warrants on the TSX Venture Exchange ("TSXV"). |
| | |
Offering Price: | | C$0.22 per Unit. |
| | |
Offering Amount: | | A minimum of 15,909,091 Units for minimum gross proceeds to the Company of |
| | C$3,500,000 ("Minimum Offering") and a maximum of 24,090,910 Units for maximum gross |
| | proceeds to the Company of C$5,300,000 ("Maximum Offering"), subject to the terms and |
| | conditions set out herein ("Offering"). |
| | |
Closing Date: | | The Offering is expected to close on or about the week of October 30, 2023 ("Closing Date"). |
| | |
Exchange: | | The Common Shares are listed on the TSXV under the symbol "TLT-V" and the OTCQB |
| | trading platform ("OTCQB") in the United States under the trading symbol "TLTFF". |
| | |
Last Closing Price: | | On October 23, 2023, the last trading day prior to the announcement of the Offering, the |
| | closing price of the Common Shares on the TSXV and the OTCQX was C$0.26 and USD$0.185, |
| | respectively. |
| | |
Concurrent Private | | The Offering is being conducted concurrently with a non-brokered private placement of |
Placement: | | Units. Gross proceeds from the Units issued pursuant to the Concurrent Private Placement |
| | will be included under the Offering. |
| | |
No securities regulatory authority or regulator has assessed the merits of these securities or reviewed this Offering Document. Any representation to the contrary is an offence. This Offering may not be suitable for you and you should only invest in Units if you are willing to risk the loss of your entire investment. In making this investment decision, you should seek the advice of a registered dealer.
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Theralase® is conducting a listed issuer financing under section 5A.2 of National Instrument 45-106 - Prospectus Exemptions. In connection with this Offering, the Company represents the following is true:
- the Company has active operations and its principal asset is not cash, cash equivalents or its exchange listing;
- the Company has filed all periodic and timely disclosure documents that it is required to have filed;
- the total dollar amount of this Offering, in combination with the dollar amount of all other offerings made under the listed issuer financing exemption in the 12 months immediately before the date of this Offering Document, will not exceed C$5,300,000;
- the Company will not close this Offering unless the Company reasonably believes it has raised sufficient funds to meet its business objectives and liquidity requirements for a period of 12 months following the distribution; and
- the Company will not allocate the available funds from this Offering to an acquisition that is a significant acquisition or restructuring transaction under securities law or to any other transaction for which the Company seeks security holder approval.
About this Offering Document
Readers should rely only on the information contained in this Offering Document in respect of the Issuer. We have not authorized any other person to provide additional or different information. If anyone provides additional or different or inconsistent information, including information or statements in media articles about the Issuer, prospective purchasers should not rely on it.
Meaning of Certain References
Unless otherwise noted or the context otherwise shall state, the "Company", "Issuer", "we", "us", and "our" refers to Theralase® Technologies Inc.
References to "management" in this Offering Document refer to the management of the Issuer. Any statements in this Offering Document made by or on behalf of management are made in such persons' capacities as officers of the Issuer and not in their personal capacities.
Words importing the singular number include the plural, and vice versa, and words importing any gender include all genders.
All currency amounts in this Offering Document are expressed in Canadian dollars, unless otherwise stated.
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Cautionary Statement on Forward-Looking Information
This Offering Document contains forward-looking information and statements within the meaning of applicable Canadian securities laws (herein referred to as "Forward-LookingStatements" or "FLS") that involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or industry results to be materially different from any future results, performance, achievements or industry results expressed or implied by such FLS. All information and statements in this Offering Document, which are not statements of historical fact may be FLS. Such statements and information may be identified by words such as "may", "believe", "could", "expect", "will", "intend", "should", "plan", "objective", "predict", "potential", "project", "anticipate", "estimate", "suggest", "continuous" or similar words or the negative thereof or other comparable terminology; including, references to assumptions. Such information may involve, but is not limited to, comments with respect to strategies, expectations, planned operations or future actions.
FLS included in this Offering Document include, but are not limited to, statements with respect to the: outlook of the revenues, business and timing of initiatives of the Company; competitive environment in which the Company operates; business strategy and objectives of the Company; research, development and/or commercialization plans, as well as acquisition and disposition plans of the Company; preclinical research, clinical development and clinical study, status, timing and/or strategies; supply and demand of products or services; Company's future revenue projections; Company's ability to meet its current and future obligations; Company's ability to execute its business and/or growth strategy and management's assessment of future plans and/or operations.
Readers are cautioned not to place undue reliance on FLS as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, FLS involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections and other things contemplated by the FLS will not occur. Such FLS or information are based on a number of assumptions which may prove to be incorrect, including those assumptions listed below and those discussed elsewhere in this Offering Document. Some of the assumptions made by the Company, upon which such FLS are based, include, but are not limited to, assumptions about the: business operations of the Company continuing on a basis consistent with prior years; ability of the Company to access financing from time to time on favourable terms or at all; continuation of executive management, operating management, key personnel or key consultants or the non-disruptive replacement of them on reasonable terms; ability of the Company to maintain reasonably stable operating and general administrative expenses; future success of current research, development and/or commercialization activities of the Company; ability of the Company to achieve development and/or commercial milestones; market competition; ability of the Company to secure all necessary regulatory and/or certification approvals; geographic protection over the intellectual property of the Company in the markets in which the Company does business; market acceptance and/or revenue generation of the Company's products under development; stability of current economic conditions, strength of the economy in Canada, the United States and elsewhere; currency, exchange and/or interest rates and commodity prices being reasonably stable at current rates.
FLS reflect current expectations of management regarding future events and operating performance as of the date of this Offering Document. Such information: involves significant risks and uncertainties; should not be read as guarantees of future performance and/or results; will not necessarily be accurate indications of whether or not such results will be achieved. A number of factors could cause actual results to differ materially from the results discussed in the FLS, including, but not limited to, the risks related to: limited
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operating history; working capital and capital resources; ability to retain key personnel; protection of intellectual property; competition; implementation delays; strategic alliances; trade secret protection; product deficiencies; dependence on third party suppliers; volatility of share price; regulatory risks; early stage of product development; reliance on third parties; clinical study and study risk; clinical study timing delays; patient enrolment; failure to achieve milestones; currency risk; material weakness in internal control over financial reporting; credit risk and product liability. New risks may emerge from time to time and the importance of current factors may change from time to time and it is not possible for the Company to predict all such factors. Further discussion of factors and risks that could affect the Company can be found in the Annual Information Form of the Company for the year ended December 31, 2022.
Although the FLS contained in this Offering Document are based upon what the Company's management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with such information. FLS reflect management's current beliefs and are based on information currently available to the Company. Readers of this Offering Document are cautioned not to place undue reliance on the Company's FLS because a number of factors, such as those referred to in the paragraphs above, could cause actual future results, conditions, actions or events to differ materially from the targets, expectations, estimates and/or intentions expressed in the FLS contained in this Offering Document. The FLS are made as of the date of this Offering Document and the Company assumes no obligation to update or revise such information to reflect new events or circumstances, except as may be required by applicable law.
Summary Description of Business
What is our business?
Theralase® is a clinical stage pharmaceutical company with two main divisions.
The Drug Division conducts preclinical and clinical research and development for Photo Dynamic Compounds ("PDCs"), in the destruction of cancer, bacteria and viruses, with assistance from the Device Division to develop medical lasers to activate them.
In addition to the research and development of medical lasers used by the Drug Division, the Device Division designs, develops, manufactures and markets proprietary super-pulsed laser Cool Laser Technology indicated and cleared by Health Canada and the Food and Drug Administration for the treatment of chronic knee pain and when used off-label for treating numerous nerve, muscle and joint conditions.
Recent Developments
On January 5, 2023, the Issuer announced the extension of 4,095,157 Common Share purchase warrants, from the previously amended expiry date of January 9, 2023, to January 9, 2024, all of which are exercisable at C$0.50 per share.
On January 25, 2023, the Issuer announced that its Phase II Bacillus Calmette Gurin-Unresponsive Non- Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ (with or without resected Ta / T1 papillary disease) clinical study ("Study II") interim data was accepted by the American Society of Clinical Oncology Genito Urinary Cancer Symposium for a moderated poster presentation at its symposium that took place between February 16th to 18th, 2023.
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On February 2, 2023, the Issuer announced that its Study II interim data was accepted by the American Urology Association for a moderated poster presentation at its annual meeting that took place between April 28th to May 1st, 2023.
On February 21, 2023, the Issuer announced it was named a 2023 TSX Venture 50™ company. This award recognized the top 10 performing companies from five industry sectors based on three equally weighted criteria: market capitalization growth, share price appreciation and trading volume amount.
On February 23, 2023, the Issuer announced that its Study II interim data was presented at the American Society of Clinical Oncology Genito Urinary Cancer Symposium for a moderated poster presentation at its symposium.
On May 10, 2023, the Issuer announced an update on Study II, where for the primary objective, 65% of evaluable patients (patients evaluated by a principal investigator) achieved a complete response ("CR") at any assessment date post primary study treatment and 30% of evaluable patients achieved a CR at 450 days.
On May 24, 2023, the Issuer announced that Roger DuMoulin-White, B.Sc., P.Eng., Pro. Dir. Was appointed President and Chief Executive Officer ("CEO") of the Company. Dr. Arkady Mandel, MD, PhD, DSc tendered his resignation as Interim CEO and continues to serve as Chief Scientific Officer and as a member of Theralase®'s Board of Directors. Mr. DuMoulin-White is the founder of Theralase® and its former President and CEO. He stepped down as President and CEO in 2018 and served in a non-executive business development role. Mr. DuMoulin-White was the subject of a voluntary settlement agreement with the Ontario Securities Commission ("OSC") dated February 16, 2018 and an OSC Order dated February 26, 2018, which required, among other things, that he resign as a director and officer of Theralase® and refrain from holding those positions for a period of five (5) years. That period has expired and Theralase® obtained the approval of the TSXV to appoint Mr. DuMoulin-White as President and CEO of the Company and to nominate him for election to the Company's Board of Directors at the Company's Annual Meeting held on June 29, 2023.
On June 6, 2023, the Issuer announced that Ms. Kaouthar Lbiati, M.D., M.Sc. was appointed a director of the Company.
On June 29, 2023, Mr. DuMoulin-White was appointed a director of the Company.
On June 30, 2023, the Issuer announced the closing of a non-brokered private placement, where 4,800,000 units were issued at a price of C$0.25 per unit for gross proceeds of C$1,200,000.
On September 7, 2023, the Issuer announced the closing of a non-brokered private placement, where 1,840,000 units were issued at a price of C$0.25 per unit for gross proceeds of C$460,000.
On September 21, 2023, the Issuer announced the grant of stock options to certain directors and employees.
On September 27, 2023, the Issuer announced that it has successfully completed its non-Good Laboratory Practices ("GLP") preclinical toxicology analysis of Rutherrin® for Glio Blastoma Multiforme ("GBM").
On September 29, 2023, the Issuer announced that it has successfully demonstrated an 8 year, real-time, shelf life of its lead PDC, RuvidarTM. This is supported by current GLP analysis conducted by an independent manufacturing and testing laboratory.
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On October 5, 2023, the Issuer announced that it has filed a US patent, titled "Enhanced Immunotherapeutic Method Comprising Combined Administration of Photodynamic / Radiotherapeutic Compounds and Immunotherapeutic Agents" for enhanced destruction of cancer.
On October 16, 2023, the Issuer announced an update on Study II demonstrating that 65% of patients treated in Study II achieved CR.
On October 23, 2023, the Issuer announced an optimization for Study II; specifically, for: Post Study II Monitoring of Response, Optional Maintenance Study II Treatments and Central Pathology Laboratory Review.
Material Facts
There are no material facts about the Units being distributed that have not been disclosed in this Offering Document or in any other document filed by the Company in the twelve (12) months preceding the date of this Offering Document.
Business Objectives and Milestones
What are the business objectives that we expect to accomplish using the available funds?
The business objectives that the Company expects to accomplish using the net proceeds of the Offering and the Concurrent Private Placement include: advancing the preclinical research and clinical development of the Company's proprietary PDCs, in the destruction of cancer, bacteria and viruses.
The Company intends to complete the following:
- Advancement of Phase II NMIBC clinical study expected to incur in 2023 and 2024, costing approximately C$3,300,000
- GLP toxicology study for intravenous installation of Rutherrin® intended for the treatment of GBM expected to occur in 2023 and 2024; costing, approximately C$1,500,000
Use of Available Funds
What will our available funds be upon the closing of the Offering and the Concurrent Private Placement?
Based on the Company's existing working capital as of October 26, 2023 of approximately C$1,000,000, the Company's expected availability of funds in the case of the Minimum Offering will be approximately C$4,205,000 and C$6,344,000 in the case of the Maximum Offering.
The Company has experienced a decline in working capital of approximately C$1,500,000 since September 30, 2022. The Company is a clinical stage pharmaceutical company with minimal revenue, with research and development undertaken by the Company funded primarily by available cash from financing activities. The Company has raised working capital through the sale of Common Shares and Warrants, but has also funded significant research and development activity throughout 2022 and 2023, which has resulted in a decrease in working capital.
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| | Assuming | Assuming |
Sources of Funds | Minimum Offering | Maximum Offering |
| | (C$000s) | (C$000s) |
| | |
A. Amount to be raised by this Offering | 3,500 | 5,300 |
| | | |
B. | Selling commissions and fees(1) | 210 | 336 |
| |
| | |
C. Estimated Offering costs (e.g.: legal, accounting, audit) | 75 | 75 |
| | |
D. Net proceeds of Offering: D = A - (B + C) | 3,215 | 4,889 |
| | | |
E. | Working capital as at most recent month end (deficiency) | 1,000 | 1,000 |
| | |
F. Additional sources of funding | - | - |
| | | |
G. | Total Available Funds: G = D + E + F | 4,215 | 5,889 |
| | | |
Notes:
- Assumes a cash fee of 7% of the gross proceeds of the Offering and a Corporate Finance Fee in the amount of 3.5% of the Concurrent Private Placement of $CAN 1,000,000.
How will we use the available funds?
The Company intends to use the net proceeds from the Offering as noted in the table below:
Description of intended use of available funds listed in order of | Assuming | Assuming |
Minimum Offering | Maximum Offering |
priority |
(C$000s) | (C$000s) |
|
| | |
Phase II NMIBC clinical study | 3,300 | 3,300 |
| | |
GLP toxicology study for intravenous installation of Rutherrin intended | - | 1,500 |
for the treatment of NSCLC and GBM. |
| |
| | |
Working capital purposes | 915 | 1,089 |
| | |
Total | 4,215 | 5,889 |
| | |
The above-mentioned allocation represents the Company's current intentions with respect to its use of proceeds of the Offering based on current knowledge, planning and expectations of the Company's management. Although the Company intends to expend the proceeds from this Offering as set forth above, there may be circumstances where, for sound business reasons, a reallocation of funds may be deemed prudent or necessary and may vary materially from that set forth above, as the amounts actually allocated and spent will depend on a number of factors, including the Company's ability to execute on its business plan and financing objectives.
The Company has generated negative cash flows from operating activities since inception and anticipates that it will continue to have negative operating cash flow until the profitable commercial launch of its NMIBC cancer therapy treatment is achieved, which may never occur. As a result, certain of the net proceeds from this Offering may be used to fund such negative cash flow from operating activities in future periods. See "Cautionary Statement on Forward-LookingInformation".
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The most recent audited consolidated annual financial statements and unaudited condensed consolidated interim financial statement of the Company included a going concern note. The Company is still in the preclinical stage and the Company has not yet generated positive cash flows from its operating activities, which may cast doubt on the Company's ability to continue as a going concern. The Offering is intended to permit the Company to advance its business objectives and is not expected to affect the decision to include a going concern note in future consolidated financial statements of the Company.
How have we used the other funds we have raised in the past 12 months?
| | | | | | Use of funds to | | Variance and impact on |
| Previous financing | | | Intended use of funds | | | ability to achieve business |
| | | | date | |
| | | | | | | objectives and milestones |
| | | | | | | |
| September 7, 2023- Non- | | | | Clinical | | Business objectives and |
| | For clinical | | | milestones have been |
| brokered private placement of | | | development | |
| | development of the | | | advanced as a result of the |
| 1,840,000 units (1 common share | | | activities: | |
| | Company's PDCs to | | | funding. All funds were |
| + 1 common share purchase | | | C$245,571 | |
| | destroy cancer and for | | | used for clinical |
| warrant) of the Company for | | | | |
| | general working capital | | | | development activities |
| gross proceeds of | | | | General working | |
| | | purposes. | | | with the balance retained |
| C$454,271 | | | | capital: C$Nil | |
| | | | | | as general working capital. |
| | | | | | | |
| | | | | | | | |
| June 30, 2023- Non-brokered | | | | Clinical | | Business objectives and |
| | For clinical | | | milestones have been |
| private placement of 4,800,000 | | | development | |
| | development of the | | | advanced as a result of the |
| units (1 common share + 1 | | | activities: | |
| | Company's PDCs to | | | funding. All funds were |
| common share purchase warrant) | | | $ CAN 841,780 | |
| | destroy cancer and for | | | used for clinical |
| of the Company for | gross | | | | |
| | general working capital | | | | development activities |
| proceeds of | | | | General working | |
| | | purposes. | | | with the balance retained |
| C$1,188,275 | | | | capital: C$346,495 | |
| | | | | | as general working capital. |
| | | | | | | |
| | | | | | | | |
| November 17, 2022- Brokered | | | | Clinical | | Business objectives and |
| | For clinical | | | milestones have been |
| private placement of 1,000,000 | | | development | |
| | development of the | | | advanced as a result of the |
| units (1 common share + 1 | | | activities: | |
| | Company's PDCs to | | | funding. All funds were |
| common share purchase warrant) | | | C$197,346 | |
| | destroy cancer and for | | | used for clinical |
| of the Company for | gross | | | | |
| | general working capital | | | | development activities |
| proceeds of | | | | General working | |
| | | purposes. | | | with the balance retained |
| C$246,682 | | | | capital: C$49,336 | |
| | | | | | as general working capital. |
| | | | | | | |
| | | | | | | | |
Fees and Commissions
Who are the dealers or finders that we have engaged in connection with this Offering, if any, and what are their fees?
Agent: | The Company has engaged Research Capital Corporation ("Agent") |
| |
Compensation Type: | A cash fee, Compensation Options (as defined herein), Corporate Finance Fee (as defined |
| herein), and Corporate Finance Fee Compensation Options (as defined herein) |
| |
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Cash Fee: | The Company will pay the Agent a cash fee equal to 7% of the gross proceeds of the |
| Offering. |
| |
Compensation Options: | The Company will issue the Agent such number of compensation options |
| ("Compensation Options") exercisable at any time up to 60 months following the |
| Closing Date to purchase Units of the Company at a price of C$0.22 per Unit in an |
| amount equal to 5% of the Units sold in connection with the Offering. |
| |
Corporate Finance Fee: | Assuming completion of the Minimum Offering, the Company will pay the Agent a |
| corporate finance fee ("Corporate Finance Fee") in the amount of 3.5% of the gross |
| proceeds of the Concurrent Private Placement, subject to increase if the gross |
| proceeds raised and received by the Company from purchasers under the Concurrent |
| Private Placement exceeds $1 million. |
| |
Corporate Finance Fee | The Company will issue the Agent such number of Corporate Finance Fee |
Compensation Options | compensation options ("Corporate Finance Fee Compensation Options") exercisable |
| at any time up to 60 months following the Closing Date to purchase Units of the |
| Company at a price of C$0.22 per Unit in an amount equal to 2.5% of the Units sold to |
| purchasers included in the Concurrent Private Placement. |
| |
Does the Agent have a conflict of interest?
To the knowledge of the Company, it is not a "related issuer" or "connected issuer" of or to the Agent, as such terms are defined in National Instrument 33-105 - Underwriting Conflicts.
Purchasers' Rights
Rights of Action in the Event of a Misrepresentation
If there is a misrepresentation in this Offering Document, you have a right:
- to rescind your purchase of these securities with the Company, or
- to damages against the Company and may, in certain jurisdictions, have a statutory right to damages from other persons.
These rights are available to you whether or not you relied on the misrepresentation; however, there are various circumstances that limit your rights. In particular, your rights might be limited if you knew of the misrepresentation when you purchased the securities.
If you intend to rely on the rights described in paragraph (a) or (b) above, you must do so within strict time limitations.
You should refer to any applicable provisions of the securities legislation of your province or territory for the particulars of these rights or consult with a legal adviser.
Additional Information
Where can you find more information about us?
The Company's continuous disclosure filings with applicable securities regulatory authorities in the provinces and territories of Canada are available electronically under the Company's profile on the System
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for Electronic Document Analysis and Retrieval Plus ("SEDAR+") at www.sedarplus.ca.
For further information regarding Theralase®, please visit our website at: https://www.theralase.com.
Investors should read this Offering Document and consult their own professional advisors to assess the income tax, legal, risk factors and other aspects of their investment of Units.
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