On May 14, 2021 IntelGenx Technologies Corp. (the "Corporation") reported that issued (i) 37,300,000 shares of common stock of the Corporation (the "Shares"), (ii) 22,380,000 warrants (the "Warrants") and (iii) a unit purchase warrant (the "Additional Unit Warrant") to purchase up to 130,000,000 additional units ("Additional Units"), to ATAI Life Sciences AG ("atai") for aggregate gross proceeds of US$12,346,300 (the "Investment"), pursuant to an amended and restated securities purchase agreement (the "Securities Purchase Agreement") entered into by the Corporation and atai on the Initial Closing Date (Filing, 8-K, IntelGenx, MAY 14, 2021, View Source [SID1234580127]). The Securities Purchase Agreement amended and restated in its entirety the securities purchase agreement previously entered into between the parties on March 15, 2021 and includes certain mechanical amendments involving the settlement of securities.

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Each Warrant will entitle atai to purchase one Share at a price of US$0.35 for a period of three years from the Initial Closing Date. The Additional Unit Warrant will entitle atai to purchase the Additional Units for a period of three years from the Initial Closing Date. Each Additional Unit will be comprised of (i) one share of common stock (an "Additional Share") and (ii) one half of one warrant (each whole warrant, an "Additional Warrant"). The price for the Additional Units will be (i) until the date which is 12 months following May 11, 2021, the date on which the Investment was approved by the shareholders of the Corporation (the "Shareholder Approval Date"), US$0.331 (subject to certain exceptions), and (ii) following the date which is 12 months following the Shareholder Approval Date, the lower of (A) a 20% premium to the market price on the date of purchase, and (B) US$0.50 if purchased in the second year following the Shareholder Approval Date and US$0.75 if purchased in third year following the Shareholder Approval Date. Each Additional Warrant will entitle atai, for a period of three years from the date of issuance, to purchase one Share at the lesser of either (i) a 20% premium to the price of the corresponding Additional Share, or (ii) the price per share under which shares of the Corporation are issued under convertible instruments that were outstanding on February 16, 2021, the date on which the parties entered into a non-binding letter of intent to enter into a definitive Securities Purchase Agreement ("Outstanding Convertibles"), provided that atai may not exercise Additional Warrants to purchase more than the lesser of (x) 44,000,000 common shares of the Corporation, and (y) the number of common shares issued by the Corporation under Outstanding Convertibles.

Under the Securities Purchase Agreement, the Corporation also granted atai a pro-rata equity participation right for any issuances of new securities, subject to certain exceptions.

Amendment to Term Loan

On March 9, 2021 atai funded a secured loan in the amount of US$2,000,000 pursuant to a loan agreement entered into between IntelGenx Corp. (the "IntelGenx"), a wholly owned subsidiary of the Corporation, and atai. On May 14, 2021, IntelGenx and atai entered into a first amendment to loan agreement (the "Amendment") providing that the loan is repayable on the business day after the closing of the first subscription for Additional Units under the Securities Purchase Agreement if the additional subscription proceeds at such closing amount to at least US$3,000,000 in the aggregate and such proceeds are paid in cash.

The foregoing is a summary of certain material terms and conditions of the Securities Purchase Agreement and Amendment and are not a complete discussion of such agreements. Accordingly, the foregoing is qualified in its entirety by reference to the full text of the Securities Purchase Agreement and Amendment attached to this Current Report on Form 8-K as Exhibit 10.1 and Exhibit 10.2 respectively and incorporated herein by reference

On May 14, 2021 IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQB:IGXT) ("IntelGenx"), a leader in pharmaceutical films, reported that the previously announced US$12,346,300 investment in IntelGenx by ATAI Life Sciences AG ("atai") has been completed (Press release, IntelGenx, MAY 14, 2021, View Source,atai%E2%80%9D)%20has%20been%20completed.&text=Zerbe%2C%20CEO%20of%20IntelGenx. [SID1234580072]). As a result of the investment, atai now holds approximately 25% of the issued and outstanding common stock of IntelGenx.

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"We would again like to thank our shareholders for their support of our transformative strategic partnership with atai," said Dr. Horst G. Zerbe, CEO of IntelGenx. "In addition to positioning IntelGenx as a leader within the novel therapeutics field of psychedelics, atai’s investment provides us with the requisite financial resources to continue to advance our portfolio of other pharmaceutical film product candidates towards commercialization."

"We are pleased to have achieved our goal of progressing from collaborators to partners with IntelGenx via this transaction, and we are excited to make IntelGenx’s innovative film technology an integral part of our platform," said Florian Brand, CEO of atai."

On May 14, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conferences (Press release, Gilead Sciences, MAY 14, 2021, View Source [SID1234580050]):

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Cowen Annual Virtual Oncology Innovation Summit on Friday, May 21 at 12:00pm ET
Jefferies Virtual Healthcare Conference on Tuesday, June 1 at 1:30pm ET
Bernstein Annual Strategic Decisions Conference on Wednesday, June 2 at 4:30pm ET
Goldman Sachs Annual Global Healthcare Conference on Wednesday, June 9 at 2:10pm ET
The live webcasts can be accessed at the company’s investors page at investors.gilead.com. The replays will be available for at least 30 days following the presentation.

On May 14, 2021 Kiromic BioPharma (NASDAQ: KRBP), a pre-clinical stage biotechnology company using its proprietary DIAMOND artificial intelligence ("A.I.") platform to improve drug discovery and development with a therapeutic focus on immune-oncology, reported its quarterly results for the three months ended March 31, 2021, and provided an update on its corporate developments.

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"We are thankful to our employees and collaborators who have maintained this high level of execution this year. From their efforts, we plan to submit two investigational new drug applications to the United States Food and Drug Administration by the end of May 2021."

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"Kiromic BioPharma achieved important scientific and operational milestones during the year that we believe have us well positioned for preparing our staff and our facilities for the first in-human dosing in Q3 2021," said Dr. Maurizio Chiriva-Internati, PhD, CEO and President of Kiromic BioPharma. "We are thankful to our employees and collaborators who have maintained this high level of execution this year. From their efforts, we plan to submit two investigational new drug applications to the United States Food and Drug Administration by the end of May 2021."

Our approach and goal are to defeat cancer by developing immunotherapies by improving target discovery and validation. With better targets, we believe our therapies will be more effective than the current array of immunotherapies using older targets.

Corporate and Scientific Highlights

Events Occurring during the three months ended March 31, 2021

Facility Expansion in Houston, TX – On March 22, 2021, we executed a lease expansion within our premises in Houston, TX. The amended lease agreement will commence on August 1, 2021 under an operating lease agreement that is noncancelable from commencement until May 1, 2024. The amended lease agreement adds approximately 15,385 square feet to the current facility. Total square feet will be approximately 38,223 square feet.
Leon Office, Asia, Strategic Marketing Agreement – On January 28, 2021, we executed a strategic alliance agreement with Leon Office, Asia (H.K.) ("Leon") a company established under existing laws of Hong Kong. Leon will act as an independent business development advisor on the behalf of the Company. Leon will seek to introduce organizations and individuals that will create business development opportunities for the Company, to expand the Company’s reach to international markets with a focus on certain Asian markets and to increase brand recognition and exposure through developing liaisons, collaborations, branches and subsidiaries. They will also use commercially reasonable efforts to research the Asian market, with a primary, but not exclusive, focus on determining the most suitable structures for the development of medical partnerships or joint ventures with scientific partners in the Asian market with a mission to test products to be created by the joint venture resulting from such partnership and to develop validation programs for any products produced by such joint venture, including programs for clinical trials and human testing and, ultimately, for product certification. The cost of the agreement is $360,000 annually, payable in four quarterly installments.
SBA Loan Extinguishment – On February 16, 2021 the Small Business Administration ("SBA") granted forgiveness of our SBA loan and all applicable interest. On the date of forgiveness, the principal and accrued interest totaled $105,800. The forgiveness was classified as a gain on loan extinguishment in the consolidated statement of operations.
Events occurring after March 31, 2021 until May 14, 2021

Research Grant Agreement with University of Texas MD Anderson Cancer Center – On April 8, 2021, we entered into a letter of intent (the "Letter of Intent") with the University of Texas MD Anderson Cancer Center ("MD Anderson") pursuant to which MD Anderson shall receive a research grant from us entitled, "Validation of biomarker isomeso for pancreatic cancer," which is aimed at discovering new cancer-specific antigen targets (the "Grant"). The total costs to us to be paid in connection with the Grant shall be $300,000. Pursuant to the Letter of Intent, the Grant shall commence on April 1, 2021 and end on March 31, 2022.
Upcoming Investigational New Drug Application Submissions – We are planning to submit two investigational new drug ("IND") applications to the United States Food and Drug Administration by the end of May 2021. These INDs will be for our ALEXIS-PRO-1 and ALEXIS-ISO-1 product candidates. ALEXIS-PRO-1 is our allogeneic gamma delta chimeric T cell therapy product candidate targeting PD-L1. ALEXIS-ISO-1 is our allogenic gamma delta CAR-T cell therapy product candidate targeting Isomesothelin (the isoform of Mesothelin).
Q1 2021 Financial Highlights

Cash Position: Cash and cash equivalents were $7,335,300 as of March 31, 2021, compared to $10,150,500 as of December 31, 2020. The difference is attributable to cash outflows of $2,635,900, $44,700, and $134,600 for operating activities, investing activities, and financing activities respectively.

R&D Expenses: Our research and development expenses increased by $857,500, (83.41%), to $1,885,600 for the three months ended March 31, 2021. The increase was attributable to increased headcount, manufacturing, and experimentation costs for our ALEXIS-ISO-1 product candidate.

G&A Expenses: Our general and administrative expenses increased by $1,246,400, (151.15%), to $2,071,000 for the three months ended March 31, 2021 from $824,600 for the three months ended March 31, 2020. This increase was primarily due to increased headcount, stock compensation expenses from prior year grant modifications, and professional services.

Net Loss: Our net loss increased to $3,854,500 during the three months ended March 31, 2021 compared to $1,852,700 during the three months ended March 31, 2020.

On May 14, 2021 Odonate Therapeutics, Inc. (NASDAQ: ODT) reported financial results for the three months ended March 31, 2021 (Press release, Odonate Therapeutics, MAY 14, 2021, View Source [SID1234580048]).

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Odonate recently announced the discontinuation of development of tesetaxel and its intent to wind down tesetaxel-related operations. Odonate is working with clinical sites to transition patients in ongoing tesetaxel studies to appropriate alternative therapies or facilitate continuation of treatment with tesetaxel under compassionate use programs where appropriate.

As of March 31, 2021, Odonate had $133.2 million in cash compared to $157.3 million as of December 31, 2020. This decrease in cash resulted primarily from cash used in operating activities for the three months ended March 31, 2021 of $24.9 million. Odonate’s net loss for the three months ended March 31, 2021 and 2020 was $33.8 million and $30.2 million, or $0.90 and $0.99 per share, respectively.