IntelGenx Announces Initial Closing of atai Investment

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."

Gilead Sciences to Present at Upcoming Investor Conferences

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.

Kiromic BioPharma Reports First Quarter 2021 Financial Results and Continued Corporate Progress

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.

Odonate Therapeutics Announces Financial Results for the Three Months Ended March 31, 2021

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.

Knight Therapeutics Reports First Quarter 2021 Results

On May 14, 2021 Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company"), a leading pan-American (ex-US) specialty pharmaceutical company, reported financial results for its first quarter ended March 31, 2021 (Press release, Knight Therapeutics, MAY 14, 2021, View Source [SID1234580047]). All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

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Q1 2021 Highlights

Financials

Revenues were $46,069, an increase of $230 or 1% over prior year.
Gross margin generated of $20,580 or 45% compared to $19,860 or 43% in prior year.
Adjusted EBITDA1 was $5,580, an increase of $2,383 or 75% over prior year.
Interest income generated of $1,998 a decrease of $2,651 or 57% over prior year.
Net income was $3,558 compared to net loss of $9,477 in prior year.
Cash inflow from operations was $17,207 compared to cash outflow of $21,167 in prior year.
Corporate Developments

Promoted Amal Khouri to Chief Business Officer.
Purchased 3,557,340 common shares through a Normal Course Issuer Bid ("NCIB") for an average cost of $18,592.
Products

Launched Ibsrela in Canada for the treatment of Irritable Bowel Syndrome with Constipation ("IBS-C").
Strategic Investments

Disposed of 315,600 common shares of Medexus for total proceeds of $2,624.
Received distributions of $4,336 from strategic fund investments and realized a gain of $3,031.
Key Subsequent Events

Entered into a definitive agreement with Novartis to acquire the exclusive rights to manufacture, market and sell Exelon in Canada and LATAM for an upfront payment of USD 168,000 ($211,2602) and a milestone payment of up to USD 12,000 ($15,0902).
Shareholders re-elected James C. Gale, Jonathan Ross Goodman, Samira Sakhia, Robert N. Lande, Michael J. Tremblay, Nicolás Sujoy and Janice Murray on the Board of Directors.
Announced leadership change with Samira Sakhia assuming role of CEO and Jonathan Goodman assuming role of Executive Chairman effective September 1, 2021.
Purchased 512,271 common shares through its NCIB for an aggregate cost of $2,695.
"We are continuing to execute on multiple fronts. I am excited to report that our key launch brands in Latin America, including Cresemba, Halaven, Lenvima, Trelstar and Nerlynx in Canada grew 116% compared to the prior year quarter. We continue to progress on our integration activities and have commenced implementation of our ERP, CRM and HR and learning management systems. On the business development front, we executed on another transformational transaction with the acquisition of Exelon from Novartis for Canada and Latin America, said Samira Sakhia, President and Chief Operating Officer of Knight Therapeutics Inc. "I am humbled and honored to be leading talented Knights in Canada and across Latin America as we continue to execute on our strategy of acquiring, in-licensing and developing innovative medicines and high quality treatments for Latin America and Canada."

1 Adjusted EBITDA is not defined terms under IFRS, refer to the definitions below for additional details.
2Converted to CAD using the closing foreign exchange rate, actual amount in CAD will vary depending on the exchange rate on the close of the transaction

Revenue: For the quarter ended March 31, 2021, revenues increased by $230 or 1% as a result of an increase in sales from new product launches, partially offset by the depreciation in the LATAM currencies. Excluding the impact of hyperinflation and under constant currency, revenues would have increased by $4,123, which is mainly attributable to the launch of Cresemba, Lenvima, Halaven, Nerlynx and certain BGx products as well as Trelstar, which Knight began commercializing in April 2020.

Gross margin: For the quarter ended March 31, 2021, the gross margin increased from 43% to 45% compared to the same period in the prior year due to lower inventory provision and product mix, partially offset by re-negotiation of certain license agreements and the depreciation of the LATAM currencies. The gross margin would have been 47%, an increase of 2%, from 45% after excluding the adjustment of hyperinflation accounting in accordance with IAS 29.

Selling and marketing: The decrease of $2,501 or 25% for the quarter ended March 31, 2021 compared to the same period in the prior year is due to $1,133 of expected credit loss that was recorded in Q1 20 compared to none in Q1 21 and $783 due to the depreciation of the LATAM currencies.

General and administrative: For the quarter ended March 31, 2021, the general and administrative expenses decreased by $1,336 or 16% as compared to the same period in prior year driven by $671 in savings due to restructuring activities and $789 due to the depreciation of the LATAM currencies.

Amortization of intangible assets: For the quarter ended March 31, 2021, amortization of intangible assets decreased by $737, or 12%, mainly explained by the depreciation in the LATAM currencies partially offset by the amortization of intangible assets acquired during 2020.

Interest income: Interest income is the sum of interest income on financial instruments measured at amortized cost and other interest income. For the quarter, interest income was $1,998, a decrease of 57% or $2,651 compared to the same prior year period due to a decrease in interest rates, the average cash and marketable securities balances and a lower average loan balance.

Interest expense: The interest expense relates to interest incurred on bank loans. For the quarter ended March 31, 2021 interest expenses was $660, a decrease of $487 or 42% compared to the same period in the prior year due to decrease in the average loan balance outstanding.

Adjusted EBITDA: For the three-month period ended March 31, 2021, adjusted EBITDA was $5,580, an increase of $2,383 or 75% compared to the same period last year. The variance is explained by the above mentioned increase in gross margin and decrease in operating expenses.

Net income or loss: For the quarter ended March 31, 2021, net income was $3,558 compared to a net loss of $9,477 for the same period last year. The variance mainly resulted from the above-mentioned items as well as a net gain on the revaluation of financial assets measured at fair value through profit or loss of $9,473 in the first quarter of 2021 versus a loss of $6,730 in the prior year period.

Cash, cash equivalents and marketable securities: As at March 31, 2021, Knight had $382,381 in cash, cash equivalents and marketable securities, a decrease of $9,844 or 3% as compared to December 31, 2020. The variance is primarily due to cash outflows related to the shares repurchased through NCIB, the bank loans repaid by Knight offset by cash generated from operating activities.

Financial assets: There is no significant variance for financial assets. However, given the nature of the fund investments there could be significant fluctuations in the fair value of the underlying assets. More specifically, an investment held within Sectoral Asset Management ("Sectoral") fund, Atea Pharmaceutics Inc ("Atea"), announced in October 2020, the closing of its initial public offering at a public offering price of USD 24 per share. The shares held by Sectoral are subject to a 180-day lockup period. As at March 31, 2021, Atea’s share price closed at USD 61.75 compared to USD 41.78 as at December 31, 2020. As at May 12, 2021, Atea’s share price closed at USD 19.74 Should the share price of Atea remain at this level, the Company would record a loss of approximately $15.2M.

Bank Loans: As at March 31, 2021, bank loans were at $38,192, a decrease of $13,578 as compared to the prior period, mainly due to loan repayment of $8,848 and a further decrease of $4,854 due to the foreign exchange revaluation.

Product Updates

On March 1, 2021 the Company launched Ibsrela (tenapenor) for the treatment of IBS-C. The Company entered into an exclusive licensing agreement with Ardelyx to commercialize Ibsrela in Canada in March 2018. Ibsrela is a first-in-class small molecule treatment for IBS-C. Ardelyx received regulatory approval for Ibsrela from the US FDA in September 2019. On April 17, 2020, the Company announced that Ibsrela was approved by Health Canada.

On April 23, 2021, the Company announced that it has entered into a definitive agreement to acquire the exclusive rights to manufacture, market and sell Exelon, indicated for the symptomatic treatment of mild to moderately severe dementia in people with Alzheimer’s disease, in Canada and Latin America ("Territory"). In addition, the Company obtained an exclusive license to use the intellectual property and the Exelon trademark in the Territory. At closing, Knight will pay USD 168,000 ($211,2601) in cash and may pay up to USD 12,000 ($15,0901) upon the achievement of certain conditions. For the year ended December 31, 2020, Exelon sales in the Territory were approximately USD 47,000.

The closing of this transaction is subject to the completion of the anti-trust clearance process in Brazil. In conjunction with closing, Knight will enter into a transition service agreement until transfer of marketing authorization, on a country by country basis during which Knight will receive a net profit transfer. Knight will begin distributing Exelon upon transfer of marketing authorization, on a country by country basis.

NCIB

On July 10, 2020, the Company announced that the Toronto Stock Exchange approved its notice of intention to launch an additional NCIB (‘2020 NCIB"). Under the terms of the 2020 NCIB, Knight may purchase for cancellation up to 10,856,710 common shares of the Company which represented 10% of its public float as at July 6, 2020. The 2020 NCIB commenced on July 14, 2020 and will end on the earlier of July 13, 2021 or when the Company completes its maximum purchases under the 2020 NCIB. Furthermore, Knight entered into an agreement with a broker to facilitate purchases of its common shares under the 2020 NCIB. Under Knight’s automatic share purchase plan, the broker may purchase common shares which would ordinarily not be permitted due to regulatory restrictions or self-imposed blackout periods. During the three-month period ended March 31, 2021, the Company purchased 3,557,340 common shares, for an aggregate cash consideration of $18,592, of which $44 remains to be settled as at March 31, 2021. Subsequent to the quarter, the Company purchased an additional 512,271 common shares, for an aggregate cash consideration of $2,695.

1 Converted using the March 31, 2021 closing foreign exchange rate, actual amount in CAD will vary depending on the exchange rate on the close of the transaction.

Conference Call Notice

Knight will host a conference call and audio webcast to discuss its first quarter results today at 8:30 am ET. Knight cordially invites all interested parties to participate in this call.