Magenta Therapeutics to Participate in Upcoming Healthcare Investor Conferences in May

On May 14, 2021 Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplants to more patients, reported that Jason Gardner, D.Phil., President and Chief Executive Officer, will participate in fireside chats at the following investor conferences this month (Press release, Magenta Therapeutics, MAY 14, 2021, View Source [SID1234580015]):

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Cowen 2nd Annual Virtual Oncology Innovation Summit on Thursday, May 20, at 10:40 a.m. ET
Oppenheimer Rare & Orphan Disease Summit on Friday, May 21, at 2:55 p.m. ET
Live webcasts of the fireside chats can be accessed on the Magenta Therapeutics website at View Source The webcast replays will be available for 90 days following each event.

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.

Armata Pharmaceuticals Announces First Quarter Results and Provides General Corporate Update

On May 14, 2021 Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, reported results for the first quarter of 2021 and provided a corporate update (Press release, AmpliPhi Biosciences, MAY 14, 2021, View Source [SID1234580000]).

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First Quarter 2021 and Recent Highlights:

Continued to advance the single ascending dose (SAD) cohort of the SWARM-P.a. Phase 1b/2a clinical trial evaluating AP-PA02 as a potential treatment for cystic fibrosis patients with chronic Pseudomonas aeruginosa airway infection
Progressed IND-enabling activities in preparation for a Phase 1b/2 clinical trial evaluating AP-SA02 as a potential treatment for Staphylococcus aureus bacteremia
Raised gross proceeds of $20.0 million through a securities purchase agreement with Innoviva Strategic Opportunities LLC, a wholly owned subsidiary of Innoviva, Inc., Armata’s largest shareholder
Subsequent to the end of the quarter, the Company earned a $750,000 payment from the Cystic Fibrosis (CF) Foundation for achieving a milestone related to the SWARM-P.a. study
"Despite the risks COVID-19 present to people with chronic lung infections, we are making progress with our SWARM-P.a. study as the pandemic’s negative impact on trial operations continues to improve," stated Todd R. Patrick, Chief Executive Officer of Armata. "As we have noted previously, the study is being funded in part by a Therapeutics Development Award from the CF Foundation and we are grateful for their support. At the same time, we continue to engage in IND-enabling activities in support of a Phase 1b/2 trial of our second candidate, AP-SA02, in Staphylococcus aureus bacteremia, which would give us line-of-sight to two programs in the clinic.

"Beyond these programs, we are working toward the initiation of additional clinical trials assessing our phage-based therapeutic candidates in other difficult to treat indications, including non-cystic fibrosis bronchiectasis, pneumonia and prosthetic joint infection.

"With our recent financing, we believe we are well funded to achieve multiple pre-clinical and clinical milestones over the next two years," Mr. Patrick concluded.

Anticipated 2021 and 2022 Milestones:

Complete the single ascending dose (SAD) cohort of the SWARM-P.a. Phase 1b/2a clinical trial evaluating AP-PA02 as a potential treatment for Pseudomonas aeruginosa infections in the coming months
Initiate and complete the multiple ascending dose (MAD) cohort of SWARM-P.a. trial in the fourth quarter of 2021 or first quarter of 2022
Initiate a Phase 1b/2 clinical trial evaluating AP-SA02 as a potential treatment for Staphylococcus aureus bacteremia
Initiate at least one additional clinical trial in a new indication
First Quarter Financial Results

Grant Revenue. The Company recognized grant revenue of $1.1 million for the three months ended March 31, 2021, which represents Medical Technology Enterprise Consortium (MTEC)’s share of the costs incurred for the Company’s AP-SA02 program for the treatment of Staphylococcus aureus bacteremia. The Company will receive a $15.0 million grant award from MTEC over a three-year period administered by the U.S. Department of Defense with funding from the Defense Health Agency and Joint Warfighter Medical Research Program. The Company recognized no grant revenue in the comparable period in 2020.

Research and Development. Research and development expenses for the three months ended March 31, 2021 were approximately $4.4 million as compared to $2.8 million for the comparable period in 2020. The increase was primarily related to the increase in clinical trial and personnel related expenses.

General and Administrative. General and administrative expenses for the three months ended March 31, 2021 and 2020 were $2.2 million in both years.

Loss from Operations. Loss from operations for the three months ended March 31, 2021 was $(5.4) million as compared to a loss from operations of $(4.9) million for the comparable period in 2020.

Cash and Equivalents. As of March 31, 2021, Armata held approximately $22.5 million of unrestricted cash and cash equivalents, as compared to $9.7 million as of December 31, 2020. During the first quarter, Armata completed a $20 million private placement financing with Innoviva Strategic Opportunities LLC, a wholly-owned subsidiary of Innoviva.

As of May 13, 2021, there were approximately 24.9 million shares of common stock outstanding.

Mustang Bio Reports First Quarter 2021 Financial Results and Recent Corporate Highlights

On May 14, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported financial results and recent corporate highlights for the first quarter ended March 31, 2021 (Press release, Mustang Bio, MAY 14, 2021, View Source [SID1234580016]).

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "In the first quarter of 2021, we successfully executed our clinical and regulatory strategies and achieved milestones that we believe will drive Mustang’s continued progress. We announced encouraging MB-107 and MB-207 clinical updates from our investigator-IND trials for X-Linked Severe Combined Immunodeficiency ("XSCID"), as well as additional consistent safety and efficacy data pertaining to our lentiviral vector gene therapies that we have seen over the more than eight years since the first patient was treated in 2012. In January, the U.S. Food and Drug Administration ("FDA") lifted a Chemistry, Manufacturing and Controls ("CMC") hold on the MB-107 Investigational New Drug ("IND") application for newly diagnosed infants under the age of two and we expect to dose the first infant in the multicenter trial soon. We also plan to file an IND for our MB-207 clinical trial for patients with XSCID who have been previously treated with hematopoietic stem cell transplantation ("HSCT") and for whom re-treatment is indicated."

Dr. Litchman continued, "Notably, we are thrilled with the progress of our MB-106 CD20-targeted CAR T cell therapy program for relapsed or refractory CD20+ B-cell non-Hodgkin lymphomas ("B-NHL") and chronic lymphocytic leukemia ("CLL"). Earlier this month, we announced that the FDA approved Mustang’s IND to initiate a multicenter Phase 1/2 clinical trial investigating the safety and efficacy of MB-106 for relapsed or refractory CD20+ B-NHL and CLL. Also, we look forward to the Fred Hutchinson Cancer Research Center presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 ("EHA2021") Virtual Congress next month, where Dr. Mazyar Shadman will present updated interim data from their ongoing CD20-targeted CAR T clinical trial. We are very pleased to have three active Mustang-sponsored INDs, and we anticipate having four active Mustang-sponsored INDs by the end of the year."

Financial Results:

As of March 31, 2021, Mustang’s cash and cash equivalents and restricted cash totaled $130.4 million, compared to $98.8 million as of December 31, 2020, an increase of $31.6 million year-to-date.
Research and development expenses including license acquisitions were $11.6 million for the first quarter of 2021, compared to $9.6 million for the first quarter of 2020. Non-cash, stock-based expenses included in research and development were $0.7 million for the first quarter of 2021, compared to $0.4 million for the first quarter of 2020.
General and administrative expenses were $3.5 million for the first quarter of 2021, compared to $2.0 million for the first quarter of 2020. Non-cash, stock-based expenses included in general and administrative expenses were $1.5 million for the first quarter of 2021, compared to $0.5 million for the first quarter of 2020.
Net loss attributable to common stockholders was $15.0 million, or $0.19 per share, for the first quarter of 2021, compared to a net loss attributable to common stockholders of $11.9 million, or $0.28 per share, for the first quarter of 2020.
Recent Corporate Highlights:

In February 2021, Mustang announced encouraging MB-107 and MB-207 clinical updates from its investigator-IND XSCID trials, as well as additional consistent safety and efficacy data. On January 28, 2021, the FDA removed a CMC hold on the MB-107 Phase 2 clinical trial IND after reviewing a comprehensive CMC package that was submitted by Mustang in late December 2020. The company expects to enroll the first patient in this pivotal multicenter trial in the second quarter of 2021 and is targeting topline data from the trial in the second half of 2022. The company also expects to file an IND in the second quarter of 2021 for its pivotal multicenter Phase 2 clinical trial of MB-207.
In May 2021, Mustang announced that the FDA approved its IND application to initiate a multicenter Phase 1/2 clinical trial investigating the safety and efficacy of MB-106, a CD20-targeted CAR T therapy for high-risk B-NHL and CLL.
Also in May 2021, Mustang announced that CD20-targeted CAR T therapy data were selected for presentation at the EHA (Free EHA Whitepaper)2021 Virtual Congress scheduled to take place in June. Dr. Mazyar Shadman of Fred Hutch will present updated interim data from the ongoing Phase 1/2 clinical trial for B-NHL and CLL. A copy of the abstract can be viewed online through the EHA (Free EHA Whitepaper)2021 website here.

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.