KemPharm to Report Second Quarter 2021 Results

On August 5, 2021 KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, reported that the Company will host a conference call and live audio webcast on Thursday, August 12, 2021, at 4:30 p.m. ET, to discuss its corporate and financial results for the second quarter 2021 (Press release, KemPharm, AUG 5, 2021, View Source [SID1234585933]).

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Conference Call Information:

Telephone Access: To access the conference call telephonically, interested participants and investors will be required to register via the following online form: View Source
Once registered, all individuals will be provided with participant dial-in numbers, a passcode and a registrant ID, which can then be used to access the conference call.
Participants may register at any time. It is recommended that the registration process be completed at least 15 minutes prior to the start of the call.
Webcast Access: The live audio webcast with slide presentation will be accessible via the Investor Relations section of KemPharm’s website, View Source An archive of the webcast and presentation will be available for 90 days beginning at approximately 5:30 p.m. ET, on August 12, 2021.
Investors may submit questions to KemPharm prior to the Second Quarter 2021 Results conference call by e-mail to [email protected]. Please use the e-mail subject heading "KemPharm Second Quarter 2021 Question" to ensure that the information is received. KemPharm’s management will then respond to select questions during the conference call.

Autolus Therapeutics Reports Second Quarter 2021 Financial Results and Operational Progress

On August 5, 2021 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported its operational and financial results for the quarter ended June 30, 2021 (Press release, Autolus, AUG 5, 2021, View Source [SID1234585932]).

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"We are very encouraged by the obe-cel data in adult acute lymphoblastic leukemia (ALL) and in B-cell non-Hodgkins Lymphoma (B-NHL) presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congress in June. In adult patients with ALL, event-free survival stabilized at 50% with 12 months follow up and was sustained at 24 months. These data indicate that obe-cel may be the first stand-alone therapy in adult ALL with curative potential in a last line setting. The FELIX trial is progressing well, and we expect pivotal data during 2022," said Dr. Christian Itin, chief executive officer of Autolus. "Additional data were presented at EHA (Free EHA Whitepaper) for obe-cel in indolent B-NHL indicating a high level of clinical activity combined with a well manageable safety profile. Further data in patients with aggressive B-NHL and chronic lymphocytic leukemia (CLL) are expected by the end of the year."

Key Pipeline Updates:

Obe-cel in relapsed / refractory (r/r) adult B-Acute Lymphocytic Leukemia (ALL).
Data presented at EHA (Free EHA Whitepaper) in June 2021 from the ALLCAR19 trial in r/r adult ALL patients demonstrated that obe-cel was generally well tolerated, with no patients experiencing Grade 3 or higher cytokine release syndrome (CRS). Three patients (15%), all of whom had high leukemia burden (>50% blasts), experienced Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) that resolved swiftly with steroids. Of the 20 patients treated with obe-cel, 17 (85%) achieved minimum residual disease (MRD)-negative complete remission (CR) at one month. Most notably, as of the data cutoff date of May 17, 2021, the durability of remissions is encouraging. Across all treated patients, event free survival (EFS) at twelve months and twenty-four months was 50.2% with median EFS not being reached.
Obe-cel in other relapsed/refractory B-NHL – ALLCAR19 extension (Cohort D)
Data presented at EHA (Free EHA Whitepaper) in June 2021 in r/r B-NHL (Follicular Lymphoma (FL) and Mantle Cell Lymphoma (MCL)) patients demonstrated that, as of the data cut-off date of May 17, 2021, 9 r/r B-NHL patients (7 FL, 2 MCL) infused with obe-cel achieved a complete metabolic remission and, apart from one, all evaluable patients remained in CR. Obe-cel has a tolerable safety profile in adult patients with r/r FL and MCL, despite high disease burden. Grade 1 CRS was reported in 4 patients and Grade 2 CRS in 1 patient. No ICANS of any grade was observed in the trial.
Obe-cel in high grade B-NHL and CLL – ALLCAR19 extension (Cohorts B & C)
The ALLCAR extension trial also involves two cohorts of patients with high grade B-NHL (DLBCL) and CLL. These cohorts are progressing well and Autolus plans to present updated data at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting in December 2021.
Autolus received preferred regulatory access for obe-cel from UK Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA):
Autolus received an innovative licensing and access pathway (ILAP) designation from the MHRA for obe-cel being investigated in the ongoing FELIX trial in ALL.
Autolus received PRIority MEdicines (PRIME) designation from the EMA.
These designations are designed to accelerate the review of a promising therapy targeting an unmet medical need. Data from the FELIX trial is expected in 2022, which, if positive, could enable Autolus to file for accelerated approval.
AUTO4 in Peripheral T Cell Lymphoma (PTCL).
Autolus received ILAP designation from the MHRA for AUTO4 being investigated in PTCL.
AUTO4 Phase 1 clinical trial is progressing through dose escalation and Autolus expects to provide a next data update in the first half of 2022.
Operational Highlights:

Post the period end, in July 2021, Autolus announced an agreement with Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, granting Moderna an exclusive license to develop and commercialize mRNA-based therapeutics incorporating Autolus’ proprietary binders to up to four immuno-oncology targets. Under the terms of the agreement, Autolus would be eligible to receive an upfront payment for each target licensed by Moderna and development and commercial milestone payments for each product successfully commercialized. In addition, Autolus will be entitled to receive royalties on net sales of all products commercialized under the agreement. The use of the technology in Moderna’s mRNA platform underscores Autolus’ leadership in the development of innovative differentiated binder and cell programming technologies.

Post the period end, in July 2021, Autolus announced the appointment of Edgar Braendle M.D., Ph.D., as chief development officer. Dr Braendle is an experienced oncologist who joined Autolus from Sumitomo Dainippon Pharma Oncology, where he held the position of Chief Medical Officer and Global Head of Development and was responsible for leading the global oncology development programs of Sumitomo Dainippon. He is part of Autolus’ executive team and is leading the company’s development organization. In addition, Wolfram Brugger M.D., Ph.D. joined Autolus as VP, Head of Clinical Development in June 2021. Wolfram is a highly experienced hematologist, medical oncologist, and internal medicine specialist with 21 years of academia and hospital-based clinical physician experience in hematological malignancies in Germany, including 15 years of leadership as Chief Medical Director at the teaching hospital of Freiburg University. Wolfram joined Autolus from MorphoSys, where he was Head of Global Clinical Programs and oversaw the development of Monjuvi (tafasitamab).
Key Upcoming Clinical Milestones:

Obe-cel updates from the ALLCAR19 extension trial in patients with r/r B-NHL and longer term follow up of the fully enrolled r/r aALL cohort in H2 2021

Obe-cel currently enrolling the FELIX trial in r/r adult ALL patients with pivotal data expected in 2022

Updates on the obe-cel Phase 1 trial, CAROUSEL, in Primary CNS Lymphoma in Q1 2022

Updates on the AUTO1/22 CARPALL extension trial in pediatric ALL in Q4 2021

Updates on the AUTO4 Phase 1 trial in TRBC1+ Peripheral TCL in H1 2022

Phase 1 trials are expected to be initiated in H2 2021 with AUTO8 in Multiple Myeloma

Phase 1 trials are expected to be initiated in H1 2022 with AUTO6NG in solid tumors and AUTO5 in TRBC2+ Peripheral TCL

First exploratory allogeneic development candidate expected to enter the clinic in 2021
Financial Results for the Quarter Ended June 30, 2021

Cash at June 30, 2021, totaled $216.4 million, as compared to $239.0 million at March 31, 2020. During the three months ended June 30, 2021, the company issued an aggregate of 2,069,466 ADSs under its Sales Agreement with Jefferies for net proceeds, after underwriting discounts and offering expenses, of $14.3 million.

Net total operating expenses for the three months ended June 30, 2021 were $37.7 million, net of grant income and license revenue of $1.6 million, as compared to net operating expenses of $39.5 million, net of grant income of $0.3 million, for the same period in 2020.

Research and development expenses increased to $32.1 million for the three months ended June 30, 2021, from $31.3 million for the three months ended June 30, 2020. Cash costs, which exclude depreciation and amortization as well as share-based compensation, increased to $29.2 million from $26.5 million. The increase in research and development cash costs of $2.7 million consisted primarily of (i) an increase in compensation and employment related costs of $0.7 million due to severance payments related to the reduction in workforce that started in the first quarter, and offset by a reduction in employment costs due to a decrease in headcount, (ii) an increase of $1.0 million in facilities costs related to the continued scaling of manufacturing operations, (iii) an increase of $0.9 million related to purchased materials, (iv) an increase of $0.3 million related to cell logistics, and (v) an increase of $0.3 million related to IT infrastructure and support for information systems related to the conduct of clinical trials and manufacturing operations. This was offset by a decrease of $0.4 million in clinical costs and $0.1 million of legal expenses.

Non-cash costs decreased to $2.9 million for the three months ended June 30, 2021, from $4.8 million for the three months ended June 30, 2020. The decrease is primarily related to share-based compensation expense included in research and development expenses, which decreased by $2.8 million as a result of the lower fair value of stock options recognized during the period, combined with forfeitures of incentive share options and unvested RSUs related to employees affected by the reduction in workforce. This was offset by an increase in depreciation of $0.9 million.

General and administrative expenses decreased to $7.2 million for the three months ended June 30, 2021, from $8.5 million for the three months ended June 30, 2020. Cash costs, which exclude depreciation expense as well as share-based expense compensation decreased to $6.6 million from $6.7 million. The decrease in general and administrative cash costs of $0.1 million related to decreases of (i) $0.3 million related to the reduction in workforce that began to take place in the first quarter, which reduced the headcount, and (ii) $0.3 million of expenses related to preparations for becoming a commercial stage company. These decreases were offset by an increase of $0.5 million in legal fees and directors & officers liability insurance premiums.

Non-cash costs decreased to $0.6 million for the three months ended June 30, 2021, from $1.8 million for the three months ended June 30, 2020. The decrease is mainly attributed to share-based compensation expense as a result of the lower fair value of stock options recognized during the period, combined with forfeitures of incentive share options and unvested RSUs related to employees affected by the reduction in workforce.

Other income/(expense) decreased by $2.3 million for the three months ended June 30, 2021, from other income of $0.5 million for the three months ended June 30, 2020, to an other expense of $1.8 million. The decrease was primarily due to the weakening of the U.S. dollar exchange rate relative to the pound sterling during the three months ended June 30, 2021 as compared to the three months ended June 30, 2020.

Income tax benefit decreased to $6.4 million for the three months ended June 30, 2021 from $7.0 million for the three months ended June 30, 2020 due to a decrease in the research and development expenditures which were qualifying for the quarter. As research and development credits fell at a faster rate than our net loss before income tax, this led to a lower effective tax rate. Research and development credits are obtained at a maximum rate of 33.35% of our qualifying research and development expenses, and the increase in the net credit was primarily attributable to an increase in our eligible research and development expenses.

Net loss attributable to ordinary shareholders was $33.2 million for the three months ended June 30, 2021, compared to $32.1 million for the same period in 2020. The basic and diluted net loss per ordinary share for the three months ended June 30, 2021 totaled $(0.47) compared to a basic and diluted net loss per ordinary share of $(0.62) for the three months ended June 30, 2020.

Autolus estimates that its current cash on hand will provide the Company with a cash runway into H1 2023.

Conference Call

Management will host a conference call and webcast today at 8:30 am ET/1:30 pm BST to discuss the company’s financial results and provide a general business update. To listen to the webcast and view the accompanying slide presentation, please go to the events section of Autolus’ website.

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 9757293. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 9757293.

iTeos to Report Second Quarter 2021 Financial Results and Provide Corporate Update on August 12, 2021

On August 5, 2021 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, reported that it will host a conference call and live webcast at 8:00 a.m. ET on Thursday, August 12, 2021 to report its second quarter 2021 financial results and provide a corporate update (Press release, iTeos Therapeutics, AUG 5, 2021, View Source [SID1234585930]).

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To pre-register for the call, please use the following link, and you will receive access details via email.

Webcast

This registration link, along with a live audio webcast, will be accessible from the Events page of the Company’s IR website at View Source A replay will be available on the Company’s website approximately two hours after completion of the event and for 30 days following the call

BIO-TECHNE RELEASES FOURTH QUARTER FISCAL 2021 RESULTS

On August 5, 2021 Bio-Techne Corporation (NASDAQ:TECH) reported its financial results for the fourth quarter ended June 30, 2021 (Press release, Bio-Techne, AUG 5, 2021, View Source [SID1234585929]).

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Fourth Quarter FY2021 Snapshot

Fourth quarter organic revenue increased by 39% (47% reported) to $259.0 million. Full year organic growth of 22% (26% reported) to $931.0 million.
GAAP EPS was $0.37 versus $1.48 one year ago. Delivered adjusted earnings per share (EPS) of $1.87 versus $1.00 one year ago. Full year GAAP EPS was $3.47 vs $5.82 one year ago. Full year adjusted EPS was $6.75 vs $4.55 in the prior year.
Adjusted Operating Margin increased to 38.5% in the fourth quarter of fiscal 2021 compared to 31.1% in the fourth quarter of fiscal 2020.
Excellent commercial execution in both operating segments with Protein Sciences and Diagnostics and Genomics achieving record organic growth of 46% and 22%, respectively.
Delivered record operating cash flow in fiscal 2021 of $352 million.
The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). Adjusted EPS, adjusted earnings, adjusted gross margin, adjusted operating income, adjusted tax rate, organic growth, and adjusted operating margin are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of non-GAAP Adjusted Financial Measures." A reconciliation of GAAP to non-GAAP financial measures is included in this press release.

"I am very pleased with the strong finish to fiscal 2021 as the Bio-Techne team delivered 39% organic growth for the fourth quarter and 22% organic growth for the year," said Chuck Kummeth, President and CEO of Bio-Techne. "Last quarter’s 25-year record setting results are only exceeded by this quarter’s results as our team met and conquered amazing challenges. Consistent with our performance all year, the team delivered these results with a continued focus on profitability leading to a 38.5% adjusted operating margin for the quarter."

Kummeth added, "We have discussed the strong momentum in our business these past few quarters and Q4 delivered as promised. Going forward we see continued momentum as we increase our penetration into the life science markets we serve, and our businesses reach and exceed the tipping points in size necessary to accelerate growth. The demand is there, and we are reaching this tipping point across our portfolio of proteomic, genomic, diagnostic and reagent solutions. Our portfolio of products is extremely well positioned for the coming wave of Cell & Gene Therapies, and we are seeing demand across our instrument and reagent portfolio from these customers, which drove 145% growth in our GMP protein business."

Kummeth continued, "Fiscal 2021 was a fantastic year for the Bio-Techne team. As we begin fiscal 2022, I have never felt better about the opportunities in front of the Company."

Fourth Quarter Fiscal 2021

Revenue

Net sales for the fourth quarter increased 47% to $259.0 million. Organic growth was 39% compared to the prior year, with foreign currency exchange having a favorable impact of 4% and acquisitions contributing a favorable impact of 4% to revenue growth. Organic revenue growth was broad based and driven by accelerated momentum of the Company’s long-term growth strategy combined with the non-recurring impact of customer site shutdowns in the comparative period related to the COVID-19 pandemic.

GAAP Earnings Results

GAAP EPS was $0.37 per diluted share, versus $1.48 in the same quarter last year. GAAP EPS was impacted by a non-operating mark-to-market loss on our ChemoCentryx investment. GAAP operating income for the fourth quarter of fiscal 2021 increased 74.5% to $68.6 million, compared to $39.3 million in the fourth quarter of fiscal 2020. GAAP operating margin was 26.5%, compared to 22.4% in the fourth quarter of fiscal 2020. GAAP operating income and operating margin compared to prior year was positively impacted by volume leverage, operational productivity and product mix.

Non-GAAP Earnings Results

Adjusted EPS increased to $1.87 per diluted share, versus $1.00 in the same quarter last year, an increase of 87%. Adjusted EPS increased due to revenue growth. Adjusted operating income for the fourth quarter of fiscal 2021 increased 82.6% compared to the fourth quarter of fiscal 2020. Adjusted operating margin was 38.5%, compared to 31.1 % in the fourth quarter of fiscal 2020. Adjusted operating margin compared to the prior year was favorably impacted by volume leverage, operational productivity, and product mix.

Full Year Fiscal 2021

Revenue

Net sales for the full year fiscal 2021 increased 26% to $931.0 million. Organic growth was 22%, with foreign currency translation and acquisitions having a favorable impact of 3% and 1%, respectively. Organic revenue growth was broad based and driven by accelerated momentum of the Company’s long-term growth strategy.

GAAP Earnings Results

GAAP EPS was $3.47 per diluted share compared to $5.82 per diluted share last fiscal year. GAAP EPS was unfavorably impacted by a non-operating mark-to-market loss of $67 million on our ChemoCentryx investment, compared to a gain on investment of $137 million in the last fiscal year. GAAP operating income for full year fiscal 2021 increased 51% to $237.3 million, compared with $157.4 million in the full year fiscal 2020. GAAP operating margin was 25.5%, compared to 21.3% in the full year fiscal 2020. GAAP operating income and operating margin compared to prior year was positively impacted by both volume leverage and product mix.

Non-GAAP Earnings Results

Adjusted EPS was $6.75 per diluted shares, versus $4.55 in full fiscal year 2020. Adjusted operating margin for full fiscal year 2021 increased to 38.9%, compared with 33.3% in full year fiscal 2020. Adjusted operating margin compared to the prior year was favorably impacted by volume leverage, operational productivity and product mix.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the Company’s business segments, as highlighted below.

Protein Sciences Segment

The Company’s Protein Sciences segment is one of the world’s leading suppliers of specialized proteins such as cytokines and growth factors, immunoassays, antibodies and reagents, to the biotechnology and academic research communities. Additionally, the segment provides an array of platforms useful in various areas of protein analysis. Protein Sciences segment’s fourth quarter fiscal 2021 net sales were $192.3 million, an increase of 51% from $127.3 million for the fourth quarter of fiscal 2020. Organic growth for the segment was 46%, with foreign currency exchange having a favorable impact of 5% on revenue growth and acquisitions contributing an immaterial amount to revenue growth. Protein Sciences segment’s operating margin was 46.7% in the fourth quarter of fiscal 2021 compared to 38.9% in the fourth quarter of fiscal 2020. The segment’s operating margin compared to the prior year was positively impacted by volume leverage and operational productivity.

Protein Sciences segment’s full year fiscal 2021 net sales were $704.6 million, an increase of 27% from $555.4 million for fiscal 2020. Organic growth for the segment was 24% for the fiscal year, with currency translation having a positive 3% impact and acquisitions having an immaterial impact on revenue. Protein Sciences segment’s operating margin was 46.7% in fiscal 2021 compared to 42.3% in fiscal 2020. Segment operating margin compared to the prior year was positively impacted by volume leverage, operational productivity and cost management.

Diagnostics and Genomics Segment

The Company’s Diagnostics and Genomics segment provides blood chemistry and blood gas quality controls, hematology instrument controls, immunoassays and other bulk and custom reagents for the in vitro diagnostic market. The Diagnostics and Genomics segment also develops and provides in situ hybridization products as well as exosome-based diagnostics for various pathologies, including prostate cancer. The Diagnostics and Genomics segment’s fourth quarter fiscal 2021 net sales were $67.1 million, an increase of 38% from $48.7 million for the fourth quarter of fiscal 2020. Organic growth for the segment was 22% with acquisitions contributing 15% to revenue growth and foreign currency exchange having a 1% favorable impact. The Diagnostics and Genomics segment’s operating margin was 16.7% in the fourth quarter of fiscal 2021 compared to 12.4% in the fourth quarter of fiscal 2020. The segment’s operating margin was favorably impacted by volume leverage, operational productivity and cost management.

The Diagnostics segment’s full year fiscal 2021 net sales were $227.7 million, an increase of 23% from $184.5 million for fiscal 2020. Organic growth for the segment was 18% with acquisitions contributing 4% to revenue growth and currency translation having a positive 1% impact on revenue. The Diagnostics segment’s operating margin was 16.9% in fiscal 2021 compared to 8.1% in fiscal 2020. Fiscal 2021 operating margin was favorably impacted by volume leverage, operational productivity and cost management.

Conference Call

Bio-Techne will host an earnings conference call today, August 5th, 2021 at 8:00 a.m. CDT. To listen, please dial 1-800-289-0438 or 1-323-794-2423 for international callers, and reference conference ID 3330876. The earnings call can also be accessed via webcast through the following link View Source

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512-2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 3330876. The replay will be available from 11:00 a.m. CDT on Thursday, August 5, 2021 until 11:00 p.m. CDT on Sunday, September 5, 2021.

Use of non-GAAP Adjusted Financial Measures:

This press release contains financial measures that have not been calculated in accordance with accounting principles generally accepted in the U.S. (GAAP). These non-GAAP measures include:

Organic growth
Adjusted diluted earnings per share
Adjusted earnings
Adjusted tax rate
Adjusted gross margin
Adjusted operating income
Adjusted operating margin
We provide these measures as additional information regarding our operating results. We use these non-GAAP measures internally to evaluate our performance and in making financial and operational decisions, including with respect to incentive compensation. We believe that our presentation of these measures provides investors with greater transparency with respect to our results of operations and that these measures are useful for period-to-period comparison of results.

Our non-GAAP financial measure of organic growth represents revenue growth excluding revenue from acquisitions within the preceding 12 months as well as the impact of foreign currency. Excluding these measures provides more useful period-to-period comparison of revenue results as it excludes the impact of foreign currency exchange rates, which can vary significantly from period to period, and revenue from acquisitions that would not be included in the comparable prior period.

Our non-GAAP financial measures for adjusted gross margin, adjusted operating margin, and adjusted net earnings, in total and on a per share basis, exclude the costs recognized upon the sale of acquired inventory, amortization of acquisition intangibles, acquisition related expenses inclusive of the changes in fair value of contingent consideration, and other non-recurring items including non-recurring costs and gains. The Company excludes amortization of purchased intangible assets, purchase accounting adjustments, including costs recognized upon the sale of acquired inventory and acquisition-related expenses inclusive of the changes in fair value contingent consideration, and other non-recurring items including gains or losses on legal settlements and one-time assessments from this measure because they occur as a result of specific events, and are not reflective of our internal investments, the costs of developing, producing, supporting and selling our products, and the other ongoing costs to support our operating structure. Additionally, these amounts can vary significantly from period to period based on current activity.

The Company’s non-GAAP adjusted operating margin and adjusted net earnings, in total and on a per share basis, also excludes stock-based compensation expense, which is inclusive of the employer portion of payroll taxes on those stock awards, restructuring, impairments of equity method investments, gain and losses from investments, and certain adjustments to income tax expense. Stock-based compensation is excluded from non-GAAP adjusted net earnings because of the nature of this charge, specifically the varying available valuation methodologies, subjective assumptions, variety of award types, and unpredictability of amount and timing of employer related tax obligations. Impairments of equity investments are excluded as they are not part of our day-to-day operating decisions. Additionally, gains and losses from other investments that are either isolated or cannot be expected to occur again with any predictability are excluded. Costs related to restructuring activities, including reducing overhead and consolidating facilities, are excluded because we believe they are not indicative of our normal operating costs. The Company independently calculates a non-GAAP adjusted tax rate to be applied to the identified non-GAAP adjustments considering the impact of discrete items on these adjustments and the jurisdictional mix of the adjustments. In addition, the tax impact of other discrete and non-recurring charges which impact our reported GAAP tax rate are adjusted from net earnings. We believe these tax items can significantly affect the period-over-period assessment of operating results and not necessarily reflect costs and/or income associated with historical trends and future results.

Investors are encouraged to review the reconciliations of adjusted financial measures used in this press release to their most directly comparable GAAP financial measures as provided with the financial statements attached to this press release.

IntelGenx Reports Second Quarter 2021 Financial Results

On August 5, 2021 IntelGenx Technologies Corp. (TSX V:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") reported financial results for the second quarter ended June 30, 2021 (Press release, IntelGenx, AUG 5, 2021, View Source [SID1234585928]). All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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2021 Second Quarter Financial Summary:

Revenue was $162,000, compared to $42,000 in the 2020 second quarter.

Net comprehensive loss was $2.5 million, compared to $1.3 million in Q2-2020.

Adjusted EBITDA loss was $1.7 million, compared to $1.5 million in the 2020 second quarter.
Second Quarter and Recent Developments:

Strengthened Board of Directors with the appointments of Srinivas G. Rao, M.D., Ph.D. and Frank Stegert pursuant to the purchaser rights agreement by and between the Company and ATAI Life Sciences AG ("atai").

Received subscriptions from investors in the United States for $2.1 million principal amount of 8% convertible notes due July 31, 2025. IntelGenx intends to use the proceeds to finance its Montelukast study.

Entered into a Materials Transfer Agreement with an undisclosed global veterinary health company, which will evaluate IntelGenx’s proprietary VetaFilm platform in cats.

Completed the $12,346,300 investment in IntelGenx by atai. As a result of the investment, ATAI now holds approximately 25% of the issued and outstanding common stock of IntelGenx.

Received a second secured loan of $500,000 from atai.

Entered into a second feasibility agreement with atai for the development of novel formulations of Salvinorin A, a naturally occurring psychedelic compound being developed for the treatment of treatment-resistant depression and other indications, based on IntelGenx’s polymeric film technologies.
"During the second quarter, we executed two agreements that further solidified IntelGenx’s position as a leader in oral films," commented Dr. Horst G. Zerbe, CEO of IntelGenx. "The expansion of our strategic partnership with atai to include an additional psychedelic compound is a testament to the benefits of our technology, while our agreement with one of the world’s fastest growing animal healthcare companies represents another step toward establishing VetaFilmTM as a new standard for pets. In addition, since the beginning of the quarter, we significantly strengthened our balance sheet, which well positions us to continue advancing our portfolio of innovative film products and product candidates."

Financial Results:

Total revenues for the three-month period ended June 30, 2021 amounted to $162,000, an increase of $120,000, or 286%, compared to $42,000 for the three-month period ended June 30, 2020. The change is mainly attributable to an increase in research and development ("R&D") revenues of $120,000.

Operating costs and expenses were $2.1 million for the second quarter of 2021, versus $1.8 million for the corresponding three-month period of 2020. The increase for the three-month period ended June 30, 2021 is mainly attributable to a $158,000 increase in manufacturing expenses, a $132,000 increase in selling, general and administrative expenses, and an increase of $23,000 in depreciation of tangible assets, partially offset by a $37,000 decrease in R&D expenses.

For the second quarter of 2021, the Company had an operating loss of $1.9 million, compared to an operating loss of $1.8 million for the comparable period of 2020.

Net comprehensive loss for the three-month period ended June 30, 2021 was $2.5 million, or $0.02 per basic and diluted share, compared to net comprehensive loss of $1.3 million, or $0.01 per basic and diluted share, for the comparable period of 2020.

As at June 30, 2021, the Company’s cash and short-term investments totalled $12.1 million.

Conference Call Details:

IntelGenx will host a conference call to discuss these second quarter 2021 financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (844) 602-0380 (Canada and the United States) and (862) 298-0970 (International). The call will also be webcast live and archived on the Company’s website at www.intelgenx.com under "Webcasts" in the Investors section.