On August 4, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that the subscription period for the previously announced rights offering has commenced (Press release, Navidea Biopharmaceuticals, AUG 4, 2022, View Source [SID1234617591]). If exercising subscription rights through a broker, dealer, bank or other nominee, rights holders should promptly contact their nominee and submit subscription documents and payment for the units subscribed for in accordance with the instructions and within the time period provided by such nominee. The broker, dealer, bank or other nominee may establish a deadline before August 17, 2022, by which instructions to exercise subscription rights, along with the required subscription payment, must be received.

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All record holders of rights that wish to participate in the rights offering must deliver a properly completed and signed subscription rights certificate, together with payment of the full subscription price for the units the holder wishes to purchase pursuant to both the basic subscription right and the over-subscription privilege to the Subscription Agent, to be received before 5:00 PM Eastern Time on August 17, 2022. The completed rights certificate and payment should be delivered to the Subscription Agent as follows:

The Company also announced updated pricing information for its previously announced rights offering. Each subscription right will entitle the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one share of the Company’s newly created Series I Convertible Preferred Stock with a face value of $1,000 (and immediately convertible into shares of Navidea’s common stock at a conversion price of $0.65 per share) and one (1) warrant to purchase 1,538 shares of Navidea’s common stock with an exercise price of $0.70 per share. The warrants will be exercisable for 5 years after the date of issuance.

Navidea has engaged Maxim Group LLC as dealer-manager for the proposed rights offering. Questions about the rights offering or requests for copies of the final prospectus, when available, may be directed to Maxim Group LLC at 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

The Company will release financial results for the second quarter of 2022 on August 15, 2022. In light of the Company’s pending rights offering, the Company will host a second quarter earnings conference call and business update following the conclusion of the rights offering. The Company will issue a press release announcing the date and time of the earnings conference call.

The Company’s registration statement on Form S-1 (Registration No. 333-262691) was declared effective by the Securities and Exchange Commission ("SEC") on August 3, 2022. The prospectus relating to and describing the terms of the rights offering has been filed with the SEC as a part of the registration statement and is available on the SEC’s web site at View Source Copies of the final prospectus for the rights offering may be obtained, when available, from Maxim Group LLC, 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, email: [email protected] or telephone (212) 895-3745.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On August 4, 2022 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 second quarter ended June 30, 2022 (Press release, Autolus, AUG 4, 2022, View Source [SID1234617590]).

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"Autolus has had a successful second quarter, with progress made across all fronts. We were awarded Regenerative Medicine Advanced Therapy (RMAT) Designation for obecabtagene autoleucel (obe-cel) for the treatment of adult acute lymphoblastic leukemia (ALL) by the US Food and Drug Administration (FDA) in April 2022, showcased cell programming technology at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) meeting in May 2022, and announced first clinical data from four pipeline programs at the European Hematology Association (EHA) (Free EHA Whitepaper) congress in June 2022. During this time, we also continued to progress the pivotal Phase 2 FELIX clinical trial of obe-cel in r/r ALL, and the build of our commercial manufacturing site is progressing on schedule," said Dr. Christian Itin, CEO of Autolus. "Obe-cel continues to show very encouraging activity with a high level of sustained complete remissions in B-NHL patients, without inducing severe CRS or neurotoxicity, and AUTO1/22 reached clinical proof of concept with a high level of activity observed in children with ALL who are not eligible for commercial CAR T therapy. We are particularly excited about AUTO4 reaching clinical proof of concept in patients with T cell lymphoma. We are looking forward to releasing initial results for the FELIX trial in Q4 2022 and are planning updates on our other clinical studies at the end of the year."

Key Pipeline Updates:

Obecabtagene autoleucel (obe-cel) in relapsed / refractory (r/r) adult ALL
The FELIX Phase 2 trial continues to progress well, and Autolus is on track to report initial results from the trial in Q4 2022. The Company continues to expect to report full data in H1 2023, with plans to present this data at a medical conference in mid-2023.
Following the RMAT designation granted to obe-cel in April 2022 by FDA, Autolus met with the FDA to review the regulatory pathway for obe-cel in r/r ALL. Consistent with prior guidance, and assuming a positive outcome from the FELIX trial in H1 2023, the Company expects the data to form the basis of a planned Biologics License Application (BLA) submission to FDA.
As previously announced, Autolus initiated a separate cohort of up to 50 additional patients with Minimal Residual Disease (MRD), with the intention of establishing the profile of obe-cel in patients across all levels of disease burden in adult ALL.
Pipeline updates at the European Hematology Congress (EHA) (Free EHA Whitepaper), June 2022:

Obe-cel shows high level of sustained clinical activity in r/r B-NHL patients – ALLCAR19 Extension Trial
Patients continue to be enrolled into the Phase 1 ALLCAR19 extension trial. The latest data readout from this extension study of obe-cel in patients with r/r B-Cell Non-Hodgkin’s Lymphoma (B-NHL) and Chronic Lymphocytic Leukemia (CLL) were presented at EHA (Free EHA Whitepaper) in June 2022. In this patient population, obe-cel continues to display a favorable safety profile with no neurotoxicity/immune effector cell-associated neurotoxicity (ICANS) or Grade ≥ 3 Cytokine Release Syndrome (CRS). Long term persistence of obe-cel in the peripheral blood was demonstrated by qPCR. Of the 20 patients evaluable for efficacy, the overall response rate was 18/20 (90%). In the B-NHL cohorts the CRR was 16/17 (94%) (FL: 7/7, MCL: 3/3, DBCL: 6/7). In the CLL cohort 2/3 patients achieved a PR, notably both achieved MRD-negativity in their marrow and both remain in PR at 10 and 6 months respectively. Of the responding MCL, DLBCL, FL and CLL patients, 17/18 (94%) are without disease progression at last follow-up. One MCL patient relapsed six months following treatment and 1 FL patient died in CR from COVID-19. Longer follow-up and enrolment of additional MCL, FL, DLBCL and CLL patients is ongoing.
Obe-cel shows first activity in Primary CNS Lymphoma – CAROUSEL Trial
Patients continue to be enrolled into the Phase 1 CAROUSEL trial. Data from the trial were presented at EHA (Free EHA Whitepaper) in June 2022, where excellent expansion was observed in the peripheral blood by qPCR, with persistence in all treated patients at last follow-up. No Grade 3 or higher CRS was observed using IV or I-VEN AUTO1 administration. Two cases of Grade 3 ICANS were reported following IV infusion. In the first case the patient had several neurological deficits that evolved despite ICANS treatment and were compatible with progressive PCNSL, as confirmed with the month 1 MRI scan. The second case was a patient whose neurological deficits improved with steroids/anakinra. Encouraging response rates were observed: of 6 patients evaluable for efficacy following IV AUTO1, the ORR was 4/6 (67%), with 2 CRs and 2 PRs. These four responding patients are without disease progression at last follow up. Two patients died from progressive PCNSL on study.
AUTO1/22 in pediatric ALL demonstrates encouraging and durable responses in children ineligible for commercial CAR T product – CARPALL Trial
Autolus, in collaboration with UCL, continues to enroll patients into the AUTO1/22 Phase 1 CARPALL trial. The results from 11 treated patients, who were ineligible for receiving commercial CAR T therapy, were presented in an oral presentation at EHA (Free EHA Whitepaper) in June 2022. AUTO1/22 has demonstrated a favorable safety profile with no incidences of severe CRS, and one Grade 4 ICANS which was indistinguishable from chemotherapy-related leukoencephalopathy. We have seen excellent CAR T expansion, with only 4 patients losing CAR T persistence at the last follow up. Overall, 9 out of 11 patients achieved a molecular complete response, with 2 non-responders. Notably, 2 out of 3 patients with CD19-negative disease achieved molecular complete response demonstrating the efficacy of the CD22 CAR. Two patients relapsed with CD19+CD22+ disease. No antigen negative relapses were seen in responding patients. At a median follow up of 8.7 months, 6 of 9 responding patients were in MRD-negative complete remission (1-12 months) and the median duration of B-cell aplasia has not been reached.
AUTO4 shows high level of clinical activity with a novel targeting approach for patients with T Cell Lymphoma – LibrA T1 Trial
Autolus continues to enroll patients into the AUTO4 Phase 1 clinical trial. Interim Phase 1 data were presented as an oral presentation at EHA (Free EHA Whitepaper) in June 2022 from 10 patients with TRBC1-positive r/r T-cell lymphoma (Peripheral T-cell lymphoma Not Otherwise Specified (PTCL-NOS), Angioimmunoblastic T-cell lymphoma (AITL), Anaplastic Large cell lymphoma (ALCL)) in a Phase 1 dose escalation trial. The median prior lines of treatment was 3 (1-5) and three patients had prior stem cell transplantation. After lymphodepletion with Flu/Cy, patients received either 25, 75, 225 or 450 x 106 CAR T cells. AUTO4 demonstrated a tolerable safety profile, with no patient experiencing any dose limiting toxicities, and no ICANS and no Grade 3 or higher infections. CRS was only seen at the highest dose level of 450 x 106 CAR T cells (Grade 3 in 1 patient; Grade 1-2 in 3 patients). As of April 26, 2022, 9 patients were evaluable for efficacy. At the highest dose level 3 of the 3 patients dosed achieved a complete metabolic remission (CMR) at 1 month. 2 of these patients remain in ongoing CMR by PET-CT at Month 3 and 6 respectively, whilst the 3rd relapsed at 3 months.
Other pipeline updates:

AUTO8 in Multiple Myeloma – MCARTY Trial
Autolus, in collaboration with UCL, initiated a Phase 1 clinical trial of AUTO8, the Company’s next-generation product candidate for multiple myeloma, in Q1 2022, with the first patient dosed during the quarter. AUTO8 comprises two independent CARs targeting BCMA and CD19 designed to induce deep and durable responses and extend the durability of effect.
Autolus presented three abstracts at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) meeting in May 2022. The three abstracts focused on Autolus’ modular approach to CAR T product development, using innovative technology to improve our pipeline of precise, controlled and highly active products. The three abstracts covered: 1) enhancing CAR T therapy using constitutively active cytokine receptors, 2) engineering CAR T cells to express a Fas-CD40 to increase its persistence and tumor cytotoxicity and 3) developing a minocycline mediated protein-protein displacement platform to make cell therapies tunable, dose dependent and reversible.
Key Operational Updates during Q2 2022

The build phase of the Company’s new 70,000 square foot commercial manufacturing facility in Stevenage, UK continues to progress on track with the anticipated schedule. This facility is expected to be ready for Good Manufacturing Practice (GMP) operations by H2 2023 and is designed for a capacity of 2,000 batches per year with the option to expand capacity as needed.
Key Anticipated Clinical Milestones:

Initial clinical results from the pivotal FELIX Phase 2 trial in Q4 2022 and Autolus plans to present full data at a medical meeting in H1 2023.

Longer-term follow up data from Phase 1 ALLCAR19 extension trial of obe-cel in patients with r/r B-NHL and CLL planned in H2 2022.

Longer-term follow up data from Phase 1 CAROUSEL trial of obe-cel in patients with Primary CNS Lymphoma planned in 2023.

Longer-term follow up data from the Phase 1 CARPALL extension trial of AUTO1/22 in pediatric ALL patients planned in H2 2022.

Longer-term follow up data from Phase 1 LibrA T1 trial of AUTO4 in patients with Peripheral T Cell Lymphoma planned in H2 2022.

AUTO6NG Phase 1 clinical trial in patients with neuroblastoma expected to start H2 2022. First data is expected in H2 2023.

AUTO8 Phase 1 MCARTY clinical trial in patients with multiple myeloma has started, with the first patient dosed. First data is expected in H2 2023.
Financial Results for the Quarter Ended June 30, 2022

Cash at June 30, 2022, totaled $216.4 million, as compared to cash of $310.3 million at December 31, 2021.

Total operating expenses for the three months ended June 30, 2022, were $46.5 million, as compared to total operating expenses, net of grant income and license revenue of $1.6 million, of $37.7 million for the same period in 2021.

Research and development expenses increased by $6.1 million to $38.2 million from $32.1 million for the three months ended June 30, 2022 as compared to the same period in 2021. The net increase in research and development expenses of $6.1 million was primarily due to:

an increase of $3.5 million in clinical costs and manufacturing costs primarily relating to the obe-cel clinical product candidate,
an increase of $1.4 million in salaries and other employment related costs including share-based compensation expense, which is mainly driven by an increase in the number of employees engaged in research and development activities,
an increase of $1.4 million in legal fees and professional consulting fees in relation to the Company’s research and development activities,
an increase of $0.5 million related to information technology infrastructure and support for information systems related to the conduct of clinical trials and manufacturing operations,
a decrease of $0.5 million in facilities costs related to the termination and closure of the Company’s US manufacturing facility in 2021 and shift in its manufacturing strategy, and
a decrease of $0.2 million in depreciation and amortization related to property, plant and equipment and intangible assets.
General and administrative expenses increased by $1.1 million to $8.3 million for the three months ended June 30, 2022 from $7.2 million for the three months ended June 30, 2021 primarily due to:

an increase of $1.3 million in salaries and other employment related costs including share-based compensation expenses, which was mainly driven by an increase in the number of employees engaged in general and administrative activities,
an increase of $0.1 million primarily related to higher directors’ and officers’ liability insurance premiums, professional fees and information technology costs,
a decrease of $0.2 million in facilities costs related to the termination by the Company of certain lease agreements in the prior year, and
a decrease of $0.1 million in depreciation and amortization related to property, plant and equipment and intangible assets.
Other expense, net decreased by $0.5 million to $1.3 million for the three months ended June 30, 2022 from $1.8 million for the three months ended June 30, 2021, relating primarily due to the strengthening of the U.S. dollar exchange rate relative to the pound sterling.

Interest expense increased to $1.8 million for the three months ended June 30, 2022 and relates to the liability related to sales of future royalties and sales milestones which arose upon the Company’s entry into the strategic collaboration and financing agreement with Blackstone, in November 2021. There was no interest expense during the comparable period in 2021.

Income tax benefit increased by $1.1 million to $7.5 million for the three months ended June 30, 2022 from $6.4 million for the three months ended June 30, 2021 due to an increase in qualifying research and development expenditures for the quarter.

Net loss attributable to ordinary shareholders was $42.1 million for the three months ended June 30, 2022, as compared to $33.2 million for the same period in 2021. The basic and diluted net loss per ordinary share for the three months ended June 30, 2022, totaled $(0.46) compared to a basic and diluted net loss per ordinary share of $(0.47) for the three months ended June 30, 2021.

Autolus estimates that its current cash on hand and anticipated milestone payments from Blackstone extends the Company’s runway into 2024.

Conference Call
Management will host a conference call and webcast at 8:30 am ET/1:30 pm BST to discuss the Company’s financial results and provide a general business update. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call. The conference call system has changed, so please make sure you dial in 15 minutes before to ensure timely access to the call.

A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website.

On August 4, 2022 Bio-Techne Corporation (NASDAQ: TECH) reported its financial results for the fourth quarter ended June 30, 2022 (Press release, Bio-Techne, AUG 4, 2022, View Source [SID1234617589]).

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Fourth Quarter FY2022 Highlights

Fourth quarter organic revenue increased by 14% (11% reported) to $288.2 million. Full year organic growth of 17% (19% reported) to $1.1 billion.
GAAP EPS was $1.51 versus $0.37 one year ago. Delivered adjusted earnings per share (EPS) of $2.05, an increase of 9% from the prior year. Full year GAAP EPS was $6.63 vs $3.47 a year ago. Achieved record full year adjusted EPS of $7.89, an increase of 17% from the prior year.
Sustained operational excellence across the organization, including Protein Sciences which achieved 16% organic growth (13% reported) in the fourth fiscal quarter and 19% organic growth (18% reported) for the full year.
Fourth quarter adjusted operating income was $106.6 million ($80.6 million reported), an increase of 6% (17% reported) from the prior year, despite foreign currency exchange negatively impacting operating income by 6%. Adjusted operating income for full year 2022 was $421.3 million ($296.6 million reported), an increase of 16% (25% reported) from the prior year.
Expanded Bio-Techne’s proteomic analytical tools portfolio through the acquisition of leading cell sorting company Namocell, which closed on July 1, 2022.
The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). Adjusted diluted 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.

"We had a tremendous finish to a spectacular fiscal 2022, as the Bio-Techne team delivered 14% organic growth for the fourth quarter and 17% organic growth for the year. This growth enabled us to cross the $1 billion in fiscal year revenue for the first time in our corporate history," said Chuck Kummeth, President and CEO of Bio-Techne. "I am particularly pleased with this performance given the prolonged headwinds we faced in China, as lockdowns in this geography lasted longer than we initially expected. We experienced robust demand across our portfolio of proteomic reagents and analytical tools, especially from our biopharma end markets, as well as accelerating momentum in our ExosomeDx business and a return to double-digit growth in our Spatial Biology business."

Kummeth added, "We recently strengthened our proteomic analytical tools portfolio with the acquisition of Namocell, a leading provider of cell sorting and dispensing instruments and consumables, adding to our portfolio of solutions for Cell and Gene Therapy workflows. In the quarter, we continued to scale our GMP protein manufacturing facility, commercializing two additional GMP proteins at scale to address current and forecasted demand. Overall, our portfolio of Cell and Gene Therapy workflow solutions had a stellar year, including greater than 50% organic growth. Separately, our ExoDx Prostate test continued its momentum from the prior quarter, as test volume set another record, increasing almost 70% in the quarter."

Kummeth continued, "Fiscal 2022 was an incredible year for Bio-Techne. We strengthened our team across the organization, announced another acquisition and continued to advance our leading portfolio of diagnostic solutions, proteomic reagents and analytical tools to advance science and enable discoveries. We are positioned to successfully navigate the current environment and continue our momentum into fiscal 2023 and beyond."

Fourth Quarter Fiscal 2022

Revenue

Net sales for the fourth quarter increased 11% to $288.2 million. Organic growth was 14% compared to the prior year with foreign currency exchange having an unfavorable impact of 3%.

GAAP Earnings Results

GAAP EPS was $1.51 per diluted share, versus $0.37 in the same quarter last year. GAAP EPS was negatively impacted in the prior year by a non-operating mark-to-market loss on our ChemoCentryx investment. GAAP operating income for the fourth quarter of fiscal 2022 increased 17% to $80.6 million, compared to $68.6 million in the fourth quarter of fiscal 2021. GAAP operating margin was 28.0%, compared to 26.5% in the fourth quarter of fiscal 2021. GAAP operating margin compared to prior year was positively impacted by volume leverage, which was partially offset by unfavorable foreign currency exchange impacts.

Non-GAAP Earnings Results

Adjusted EPS increased to $2.05 per diluted share, versus $1.88 in the same quarter last year, an increase of 9%. Adjusted EPS increased primarily due to revenue growth. Adjusted operating income for the fourth quarter of fiscal 2022 increased 6% compared to the fourth quarter of fiscal 2021. Adjusted operating margin was 37.4%, compared to 38.8% in the fourth quarter of fiscal 2021. Adjusted operating margin decreased compared to the prior year due to the impact of unfavorable foreign currency exchange.

Full Year Fiscal 2022

Revenue

Net sales for the full year fiscal 2022 increased 19% to $1,105.6 million. Organic growth was 17%, with acquisitions having a favorable impact of 3% and foreign currency translation having an unfavorable impact of 1%. 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 $6.63 per diluted share compared to $3.47 per diluted share last fiscal year. GAAP EPS was favorably impacted by a non-operating mark-to-market gain of $16 million on our ChemoCentryx investment, compared to a loss on investment of $68 million in the prior fiscal year. GAAP operating income for full year fiscal 2022 increased 25.0% to $296.6 million, compared with $237.3 million in the full year fiscal 2021. GAAP operating margin was 26.8%, compared to 25.5% in the full year fiscal 2021. 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 $7.89 per diluted shares, versus $6.76 in full fiscal year 2021. Adjusted operating margin for full fiscal year 2022 decreased to 38.3%, compared with 39.1% in full year fiscal 2021. Adjusted operating margin compared to the prior year was unfavorably impacted by foreign currency exchange, the full year impact of prior year’s Asuragen acquisition, and strategic investments.

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 2022 net sales were $217.0 million, an increase of 13% from $192.3 million for the fourth quarter of fiscal 2021. Organic growth for the segment was 16%, with foreign currency exchange having an unfavorable impact of 3%. Protein Sciences segment’s operating margin was 44.9% in the fourth quarter of fiscal 2022 compared to 47.0% in the fourth quarter of fiscal 2021. The segment’s operating margin compared to the prior year was negatively impacted by foreign currency exchange.

Protein Sciences segment’s full year fiscal 2022 net sales were $832.3 million, an increase of 18% from $704.6 million for fiscal 2021. Organic growth for the segment was 19% for the fiscal year, with currency translation having an unfavorable 1% impact on revenue. Protein Sciences segment’s operating margin was 45.4% in fiscal 2022 compared to 46.9% in fiscal 2021. Segment operating margin compared to the prior year was unfavorably impacted by foreign currency exchange and strategic investments.

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 2022 net sales were $71.7 million, an increase of 7% from $67.1 million for the fourth quarter of fiscal 2021. Organic growth for the segment was 8%, with foreign currency exchange having an unfavorable 1% impact. The Diagnostics and Genomics segment’s operating margin was 15.7% in the fourth quarter of fiscal 2022 compared to 16.7% in the fourth quarter of fiscal 2021. The segment’s operating margin was negatively impacted by foreign currency exchange and strategic investments.

The Diagnostics segment’s full year fiscal 2022 net sales were $274.8 million, an increase of 21% from $227.7 million for fiscal 2021. Organic growth for the segment was 10% with acquisitions contributing a favorable impact of 11% and currency translation having an immaterial impact on revenue growth. The Diagnostics segment’s operating margin was 17.8% in fiscal 2022 compared to 16.9% in fiscal 2021. Fiscal 2022 operating margin was favorably impacted by volume leverage and product mix.

Conference Call

Bio-Techne will host an earnings conference call today, August 4, 2022 at 8:00 a.m. CDT. To listen, please dial 1-800-926-5187 or 1-312-281-2972 for international callers, and reference conference ID 22019664. 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 22019664. The replay will be available from 11:00 a.m. CDT on Thursday, August 4, 2022 until 11:00 p.m. CDT on Sunday, September 4, 2022.

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, the impact of foreign currency, as well as the impact of partially-owned consolidated subsidiaries. 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. Revenues from partially-owned subsidiaries consolidated in our financial statements are also excluded from our organic revenue calculation, as those revenues are not fully attributable to the Company. Revenue from partially-owned subsidiaries was $3.0 million and $4.6 million for the quarter and year ended June 30, 2022, respectively.

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 stock-based compensation, 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, goodwill and long-lived asset impairments, and gains. Stock-based compensation is excluded from non-GAAP adjusted net earnings because of the nature of this charge, specifically the varying available valuation methodologies, subjection assumptions, variety of award types, and unpredictability of amount and timing of employer related tax obligations. 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, goodwill and long-lived asset impairment charges, 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 also excludes revenue and expense attributable to partially-owned consolidated subsidiaries in the calculation of our non-GAAP financial measures as the revenues and expenses are not fully attributable to the Company.

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. 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.

On August 4, 2022 Affimed N.V. (Nasdaq: AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that it will release second quarter 2022 results and corporate update on Thursday, August 11, 2022 (Press release, Affimed, AUG 4, 2022, View Source [SID1234617588]). The Company will host a conference call at 8:30 a.m. Eastern Daylight Time.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The conference call will be available via phone and webcast. To access the call, please dial +1 (866) 374-5140 for U.S. callers, or +1 (404) 400-0571 for international callers, and use PIN : 54780189# approximately 15 minutes prior to the call. To access the live audio webcast of the conference call please visit the "Investors" section of the Company’s website at View Source A replay of the call will be archived on Affimed’s website for 30 days after the call.

On August 4, 2022 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) reported its financial results for the second quarter ended June 30, 2022 (Press release, Aurinia Pharmaceuticals, AUG 4, 2022, View Source [SID1234617587]). Amounts, unless specified otherwise, are expressed in U.S. dollars.

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Second Quarter 2022 and Recent Highlights & Upcoming Milestones

Net product revenues were $28.2 million for the quarter ended June 30, 2022, compared to $6.6 million for the same period ended June 30, 2021.
Aurinia added 409 patient start forms (PSFs) during the second quarter 2022, as compared to 415 in the second quarter of 2021. As of Friday, July 29, 2022, the Company recorded 981 total PSFs since January 1, 2022.
PSF conversion rates after 90 days and confirmed patient access remain at peak levels since launch.
There were approximately 1,274 patients on LUPKYNIS therapy at June 30, 2022, compared with 1,071 at March 31, 2022.
At 6 months post-treatment-start, an average of approximately 70% of patients remain on treatment; and at 9 months, approximately 60% of patients are still on treatment.
Received positive CHMP opinion for LUPKYNIS (voclosporin) for the treatment of adults with active lupus nephritis in Europe. Regulatory review of the European Medicines Agency (EMA) marketing authorization application (MAA) remains on track with a European Commission (EC) approval decision expected by the end of the third quarter of 2022.
The first presentations of final AURORA 2 continuation study data were presented at the following medical meetings:
59th European Renal Association (ERA) Congress;
the European Congress of Rheumatology;
the European Alliance of Associations for Rheumatology (EULAR); and,
Submission of a manuscript with the full results is expected in the second half of 2022.
Recruitment of patients and initiation of new sites into both the VOCAL pediatric study and the ENLIGHT-LN registry continue as planned.
The Company received notice regarding the U.S. Patent Office (USPTO) Patent Trial and Appeal Board (PTAB) decision to institute trial on the Inter Partes review (IPR) filed by Sun Pharmaceuticals, directed at U.S. Patent No. 10,286,036. This patent is related to the LUPKYNIS dosing protocol for lupus nephritis. A determination on patentability, relative to the IPR, is expected on or prior to July 26, 2023.
Financial Results for the Quarter and Six Months Ended June 30, 2022

Total net revenue was $28.2 million and $6.6 million for the quarters ended June 30, 2022 and June 30, 2021, respectively. Total net revenue was $49.8 million and $7.5 million for the six months ended June 30, 2022 and June 30, 2021, respectively. Our net revenues primarily consisted of product revenue, net of adjustments, for LUPKYNIS following FDA approval in late January 2021. Revenue growth is attributed to further progress in the launch of LUPKYNIS, driven by further penetration in the lupus nephritis market coupled with improvements in a number of key revenue driving metrics as noted above. No product sales commenced and no product marketing was permitted prior to January 22, 2021.

Total cost of sales and operating expenses for the quarters ended June 30, 2022 and June 30, 2021 were $64.2 million and $53.8 million, respectively. Total cost of sales and operating expenses were $123.7 million and $105.2 million for the six months ended June 30, 2022 and June 30, 2021, respectively. Further breakdown of operating expenses drivers and fluctuations are highlighted in the following paragraphs.

Cost of sales were $1.6 million and $0.3 million for the quarters ended June 30, 2022 and June 30, 2021, respectively. Cost of sales were $1.9 million and $0.4 million for the six months ended June 30, 2022 and June 30, 2021, respectively. The increase for both periods was primarily due to an increase in product revenue coupled with safety stock reserves.

Gross margin for the quarters ended June 30, 2022 and June 30, 2021 was approximately 94% and 95% respectively. Gross margin for the six months ended June 30, 2022 and June 30, 2021 was approximately 96% and 95% respectively.

Selling, general and administrative (SG&A) expenses, inclusive of share-based compensation, were $51.5 million and $44.3 million for the quarters ended June 30, 2022 and June 30, 2021, respectively. For the six months ended June 30, 2022 and June 30, 2021, SG&A expenses, inclusive of share-based compensation, were $96.7 million and $84.1 million, respectively. The primary drivers for the increase for both periods ended June 30, 2022 as compared to June 30, 2021 were an increase in share-based compensation expense, corporate legal matters and increased investment in infrastructure to support the commercialization of LUPKYNIS.

Non-cash SG&A share-based compensation expense included above for the quarters ended June 30, 2022 and June 30, 2021 was $8.9 million and $6.5 million, respectively. Non-cash SG&A share-based compensation expense included above for the six months ended June 30, 2022 and June 30, 2021 was $14.9 million and $13.2 million, respectively. The increase in share-based compensation is primarily due to an increase in annual grants in 2022 coupled with the full year expense impact from prior year grants.

Research and Development (R&D) expenses, inclusive of share-based compensation, were $11.5 million and $10.1 million for the quarters ended June 30, 2022 and June 30, 2021, respectively. For the six months ended June 30, 2022 and June 30, 2021, R&D expenses, inclusive of share-based compensation expense, were $24.1 million and $19.9 million, respectively. The primary drivers for the increase for both periods were due to an increase in CRO and developmental expenses related to AUR200 and AUR300.

Non-cash R&D share-based compensation expense included above for the quarters ended June 30, 2022 and June 30, 2021 was $1.1 million for both periods. Non-cash R&D share-based compensation expense included above for the six months ended June 30, 2022 and June 30, 2021 was $2.0 million and $2.2 million, respectively.

For the quarter ended June 30, 2022, Aurinia recorded a net loss of $35.5 million or $0.25 net loss per common share, as compared to a net loss of $47.0 million or $0.37 net loss per common share for the quarter ended June 30, 2021. For the six months ended June 30, 2022, Aurinia recorded a net loss of $73.1 million or $0.52 net loss per common share, as compared to a net loss of $97.4 million or $0.76 net loss per common share for the six months ended June 30, 2021.

Financial Liquidity at June 30, 2022

As of June 30, 2022, Aurinia had cash, cash equivalents and restricted cash and investments of $391.7 million compared to $466.1 million at December 31, 2021. The decrease in cash, cash equivalents and restricted cash and investments is primarily related to the continued investment in commercialization activities, advancement of our pipeline and a payment for the achievement of a one-time milestone, partially offset by an increase in cash receipts from sales of LUPKYNIS.

Aurinia believes that it has sufficient financial resources to fund its operations, which include funding commercial activities, including FDA related post approval commitments, manufacturing and packaging of commercial drug supply, funding its supporting commercial infrastructure, conducting planned R&D programs and investing in its pipeline and operating activities for at least the next few years.

This press release is intended to be read in conjunction with the Company’s unaudited condensed consolidated financial statements and Management’s Discussion and Analysis for the quarter ended June 30, 2022 in the Company’s Quarterly Report on Form 10-Q, which will be accessible on Aurinia’s website at www.auriniapharma.com, on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar.

Conference Call Details

Aurinia will host a conference call and webcast to discuss the quarter ended June 30, 2022 financial results today, Thursday, August 4, 2022 at 8:30 a.m. ET. The audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. In order to participate in the conference call, please dial +1 (877) 407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

About Lupus Nephritis

LN is a serious manifestation of SLE, a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and about one-third of these people are diagnosed with lupus nephritis at the time of their SLE diagnosis. About 50 percent of all people with SLE may develop lupus nephritis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.