On November 3, 2022 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported it will host a conference call to discuss the third quarter 2022 financial results and provide a corporate update on Thursday, November 10, 2022, at 4:30 p.m. Eastern/1:30 p.m. Pacific (Press release, Spectrum Pharmaceuticals, NOV 3, 2022, View Source [SID1234622995]).

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Conference Call and Webcast:

Thursday, November 10, 2022 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

To access the live call by phone, please go to this link (registration link), and you will be provided with dial in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time.

A live webcast of the call will be available online in the Investor Relations section of the company’s website at View Source and will be archived there shortly after the live event.

On November 3, 2022 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported a corporate and financial update for the third quarter ended September 30, 2022 (Press release, Athenex, NOV 3, 2022, View Source [SID1234622994]).

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"We are excited by the promise of our innovative, first-in-class NKT cell therapy platform with potential for improved efficacy, safety, and accessibility over current cell therapy approaches. This quarter, we continued to implement efficiencies by reducing cash used for operations by 53% and strengthening our balance sheet with our $30 million equity raise," said Dr. Johnson Lau, Chief Executive Officer of Athenex. "As we look ahead, we have several exciting upcoming milestones and expect to report Phase 1 study data updates for our KUR-501 cell therapy program and our allogeneic KUR-502 cell therapy program by the first half of 2023. We also look forward to clinical updates from the Phase 2 trial of Oral Paclitaxel with a checkpoint inhibitor in neoadjuvant breast cancer, which is expected to complete by year-end."

Third Quarter 2022 and Recent Business Highlights

Business Updates

Announced pricing of $30 million public offering of common stock and warrants
Successful Nasdaq hearing confirming the company can continue its listing on The Nasdaq Stock Market subject to demonstrating compliance with the minimum bid price requirement by March 14, 2023
Athenex has met all closing conditions for the sale of the China API operations for approximately $18 million and is in the final stages of closing the transaction, which is expected to occur as soon as COVID-related restrictions are lifted. At closing, the company expects to receive 70% of the proceeds, with 20% and 10% of proceeds receivable within three months and six months of closing, respectively. Furthermore, the company anticipates entering into a supply agreement for API and a waiver of the rights of its senior secured lender to receive any additional proceeds from the sale
Cash Flows from Operating Activities in Continuing Operations was -$15.7M, a 53% year-over-year decrease
NKT Cell Therapy Programs

KUR-501: Autologous GD2 CAR-NKT cell therapy for relapsed/refractory high-risk neuroblastoma

Ongoing sequential enrollment of two additional cohorts in single-institution Phase 1 dose escalation GINAKIT2 study at the 2 highest dose levels (DL5: 3×108 cells/m2; DL6: 1×109 cells/m2)
Early Phase 1 GINAKIT2 study dose escalation data at the American Society of Gene-Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual meeting in May 2022 demonstrated:
Expansion of CAR-NKT cells in all patients, with dose response observed
2 out of 3 responses at the 1×108 cells/m2 dose level, including a durable complete response lasting more than 12 months
Responses correlating with CD62L+ NKT cell expression as well as CAR-NKT cell exposure (area under the curve [AUC]).
Well-tolerated with no dose-limiting toxicity, no immune effector cell-associated neurotoxicity syndrome (ICANS), and 1 case of Grade 2 cytokine release syndrome (CRS)
KUR-502: Allogeneic CD19 CAR-NKT cell therapy for relapsed/refractory B-cell malignancies

Ongoing multicenter expansion of Phase 1 dose escalation ANCHOR study
Early Phase 1 ANCHOR study dose escalation data at the American Society of Transplantation and Cellular Therapy (ASTCT)/Center for International Blood & Marrow Transplant Research (CIBMTR) Tandem Meetings in April 2022 demonstrated:
60% ORR and 6-month CR rate of 40% in 5 patients from the NHL cohort, including 1 ongoing CR at 34 weeks
Encouraging responses at the lowest dose levels, including 2 durable responses in patients whose NHL failed prior autologous CAR-T cell therapy
Well-tolerated with no cases of CRS in the NHL cohort, ICANS, or graft versus host disease (GvHD)
KUR-503: Allogeneic GPC3 CAR-NKT cell therapy for hepatocellular carcinoma

Pre-clinical data at the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2022 demonstrated:
BATF3 CAR overexpression enhances NKT cell proliferation, long-term tumor control, and survival compared to IL-15 CAR-NKT cells
Commercial Update

Specialty Pharmaceutical Business

Athenex Pharmaceutical Division (APD) currently markets a total of 34 products with 62 SKUs.
Athenex Pharma Solutions (APS) currently markets 4 products with 13 SKUs.
Key Anticipated Milestones

Oral Paclitaxel:
Update on Phase 2 data from I-SPY 2 trial evaluating Oral Paclitaxel in combination with dostarlimab in neoadjuvant breast cancer
Regulatory interactions with UK MHRA for Oral Paclitaxel in advanced breast cancer remain on track with responses to questions submitted in Q3 2022
KUR-501:
Phase 1 GINAKIT2 study dose escalation, safety, and preliminary efficacy data update in 1H 2023
KUR-502:
Next clinical trial data update from the ongoing ANCHOR study anticipated in 1H 2023
KUR-503:
IND application filing for KUR-503 in advanced GPC3-expressing hepatocellular carcinoma planned in 2023
Special Shareholder Meeting

Athenex is hosting a special meeting of stockholders virtually on November 22, 2022 at 9:30 am EST. This special meeting is being held to vote on three matters, including: (1) to effect an increase in the total number of authorized shares of common stock of the Company, (2) to authorize a reverse stock split of the Company’s common stock, which is intended to increase the per share price of the common stock and enable the Company to regain compliance with the Nasdaq continued listing requirements, and (3) to increase the number of shares available for issuance under the Company’s 2017 Omnibus Incentive Plan.

Please refer to the definitive proxy statement filed by the Company with the SEC on October 11, 2022 at the SEC’s website (View Source) and accessible at the Company’s website (View Source) for more information about the special meeting, including instructions for voting and attending the special meeting.

Third Quarter 2022 Financial Highlights

Revenues from product sales increased to $31.3 million for the three months ended September 30, 2022, from $26.3 million for the three months ended September 30, 2021, an increase of $5.0 million or 19%. This increase was primarily attributable to an increase in APD specialty product sales, which increased by $3.8 million as the result of increases in shortage product sales and product launches during 2022. 503B product sales increased by $1.0 million from additional product launches.

License fees and other revenue for the three months ended September 30, 2022, was $2.2 million, compared to $5.1 million for the same period in 2021, a decrease of $2.9 million.

Cost of sales for the three months ended September 30, 2022, totaled $27.7 million, an increase of $2.6 million, or 11%, as compared to $25.1 million for the three months ended September 30, 2021. The increase was primarily due to an increase of $1.5 million in cost of APD product sales and an increase of $1.1 million in cost of 503B product sales.

R&D expenses totaled $9.2 million for the three months ended September 30, 2022, a decrease of $8.5 million, or 48%, as compared to $17.7 million for the three months ended September 30, 2021. This decrease was primarily due to a decrease in costs of clinical and regulatory operations, compensation costs, drug licensing costs, cell therapy costs, and preclinical operations.

SG&A expenses totaled $9.4 million for the three months ended September 30, 2022, a decrease of $8.7 million, or 48%, as compared to $18.1 million for the three months ended September 30, 2021. The decrease was primarily due to a $5.2 million gain on change in earnout liability related to the Kuur contingent consideration, while 2021 had a $3.2 million loss on change in earnout liability. Additionally, there was a $1.4 million decrease in costs for preparing to commercialize Oral Paclitaxel. These decreases were partially offset by a $1.2 million increase in compensation-related and operating costs.

Interest expense totaled $6.3 million and $5.1 million, respectively, for the three months ended September 30, 2022, and 2021. Interest expense in 2022 was related to the Senior Credit Agreement with Oaktree and the Royalty financing liability, while interest expense in 2021 was related to the Senior Credit Agreement only. The increase in interest expense during the three months ended September 30, 2022 was due to the Royalty interest financing carrying a higher effective interest rate.

Income tax expense for the three months ended September 30, 2022, amounted to $0.6 million, compared to $0.3 million expense for the same period in 2021. Income tax expense in the current period is primarily attributable to foreign income tax withholdings on our license revenue.

Net loss attributable to Athenex for the three months ended September 30, 2022, was $19.7 million, or ($0.14) per diluted share, as compared to a net loss of $36.1 million, or ($0.33) per diluted share, for the same period in 2021.

For further details on the Company’s financial results, including the results for the three months ended September 30, 2022, refer to the Form 10Q filed with the SEC.

2022 Financial Guidance

Athenex expects to maintain product sales growth in the range of 20-25% over the prior year period.

Cash Conservation Update

As of September 30, 2022, the Company had cash and cash equivalents, restricted cash, and short-term investments of $41.4 million. The Company is implementing cost savings programs and monetizing non-core assets, and as the Company completes such activities, the Company plans to extend its cash runway into next year.

Conference Call and Webcast Information

Athenex will host a conference call and live audio webcast today, Thursday, November 3, 2022, at 8:00 a.m. Eastern Time to discuss the financial results and provide a business update.

To participate in the call, dial either the domestic or international number fifteen minutes before the conference call begins:

The live conference call and replay can also be accessed via audio webcast here and on the Investor Relations section of the Company’s website under "Events and Presentations", located at View Source

On November 3, 2022 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported financial results for the third quarter ended September 30, 2022 and provided a corporate update (Press release, Deciphera Pharmaceuticals, NOV 3, 2022, View Source [SID1234622993]).

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"Our strong third quarter results continue the exceptional progress we have made across our business in 2022: QINLOCK delivered another quarter of record revenue, we reported exciting data at ESMO (Free ESMO Whitepaper) for our two clinical programs and we nominated the next clinical development candidate from our proprietary research platform," said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. "We have already begun building upon this momentum in the fourth quarter with key milestones including our announcement today of the opening of enrollment in our combination escalation cohorts in the Phase 1 study of DCC-3116 and the treatment of the first patient."

Mr. Hoerter continued, "We remain inspired by QINLOCK’s impact on the treatment of patients with GIST, in the U.S., Europe, and other countries around the world, as we focus on expanding the geographic reach of this breakthrough medicine. We achieved important milestones in the third quarter in our two clinical programs, vimseltinib and DCC-3116, with exciting data updates at the ESMO (Free ESMO Whitepaper) Congress in September. The best-in-class potential of vimseltinib in TGCT was underscored by the high response rates and the preliminary patient-reported outcome results, which found clinically meaningful improvements in both pain and stiffness. We also presented first-in-human data for DCC-3116 demonstrating a favorable safety and pharmacokinetic profile and strong target inhibition across all dose levels studied. Building upon this quarter’s clinical success and leveraging the full potential of our switch control kinase inhibitor discovery platform, we are excited to announce our new clinical development candidate, DCC-3084, that has best-in-class potential as a pan-RAF inhibitor."

Third Quarter 2022 Highlights and Upcoming Milestones

QINLOCK (ripretinib)

Recorded $32.3 million in QINLOCK net product revenue in the third quarter of 2022, including $24.5 million in U.S. net product revenue and $7.8 million in international net product revenue, an increase of 49% from net product revenue of $21.7 million in the third quarter of 2021.
Announced that the Journal of Clinical Oncology published results from the Company’s INTRIGUE Phase 3 study of QINLOCK in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib. Although QINLOCK did not offer a statistically significant improvement in progression-free survival (PFS) compared to sunitinib, QINLOCK showed meaningful clinical activity with fewer Grade 3/4 treatment-emergent adverse events (TEAEs) and improved tolerability.
Vimseltinib

Presented updated results from the ongoing Phase 1/2 study of vimseltinib in tenosynovial giant cell tumor (TGCT) in two poster presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 in September. The results showed an objective response rate of 69% in Phase 1, 53% in Phase 2 Cohort A, and 46% in Phase 2 Cohort B, with a demonstrated clinical benefit rate of 100% across all Phase 1/2 patients. Preliminary patient-reported outcome data in the Phase 2 portion demonstrated clinically meaningful improvements in pain and stiffness at week 25 compared to baseline. Treatment with vimseltinib across all Phase 1/2 patients was well-tolerated. Duration of treatment continued to increase from the data cut at ESMO (Free ESMO Whitepaper) 2021 including 17.5 months of median treatment duration for patients in the Phase 1 portion of the study.
Continued patient enrollment in the pivotal Phase 3 MOTION study of vimseltinib for the treatment of TGCT. MOTION is a two-part, randomized, double-blind, placebo-controlled study of vimseltinib to assess the efficacy and safety in patients with TGCT who are not amenable to surgery. The primary endpoint of the study is objective response rate at week 25 as measured by RECIST v1.1 by blinded independent radiologic review.
DCC-3116

Presented initial clinical data in an oral presentation as a Proffered Paper at the ESMO (Free ESMO Whitepaper) Congress 2022 from the single agent dose escalation portion of the Phase 1 study of DCC-3116 in patients with advanced or metastatic tumors with a mutant RAS or RAF gene. The results showed DCC-3116 was well-tolerated at doses from 50 to 300 mg twice daily with no dose limiting toxicities or treatment-related serious adverse events observed. Pharmacokinetic and pharmacodynamic data across all dose levels demonstrated exposure and ULK 1/2 inhibition associated with anti-cancer efficacy in preclinical studies.
Completed enrollment in the single agent dose escalation Phase 1 study in the fourth quarter of 2022; single-agent DCC-3116 did not reach a maximum tolerated dose; and selected 50 mg twice daily as the starting dose for the combination dose escalation cohorts.
Opened enrollment in three Phase 1b combination dose escalation cohorts and treated the first patient in the fourth quarter of 2022:
In combination with trametinib, a Food and Drug Administration (FDA)-approved MEK inhibitor, in patients with advanced or metastatic solid tumors with RAS, NF1, or RAF mutations.
In combination with binimetinib, an FDA-approved MEK inhibitor, in patients with advanced or metastatic solid tumors with RAS, NF1, or RAF mutations.
In combination with sotorasib, an FDA- approved KRASG12C inhibitor, in patients with advanced or metastatic solid tumors with KRASG12C mutations.
DCC-3084

Nominated DCC-3084 as the Company’s new pan-RAF clinical development candidate. DCC-3084 is a selective inhibitor of BRAF/CRAF kinases that inhibits Class I, II and III BRAF mutants, BRAF fusions and NRAS mutant cell lines using the Company’s novel switch-control kinase inhibitor platform. Preclinical studies of DCC-3084 demonstrate both single-agent and combination activity and favorable pharmaceutical properties, a key potential differentiator from other pan-RAF programs in development.
Corporate Update

Appointed Lisa Amaya Price as Senior Vice President and Chief Human Resources Officer to lead the Company’s human resources, recruitment, and talent development strategy. Ms. Amaya Price brings over 20 years of experience with a strong track record of developing human resource strategies and leading talent recruitment, selection, and development in the biopharmaceutical industry.
Third Quarter 2022 Financial Results

Revenue: Total revenue for the third quarter of 2022 was $36.0 million, which includes $32.3 million of net product revenue of QINLOCK and $3.7 million of collaboration revenue compared to $23.2 million of total revenue, including $21.7 million of net product revenue of QINLOCK and $1.5 million of collaboration revenue, for the same period in 2021.
Cost of Sales: Cost of sales were $3.3 million in the third quarter of 2022, which includes $0.7 million in cost of product sales, compared to $0.9 million for the third quarter of 2021, which included $0.2 million in cost of product sales. In the third quarter of 2022, the Company completed the sales of zero cost inventories of QINLOCK that had been expensed prior to FDA approval.
R&D Expenses: Research and development expenses for the third quarter of 2022 were $47.5 million, compared to $66.4 million for the same period in 2021. The decrease was primarily due to lower clinical trial costs related to QINLOCK, including INTRIGUE, the Phase 3 study for the treatment of second-line GIST for which top-line results were announced in November 2021, the discontinuation of the rebastinib program following the corporate restructuring implemented in the fourth quarter of 2021, and preclinical costs including the recognition of a $4.0 million up-front payment to Sprint Bioscience (Sprint) in the prior year, partially offset by an increase in clinical trial costs related to the Phase 3 study of vimseltinib and the Phase 1 study of DCC-3116. Non-cash, stock-based compensation was $5.3 million and $5.4 million for the third quarters of 2022 and 2021, respectively.
SG&A Expenses: Selling, general, and administrative expenses for the third quarter of 2022 were $30.0 million, compared to $35.5 million for the same period in 2021. The decrease was primarily due to a decrease in personnel-related costs and professional and consultant fees. Non-cash, stock-based compensation was $7.1 million and $6.4 million for the third quarters of 2022 and 2021, respectively.
Net Loss: For the third quarter of 2022, Deciphera reported a net loss of $43.0 million, or $0.55 per share, compared with a net loss of $79.8 million, or $1.37 per share, for the same period in 2021.
Cash Position: As of September 30, 2022, cash, cash equivalents, and marketable securities were $371.6 million, compared to $393.1 million as of June 30, 2022. Based on its current operating plans, Deciphera expects its current cash, cash equivalents, and marketable securities together with anticipated product, royalty, and supply revenues, but excluding any potential future milestone payments under its collaboration or license agreements, will enable the Company to fund its operating and capital expenditures into 2025.
Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, November 3, 2022, at 8:00 AM ET. The conference call may be accessed via this link: https://register.vevent.com/register/BIddf165cd801a473885dd3605fd55f7da. A live webcast of the conference call will be available in the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.

On November 3, 2022 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported financial results for the third quarter ended September 30, 2022 and provided recent corporate updates (Press release, Bicycle Therapeutics, NOV 3, 2022, View Source [SID1234622992]).

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"We are encouraged by the continued clinical progress across our pipeline," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "In the third quarter, we announced top-line results from the completed dose escalation portion of the Phase I/II trial in BT5528 and expect to complete enrollment in the initial expansion cohorts this quarter. In addition, clinical development of BT8009 remains on-track and we look forward to providing an update this quarter following completion of the dose escalation portion of the Phase I/II clinical trial. Finally, the dose escalation portion of our Phase I/II trial of BT7480 continues at a healthy pace and we expect to share clinical information in 2023."

"Recently, we added to our balance sheet through Genentech’s second expansion of our immuno-oncology collaboration, resulting in a $10 million payment to us this quarter. We are pleased to have a strong balance sheet which helps support the advancement of our clinical oncology pipeline as well as our earlier discovery and development efforts and which we anticipate provides financial runway into 2025."

Third Quarter 2022 and Recent Highlights

Announced Top-Line Dose Escalation Results of Phase I Trial of BT5528. In September, Bicycle announced top-line results from the Phase I dose escalation portion of its Phase I/II trial of BT5528, a Bicycle Toxin Conjugate (BTC) targeting EphA2, in patients with advanced solid tumors. Bicycle observed signs of anti-tumor activity in heavily pre-treated patients with EphA2-postive ovarian and urothelial cancers, demonstrating an overall response rate of 22% (including one complete response) and 67%, respectively. Previously, the company had established a recommended Phase II dose of 6.5mg/m2 every other week. Low, or no, levels of incidence of neutrophil count decrease, peripheral neuropathy, skin rash and eye disorders were reported. Low-grade GI treatment-related events were those most commonly reported amongst the 15 patients at this dose. In addition, and in contrast to the toxicities observed with EphA2 antibody drug conjugates, Bicycle has observed no signs of treatment-related coagulopathy to date in any patient.
Enrollment of the Initial Cohorts of The Initial Expansion Cohorts of the BT5528 Phase I/II Trial Remains on Track to Complete This Quarter. The company expects to provide an update on BT5528’s clinical progress in 2023. In June 2022, Bicycle announced the dosing of the first patient in the Phase II dose expansion portion of the Phase I/II trial. The initial dose expansion enrollment plan includes urothelial (n=14) and ovarian (n=14) cancers as well as in a basket cohort of other solid tumors (n=28), including non-small cell lung, triple-negative breast, head and neck, and esophageal cancers.
Announced Publications Highlighting Preclinical Data from BT8009 in Molecular Cancer Therapeutics and the Journal of Medicinal Chemistry. In September, Bicycle announced that an article titled "BT8009: a Nectin-4 targeting Bicycle Toxin Conjugate for treatment of solid tumors" highlighting preclinical data from BT8009 was published in Molecular Cancer Therapeutics. In October, Bicycle announced an additional publication highlighting preclinical BT8009 data in the Journal of Medicinal Chemistry, titled "Discovery of BT8009: a Nectin-4 Targeting Bicycle Toxin Conjugate for the Treatment of Cancer." Both articles are available at the publications section of the Bicycle website via this link.
Announced Expansion of Genentech Immuno-Oncology Collaboration. In July 2022, Bicycle announced that Genentech exercised an option to initiate a new program, expanding the exclusive strategic collaboration agreement with Bicycle to discover, develop and commercialize novel Bicycle-based immuno-oncology therapies. This expansion represented the second option exercised by Genentech under the terms of the original February 2020 agreement and triggered a $10 million payment to Bicycle, which was received in the third quarter of 2022.
Financial Results

Cash and cash equivalents were $361.5 million as of September 30, 2022, compared to $438.7 million as of December 31, 2021. The decrease in cash is primarily due to cash used in operating activities.
Research and development expenses were $22.8 million for the three months ended September 30, 2022, compared to $10.5 million for the three months ended September 30, 2021. The increase in expense of $12.2 million for the three months ended September 30, 2022 as compared to the same period in the prior year was primarily due to increased clinical program expenses for BT5528 and BT8009, Bicycle TICA program development expenses, and other discovery and platform related expenses, as well as increased personnel-related expenses, including $1.4 million of incremental non-cash share-based compensation expenses.
General and administrative expenses were $10.0 million for the three months ended September 30, 2022, compared to $8.1 million for the three months ended September 30, 2021. The increase of $1.9 million for the three months ended September 30, 2022 as compared to the same period in the prior year was primarily due to an increase in personnel-related costs, including $1.3 million of incremental non-cash share-based compensation expense.
Net loss was $28.3 million, or $(0.96) basic and diluted net loss per share, for the three months ended September 30, 2022, compared to net loss of $14.7 million, or $(0.59) basic and diluted net loss per share, for the three months ended September 30, 2021.

On November 3, 2022 Bio-Techne Corporation (NASDAQ: TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at the Credit Suisse 31st Annual Healthcare Conference on Wednesday, November 9, 2022, at 8:35 a.m. PST (Press release, Bio-Techne, NOV 3, 2022, View Source [SID1234622991]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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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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