On November 7, 2023 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, reported that its President and Chief Executive Officer, Mark A. Velleca, M.D., Ph.D., will participate in fireside chats during two upcoming investor conferences (Press release, Black Diamond Therapeutics, NOV 7, 2023, View Source [SID1234637123]):

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The Stifel 2023 Healthcare Conference at 2:25pm ET on Tuesday, November 14, 2023, in New York, NY.
The Piper Sandler 35th Annual Healthcare Conference at 4:30pm ET on Wednesday, November 29, 2023, in New York, NY.

Webcasts will be available at the start of the presentations on the investor relations section of the Company’s website, www.blackdiamondtherapeutics.com. Replays of the presentations will also be available and archived on the site for 90 days.

On November 7, 2023 Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company with a focus in lung disease, reported its financial and operating results for the third quarter ended September 30, 2023 and provided a corporate update (Press release, Biodesix, NOV 7, 2023, View Source [SID1234637122]).

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"I am pleased to announce yet another impressive quarter of growth at Biodesix," said Scott Hutton, President and Chief Executive Officer. "The team delivered over 10,400 Lung Diagnostics tests, growing 60% over the 6,500 tests delivered in the third quarter of 2022, the fifth straight quarter of at least 60% year-over-year growth, and 6% improvement over second quarter 2023. Our Biopharma Services business also had a strong quarter, growing 79% year-over-year and 181% over the second quarter. I am thrilled with Biodesix’s ability to consistently grow the business while maintaining a strong cost disciplined approach. Starting this quarter, we are now providing Adjusted EBITDA to provide additional insight into our progress toward profitability. Our third quarter Adjusted EBITDA was ($5.4) million, a 40% improvement over both the third quarter of 2022 and the second quarter of 2023. In the fourth quarter we are continuing to improve our balance sheet with the final closing of our private placement announced in August and plan to draw down an additional $10 million from the second tranche of our term loan with Perceptive Advisors. I am exceptionally pleased with our progress as we continue to increase test volumes, drive revenue growth, advance operational effectiveness, and improve Adjusted EBITDA as we strive to impact more patients with lung disease than ever before."

Third Quarter 2023 Financial Results

For the three-month period ended September 30, 2023, as compared to the same period of 2022 (where applicable):

Total revenue of $13.5 million, an increase of 21%, including COVID testing revenue in third quarter 2022, driven primarily by strong year-over-year growth in lung diagnostics, and a 37% year-over-year increase excluding COVID testing revenues from the prior year comparison;
Lung diagnostic revenue of $12.3 million reflected a year-over-year increase of 34% driven primarily by the continued adoption of Nodify Lung nodule risk assessment tests, and approximately 60% when excluding one-time cash revenue from tests performed in prior periods primarily from Medicare coverage of the Nodify CDT test;
Biopharma Services and other revenue of $1.2 million increased 79% year-over-year, a result of both delivering against our increasing book of business and new agreements;
COVID-19 testing revenue decreased by 100% year-over-year, as the Company no longer provides COVID-19 diagnostic testing services;
Third quarter 2023 gross profit of $10.3 million, or 76% gross margin compared to 67% gross margin in the comparable prior year period, primarily driven by growth in Lung Diagnostic Testing and optimization of testing workflows that resulted in improvements in costs per test, the ongoing recovery of our Biopharma Services business, and the commercial discontinuation of our lower-margin COVID-19 diagnostic testing;
Operating expenses (excluding direct costs and expenses) of $17.4 million, a decrease of approximately $0.7 million, or 4% as compared to the third quarter 2022 (includes non-cash stock compensation expense of $1.0 million as compared to $1.2 million). This decrease is primarily attributable to a decrease in research and development costs, partially offset by increased sales and marketing costs to support lung diagnostic sales growth to enhance product awareness and drive adoption;
Net loss of $10.9 million, a decrease of approximately $2.8 million, or 20%;
Adjusted EBITDA was a loss of $5.4 million, an improvement of $3.6 million, or 40%;
Cash and cash equivalents of $19.8 million as of September 30, 2023, an increase of $2.4 million from June 30, 2023;
The Company plans to draw down an additional $10 million from the second tranche of its $50 million term loan facility with Perceptive Advisors in the fourth quarter of 2023, subject to the terms and conditions of such facility;
Cash balance includes $15.3 million of the $27.5 million private placement announced in August. The remaining $12.2 million will be received in the fourth quarter of 2023.
2023 Financial Outlook

Third quarter revenues were impacted by a change in the timing and assumptions regarding the anticipated collection of revenue from a backlog of previously unrecognized Medicare Advantage claims. Based on these new assumptions, the Company is adjusting its 2023 financial outlook to remove the backlog and is not making any change to core business expectations. The Company expects to generate $50 to $52 million in total revenue in 2023.

Conference call and webcast information

Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link. A replay of the webcast will be available via the Company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.

For a full list of Biodesix’s press releases and webinars, please visit biodesix.com.

On November 7, 2023 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a global clinical-stage biopharmaceutical company focused on using a groundbreaking technology platform for drug discovery and developing innovative therapies to improve clinical outcomes for patients with high unmet medical needs, reported new data that translates preclinical proof-of-concept to clinical evidence of plinabulin’s immunomodulating activity (Press release, BeyondSpring Pharmaceuticals, NOV 7, 2023, View Source;utm_medium=rss&utm_campaign=beyondspring-presents-poster-highlighting-preclinical-and-clinical-poc-immunomodulating-activity-of-plinabulin-inducing-dendritic-cell-maturation-and-re-sensitization-in-immunotherapy-refractory-tumor [SID1234637121]). BeyondSpring and MD Anderson presented the data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 38th Annual Meeting on Nov 4th in San Diego, CA on an open-label, Phase 1 basket study at The University of Texas MD Anderson Cancer Center in cancer patients after progressing on PD-1, PD-L1 and/or CTLA-4 antibodies (NCT04902040) in six cancer types.

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Based on preclinical models, where plinabulin plus radiation and anti-PD-1 antibody enhances dendritic cell (DC) activation, T-cell proliferation, and abscopal effect, a clinical study was initiated to test these findings. At the Phase 1 data cut-off (August 31, 2023), 19 heavily pretreated patients with 6 different cancers were exposed to plinabulin (30 mg/m2) after radiation initiation to an amendable lesion (3-6 hours apart) plus anti-PD-1 antibody, including pembrolizumab or nivolumab. 11 out of 14 patients eligible for efficacy assessment per RECIST criteria and had measurable target lesion responses in the non-irradiated tumor lesion. Disease control rate evaluates the tumor reduction in non-irradiated tumor to assess abscopal effect from immune agents.

80% DCR (disease control rate) in non-irradiated tumor: In 10 immunotherapy-refractory patients of 6 different cancers (Hodgkin Lymphoma, NSCLC, SCCHN, Merkel Cell Carcinoma, RCC, Fibrolamellar HCC), plinabulin triple combination is safe and yields encouraging response with 80% disease control rate (3 PR, 5 SD, 2 PD).
Durable Response in heavily pre-treated patients: 2 Hodgkin’s lymphoma patients who progressed after 12 or 16 prior lines of therapy respectively, had durable responses with one PR and one SD. These patients continued treatment after data cutoff.
DC maturation in responding patients: Plinabulin administered after radiation initiation induces an early systemic immune response (detectable 3 days later) in subsets of peripheral blood DC and monocytes in patients with clinical benefits (PR+SD).
Plinabulin mediates GEF-H1-dependent immune activation in responding patients: In patients with PR+SD, tumor scRNAseq analysis indicates GEF-H1-dependent immune activation in subsets of DC and monocyte-derived macrophages. Such activation was not seen in patients with PD.
Additional biomarker analyses at baseline and post-treatment are underway.
"There are severe unmet medical needs for cancer patients who progress on immunotherapies. We have been studying Plinabulin for 6 years, starting from preclinical proof-of-concept work in showing its DC maturation, abscopal effect and selective sequencing benefit with radiation, presented at the 2020 AACR (Free AACR Whitepaper) meeting, and now the successful clinical translation in the triple IO regimen and its notable high disease control rate in these hard-to-treat and multiple refractory cancers", Dr. Steven H. Lin, MD/PhD, professor of radiation oncology at MD Anderson commented. "These results are encouraging but preliminary. Based on the consistent mechanism in DC maturation in responding patients, this sets the stage for additional clinical studies of plinabulin/IO combinations in IO-refractory settings in a number of indications, including NSCLC and Hogkins Lymphoma".

SITC Conference Abstract Number: 732

Title: Immune Activation with Plinabulin Enhances Anti-tumor response Combining Radiation with Immune Checkpoint Blockade

Presenter: Steven H. Lin, MD/PhD

Session: Poster Hall

Phase 1 Study Regimen

All subjects received a triple combo treatment of Radiation Therapy (RT) + Plinabulin + Pembrolizumab or Nivolumab in Cycle 1, followed by the same anti-PD-1 antibody and plinabulin combo regimen in Cycle 2 and beyond until disease progression or development of unacceptable toxicity, withdrawal from study treatment, or discontinuation of this study.

A short course of local consolidative RT was administered in Cycle 1 starting from Day 1. Optional sequential RT may have been administered to target other untreated lesions at discretion of the treating doctor in Cycle 2 of any regimens.
Plinabulin was dosed on Day 1 and Day 4 of Cycle 1 of any anti-PD-1 regimen, and if optional RT was given in Cycle 2, Plinabulin was also given on Day 4 of Cycle 2. Plinabulin was given on Day 1 of Cycle 3 and thereafter. Anti-PD-1 antibody was dosed on Day 1 of every treatment cycle (also on Day 15 [Q4W] in case of regimen containing Nivolumab as Anti-PD-1 mAb).
Subjects received the same anti-PD-1/PD-L1 mAb they failed in the prior treatment.
Conference Call and Webcast Information

BeyondSpring will host a conference call and webcast today at 8:30 a.m. Eastern Time. The dial in numbers for the conference call are 1-877-407-0792 (U.S.) or 1-201-689-8263 (international). Please reference conference title: Clinical Significance of Plinabulin SITC (Free SITC Whitepaper) Presentation with PI Dr. Steven Lin from MD Anderson. A live webcast will be available on BeyondSpring’s website at www.beyondspringpharma.com under "Events & Presentations" in the Investors section. An archived replay of the webcast will be available for 30 days.

On November 7, 2023 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the third quarter ended September 30, 2023 and provided business updates (Press release, Ascendis Pharma, NOV 7, 2023, View Source [SID1234637119]).

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"This quarter marks an important milestone for Ascendis on our path to become a leading, sustainable biopharma company, where we began our journey to extend our SKYTROFA U.S. market value leadership globally with our first EU product launch in Germany," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. "Expected approval in the EU for our second product, TransCon PTH, this month demonstrates the value of following our algorithm for product innovation."

Corporate Highlights

TransCon hGH (marketed in the U.S. and EU as SKYTROFA):
Third quarter 2023 SKYTROFA revenue totaled €47.0 million, a 31% sequential increase. Increased full year 2023 SKYTROFA revenue expectations from €165 – €170 million to €170 – €175 million.

Q3-2022 Q4-2022 Q1-2023 Q2-2023 Q3-2023
SKYTROFA revenue (millions) €12.3 €17.1 €31.6 €35.9 €47.0

Announced results from enliGHten, the Company’s open-label extension trial evaluating the long-term safety and efficacy of TransCon hGH for children and adolescents with growth hormone deficiency (GHD), demonstrating the long-term safety and efficacy of TransCon hGH in patients treated up to six years, with the majority of children meeting or exceeding average parental height SDS at time of treatment completion or last visit.
Topline results from Phase 3 foresiGHt Trial in adult growth hormone deficiency expected in the fourth quarter of 2023, potentially opening a new label expansion opportunity.
TransCon PTH:
On September 14, 2023, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the approval of TransCon PTH (palopegteriparatide) as a parathyroid hormone replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. Final European Commission decision is expected this month. If approved, the first launch is planned in Germany, leveraging the Company’s existing SKYTROFA commercial infrastructure, in January 2024.
In the U.S., expect to resubmit NDA for TransCon PTH for adults with hypoparathyroidism to the FDA before mid-November.
Presented 52-week data from Phase 3 PaTHway Trial demonstrating that skeletal dynamics of patients with chronic hypoparathyroidism trended toward a new steady state closer to age-appropriate norms with continued use of TransCon PTH. Results confirm trends previously reported in the Phase 2 PaTH Forward Trial.
As of September 30, 2023, 145 out of 154 participants continue in the open-label extension (OLE) portions of the Phase 2 PaTH Forward, Phase 3 PaTHway, and PaTHway Japan trials.
TransCon CNP:
Completed enrollment in ApproaCH, a Phase 3, global randomized, double-blind, placebo-controlled trial in children ages 2–11 years with achondroplasia. Topline results are expected in the second half of 2024.
Filed an Investigational New Drug (IND) amendment with the FDA to initiate reACHin, a Phase 2, multicenter, double-blind, randomized, placebo-controlled trial, designed to evaluate the safety, tolerability, and efficacy of 100 μg/kg of TransCon CNP once-weekly for 52 weeks in infants aged 0 to < 2 years with achondroplasia.
One-year follow-up data from AComplisH OLE expected in the fourth quarter of 2023.
During the fourth quarter of 2023, the Company expects to file an IND amendment or similar for COACH, a combination trial evaluating TransCon CNP and TransCon hGH in children with achondroplasia. The Company believes that this combination therapy may provide greater annualized height velocity than CNP alone, and at the same time, address the comorbidities of achondroplasia.
TransCon IL-2 β/γ:
Reported new data from ongoing Phase 1/2 IL-Believe Trial demonstrating clinical activity of TransCon IL-2 β/γ as monotherapy or in combination with a checkpoint inhibitor. Of three small-cell lung cancer patients treated in the combination portion of the trial who had previously progressed on checkpoint inhibitors, a partial response (confirmed) and a complete response (unconfirmed, treatment ongoing) were observed to date.
Enrollment continues in the Phase 2 portion in indication-specific cohorts; first patient dosed with TransCon IL-2 β/γ and TransCon TLR7/8 Agonist in combination. Initial data from indication-specific cohorts expected in the second half of 2024.
TransCon TLR7/8 Agonist:
Enrollment continues in Phase 2 portion of transcendIT-101, a Phase 1/2 trial to evaluate TransCon TLR7/8 Agonist as monotherapy or in combination with pembrolizumab in dose escalation and dose expansion. Initial data expected in the second half of 2024.
Ended the third quarter of 2023 with cash, cash equivalents, and marketable securities totaling €455.4 million.
Third Quarter 2023 Financial Results
Total revenue for the third quarter of 2023 was €48.0 million compared to €15.3 million during the same period in 2022. The increase was primarily attributable to higher SKYTROFA revenue of €47.0 million compared to €12.3 million in the same period last year.

Research and development (R&D) costs for the third quarter were €111.4 million compared to €97.4 million during the same period in 2022. This increase was primarily due to higher development costs for the Oncology and Ophthalmology programs, increasing clinical trial activities for TransCon CNP, and higher employee-related costs, and was partly offset by lower development costs for TransCon hGH.

Selling, general, and administrative (SG&A) expenses for the third quarter were €63.6 million compared to €60.7 million during the same period in 2022. This increase was primarily due to higher employee related expenses and other expenses attributable to organizational growth.

Net finance expenses were €20.4 million in the third quarter compared to €20.9 million in the same period in 2022.

For the third quarter of 2023, Ascendis Pharma reported a net loss of €162.2 million, or €2.88 per share (basic and diluted) compared to a net loss of €169.0 million, or €3.03 per share (basic and diluted) for the same period in 2022.

As of September 30, 2023, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling €455.4 million compared to €742.9 million as of December 31, 2022. As of September 30, 2023, Ascendis Pharma had 57,656,568 ordinary shares outstanding.

Conference Call and Webcast Information
Ascendis Pharma will host a conference call and webcast today at 4:30 pm Eastern Time (ET) to discuss its third quarter 2023 financial results.

To participate in the call, please dial (800) 445-7795 (domestic) or +1 (785) 424-1699 (international), and reference passcode ASNDQ323. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at View Source A replay of the webcast will be available on this section of our website shortly after conclusion of the event for 30 days.

On November 7, 2023 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported financial results for the third quarter ended September 30, 2023 and provided a corporate update (Press release, Arvinas, NOV 7, 2023, View Source [SID1234637118]).

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"We continued making strong progress in the third quarter of 2023 as we executed across our entire portfolio of PROTAC protein degraders," said John Houston, Ph.D., chairperson, chief executive officer, and president at Arvinas. "We remain focused on developing best-in-class medicines and are very pleased with the progress of our ER and AR degraders, both of which have the potential to make meaningful differences for patients. In the second half of next year, we anticipate completion of our first Phase 3 trial with our novel PROTAC ER degrader, vepdegestrant, in a second-line metastatic breast cancer setting, which we are jointly developing with Pfizer. Additionally, the profile of our PROTAC AR degrader, ARV-766, gives us the confidence to initiate a Phase 3 trial in metastatic castration resistant prostate cancer as soon as possible. We are also preparing to move two new compounds – our LRRK2 and BCL6 PROTAC protein degraders – into the clinic in 2024, with two more PROTAC protein degraders in IND-enabling studies by the end of 2023. We have a lot of milestones to deliver on in 2024 and I look forward to Arvinas’ continued success, with the ultimate, and most important goal of improving the lives of patients with serious diseases."

Recent Developments and Third Quarter Business Highlights

Androgen Receptor Franchise

Presented data from the Phase 1/2 clinical trial with bavdegalutamide at the European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper) showing a median radiographic progression free survival (rPFS) of 11.1 months in patients with AR 878/875 tumor mutations, demonstrating the strong potential for a PROTAC AR degrader in prostate cancer.
Manageable tolerability profile with no grade >4 treatment-related adverse events (TRAEs).
Prioritized the initiation of a Phase 3 trial with ARV-766 in mCRPC instead of the previously planned Phase 3 trial for bavdegalutamide.
New interim data from Phase 1/2 trial with ARV-766 showed a broader efficacy profile and superior tolerability versus bavdegalutamide in the clinical setting, with a potentially differentiated profile against other AR directed therapies.
Completed enrollment in the bavdegalutamide Phase 1b combination trial with abiraterone.
Vepdegestrant (ARV-471)

Presented updated dose-escalation data from the Phase 1/2 trial with vepdegestrant at ESMO (Free ESMO Whitepaper) showing continued strong anti-tumor activity and highly differentiated tolerability.
Continued enrollment in the study lead-in of the VERITAC-3 Phase 3 trial of vepdegestrant plus palbociclib as a first-line treatment in patients with ER+/HER2- locally advanced or metastatic breast cancer (ClinicalTrials.gov Identifier: NCT05909397).
Continued enrollment in the VERITAC-2 Phase 3 2L+ clinical trial of vepdegestrant as a monotherapy for the treatment of patients with ER+/HER2- metastatic breast cancer (ClinicalTrials.gov Identifier: NCT05654623).
Continued enrollment in the TACTIVE-U trial evaluating vepdegestrant with targeted therapies [ClinicalTrials.gov Identifiers: NCT05548127 and NCT05573555]).
Continued enrollment in the TACTIVE-E trial of vepdegestrant in combination with everolimus (ClinicalTrials.gov Identifier: NCT05501769), and the TACTIVE-N trial of vepdegestrant as a monotherapy in the neoadjuvant setting (ClinicalTrials.gov Identifier: NCT05549505).
Received Study May Proceed letter from the U.S. FDA for the Phase 1b/2 clinical trial evaluating vepdegestrant in combination with Pfizer’s CDK4 inhibitor (PF-07220060).
Awarded Innovation Passport Designation for vepdegestrant by the U.K. Innovative Licensing and Access Pathway Steering Group.
Anticipated Upcoming Milestones and Expectations

Vepdegestrant (ARV-471)
As part of Arvinas’ global collaboration with Pfizer, the companies plan to:

Present updated data for vepdegestrant at the San Antonio Breast Cancer Symposium, including new data from the Phase 1b trial assessing vepdegestrant in combination with palbociclib (December 2023).
Continue enrollment in the study lead-in for the VERITAC-3 Phase 3 trial of vepdegestrant and palbociclib as a first-line treatment in patients with ER+/HER2- locally advanced or metastatic breast cancer.
Initiate a Phase 1b/2 trial with vepdegestrant plus Pfizer’s CDK4 (cyclin dependent kinase) inhibitor (4Q 2023).
Continue enrollment of the Phase 1b combination umbrella trial evaluating combination of vepdegestrant with abemaciclib and with ribociclib (TACTIVE-U: ClinicalTrials.gov Identifiers: NCTC05548127 and NCTC05573555); initiate additional arm with Carrick Therapeutics’ CDK7 inhibitor.
Complete enrollment in the TACTIVE-N Phase 2 trial of vepdegestrant as a monotherapy in the neoadjuvant setting (ClinicalTrials.gov Identifier: NCT05549505) in patients with ER+/HER2- localized breast cancer (2024).
Complete enrollment of the VERITAC-2 Phase 3 monotherapy trial (ClinicalTrials.gov Identifier: NCT05654623) in patients with metastatic breast cancer (2H 2024).
Androgen Receptor (AR) Franchise (ARV-766/bavdegalutamide (ARV-110))

Continue enrollment of Phase 2 dose expansion study with ARV-766, with progression free survival data anticipated in 2024.
Initiate a Phase 1b/2 dose escalation trial with ARV-766 in combination with abiraterone in patients who have not previously received novel hormonal agents (4Q 2023).
Initiate discussions with regulatory authorities for a planned Phase 3 trial with ARV-766 in mCRPC (2Q 2024).
Pipeline:

Submit two investigational new drug (IND)/clinical trial authorization (CTA) applications for the Company’s BCL6 (oncology) and LRRK2 (neuroscience) PROTAC protein degraders by year-end 2023.
Progress at least two additional PROTAC protein degrader programs into IND- or CTA-enabling studies by year-end 2023.
Financial Guidance

Based on its current operating plan, Arvinas believes its cash, cash equivalents, restricted cash and marketable securities as of September 30, 2023, is sufficient to fund planned operating expenses and capital expenditure requirements into 2026.

Third Quarter Financial Results

Cash, Cash Equivalents and Marketable Securities Position: As of September 30, 2023, cash, cash equivalents, restricted cash and marketable securities were $1,004.0 million as compared with $1,210.8 million as of December 31, 2022. The decrease in cash, cash equivalents, restricted cash and marketable securities of $206.8 million for the nine months ended September 30, 2023 was primarily related to cash used in operations of $253.0 million (net of $2.5 million received from two collaborators), leasehold improvements of $2.8 million and loss on the sale of marketable securities of $0.9 million, partially offset by net proceeds from the issuance of common stock under our ATM offering of $36.0 million, unrealized gains on marketable securities of $10.0 million and proceeds from the exercise of stock options of $3.9 million.

Research and Development Expenses: Research and development expenses were $85.9 million for the quarter ended September 30, 2023, as compared with $77.5 million for the quarter ended September 30, 2022. The increase in research and development expenses of $8.4 million for the quarter was primarily due to increases our AR program of $5.2 million, which includes ARV-766 and bavdegalutamide, and our ER program of $6.2 million, which is net of the cost sharing of vepdegestrant under the Vepdegestrant (ARV-471) Collaboration Agreement, offset by a decrease in our platform and exploratory programs of $3.0 million.

General and Administrative Expenses: General and administrative expenses were $22.6 million for the quarter ended September 30, 2023, as compared with $20.0 million for the quarter ended September 30, 2022. The increase of $2.6 million was primarily due to increased investments in our commercial operations of $1.0 million, an increase in personnel and infrastructure related costs of $1.1 million, and an increase in professional fees of $0.5 million.

Revenues: Revenues were $34.6 million for the quarter ended September 30, 2023, as compared with $33.2 million for the quarter ended September 30, 2022. Revenue is related to the Vepdegestrant (ARV-471) Collaboration Agreement, the collaboration and license agreement with Bayer, the collaboration and license agreement with Pfizer, the amended and restated option, license and collaboration agreement with Genentech and revenue related to our Oerth Bio joint venture which was initiated in July 2019. The increase in revenues of $1.4 million was primarily due to an increase in revenue from the Vepdegestrant (ARV-471) Collaboration Agreement totaling $6.4 million, partially offset by a decrease in revenue of $2.8 million of previously constrained deferred revenue related to our Oerth Bio joint venture and a decrease of $1.8 million related to the conclusion of the performance period under the collaboration agreement with Genentech.

Income Tax Expense: Income tax was zero for the quarter ended September 30, 2023, as compared with an income tax expense of $2.2 million for the quarter ended September 30, 2022. Current year income tax expense was driven by valuation allowance recorded against the full amount of its net deferred tax assets. Prior year income tax expense was driven by revenue recognized in 2022 for tax purposes from the Vepdegestrant (ARV-471) Collaboration Agreement.

Loss from Equity Method Investment: Loss from equity method investment was $0.1 million for the quarter ended September 30, 2023, as compared with $2.9 million for the quarter ended September 30, 2022, due to fully recognizing the remaining Oerth Bio related constrained revenue, which limited the amount of equity method losses recognized during the quarter.

Net Loss: Net loss was $64.0 million for the quarter ended September 30, 2023, as compared with $66.2 million for the quarter ended September 30, 2022. The decrease in net loss for the quarter was primarily due to increased revenue and interest income from our marketable securities, as well as decreased income tax expense and loss from equity method investments, partly offset by increased research and development expenses and general and administrative expenses.

About ARV-766 and bavdegalutamide (ARV-110)
ARV-766 and bavdegalutamide (ARV-110) are investigational orally bioavailable PROTAC protein degraders designed to selectively target and degrade the androgen receptor (AR). ARV-766 and bavdegalutamide are being developed as potential treatments for men with prostate cancer. Preclinically, both investigational agents have demonstrated activity in models of wild type tumors in addition to tumors with AR mutation or amplification, both common mechanisms of resistance to currently available AR-targeted therapies.

About vepdegestrant (ARV-471)
Vepdegestrant is an investigational, orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
In preclinical studies, vepdegestrant demonstrated up to 97% ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed increased anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits. Ongoing and planned clinical trials will continue to monitor and evaluate the safety and anti-tumor activity of vepdegestrant.