Candel Therapeutics Reports Second Quarter 2023 Financial Results and Recent Corporate Highlights

On August 10, 2023 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing viral immunotherapies to help patients fight cancer, reported its financial results for the second quarter ended June 30, 2023, and provided a corporate update (Press release, Candel Therapeutics, AUG 10, 2023, View Source [SID1234634182]).

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"We continue to be encouraged by the therapeutic potential of our pipeline of oncology drug candidates that have shown clinical activity across multiple hard-to-treat solid tumor cancers," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "With multiple clinical trials underway, we are well-positioned for a number of upcoming data catalysts. We expect to announce additional clinical and immunological biomarker data from our phase 2 clinical trial in late stage PD-(L)1 inhibitor therapy-resistant non-small cell lung cancer in the third quarter of this year and topline overall survival data in the second quarter of 2024. In addition, we plan to announce initial overall survival and immunological biomarker data from the phase 2 clinical trial of CAN-2409 in patients with borderline resectable pancreatic adenocarcimoma in the fourth quarter of 2023."

Dr. Tak further commented, "For our CAN-3110 drug candidate, recent data presented from our phase 1 clinical trial in 50 patients with recurrent high-grade glioma demonstrated that a single injection of CAN-3110 was associated with encouraging median overall survival without dose-limiting toxicities. We have also begun evaluating whether multiple injections of CAN-3110 in this patient population could further boost the anti-tumor immune response with added drug exposure. This clinical trial program may also enable future expansion into other indications that are characterized by Nestin expression. We remain determined in our efforts to bring the next generation of viral immunotherapies to patients with cancer."

Second Quarter 2023 & Recent Highlights


Program Updates:

o
CAN-2409 – Non-Small Cell Lung Cancer (NSCLC)


Fast Track Designation granted by the U.S. Food and Drug Administration for CAN-2409 plus valacyclovir in combination with continued pembrolizumab in order to improve survival or delay progression in patients with stage III/IV NSCLC who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy.


Presented an overview of the phase 2 NSCLC clinical trial design, study protocol, and dosing regimen in a trials-in-progress poster session at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.


Based on the estimated completion of patient enrollment in Cohort 2, expect to report topline overall survival data from the phase 2 NSCLC clinical trial in Q2 2024.

o
CAN-3110 – Recurrent High-Grade Glioma (HGG)


Presented new data at the 2023 American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting. The data from the phase 1 investigator-sponsored clinical trial demonstrated that a single injection of CAN-3110 resulted in a median overall survival (mOS) of 11.8 months in patients with recurrent HGG who had failed standard of care (SoC) treatment. Further results demonstrated CAN-3110 to be well tolerated with no dose-limiting toxicities.


Advanced patient enrollment in Arm C, supported by the Break Through Cancer Foundation, to evaluate the repeat dosing regimen of CAN-3110 (up to six injections over four months) and whether additional doses can increase mOS.

Corporate Updates:
o
Appointed experienced manufacturing leader Nicoletta Loggia, PhD, RPh, to the Candel Board of Directors.

Anticipated 2023 Milestones


Expect to announce additional clinical and immunological biomarker activity data from newly enrolled patients and additional follow-up on the 26 patients who received two injections of CAN-2409 in Cohort 2 of the phase 2 clinical trial of CAN-2409 plus valacyclovir combined with continued PD-(L)1 targeting agents in patients with late-stage NSCLC in Q3.


Expect to announce initial overall survival and immunological biomarker data from the open-label, randomized phase 2 clinical trial of CAN-2409 plus valacyclovir combined with SoC for patients with borderline resectable pancreatic adenocarcimoma in Q4.

Financial Results for the Quarter Ended June 30, 2023

Research and Development Service Revenue, related party: Research and development service revenue, related party, was $0 for the second quarter of 2023 compared to $31,000 for the second quarter of 2022, as the amortizable $1.0 million up-front license fee that Candel received in 2014 and 2015 from Ventagen LLC was fully recognized as of December 2022.

Research and Development Expenses: Research and development expenses were $5.9 million for the second quarter of 2023 compared to $5.0 million for the second quarter of 2022. The increase was primarily due to personnel-related costs for additional headcount and manufacturing activities in support of the Company’s CAN-2409 programs. Research and development expenses included non-cash stock compensation expense of $0.3 million for the second quarter of 2023 compared to $57,000 for the second quarter of 2022.

General and Administrative Expenses: General and administrative expenses were $3.6 million for the second quarter of 2023 compared to $3.8 million for the second quarter of 2022. The decrease was primarily due to lower recruiting and insurance costs, partially offset by an increase in professional service and consulting expenses as well as personnel-related costs for additional headcount. General and administrative expenses included non-cash stock compensation expense of $0.4 million for both the second quarter of 2023 and the second quarter of 2022.

Net Loss: Net loss for the second quarter of 2023 was $9.6 million compared to a net loss of $4.1 million for the second quarter of 2022, and included net other expense of $35,000 and net other income of $4.6 million, respectively, primarily related to the change in the fair value of the Company’s warrant liability.

Cash Position: Cash and cash equivalents as of June 30, 2023 were $51.9 million. The Company expects that its existing cash and cash equivalents will be sufficient to fund its current operating plan into the second quarter of 2024.

Ayala Pharmaceuticals Announces Second Quarter 2023 Financial Results and Provides Corporate Update

On August 10, 2023 Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, reported second-quarter 2023 financial results and provided a corporate update (Press release, Ayala Pharmaceuticals, AUG 10, 2023, View Source [SID1234634181]).

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"We continue to make progress advancing our lead candidate AL102, which is being evaluated in the ongoing Phase 3 registration-enabling RINGSIDE for the treatment of desmoid tumors. We recently concluded an instructive and successful End-of-Phase-2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) and have confirmed that we are agreement with the FDA on key elements of the randomized Phase 3 segment of RINGSIDE," said Ken Berlin, President and Chief Executive Officer of the Company. "The most recent data from Phase 2 of RINGSIDE presented at ASCO (Free ASCO Whitepaper) were encouraging and we look forward to presenting a further update at the ESMO (Free ESMO Whitepaper) congress in October this year. We are excited, also, to expand our clinical pipeline through the recently announced proposed merger with Biosight. The addition of Biosight’s lead asset aspacytarabine (BST-236) fits with our strategic vision and core competencies. Along with the merger, we have plans to strengthen our balance sheet and execute our clinical plans, with the goal of creating sustainable value for patients and shareholders."

Second Quarter 2023 and Recent Business Highlights

End-of-Phase 2 meeting with FDA regarding AL102 for desmoid tumors: Ayala confirmed that it is in agreement with the FDA on key elements of the randomized Phase 3 segment of RINGSIDE, evaluating AL102 in desmoid tumors. The FDA accepted the selection of the 1.2 mg once daily dose for Phase 3 and the completed and proposed clinical pharmacology plan. Enrollment in Phase 3 commenced in November 2022, and is continuing globally as planned, with target enrollment of 156 patients. The primary endpoint is progression free survival with secondary endpoints including objective response rates, duration of response, and patient-reported quality of life measures.
Updated results from Phase 2 of RINGSIDE study presented at 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting: ASCO (Free ASCO Whitepaper) poster highlighted 50% partial response and 100% disease control rates in evaluable desmoid tumor patients treated with AL102 1.2 mg once daily (the selected Phase 3 dose) at a cut off date of January 3, 2023. Tumor responses, volume and T2 signal reduction were observed earlier in the 1.2 mg once daily group, with deeper and sustained treatment responses. AL102 continues to be generally well tolerated and has a manageable safety profile.
Definitive merger agreement with Biosight: Ayala entered into a definitive agreement with Biosight Ltd., pursuant to which, Ayala will combine with Biosight in an all-stock transaction. Upon completion of the proposed merger, the combined company will operate under the name Ayala Pharmaceuticals, Inc., and will continue to trade on the OTCQX under Ayala’s current ticker symbol ("ADXS"). The combined company will work to advance a portfolio of oncology assets, with a primary focus on Ayala’s AL102, and Biosight’s aspacytarabine (BST-236). The transaction is expected to close near the end of the third quarter of 2023, subject to regulatory and other conditions including approval of Biosight stockholders.
Upcoming Milestones

ESMO poster presentations on AL102 and AL101: Updated results from Phase 2 of RINGSIDE evaluating AL102 in desmoid tumors and final results from the ACCURACY trial evaluating AL101 in patients with recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) have been selected for presentation at the European Society for Molecular Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, to be held in Madrid, Spain 20-24 October 2023.
Data from Phase 1 trial of ADXS-504: ADXS-504 is being evaluated in a Phase 1 investigator-sponsored study at Columbia University in patients with biochemically recurrent (early) prostate cancer. Readout of initial clinical and PSA data are expected in 2023.
Gain clarity on path for future development plan for AL101 in recurrent/metastatic adenoid cystic carcinoma (R/M ACC), expected in 2023.
Consolidated Financial Results for the Second Quarter Ended June 30, 2023

Cash position On June 30, 2023, the Company’s consolidated cash and cash equivalents position was $7.1 million.

Revenue Collaboration revenue was $9 thousand in the three months ended June 30, 2023, compared with $38 thousand in the comparable period of 2022.

R&D Expenses Research and development expenses were $5.7 million for the three months ended June 30, 2023 compared to $5.6 million for the three months ended June 30, 2023.

G&A Expenses General and administrative expenses were $2.7 million for the three months ended June 30, 2023 compared to $2.3 million for the three months ended June 30, 2023.

Net Loss The net loss for the three months ended June 30, 2023 was approximately $8.7 million or ($1.82) per share based on approximately 4.8 million weighted average shares outstanding. This compares with a net loss for the three months ended June 30, 2022 of approximately $8.1 million or ($2.83) per share based on approximately 2.9 million weighted average shares outstanding.

For further details on the Company’s financial results, including results for the six-month period ended June 30, 2023, refer to our quarterly report on Form 10-Q for the quarter ended June 30,2023, filed with the Securities and Exchange Commission.

Atreca Reports Second Quarter 2023 Financial Results and Announces Corporate Restructuring

On August 10, 2023 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported financial results for the second quarter ended June 30, 2023, and announced a corporate reorganization to reduce expenses and extend its cash runway (Press release, Atreca, AUG 10, 2023, View Source [SID1234634180]). As part of the reorganization, Atreca will be undertaking cost-saving measures, including suspending development of ATRC-101 and reducing its workforce by approximately 40%. Going forward operations will focus on advancing current preclinical antibody-drug conjugate (ADC) candidates, including APN-497444, while preserving core discovery capabilities.

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"In order to extend our cash runway and focus on our preclinical ADC development efforts, we are suspending development of ATRC-101," said John Orwin, Chief Executive Officer of Atreca. "We are proud of our work in advancing ATRC-101 into the clinic and are encouraged by the activity and safety profile that we observed, validating the ability of our discovery platform to generate novel, tumor-targeting product candidates. Nevertheless, given both development requirements and financial considerations, we believe that the best path forward for the asset is with a larger partner, and as a result, we are suspending development and evaluating potential out-licensing opportunities. Our preclinical ADC pipeline, led by APN-497444, will continue to advance, and we are working towards declaring a clinical candidate from this program in the coming months."

"We have also made the difficult decision to reduce our headcount by approximately 40%," continued Mr. Orwin. "Given the talent and dedication of our workforce, this decision was not made lightly. We believe, however, that it is a necessary step to ensure we have the capital to execute on our mission to deliver novel therapeutics to patients in need. I’d like to thank those impacted for their important contributions to Atreca, including discovering and advancing both ATRC-101 and APN-497444."

Recent Developments and Highlights

APN-497444 (‘444), an Atreca-discovered antibody targeting a novel, tumor-specific glycan, continues to advance. ‘444 displays uniform and tumor-selective binding with high target prevalence in colorectal cancer and exhibits compelling pre-clinical anti-tumor activity and initial safety when weaponized as an ADC. Atreca expects to nominate a clinical candidate from the program in 2023 and is targeting an IND submission in late 2024/early 2025.
The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for MAM01/ATRC-501 submitted by the Gates Medical Research Institute (Gates MRI). Gates MRI plans to initiate its Phase 1 trial based in the US later this year, followed by a trial in Sub-Saharan Africa. Atreca retains commercial rights in the U.S., Europe and parts of Asia, and potential product development opportunities in those regions include prophylaxis for those traveling to malaria endemic regions.
Second Quarter 2023 Financial Results

As of June 30, 2023, cash and cash equivalents and investments totaled $38.5 million.
Research and development expenses for the three months ended June 30, 2023, were $12.9 million, including non-cash stock-based compensation expense of $1.2 million.
General and administrative expenses for the three months ended June 30, 2023, were $6.8 million, including non-cash stock-based compensation expense of $1.7 million.
Atreca reported a net loss of $19.2 million, or basic and diluted net loss per share attributable to common stockholders of $0.49, for the quarter ended June 30, 2023.

Aptose Reports Results for the Second Quarter 2023

On April 10, 2023 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral targeted agents to treat hematologic malignancies, reported financial results for the three months ended June 30, 2023, and provided a corporate update (Press release, Aptose Biosciences, AUG 10, 2023, View Source [SID1234634179]).

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"While still early in our APTIVATE dose expansion trial with tuspetinib in combination with venetoclax (TUS/VEN), we are encouraged by what we’re seeing in very difficult to treat AML populations," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "Of particular importance are the tolerability of the TUS/VEN doublet and the breadth of responses in deep relapsed or refractory (R/R) AML patients who failed prior therapy with venetoclax (4 of 9 evaluable with Prior-VEN), among which responses were achieved in patients with wildtype FLT3 (2 of 3 evaluable with FLT3-WT) and one of whom harbored a TP53 mutation. Given the paucity of treatment options in this subpopulation that failed prior venetoclax therapy, we’re excited to build off of these positive results at future medical meetings later this year and leverage the TUS/VEN doublet data as a springboard to future triplet therapy in the front line setting."

"We are delighted to strengthen our relationship with Hanmi Pharmaceutical, which we believe reflects their recognition of the growing value of tuspetinib as a unique treatment for AML and possibly MDS, of the significant progress that Aptose has made with tuspetinib’s clinical development, and of the experienced and thoughtful nature of our team," said Dr. Rice. "We thank the Hanmi team, and in particular, Ms. Juhyun Lim, President of Hanmi Pharmaceutical, for her leadership and commitment to Aptose."

Key Corporate Highlights

Tuspetinib APTIVATE Expansion Trial – In the APTIVATE Phase 1/2 clinical trial of tuspetinib, a once daily oral agent with a unique kinase targeting pattern being developed for the treatment of patients with R/R AML, the tuspetinib and venetoclax (TUS/VEN) doublet combination treatment arm has demonstrated early responses (composite Complete Response rate (CRc) includes any CR, CRh, CRi and CRp to date) among efficacy evaluable R/R patients who previously failed venetoclax treatment. Among fifteen (15) patients dosed with TUS/VEN as of August 1, 2023, ten (10) patients have reached an efficacy evaluable stage. Among the ten evaluable patients, five (5) patients have achieved responses (50% CRc). Nine (9) of the ten (10) evaluable patients had failed prior venetoclax treatment, with four (4) of the nine (9) achieving responses (44% CRc). Three (3) responses emerged among seven (7) patients with wildtype FLT3 (43% CRc), which accounts for approximately 70% of the AML population, yet there are few treatment options and little in development for the wildtype patient population. The TUS/VEN combination continues to be well tolerated.

Aptose has a growing network of U.S. and international clinical sites recruiting a large spectrum of the R/R AML population, and the APTIVATE trial is focused on the rapid enrollment of patients to the TUS/VEN doublet.

Equity Investments in Aptose – Today, Aptose announced that it has entered into a binding term sheet with Hanmi Pharmaceutical, Inc. ("Hanmi Pharmaceutical") of Seoul, South Korea, for an investment of up to $7 million or 19.99 percent ownership interest in Aptose, in two tranches. The investment will provide additional financing for Aptose’s lead hematology drug, tuspetinib, formerly HM43239, which was licensed from Hanmi Pharmaceutical in November 2021 and is currently in the APTIVATE international phase 1/2 expansion trial in which patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) receive tuspetinib monotherapy or in combination with venetoclax. The Company anticipates that the first tranche for $3 million will close by the end of August, subject to the satisfaction of customary closing conditions. The second tranche for up to $4 million or a maximum of 19.99 percent ownership interest will be triggered upon Aptose achieving certain manufacturing and data milestones related to tuspetinib, to be described in greater detail in definitive documentation and anticipated to be achieved by year-end.

The investment is conditional upon the Company receiving the conditional approval of the Toronto Stock Exchange (the "TSX") to list the Common Shares on the TSX. Listing will be subject to satisfying all of the requirements of the TSX. The investment is also subject to the requirements of the Nasdaq Capital Market.

During the quarter, Aptose also entered into a $25 million committed equity facility with Keystone Capital that provides Aptose the right to issue and sell up to $25 million of its common shares over the course of 24 months to the investor, subject to certain conditions being met, and subject to certain limitations and conditions imposed by Nasdaq, SEC and other regulators.

Completed Successful Type B EOP1 Meeting with US FDA – In June, Aptose held an End of Phase 1 (EOP1) Meeting with the FDA, where all tuspetinib data was reviewed. A monotherapy recommended Phase 2 dose of 80 mg daily was selected and all tuspetinib development paths remain open, including the single arm accelerated path.
Expected Milestones

European School of Haematology (ESH) Meeting – Plan to present expanded tuspetinib clinical data set (October 2023)

65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition – Plan to present more mature clinical data set with tuspetinib (December 2023)

Plan to discuss strategies for potential future monotherapy accelerated development, doublet phase 2 development, and triplet pilot development (4Q 2023)

Research and development expenses increased by $3.2 million to $10.6 million for the three-month period ended June 30, 2023, as compared to $7.3 million for the comparative period in 2022. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for tuspetinib were $8.1 million for the three-month period ended June 30, 2023. The higher program costs for Tuspetinib in the current period represent the enrollment of patients in our APTIVATE clinical trial, our healthy volunteer trial, manufacturing activities to support clinical development, and related expenses.
Program costs for luxeptinib decreased by approximately $1.7 million, primarily due to lower clinical trial costs and lower manufacturing costs as a result of the current formulation requiring less API than the prior formulation.
Program costs for APTO-253 decreased by approximately $169 thousand, due to the Company’s decision on December 20, 2021 to discontinue further clinical development of APTO-253.
Personnel-related expenses decreased by $354 thousand, related to fewer employees in the current three-month period, partially offset by salary increases.
Stock-based compensation decreased by approximately $266 thousand in the three months ended June 30, 2023, compared to the three months ended June 30, 2022, primarily due to stock options granted with lower grant date fair values, in the current period.
Research and development expenses increased by $4.7 million to $19.4 million for the six-month period ended June 30, 2023, as compared to $14.7 million for the comparative period in 2022. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for tuspetinib were $12.8 million for the six-month period ended June 30, 2023, an increase of $9.3 million compared with $3.5 million in the corresponding period in 2022. The higher program costs for Tuspetinib in the current period represent the enrollment of patients in our APTIVATE clinical trial, our healthy volunteer trial, clinical study supplies, and related expenses.
Program costs for luxeptinib decreased by approximately $3.2 million from $5.2 million in the six months ended June 30, 2022 to $2.0 million in the current period, primarily due to lower clinical trial costs and lower manufacturing costs as a result of the current formulation requiring less API than the prior formulation.
Program costs for APTO-253 decreased by approximately $253 thousand, due to the Company’s decision on December 20, 2021 to discontinue further clinical development of APTO-253.
Personnel-related expenses decreased by $610 thousand, related to fewer employees in the current six-month period and partially offset by salary increases.
Stock-based compensation decreased by approximately $559 thousand in the six months ended June 30, 2023, compared to the three months ended June 30, 2022, primarily due to stock options granted with lower grant date fair values, in the current period.

Conference Call & Webcast:

Date: Thursday, August 10, 2023
Time:
5:00 PM ET
Audio Webcast Only: link
Q&A Participant Registration Link*: link (https://register.vevent.com/register/BI29f5f8f4655b45cf8b92fd8f79f69f8f)

*Analysts interested in participating in the question-and-answer session will pre-register for the event from the participant registration link above to receive the dial-in numbers and a unique PIN, which are required to access the conference call. They also will have the option to take advantage of a Call Me button and the system will automatically dial out to connect to the Q&A session.

The audio webcast also can be accessed through a link on the Investor Relations section of Aptose’s website here. A replay of the webcast will be available on the Company’s website for 30 days.

The press release, the financial statements and the management’s discussion and analysis for the quarter ended June 30, 2023 will be available on SEDAR+ at www.sedarplus.ca and EDGAR at www.sec.gov/edgar.shtml.

Aprea Therapeutics Reports Second Quarter 2023 Financial Results and Provides Update on Business Operations

On August 10, 2023 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical stage biopharmaceutical company focused on precision oncology through synthetic lethality, reported financial results for the three and six months ended June 30, 2023 and provided a business update (Press release, Aprea, AUG 10, 2023, View Source [SID1234634178]).

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"We continue to execute across all our programs, with notable progress in enrollment in our lead Phase 1/2a dose escalation study with ATRN-119, our ATR inhibitor for the treatment of advanced solid tumors and anticipate initial preliminary data in the fourth quarter 2023," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "Our IND enabling studies for ATRN-1051, our WEE1 inhibitor, continue to be on track, and we continue to anticipate filing an IND by the end of the year. Our strong balance sheet continues to support our strategy and plans through our near-term milestones in both our ATR and WEE1 programs, with a cash runway into the fourth quarter of 2024. We look forward to providing more updates as we make progress throughout the rest of the year."

Key Business and Financial Updates

ATR inhibitor program: ATRN-119 – Enrollment continues in the Phase 1/2a trial of Aprea’s lead clinical candidate, ATRN-119, a potential best-in-class ATR inhibitor for the treatment of advanced solid tumors, harboring defined mutations in DDR pathways. ATRN-119 is an orally bioavailable, potent and selective macrocyclic small molecule inhibitor of ATR. ATR is one of several key regulators impacting response to defective DNA replication and DNA damage, which occurs more commonly in cancer cells than in normal cells. Primary endpoints of the Phase 1 dose escalation part of the study include safety, tolerability, pharmacokinetics and a recommended Phase 2 dose. The Company expects to report initial interim safety, tolerability, and pharmacokinetic data from the ongoing Phase 1 trial of ATRN-119 in the fourth quarter of 2023.
WEE1 inhibitor program: ATRN-1051 – ATRN-1051 is an orally-bioavailable, highly potent and selective small molecule inhibitor of WEE1, a key regulator of multiple phases of the cell cycle. The Company believes preclinical findings support potentially favorable drug selectivity and exposure. Investigational New Drug (IND) enabling studies with ATRN-1051 are under way, and the Company anticipates filing an IND by the end of 2023.
Appointed Gabriela Gruia, M.D., to the Board of Directors, strengthening the Company’s leadership. Dr. Gruia brings over 25 years of clinical, regulatory and life science leadership experience to Aprea, having worked for Novartis, Pfizer, Pharmacia, Aventis, and Rhone Poulenc. Dr. Gruia received her M.D. from Bucharest Medical School in Romania and a Masters in Breast Pathology and Mammography from René Huguenin/Curie Institute Cancer Center in Paris, France.
Select Financial Results for the Second Quarter ended June 30, 2023

As of June 30, 2023, the Company reported cash and cash equivalents of $27.7 million.
For the quarter ended June 30, 2023, the Company reported an operating loss of $3.7 million, compared to an operating loss of $98.5 million for the same period in 2022.
Research and Development (R&D) expenses were $2.2 million for the quarter ended June 30, 2023, compared to $6.8 million for the same period in 2022. The decrease in R&D expense was related to lower clinical trial expense primarily due to the close out of legacy Aprea clinical trials, lower personnel costs for the former facility in Sweden, and lower non-cash stock-based compensation expense.
General and Administrative (G&A) expenses were $1.7 million for the quarter ended June 30, 2023, compared to $15.6 million for the same period in 2022. The decrease in G&A expenses was due to lower non-cash stock-based compensation expense, lower insurance premium expenses and lower personnel costs for the former facility in Sweden.
Acquired in-process research and development (IPR&D) expenses were $0 for the quarter ended June 30, 2023, compared to $76.0 million for the same period in 2022. The decrease in IPR&D was related to the 2022 acquisition of Atrin, which was accounted for as an asset acquisition. The acquisition cost allocated to acquired IPR&D with no alternative future use was recorded as an expense as of the closing date in May 2022.
The Company reported a net loss of $3.3 million ($0.87 per basic share) on approximately 3.7 million weighted-average common shares outstanding for the quarter ended June 30, 2023, compared to a net loss of $98.3 million ($86.72 per basic share) on approximately 1.1 million weighted average common shares outstanding for the same period in 2022. The decrease in net loss was primarily attributable to the acquired IPR&D associated with the Atrin acquisition in May 2022, as well as lower R&D and G&A expenses as described above.