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.

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.

On August 10, 2023 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, reported consolidated financial results for the third quarter of fiscal 2023 ended June 30, 2023 (Press release, Applied DNA Sciences, AUG 10, 2023, View Source [SID1234634177]).

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"Our fiscal third quarter performance stands out for the substantial progress made to advance the development and commercialization of our LinearDNA platform for biotherapeutic applications that culminated shortly after the close of the quarter with our acquisition of Spindle Biotech and launch of our Linea IVT platform for mRNA production," stated Dr. James A. Hayward, president and CEO of Applied DNA. "The combination of Spindle Biotech’s proprietary RNA polymerase with our linearDNA IVT templates, we believe, significantly increases the commercial relevance of our integrated offering to mRNA manufacturers and developers while positioning us to monetize a much larger segment of the mRNA value chain.

"Concurrently during the quarter, and while approval of our pharmacogenomics (PGx) diagnostic by the New York State Department of Health (NYSDOH) remains pending, we continued to evolve revenue opportunities within our supply chain traceability segment. We added new CertainT authenticity platform customers for source verification. And, as the textile industry continues to adjust to the UFLP Act compliance requirements, we initiated a rebrand of our CertainT platform to elevate the industry’s awareness of the platform’s multi-pronged approach to ensuring that textiles passing through global cotton supply chains are true to source and free of the use of forced labor.

"Looking ahead to the fourth quarter, we are focused on driving adoption of the Linea IVT platform and closing CertainT opportunities aligned with the upcoming cotton ginning season," concluded Dr. Hayward. "We are encouraged by initial industry feedback to our Linea IVT platform, and we are already in early discussions with prospective evaluation customers at volumes that can be met from our current production footprint. Given the breadth of mRNA therapeutics in preclinical development globally, we remain committed to delivering cGMP-quality linearDNA at volumes suitable for IVT use in clinical stages and commercial launch by calendar year-end. Finally, we see the potential for cotton taggant orders and the initiation of large supply chain customers."

Summary Third Quarter Fiscal 2023 Financial Results:

Total revenues were approximately $2.9 million for the three-month period June 30, 2023, compared to $4.3 million for the same period in the prior fiscal year. The decrease in revenue of approximately $1.4 million was due to a decline in COVID-19 testing services revenue of $1.7 million driven primarily by lower testing volumes from the City University of New York (CUNY) in May with the conclusion of the academic year, as well as the wind-down of the CUNY contract by mid-June 2023. The decrease in COVID-19 testing service revenue was offset by an increase in revenue from our Therapeutic DNA Production segment of approximately $296 thousand.
Gross profit for the three-month period ended June 30, 2023, was $1.3 million, compared to $1.0 million for the three-month period ended June 30, 2022. The gross profit percentage was 44% and 24% for the three-month periods ended June 30, 2023, and 2022, respectively. The improvement in the gross profit percentage in the quarter ended June 30, 2023, was primarily from an increased gross profit percentage for the Company’s MDx testing services. This improvement was the result of continued cost management efforts within the Company’s COVID-19 testing services contracts, where the Company also provided and staffed test collection centers. Additionally, the quarter ended June 30, 2023, included a higher percentage of COVID-19 surveillance testing services revenue which generate a higher gross profit compared to the same period in the prior fiscal year.
Operating loss remained flat at $2.9 million for the third quarter of fiscal 2023 and fiscal 2022.
Net loss was $3.1 million for the third quarter of fiscal 2023 compared to $1.1 million for the third quarter of 2022.
Excluding non-cash expenses, Adjusted EBITDA was a negative $2.1 million for the third quarter of fiscal 2023 compared to a negative $2.3 million for the same period in fiscal 2022.
Cash and cash equivalents stood at $10.8 million on June 30, 2023, compared with $12.3 million as of March 31, 2023.
Third Quarter Fiscal 2023 Conference Call Information
The Company will hold a conference call and webcast to discuss its second quarter of fiscal year 2023 financial results on Thursday, August 10, 2023, at 4:30 PM ET. To participate in the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, not all questions may be answered.

To Participate, please ask to be joined to the ‘Applied DNA Sciences’ call:

Domestic callers (toll free): 844-887-9402
Canadian callers (toll free): 866-605-3852
International callers: 412-317-6798
Live and replay of webcast: View Source

Telephonic replay (available 1 hour following the conclusion of the live call through August 17, 2023):

Domestic callers (toll free): 1-877-344-7529
Canadian callers (toll free): 1-855-669-9658
Participant Passcode: 8409849
An accompanying slide presentation will be embedded in the webcast (live and replay) and can also be accessed in the ‘Company Events’ section of the ‘News & Events’ tab of the Applied DNA investor relations website at View Source

On August 10, 2023 ALX Oncology Holdings Inc., ("ALX Oncology" or "the Company") (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, reported financial results for the second quarter ended June 30, 2023, and provided an update on the Company’s portfolio of clinical programs in development (Press release, ALX Oncology, AUG 10, 2023, View Source [SID1234634176]).

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During the second quarter, ALX Oncology continued to advance evorpacept’s mid-stage clinical development programs highlighted by ASPEN-06 in HER2-positive gastric cancer which is on track to report data in Q423. In addition, the Company is transitioning its development strategy to purely focus on combinations with anti-cancer antibodies, antibody-drug conjugates ("ADCs"), and PD-1/PD-L1 immune checkpoint inhibitors. While well tolerated, the Company is terminating the ASPEN-02 program which evaluated evorpacept in combination with azacitidine for myelodysplastic syndromes ("MDS"), as the evorpacept combination did not substantially improve upon the historical activity of azacitidine alone. Patients currently on trial may continue in the study and the Company plans to present the full data set from the forty-five subjects at an upcoming scientific conference. Moreover, based on the initial results of ASPEN-02 and the close connection between the mechanism of action with azacitidine in MDS and acute myeloid leukemia ("AML"), the Company will also terminate the ASPEN-05 program in AML and will not initiate a Phase 1b dose optimization clinical evaluation of evorpacept in combination with azacitidine and venetoclax. Based upon this decision, resources originally earmarked for these trials will be allocated to support the Company’s ongoing programs evaluating combinations with anti-cancer antibodies and PD-1/PD-L1 immune checkpoint inhibitors.

Rational Design and Dual Development Pillars

Rationally engineered with an inactive Fc effector function, evorpacept’s clinical data to date has demonstrated a substantially improved safety profile over other anti-CD47 molecules in the clinic with an active Fc (i.e., binding the Fc gamma receptor on macrophages). This superior safety profile allows us to dose higher with minimal overlapping toxicity in the combination treatment setting. CD47 expressed on cancer cells binds to its receptor SIRP alpha, which is predominantly expressed on two cell types: macrophages and dendritic cells. ALX Oncology will focus evorpacept development with the standard-of-care agents as originally designed revolving around these two cell types, including:

Anti-cancer antibodies (the "don’t eat me" signal): evorpacept enables Fc-mediated antibody-dependent phagocytosis by macrophages in combination with anti-cancer antibodies (e.g., Herceptin) with an active Fc domain, which is otherwise impaired by CD47 expression on cancer cells binding to SIRP alpha on macrophages. This same mechanism of action applies to ADCs.

PD-1/PD-L1 immune checkpoint inhibitors (the "don’t activate T-cell" signal): evorpacept enables T-cell activation by dendritic cells that are constitutively inhibited by CD47 expression on cancer cells binding to SIRP alpha on dendritic cells. Activated dendritic cells present neoantigens to T-cells that once activated will kill cancer cells when the PD-1/PD-L1 inhibitory interaction is blocked by T-cell checkpoint inhibitors.

"The second quarter proved to be an important period of progress as we advanced key programs and refined the development strategy for evorpacept, our platform asset," commented Dr. Jaume Pons, Founder, President and Chief Executive Officer of ALX Oncology. "While the efficacy results from ASPEN-02 do not warrant further sponsored clinical evaluation in MDS, we remain steadfast in our conviction that the primary mechanism of action of evorpacept is unique compared to other CD47 blockers when combined with anti-cancer antibodies, ADCs, or immune checkpoint inhibitors. Evorpacept was rationally designed with an inactive Fc domain for improved safety and synergies with anti-cancer antibody-based regimens like Herceptin, antibody-drug conjugates, as well as PD-1/PD-L1 immune checkpoint inhibitors like KEYTRUDA (pembrolizumab). Moving forward the Company will conduct clinical trials where this mechanistic rationale is fulfilled. We move into the second half of 2023 with sufficient funding and with the momentum needed to advance our pipeline of therapeutic candidates led by ASPEN-06, a randomized Phase 2 trial combining Herceptin, CYRAMZA and paclitaxel for the treatment of patients with HER2-positive gastric or gastroesophageal junction ("GEJ") cancer."

Clinical Highlights for Evorpacept

ASPEN-06 Advanced HER2-Positive Gastric/GEJ Cancer

The Phase 2 (open-label)/Phase 3 (double-blind) trial of evorpacept for the treatment of patients with HER-2-positive over-expressing metastatic gastric or GEJ adenocarcinomas continues to progress. While Herceptin is currently approved in combination with cisplatin or capecitabine for HER2-positive gastric/GEJ cancers, it is not yet approved with the standard-of-care of CYRAMZA + paclitaxel. The Phase 2 portion of the ASPEN-06 study is designed to enroll 122 patients who have progressed on, or after prior HER2-directed therapy and/or platinum-containing regimens. To assess the activity of evorpacept on top of Herceptin in the Phase 2 portion of ASPEN-06, patients are randomized to receive either a four-drug combination regimen (evorpacept + Herceptin + CYRAMZA + paclitaxel) or a three-drug combination regimen (Herceptin + CYRAMZA + paclitaxel). This design enables the assessment of evorpacept’s contribution to the standard of care plus Herceptin. Should the Phase 2 portion of the trial demonstrate proof of concept, the trial will progress to the Phase 3 portion where the evorpacept containing four-drug regimen will be tested against the two-drug global standard of care of CYRAMZA + paclitaxel. The mechanistic rationale of the evorpacept combination in this setting is supported by clinical data from a Phase 1 clinical trial in 18 patients with >2L HER2 positive gastric/GEJ cancer, in combination with Herceptin plus CYRAMZA and paclitaxel which demonstrated an initial ORR of 72.2% with a median duration of response (mDOR) of 14.8 months, and a median overall survival (mOS) of 17.1 months. Positive data from ASPEN-06 would support evorpacept’s mechanism of action in combination with anti-cancer antibodies and provide additional developmental opportunities with other anti-cancer antibodies and ADCs.
Orphan drug designation ("ODD") received from the European Commission for evorpacept for the treatment of patients with gastric cancer.

In June 2023, ALX Oncology received ODD from the European Commission for evorpacept for the treatment of patients with gastric/GEJ cancer. The U.S. Food and Drug Administration ("FDA") also granted ODD to evorpacept for the treatment of patients with gastric/GEJ cancer as previously announced in January 2022.
First patient dosed in Phase 2 investigator-sponsored trial of evorpacept in combination with KEYTRUDA in patients with ovarian cancer.

In May 2023, the Company announced the initiation of a Phase 2 investigator-sponsored trial of evorpacept in combination with liposomal doxorubicin and KEYTRUDA in patients with recurrent platinum-resistant ovarian cancer at the UPMC Hillman Cancer Center. This is an open-label, single-arm Phase 2 clinical trial. The study is being led by Haider Mahdi, M.D., M.P.H., Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences, The University of Pittsburgh and UPMC Magee-Womens Research Institute.

Announced clinical trial collaboration with Sanofi to evaluate evorpacept in combination with CD38-targeting monoclonal antibody SARCLISA in patients with multiple myeloma.

In April 2023, ALX Oncology entered into a clinical trial collaboration and supply agreement with Sanofi to evaluate evorpacept and SARCLISA (isatuximab-irfc), Sanofi’s monoclonal antibody that targets a specific epitope on the CD38 receptor on multiple myeloma cells, for the treatment of patients with relapsed or refractory multiple myeloma ("RRMM"). Under the terms of the agreement, Sanofi will conduct a Phase 1/2 study to evaluate the safety, efficacy, pharmacokinetics and biomarker data of evorpacept in combination with SARCLISA and dexamethasone in patients with RRMM.
Upcoming Milestones in 2023

Update of data from a randomized Phase 2 trial of evorpacept in combination with Herceptin, CYRAMZA and paclitaxel for the treatment of patients with HER2-positive gastric/GEJ cancer (ASPEN-06) in the second half of 2023.
The investigational new drug ("IND") filing for ALTA-002, originally expected in the first half of 2023, has been delayed due to chemistry, manufacturing, and controls ("CMC") related issues and is planned for the first quarter of 2024.
Expansion of the ADC platform acquired from ScalmiBio to identify clinical development candidates by the fourth quarter of 2023.
Second Quarter 2023 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of June 30, 2023, were $224.5 million. ALX Oncology believes its cash, cash equivalents, and investments along with the ability to draw down an additional $40 million of its term loan are sufficient to fund planned operations through mid-2025.
Research and Development ("R&D") Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of the Company’s current lead product candidate, evorpacept, and R&D employee-related expenses. These expenses for the three months ended June 30, 2023, were $29.5 million, compared to $26.7 million for the prior-year period. The increase was primarily attributable to an increase of $3.9 million in clinical costs from an increase in the number of active trials and patient enrollment as well as manufacturing of clinical trial materials to support a higher number of active clinical trials and future expected patient enrollment related to the advancement of evorpacept, offset by a decrease of $1.0 million related to the Tallac Collaboration for costs related to the IND filing planned for 2023, for which the primary work was completed in 2022.
General and Administrative ("G&A") Expenses: G&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the three months ended June 30, 2023, were $7.3 million, compared to $7.0 million for the prior year period. The increase was primarily attributable to an increase in personnel and related costs primarily driven by headcount growth.
Net loss: GAAP net loss was $34.2 million for the second quarter ended June 30, 2023, or $0.84 per basic and diluted share, as compared to a GAAP net loss of $32.9 million for the second quarter ended June 30, 2022, or $0.81 per basic and diluted share. Non-GAAP net loss was $27.9 million for the second quarter ended June 30, 2023, as compared to a non-GAAP net loss of $27.1 million for the second quarter ended June 30, 2022. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.

On August 10, 2023 4SC AG (4SC, FSE Prime Standard: VSC) reported its Half-Year Report 2023, presenting all material developments up to 30 June 2023 and the Company’s current outlook (Press release, 4SC, AUG 10, 2023, View Source [SID1234634104]). The full communication is available for download on 4SC’s website.

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Jason Loveridge, Ph.D., CEO of 4SC, commented: "Given the positive topline data from the RESMAIN study, Kinselby is extremely well placed for the next stage of its development as we look to commercialize the drug through either a sale, licensing or partnership. Kinselby remains uniquely positioned as a maintenance therapy in CTCL, where there are no alternative comparable treatments and it offers significant benefits for patients by halting disease progression. We are focused on near term registrations of Kinselby to get this important drug to patients as quickly as possible."

Key highlights in Q2 2023
Resminostat met the primary endpoint in the RESMAIN study, demonstrating a statistically significant improvement in progression free survival in CTCL patients by ninety seven point six percent (97.6%) with a risk reduction of thirty eight percent (38%) compared to placebo
Further results from the RESMAIN study evaluating resminostat in maintenance treatment of patients with advanced cutaneous T-cell lymphoma (CTCL) will be presented by Professor Dr. Rudolf Stadler at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting 2023 on Saturday, 23rd September 2023 at 9:10h CEST at The Leiden University Medical Center in the Netherlands
The European Medicines Agency (EMA) has notified 4SC that it has accepted its Letter of Intent to Submit a Marketing Authorization Application (MAA)
EMA has notified 4SC that its nominated trade name for resminostat – Kinselby – has been accepted by its Name Review Group (NRG)
4SC is actively progressing the preparation of its Marketing Authorization Application in the European Union, Switzerland and UK, and intends to discuss with the US Food and Drug Administration regarding requirements for a resminostat marketing application for CTCL treatment in the US
4SC’s partner for Japan, Yakult Honsha is responsible for the filing of a marketing application for Kinselby (resminostat) in Japan
Development of cash balance in H1 2023 and financial forecast
As of 30 June 2023, 4SC holds cash balance/funds of €12.158 million, compared to €14.825 million as at 31 December 2022. The monthly use of cash from operations amounted to €0.945 million on average in the first half year of 2023 (H1 2022: €1.375 million) and was in the forecast range of €0.8 million and €1.1 million forecast for 2023.

The Management Board of 4SC estimates that current funds should be sufficient to finance 4SC into Q3 2024.

2023 business outlook
4SC is fully focused on the registration and commercialization of resminostat (Kinselby) in the European Union, Switzerland and the UK and defining the requirements for marketing resminostat for CTCL in the US through discussions with the United States (US) Food and Drug Administration. In July 2023, the Company engaged a global investment banking firm serving companies in the life sciences industry to assist 4SC in evaluating the Company’s options for the commercialization of resminostat (Kinselby).