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).

On August 9, 2023 HLB Life Science R&D, a subsidiary of HLB Life Science, is introducing next-generation targeted anticancer substances from the Lead Discovery Center (LDC), a global new drug candidate research institute in Germany, and conducting joint research (Press release, HLB Life Science, AUG 9, 2023, View Source;word=&page=1&v=386 [SID1234649276]).

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HLB Life Science R&D announced on the 9th that it signed a contract to acquire the global rights to the new anticancer substance discovered by LDC. The acquisition amount consists of a portion of the upfront payment, as well as stage-by-stage milestones and sales royalties.

LDC is a company that was spun off in 2008 from the Max Planck Society, a world-class research institute in Germany that has produced 32 Nobel Prize winners. Since its establishment, it has transferred more than 20 new drug technologies to leading global pharmaceutical companies. It is currently conducting more than 120 research projects on various diseases, including cancer, autoimmune, metabolic, cardiovascular, central nervous, and infection.

The targeted anticancer substance introduced by HLB Life Science R&D this time was also created through collaboration with the Max Planck Society Institute of Molecular Physiology. The substance, which inhibits the transcription process of a specific gene that helps cancer cells damaged by anticancer drugs to recover on their own, has confirmed a high killing effect on cancer cells through early research in the non-clinical stage.

HLB Life Science R&D plans to complete the non-clinical stage through joint research with LDC along with the new drug substance technology transfer and enter the clinical stage as quickly as possible.

Han Yong-hae, Chief Technology Officer (CTO) of HLB Group and Head of HLB Life Science R&D, said, "After a long period of in-depth discussions with LDC on discovering targeted anticancer drugs with new mechanisms, we recently agreed to begin full-scale development of next-generation targeted anticancer agents through joint research between the two companies."

He added, "As soon as we acquire LDC’s new drug substance, we will begin full-scale research and development at HLB Life Science R&D’s new drug research center."

"We are very pleased to form a strong partnership with HLB Life Science R&D," said Bert Klebble, CEO of LDC. "HLB Life Science R&D has the high capacity to stably develop anticancer compounds that are the culmination of our research results." Meanwhile, HLB Life Science R&D

is conducting research to develop an animal anticancer agent for the targeted anticancer agent ‘rivoceranib’ and to develop a medical cannabis treatment.

On August 9, 2023 Syros Pharmaceuticals, Inc. (the "Company") reported to have received notice from Incyte Corporation ("Incyte") that Incyte has elected to terminate the Target Discovery, Research Collaboration and Option Agreement dated January 8, 2018 by and between the Company and Incyte (the "Agreement") related to the discovery, development and commercialization of novel therapies for myeloproliferative neoplasms (Filing, 8-K, Syros Pharmaceuticals, AUG 9, 2023, View Source [SID1234634281]). Incyte exercised its right to terminate the Agreement for convenience. The termination will be effective within sixty days of August 9, 2023.

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Under the terms of the Agreement, the Company agreed to identify and conduct initial validation of novel therapeutic targets with a focus on myeloproliferative neoplasms, and Incyte received options to obtain exclusive worldwide rights to intellectual property resulting from the collaboration for the development and commercialization of therapeutic products directed to up to seven validated targets. The Company completed all of its allocated target identification and validation activities under the Agreement. Incyte elected not to exercise its option rights to any of the identified targets.

Incyte previously paid the Company $10.0 million in up-front consideration in connection with entering into the Agreement. The Company was also eligible to receive certain target selection milestone payments and option exercise fees if Incyte selected targets for validation and exercised its options to obtain exclusive rights to collaboration intellectual property for therapeutic products directed to validated targets, as well as other potential development, regulatory and commercial milestone payments and low single-digit royalties on net sales for any therapeutic product resulting from the collaboration. The Company will not receive any of these milestone payments or royalties.

The foregoing description of the terms of the Agreement does not purport to be complete and is subject to, and is qualified in its entirety by, reference to the Agreement filed, with confidential terms redacted, as Exhibit 10.22 to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2017, and the subsequent letter agreement, dated November 18, 2019, by and between the Company and Incyte, which was filed with confidential terms redacted as Exhibit 10.21 to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2019.