On August 14, 2023 NightHawk Biosciences (NYSE American: NHWK), a fully integrated biopharmaceutical company specializing in the end-to-end development, manufacturing, and commercialization of innovative medical countermeasures that combat unmet and emerging biothreats, reported strategic, financial, and operational updates for the quarter ended June 30, 2023 (Press release, NightHawk Biosciences, AUG 14, 2023, View Source [SID1234634360]).

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Jeff Wolf, Chief Executive Officer of NightHawk, commented, "Development of our biomanufacturing operations, continues to progress. Specifically, we continue to invest in our San Antonio facilities and are currently evaluating a variety of strategic options to advance these operations. In parallel, we are continuing our R&D activities, and are highly encouraged by the latest preclinical data. Towards this end, our strategy is to further develop these potential therapies through key milestones, with a focus on licensing or partnering these assets to maximize value for shareholders. We look forward to providing updates on these programs."

Second Quarter 2023 Financial Results

For the three months ended June 30, 2023 we recognized $0.7 million of revenue from process development. For the three months ended June 30, 2022 we recognized $0.05 million of service revenue. The increase in process development revenue is attributable to the operations of the San Antonio CDMO facility.
Research and development expenses increased approximately 21.3% to $5.7 million for the three months ended June 30, 2023 compared to $4.7 million for the three months ended June 30, 2022. The components of R&D expense are as follows, in millions: HS-110 expense increased by $0.3 million primarily due to site close out fees; HS-130 expense decreased to $0 from $0.1 million due to the de-prioritization of our oncology assets; PTX-35 expense decreased by $0.4 million primarily due to the discontinued clinical trial and development of the product candidate in the third quarter of 2022; ANTHIM was not acquired until the second quarter of 2022 and the 2023 expense primarily relates to fill finish; other programs expense decreased by $0.3 million primarily due to a decrease in laboratory supplies expense related to preclinical R&D expenses; and unallocated research expenses increased by $0.9 million primarily due to increased personnel costs, including stock-based compensation from stock awards, contractor expense and supplies purchased for discovery projects.

Cost of revenues were $0.4 million for the three months ended June 30, 2023. These expenses primarily reflect direct cost of labor, overhead and material costs. There was no cost of revenues for the three months ended June 30, 2022 as the Scorpius facility was not operational.

Selling, general and administrative expenses were $7.4 million and $4.9 million for the three months ended June 30, 2023 and 2022, respectively. The increase was primarily due to increases in consulting and other professional expenses of $0.7 million, personnel expense of $0.5 million, marketing expense of $0.5 million, facility expense of $0.3 million, rent expense of $0.2 million, depreciation and amortization of $0.3 million, insurance and taxes of $0.2 million, offset by a decrease in supplies expense of $0.2 million.
Net loss attributable to NightHawk Biosciences was approximately $13.9 million, or ($0.53) per basic and diluted share, for the three months ended June 30, 2023, compared to approximately $6.8 million, or ($0.27) per basic and diluted share, for the three months ended June 30, 2022.
As of June 30, 2023, the Company had approximately $18.6 million in cash, cash equivalents, and short-term investments.

On August 14, 2023 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported financial results for the second quarter ended June 30, 2023 (Press release, Tracon Pharmaceuticals, AUG 14, 2023, View Source [SID1234634359]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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"We were pleased to collect the arbitration award of $22M, the initial net proceeds of which extend our cash runway into early 2024 and past expected full accrual of the ENVASARC pivotal trial," said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. "We look forward to reporting the interim efficacy assessment from ENVASARC later this quarter, which includes a futility threshold that has already been achieved based on responses seen to date. In June, we reported that envafolimab treatment continues to generate a double-digit objective response rate (ORR) and has been well tolerated, and as such we believe that we remain on track to achieve the primary endpoint of the study, which is a minimum 11.25% ORR. Achieving a double-digit ORR with a well-tolerated safety profile positions envafolimab to become a potentially compelling treatment option for patients with the refractory sarcoma subtypes of UPS and MFS. The sole approved treatment for these patients is Votrient, which achieved a 4% ORR and carries a black box warning for fatal liver toxicity."

Recent Corporate Highlights

In June, we announced an ongoing double-digit ORR for single agent envafolimab in patients with two on-study scans in the ongoing ENVASARC Phase 2 pivotal trial without any > Grade 2 drug related toxicity. The single agent envafolimab ORR exceeded the futility rule that will be applied at the interim efficacy analysis expected later this quarter, and full ENVASARC accrual is expected in the fourth quarter.

In July, we announced collection of the arbitration award of $22M from I-Mab Biopharma, with the initial net proceeds of $7.1 million expected to fund the Company’s operations, as currently planned, into early 2024.

Expected Upcoming Milestones

Report the second and final interim efficacy analysis from the ENVASARC pivotal trial following the review of more than 12 weeks of efficacy data (including two on-study CT scans) by the IDMC from 46 patients who receive envafolimab as a single agent, which we expect later this quarter as the ENVASARC trial has enrolled 180 patients to date, including 56 of the 80 expected patients in cohort C of single agent envafolimab treatment that is the basis for determination of the primary endpoint of the study, which is a minimum 11.25% ORR.

Complete accrual of the ENVASARC pivotal trial in the fourth quarter of 2023.

Leverage TRACON’s cost-efficient, CRO-independent product development platform to generate non-dilutive capital by the end of 2023.

Final data from ENVASARC pivotal trial in mid-2024.

Second Quarter 2023 Financial Results

Cash, cash equivalents and restricted cash were $1.9 million at June 30, 2023, compared to $17.5 million at December 31, 2022, which does not include the $7.1 million in initial net proceeds from the arbitration award that was received in July. TRACON’s pro forma cash position of $9.0 million is expected to fund the Company into the first quarter of 2024.

An additional $4.4M of the arbitration award remains in a client trust account administered by our law firm at this time, the disbursement of which is predicated on discussions as to the amount of success-based deferred legal fees the firm is due.

Collaboration revenue was $9.0 million for the second quarter of 2023, compared to nil for the second quarter of 2022. The increase was related to the termination of the TJ4309 license.

Research and development expenses for the second quarter of 2023 were $3.5 million, compared to $2.9 million for the second quarter of 2022. The increase was primarily related to increased enrollment into the ENVASARC pivotal trial.

General and administrative expenses for the second quarter of 2023 were $1.9 million, compared to $3.3 million for the second quarter of 2022. The decrease was primarily attributable to lower legal expenses.

Net loss for the second quarter of 2023 was $6.3 million, compared to $6.2 million for the second quarter of 2022. In July we collected the arbitration award from I-Mab which will result in a one-time gain in the third quarter of 2023 of $13.0 million.

Conference Call Details

To access the call by phone, please register using this link and you will be provided with dial-in details.

A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients as well as multiple Phase 1 and Phase 2 clinical trials in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. TRACON has received orphan drug designation from the U.S. Food and Drug Administration for envafolimab for patients with soft tissue sarcoma and fast track designation from the U.S. Food and Drug Administration for envafolimab for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

About YH001

YH001 is an IgG1 antibody against CTLA-4 that has shown enhanced antibody dependent cellular cytotoxicity and complement dependent cytotoxicity in vitro. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab. YH001 also demonstrated superior activity compared to ipilimumab in human transgenic mouse tumor models when combined with a PD-(L)1 antibody. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 is being studied with envafolimab and doxorubicin in a Phase 1/2 clinical trial sponsored by TRACON (NCT05448820), and has been studied in multiple Phase 1 trials in China and Australia sponsored by TRACON’s corporate partner Eucure, a division of Biocytogen.

About TRC102

TRC102 (methoxyamine) is a novel small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the FDA in malignant glioma, including glioblastoma.

On August 14, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the second quarter ended June 30, 2023, and recent corporate highlights (Press release, Checkpoint Therapeutics, AUG 14, 2023, View Source [SID1234634358]).

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"We continue to work with the U.S. Food and Drug Administration ("FDA") toward the January 3, 2024 action date for our Biologics License Application ("BLA") for cosibelimab. Recently, our mid-cycle communication meeting with the FDA was successfully completed, and the FDA noted that no significant review issues or safety concerns have been identified in their review to date," said James Oliviero, President and Chief Executive Officer of Checkpoint.

"We are also encouraged by the recently announced longer-term data from our pivotal studies of cosibelimab in locally advanced and metastatic cutaneous squamous cell carcinoma ("cSCC"), which demonstrate a deepening of response with cosibelimab treatment over time, resulting in substantially higher complete response rates than previously reported. Specifically, complete response rates more than doubled from 10% to 23% in locally advanced cSCC and nearly doubled, from 8% to 13%, in metastatic cSCC," continued Oliviero. "We believe cosibelimab’s unique dual mechanism of action will benefit not just immunocompetent patients, but also the large number of difficult-to-treat patients with immunosuppressive conditions or taking immunosuppressive medications who are in need of more effective treatment options than available today."

"Equally important, longer-term results continue to confirm cosibelimab’s favorable safety profile, with only 2% of patients experiencing a severe immune-related adverse event ("irAE") and only 1% discontinuing treatment because of an irAE, substantially lower rates than observed with currently approved immunotherapies. We believe cosibelimab’s favorable safety profile should position the product as the preferred immunotherapy of oncologists for high-risk patients, such as those with solid organ transplants or autoimmune disease, upon its potential launch early next year," concluded Oliviero.

Recent Corporate Highlights:

Checkpoint submitted a BLA to the FDA seeking approval of cosibelimab in January 2023. In March 2023, Checkpoint announced the FDA accepted the BLA filing for cosibelimab and set a Prescription Drug User Fee Act ("PDUFA") goal date of January 3, 2024. In its BLA filing acceptance letter, the FDA indicated that no potential filing review issues have been identified, and that an advisory committee meeting to discuss the application is not currently planned.
In April, May and July 2023, Checkpoint completed registered direct offerings priced at-the-market under Nasdaq rules for total gross proceeds of approximately $26.1 million.
In June 2023, Checkpoint announced that new pharmacokinetic modeling data on cosibelimab supporting the extension to an every-three-week dosing regimen were presented at the Population Approach Group Europe 2023 annual meeting. Results support the comparability of cosibelimab 800 mg every-two-week and 1200 mg every-three-week dosing regimens.
In July 2023, Checkpoint announced new, longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cSCC. These results demonstrate a deepening of response with cosibelimab treatment over time, resulting in substantially higher complete response rates than previously reported. Furthermore, responses continue to remain durable over time with the median duration of response not yet reached in either the locally advanced or metastatic cSCC group.
Financial Results:

Cash Position: As of June 30, 2023, Checkpoint’s cash and cash equivalents totaled $7.4 million, compared to $4.8 million at March 31, 2023 and $12.1 million at December 31, 2022, an increase of $2.6 million for the quarter and a decrease of $4.7 million for the first half of 2023. Subsequent to the end of the second quarter, Checkpoint raised approximately $10.0 million of gross proceeds in a registered direct offering completed in July 2023.
R&D Expenses: Research and development expenses for the second quarter of 2023 were $13.9 million, compared to $12.1 million for the second quarter of 2022, an increase of $1.8 million. Research and development expenses for the second quarter of 2023 primarily consisted of $9.9 million related to commercial manufacturing costs and inventory build for cosibelimab to support a potential 2024 launch.
G&A Expenses: General and administrative expenses for the second quarter of 2023 were $2.3 million, compared to $2.1 million for the second quarter of 2022, an increase of $0.2 million. General and administrative expenses for the second quarter of 2023 included $0.8 million of non-cash stock expenses, compared to $0.5 million for the second quarter of 2022.

Net Loss: Net loss attributable to common stockholders for the second quarter of 2023 was $16.5 million, or $1.05 per share, compared to a net loss of $14.1 million, or $1.62 per share, in the second quarter of 2022. Net loss for the second quarter of 2023 included $1.0 million of non-cash stock expenses, compared to $0.7 million for the second quarter of 2022.

On August 14, 2023 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported its financial results for the quarter ended June 30, 2023, provided a corporate update and reiterates upcoming milestones (Press release, CNS Pharmaceuticals, AUG 14, 2023, View Source [SID1234634357]).

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"We are approaching the most important milestone to date since we launched CNS Pharma. We are just a few months away from reporting topline results from our Berubicin potentially pivotal study interim analysis and, although we do not know what the data looks like at this time, we remain hopeful as we also approach full enrollment of the trial," commented John Climaco, CEO of CNS Pharmaceuticals. "Looking ahead, we remain focused on executing on all of our operational efforts and importantly, taking our Berubicin trial for GBM across the finish line. We are poised for an exciting remainder of the year with significant milestones anticipated in the near term and look forward to optimizing our opportunities to build value for all shareholders in the near and long-term."

Recent Clinical Achievements

· Presented updated results from the on-going potentially pivotal study evaluating Berubicin in a poster presentation at the 2023 SNO/ASCO CNS Cancer Conference.
· Announced enrollment of 180 patients; The Company has opened 46 clinical trial sites of the 60 sites selected across the U.S., Italy, France, Spain, and Switzerland.
· Announced that the Company has reached the criteria required by the study protocol to conduct a pre-planned, non-binding futility analysis, which an independent Data Safety Monitoring Board will review to determine whether to recommend continuing the study as planned based on Berubicin showing potential value as a second-line treatment for patients with glioblastoma (GBM).
· Pace of enrollment is rapidly accelerating with the first 75 patients taking 18 months to enroll while the second 75 patients took less than 6 months to enroll.

Recent Corporate Achievements

·
Completed the initial phase of investigation with Shareholder Intelligence Services, LLC into potential naked short selling. As part of the investigation, the Company believes it was able to identify and eliminate the majority of the reported naked short selling activity, although there is no assurance the Company’s common stock will not experience such pressure in the future. The investigation is moving into its second phase of monitoring and taking further actions to continue to reduce the level of naked short selling.

Upcoming Expected Milestones for Potentially Pivotal Trial of Berubicin for GBM, in the order expected:

· Achieve enrollment of 200th patient in Q3 2023.
· Report topline results of interim analysis expected in Q4 2023.
· Complete enrollment in Q4 2023.

Summary of Financial Results for the Second Quarter 2023

The net loss for the three months ended June 30, 2023 was approximately $4.0 million compared to approximately $3.6 million for the comparable period in 2022. The change in net loss is attributable to an increase in research organization (CRO) expenses related to continued progress with the Company’s clinical trial, a credit to research and development expense in the prior year period for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their clinical trials, as well as increases in legal and professional fees and other expenses.

The Company reported research and development expenses of $2.8 million for the three months ended June 30, 2023 compared to approximately $2.2 million for the comparable period in 2022. The increase in research and development expenses during the period were mainly attributed to the timing of CRO expenses related to continued progress with the Company’s clinical trial.

General and administrative expense was approximately $1.2 million for the three months ended June 30, 2023 compared to approximately $1.3 million for the comparable period in 2022. The decrease in general and administrative expense was mainly attributable to decreases of approximately $176,000 for employee compensation and taxes, $100,000 in legal and professional expenses, $22,000 in insurance expenses and $12,000 in other expenses, which were offset by increases of approximately $60,000 in marketing and advertising, $24,000 in board compensation and $39,000 in travel expenses.

As of June 30, 2023, the Company had cash of approximately $4.3 million and working capital of approximately $2.1 million. The Company’s current expectation is that the cash on hand is sufficient to fund operations into the fourth quarter of 2023, through the topline data readout for the Berubicin potentially pivotal study. The timing and costs of clinical trials are difficult to predict and trial plans and timing of milestones may change in response to evolving circumstances and as such the foregoing estimates may prove to be inaccurate.

On August 14, 2023 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, is pleased to announce that its Phase 1 MAST (metastatic advanced solid tumours) trial evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA) has cleared the cohort 3 intratumoral (IT) arm of the monotherapy dose escalation study (Press release, Imugene, AUG 14, 2023, View Source [SID1234634298]).

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This allows Imugene to commence recruitment for IT cohort 4 of the monotherapy dose escalation, whereby VAXINIA will be administered in three-to-six patients.

Imugene MD & CEO Leslie Chong said: "We continue to rapidly advance our monotherapy dose while the combination study continues its positive progress. We remain incredibly eager to bring the results of this trial to our shareholders, patients and the wider public."

The multicenter Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models¹. Overall, the study aims to recruit up to 100 patients across approximately 10 trial sites in the United States and Australia.

The clinical trial is titled "A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33-hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST)." The trial commenced in May 2022 and is anticipated to run for approximately 24 months while being funded from existing budgets and resources.

Full study details can also be found on clinicaltrials.gov under study ID: NCT05346484.