On August 22, 2022 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported financial results for the second quarter ended June 30, 2022, and provided a corporate update (Press release, MAIA Biotechnology, AUG 22, 2022, View Source [SID1234618550]).

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"We continue to make significant progress with advancing the clinical development of THIO. We recently dosed the first patient in our Phase 2 clinical trial for NSCLC, THIO-101, for Non-Small Cell Lung Cancer. We have received orphan drug designation from the FDA for two other oncology indications – SCLC and HCC," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer.

"We are thrilled to have recently strengthened our balance sheet with the completion of our July IPO and continue to maintain no long-term debt," stated Joe McGuire, MAIA’s Chief Financial Officer.

Corporate Highlights

FDA Orphan Drug Designation for THIO for SCLC: The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to THIO, a telomere-targeting agent currently in development to evaluate its activity in NSCLC cancer indications, for the treatment of small-cell lung cancer (SCLC).

First patient dosed in Phase 2 trial in NSCLC: The first patient has been dosed in MAIA’s Phase 2 clinical trial, THIO-101, evaluating the administration of THIO in sequence with cemiplimab in patients with advanced Non-Small Cell Lung Cancer (NSCLC). The trial designed to evaluate THIO’s anticancer activity and potential immune system activation effects in NSCLC patients by administering THIO in advance of the checkpoint inhibitor cemiplimab (developed by Regeneron), allowing for patient immune system activation and PD-1 sensitivity to take effect.

Research collaboration with Nationwide Children’s Hospital: MAIA has entered into a research and collaboration agreement with the Nationwide Children’s Hospital to evaluate the potential of THIO in combination with current standard-of-care therapies for brain cancer. The organizations will conduct preclinical studies to assess the efficacy and safety of THIO in combination with radiotherapy and immune checkpoint inhibitors in vitro and in vivo models.

FDA Orphan Drug Designation for THIO for HCC: The FDA has granted ODD to THIO for the treatment of hepatocellular carcinoma (HCC).

Wholly owned subsidiaries established to support global development of THIO: MAIA established two wholly owned subsidiaries in Romania and Australia to broaden and accelerate its global development plan for THIO.

Initial public offering (IPO): MAIA completed its IPO on August 1st and has commenced trading on the NYSE American under the ticker symbol "MAIA." The gross proceeds from the initial public offering and the exercise of the overallotment option were $11.5 million prior to deducting underwriting discounts, commissions, and other offering expenses.

Second Quarter 2022 Financial Results

Cash Position: The Company had cash totaling $8.2 million as of June 30, 2022, compared to $10.6 million in cash as of December 31, 2021. Current cash with proceeds from the initial public offering is anticipated to be sufficient to fund operations for the next 24 months.

Research and Development (R&D) Expenses: R&D expenses were approximately $2.1 million for the quarter ended June 30, 2022, compared to approximately $0.6 million for the same quarter of 2021. The increase for the quarter was primarily due to the increase in clinical expenses related to clinical preparation and the startup of the THIO trials of approximately $1.0 million, an increase in payroll and bonus expenses of approximately $0.6 million, offset by a decrease in stock-based compensation of approximately $0.1 million. R&D expenses included approximately $0.2 million and $0.3 million of non-cash stock compensation expense in the second quarter 2022 and 2021, respectively.

General and Administrative (G&A) Expenses: G&A expenses were approximately $1.3 million for the quarter ended June 30, 2022, compared to approximately $0.9 million for the same quarter of 2021. The increase for the quarter was primarily due to approximate increases in payroll and bonus expenses of $0.2 million, professional fees of $0.2 million, and other general fees of $0.1 million, offset by a decrease in stock-based compensation of approximately $0.1 million. G&A expenses included approximately $0.4 million and $0.4 million of non-cash stock compensation expense in the quarters ended June 30, 2022, and 2021, respectively.

Other Income (Expense): Other income was approximately $0.1 million for the quarter ended June 30, 2022, and other expense for the quarter ended June 30, 2021, was approximately $2.0 million. Other income in the quarter ended June 30, 2022, consisted primarily of approximately $0.1 million in Australian research and development incentives. Other expense for the quarter ended June 30, 2021, primarily consisted of interest expense of approximately $0.3 million, the change in the fair values of the warrant liability of approximately $1.6 million, and the change in the fair value of the bifurcated embedded features of approximately $0.1 million.

Net Income (Loss): Net loss was approximately $3.3 million for the quarter ended June 30, 2022, as compared to net loss of approximately $3.5 million for the same quarter of 2021.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On August 22, 2022 Prana Thoracic, Inc., reported that Nucore Medical, Inc., the company’s wholly owned subsidiary has been awarded a $3M grant from the Cancer Prevention and Research Institute of Texas ("CPRIT"). Prana Thoracic is a medical device company developing the first minimally invasive lung tissue excision tool for early interception of lung cancer (Press release, Prana Thoracic, AUG 22, 2022, View Source [SID1234618549]). The CPRIT award will help fund the commercialization of Prana Thoracic’s technology through first-in-human studies.

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"We’re excited to be recognized by CPRIT and believe this award speaks to the potential of Prana Thoracic’s surgical oncology devices. This funding will accelerate our technology to the bedside, enabling us to provide Texans and patients all over the world with a definitive diagnosis of their pulmonary nodules earlier in their patient journey," said Joanna Nathan, CEO and founder of Prana Thoracic.

Lung cancer is the leading cause of cancer death in the U.S., making up almost 25% of all cancer deaths. Most lung cancers are diagnosed late, after the disease has spread, making survival limited. While over 14 million patients in the U.S. each year are eligible for lung cancer screening, less than 5% of these patients are currently undergoing the procedure. With Prana Thoracic’s technology – which is minimally invasive and tissue-sparing – physicians can target nodules that are challenging to sample, leading to definitive diagnosis, and dramatically improving outcomes.

"There has long been a gap between a simple needle biopsy of a nodule deep in the lung and opening the chest to remove a large segment of the lung to help diagnose early lung cancer, particularly when the nodules are very small," Dr. Edward Boyle, MD, founder and one of the inventors of the technology. "As inventors, we partnered with the Johnson & Johnson MedTech Center for Device Innovation to help take this through design and early testing. At this point we are eager to advance the technology through first-in-human studies."

On August 22, 2022 Solasia Pharma K.K. (TOKYO:4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter "Solasia") officially announced today that an organoarsenic drug "DARVIAS Injection 135mg" (SP-02, hereinafter DARVIAS) has been launched in Japan for use in relapsed or refractory Peripheral T-Cell Lymphoma (Press release, Solasia, AUG 22, 2022, View Source [SID1234618548]). DARVIAS will be commercialized by Nippon Kayaku Co., Ltd. (TOKYO:4272, Headquarters: Tokyo, Japan, President: Atsuhiro Wakumoto).

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On August 22, 2022 Oncotelic Therapeutics, Inc. ("Oncotelic", "We" or the "Company") (OTCQB:OTLC) reported financial results for the three months ended June 30, 2022 ("Q2 2022") as compared to the three months ended June 30, 2021 ("Q2 2021") (Press release, Oncotelic, AUG 22, 2022, View Source [SID1234618547]). The financial results are based on the Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 22, 2022.

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Highlights for Q2 2022 and thereafter:

As previously reported, on March 31, 2022, we entered into a joint venture, or JV, with Dragon Overseas Capital Ltd. (Dragon Overseas) and GMP Biotechnology Ltd. (GMP Bio). Dragon Overseas and GMP Bio are affiliated with Golden Mountain Partners (GMP). GMP Bio also has a wholly owned subsidiary, Sapu Therapeutics, LLC, which in turn has 2 wholly owned subsidiaries, namely Sapu Bioscience, LLC and Sapu Holdings, LLC.

The plan of the JV is to develop and ultimately market OT-101, individually and/or in combination with other products, along with our JV partners. Also, the JV is intended to be taken into an initial public offering (IPO) as some time in the future.

We plan to evaluate the development plans for the rest of our assets and see if we can leverage that to raise additional funding or seek similar strategic partnerships to monetize our assets and increase shareholder value, without or with minimal dilution to our shareholders.

Other highlights of the JV transaction include:

Oncotelic licensed OT-101 to the JV for a 45% ownership in the JV, recorded a fair value of over $22.6 million for the investment and recorded a gain of approximately $17 million.
Dragon Overseas investing approximately $27.6 million for the 55% ownership of the JV.
Oncotelic would receive up to $50 million on sale of the RPD voucher, following marketing approval of OT-101 for diffuse intrinsic pontine glioma, or DIPG, by the US Food and Drug Administration.
The JV, or a subsidiary to be taken into an IPO, is to be domiciled in Hong Kong at a future point in time.
Initial focus of JV on the further development and commercialization of OT-101, including for DIPG as well as pancreatic cancers and glioblastoma.
"With the JV transaction, commencing Q2 2022, we have recorded a one-time profit of approximately $16 million, primarily on the gain on transfer of OT-101 to the JV of approximately $17.0 million and substantial cost reductions due to transfer of our payroll and operational costs related to OT-101 to the JV." Commented Amit Shah, CFO. "This quarter has been transformational for the Company. The results of this quarter allow the Company to focus on uplisting activities going forward."

Comparing Q2 2022 to Q2 2021, we reported a net profit, before non-controlling interests, of approximately $16.0 million compared to a net loss of approximately $3.6 million, respectively. The higher gain of approximately $19.5 million for Q2 2022 as compared to Q2 2021 was primarily due to a gain on derecognition of non-financial asset, of approximately $17 million, reduced stock-based compensation by approximately $2 million recorded in Q2 2022 compared to Q2 2021, lower compensation expenses of approximately $1 million, reimbursement of expenses by a related party of approximately $0.25 million and higher interest expense of $0.7 million.

Comparing our research and development ("R&D") expenses between Q2 2022 and Q2 2021, our R&D expenses decreased by approximately $0.8 million for Q2 2022 compared to the Q2 2021, primarily due to personnel and operational expenses related to OT-101 being borne by the JV.

Comparing our general and administrative ("G&A") expenses between Q2, 2022 and Q2 2021, our G&A expenses decreased by approximately $2.6 million, primarily due to lower stock compensation expense of approximately $2.0 million during Q2 2021 as compared to $25 thousand during Q2 2022, and lower compensation and operational expenses of approximately $0.3 million which was borne by the JV.

As a result of our JV, we expect our future R&D and G&A expenses to be significantly lower, especially those related to OT-101 and payroll related costs.

Comparing our interest expense for Q2 2022 and Q2 2021, our interest expense increased by $0.7 million based on approximately $1.1 million for Q2 2022, primarily in connection with debt raised from convertible notes and the JH Darbie Financing, the November 2021 to March 2022 Financing and May/June 2022 financing as compared to $0.4 million for Q2 2021, in connection with debt raised from convertible notes and JH Darbie during 2021.

During Q2 2022, the Company was reimbursed approximately $0.25 million on behalf of our JV.

During Q2 2022, we recorded a non-cash gain of approximately $16.9 million on the derecognition of our non-financial asset upon the transfer of OT-101 as our capital contribution for the JV. We adopted the fair value measurements under the equity method and the gain was net of the fair value of the asset of approximately $22.6 million as reduced by the value of the intangibles of approximately $0.8 million for OT-101 and the value of the goodwill of $4.9 million recorded at the time of the 2019 Merger with Oncotelic Inc.

During Q2 2022, we recorded approximately $0.1 million change in value of derivatives upon conversion of certain debt from liability as compared to approximately $0.6 million during Q2 2021.

On August 22, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate tumor-specific T cells directly within the patient’s body, reported that it has dosed the first patient in a Phase 1 dose escalation study evaluating CUE-102, its second clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics, as a monotherapy for the treatment of patients with Wilms’ Tumor 1 (WT1)-positive recurrent/metastatic cancers (Press release, Cue Biopharma, AUG 22, 2022, View Source [SID1234618546]). The study will initially focus on colorectal, gastric, pancreatic, and ovarian cancers.

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"Initiating this Phase 1 clinical study of CUE-102 at a starting dose of 1mg/kg, a clinically active dose in our Phase 1 CUE-101 clinical trial for HPV+ head and neck cancer, is an important step forward in demonstrating the modularity of our Immuno-STAT platform and the broader clinical potential of our CUE-100 series of biologics," said Dan Passeri, chief executive officer of Cue Biopharma. "We believe, given the preservation of the core molecular framework between CUE-102 and CUE-101 with the primary exception of the tumor-specific epitope, initiating the dose escalation trial at 1 mg/kg will result in reduced time and cost to evaluate tolerability at therapeutically active doses."

Ken Pienta, M.D., acting chief medical officer of Cue Biopharma, added, "CUE-102 has the potential to activate the patient’s immune system against numerous WT1-expressing cancers, including solid tumors and hematologic malignancies, and has demonstrated selective and significant activation of WT1-specific T cells in preclinical studies. We believe that CUE-102 can play an important role in changing the treatment landscape for patients with WT1-positive cancers, by potentially delivering higher efficacy and lower toxicities than current available treatments."

WT1 is a well-recognized onco-fetal protein that is known to be over-expressed in several cancers, including solid tumors and hematologic malignancies such as gastric, glioblastoma, pancreatic, ovarian, endometrial, breast, lung, colorectal and acute myeloid leukemia (AML). Patients with WT1-expressing cancers, and those with recurrent metastatic disease, represent an important unmet clinical need and underscore the opportunity for this promising new therapeutic.

About the CUE-102 Clinical Trial
The trial (NCT05360680) is a multi-center, open-label, Phase 1 dose escalation and expansion study evaluating the safety, tolerability, anti-tumor activity, and immunogenicity of CUE-102 in HLA-A*0201 positive patients with WT1-positive recurrent/metastatic cancers who have failed conventional therapies. The study is designed to enroll approximately 50 patients.

About CUE-102
Leveraging the Immuno-STAT (Selective Targeting and Alteration of T cells) platform of targeted interleukin 2 (IL-2) therapies and the ongoing development of the CUE-100 series including CUE-102 being developed as a novel therapeutic fusion protein to selectively activate tumor antigen-specific T cells to treat Wilms’ Tumor 1 (WT1)-expressing cancers. CUE-102 consists of two human leukocyte antigen (HLA) molecules presenting a WT1 peptide, four affinity-attenuated IL-2 molecules, and an effector attenuated human immunoglobulin G (IgG1) Fc domain. WT1 is a well-recognized onco-fetal protein known to be over-expressed in several cancers, including solid tumors and hematologic malignancies.

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient’s body. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About Immuno-STAT
The company’s Immuno-STAT (Selective Targeting and Alteration of T cells) platform biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a peptide-major histocompatibility complex (pMHC) to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in selective T cell modulation. Because our drug candidates are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo) and reinfused.