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.

On August 22, 2022 DisperSol Technologies, LLC, a specialty pharmaceutical company, reported the appointment of Tim Scott as president and chief executive officer (CEO) of the Company (Press release, DisperSol Technologies, AUG 22, 2022, View Source [SID1234618545]). At the same time, the Company announced that it is changing its name to AustinPx, Pharmaceutics and Manufacturing, to better reflect the Company’s new direction as a contract development and manufacturing organization (CDMO) . Mr. Scott also joins the board of directors of AustinPx.

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The hiring of Mr. Scott and the Company name change to AustinPx, Pharmaceutics and Manufacturing, are part of a shift in the focus of the pharmaceutical technology company that first developed KinetiSol technology, a patented amorphous dispersion technology for improving drug bioavailability. The Company will now provide pharmaceutical chemistry services including analytical and formulation development and cGMP manufacturing at its site in Austin, Texas.

Mr. Scott was the co-founder and president of Pharmatek Laboratories from 1999 until 2016, when he sold the Company to Catalent Pharma Solutions (NYSE: CTLT). He currently serves as board chair of Biocom, a trade organization supporting 2,000 life science companies. Mr. Scott also serves on the Medical Research Advisory Committee for the Conrad Prebys Foundation, providing grants to innovative research in the health sciences.
"I can think of no one better to lead the transformation of AustinPx than Tim," said Shaun Kirkpatrick, President at Research Corporation Technologies and board chair of AustinPx. "He brings a wealth of experience in building a contract development and manufacturing business, and he has strong connections throughout the industry. We are delighted to have his leadership as we build AustinPx into a world class CDMO."

"Our goal is to build a client-centric organization that provides drug development and manufacturing services for pharma companies worldwide," says Scott. "The name AustinPx represents where we come from and what we do. Px stands for Pharmaceutics. To our core, we are a pharmaceutics company. Our approach is data-driven and agnostic, which means our formulation strategy for each drug is based on the unique physiochemistry of that compound. And for poorly soluble compounds, we have one of the most powerful tools available in KinetiSol, a truly next generation technology for rendering active pharmaceutical ingredients amorphous."
KinetiSol is a proprietary technology for improving drug bioavailability. This advanced technology transforms active pharmaceutical ingredients into amorphous solid dispersions,
512.686.4740 www.AustinPx.com [email protected]
thereby enhancing the physiochemistry and PK of drugs. KinetiSol offers many advantages over other amorphous dispersion technologies. It provides a broader formulation design space and a more efficient scale-up. Additionally, KinetiSol’s significantly smaller ecological footprint makes it a greener technology.

On August 22, 2022 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported that the Company has completed the sale of its wholly-owned non-healthcare subsidiary, Trans Ova Genetics, L.C. ("Trans Ova"), an industry-leading animal reproductive technologies company, to URUS, a holding company with cooperative and private ownership, for $170 million in upfront cash and up to $10 million earn-out based on the performance of Trans Ova in 2022 and 2023 (Press release, Precigen, AUG 22, 2022, View Source [SID1234618543]). The Company intends to use the proceeds to pay the senior convertible notes.

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