On November 14, 2022 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported financial results for the third quarter ended September 30, 2022, and provided an update on business highlights, including the announcement of a strategic collaboration and exclusive license agreements with Lantheus Holdings Inc. (NASDAQ: LNTH) for the commercialization of PNT2002 & PNT2003 (Press release, Point Biopharma, NOV 14, 2022, View Source [SID1234624036]).

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Upon consummation of the agreements, in exchange for the exclusive worldwide rights1, Lantheus will pay a total of $260 million in upfront payments between the two agreements to POINT, with the potential for additional milestone payments of approximately $1.8 billion between the two products based on U.S. Food and Drug Administration (FDA) approval and net sales and commercial milestones. Additionally, Lantheus will pay POINT royalties on net sales, beyond certain financial thresholds and subject to conditions, of 20% for PNT2002 and 15% for PNT2003. Additional terms of the agreements are summarized below and a website with more information about the collaboration is accessible at View Source and the Company’s website.

"We are very pleased to have reported the Lantheus strategic collaboration earlier this morning. The terms of the deal affirm for us the value of POINT’s platform and maximizes value for both shareholders and patients," said Joe McCann, Ph.D., CEO of POINT Biopharma. "We founded POINT to accelerate the discovery, development, and global access to life-changing radiopharmaceuticals, and with this collaboration POINT is now better positioned than ever to execute on our mission. With our financial position further strengthened, we can continue to focus on our core competencies and dedicate resources to our pipeline. Specifically, we believe that PNT2004 is an incredibly exciting, high value opportunity. PNT2004 is our pan-cancer FAP-α program, which is currently in Phase 1. We will also continue to invest in PNT2001, our actinium-225 next-generation PSMA program, which is expected to begin Phase 1 in 2023, and other next-generation radioligand opportunities."

Recent Developments and Upcoming Milestones

Pipeline Updates

PNT2002: 177Lu-based PSMA targeted radiopharmaceutical

In September 2022, the Company published a poster at ESMO (Free ESMO Whitepaper) Congress 2022 containing efficacy and safety data from the 27-patient safety and dosimetry lead-in cohort for the Company’s phase 3 SPLASH trial (NCT04647526) evaluating PNT2002 for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The poster was titled "Efficacy and Safety of 177Lu-PNT2002 prostate-specific membrane antigen (PSMA) Therapy in Metastatic Castration Resistant Prostate Cancer (mCRPC): Initial Results from SPLASH" (e-Poster #1400P). Key findings include a median rPFS time of 11.5 months, along with a well-tolerated safety profile with no treatment-related deaths and few treatment-related adverse events of grade 3 or higher.

The SPLASH trial is currently enrolling patients across 55 sites in North America, Europe, and United Kingdom, and recruitment is expected to be completed by the end of the calendar year. The Company continues to expect to report top line data from SPLASH in mid-2023.

PNT2004: fibroblast activation protein-alpha (FAP-alpha) targeted radiopharmaceutical

The phase 1 FRONTIER trial (NCT05432193) for the Company’s pan-cancer fibroblast activation protein-α (FAP-α) targeted program, PNT2004, commenced in July 2022. FRONTIER is evaluating PNT6555 (the lead candidate of PNT2004) in approximately 30 patients in five FAP-avid cancer indications: colorectal, pancreatic, esophageal, melanoma, and soft tissue sarcomas. A gallium-68 (68Ga)-based PNT6555 molecular imaging agent is being used to select patients for the study, those selected then receive a no-carrier-added (n.c.a.) lutetium-177 (177Lu)-based PNT6555 therapeutic agent.

The primary objective of the study is to determine the recommended phase 2 dose (RP2D), as guided by a modified toxicity probability interval-2 design. Phase 1 data from FRONTIER is expected in H1 2024.

PNT2001: 225Ac-labelled next-generation PSMA-targeted radiopharmaceutical

In October 2022, POINT published promising new pre-clinical data from the Company’s next-generation radioligand therapy (RLT) program for prostate cancer, PNT2001. The new PNT2001 data were shared in E-poster #039, "Development and characterization of a next-generation 225Ac-PMSA radioligand," at the 35th Annual Congress of the European Association of Nuclear Medicine (EANM) in Barcelona, Spain. The Company is targeting an IND/CTA submission for PNT2001 in H1 2023, with the first patient expected for a phase 1 clinical trial by EOY 2023.

Corporate Updates:

In September 2022, the Company closed a previously announced underwritten public offering of 13,900,000 shares of Common Stock at a public offering price of $9.00 per share. Subsequent to closing, the underwriter exercised its option to purchase an additional 1,589,779 shares. The gross proceeds to the Company from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses, were approximately $140 million.

Three Months and Nine Months Ended 2022 Financial Results

Cash, Cash Equivalents and Investments: As of September 30, 2022, POINT had approximately $291.5 million in cash, cash equivalents and investments, which is anticipated to fund operations into the fourth quarter of 2024.

Net Loss: Net loss was $24.0 million, or $0.26 net loss per share, for the three months ended September 30, 2022, as compared to a net loss of $17.1 million, or $0.19 net loss per share, for the same period in 2021. Net loss was $65.0 million, or $0.71 net loss per share, for the nine months ended September 30, 2022, as compared to a net loss of $31.7 million, or $0.46 net loss per share, for the same period in 2021.

Research and Development Expenses: Research and development expenses were $20.8 million for the three months ended September 30, 2022, as compared to $13.0 million for the same period in 2021. Research and development expenses were $54.1 million for the nine months ended September 30, 2022, as compared to $24.0 million for the same period in 2021.

General and Administrative Expenses: General and administrative expenses were $3.8 million for the three months ended September 30, 2022, as compared to $4.0 million for the same period in 2021. General and administrative expenses were $11.7 million for the nine months ended September 30, 2022, as compared to $7.4 million for the same period in 2021.

1. Excluding the following territories: China (inclusive of Taiwan, Hong Kong and Macau), Japan, South Korea, Indonesia and Singapore, which are retained by POINT.

About the SPLASH Trial

The phase 3 SPLASH trial is a multi-center, randomized, open label assessment of PNT2002 in participants with PSMA-expressing mCRPC who have progressed on androgen receptor pathway inhibitor (ARPI) therapy and refuse, or are not eligible for, chemotherapy. The randomization phase of the study is expected to enroll approximately 400 participants across North America, Europe, and the United Kingdom. Participants will be randomized 2:1 with participants in arm A receiving PNT2002 and participants in arm B receiving either abiraterone or enzalutamide. Participants in arm B who experience centrally assessed radiographic progression and meet protocol eligibility will have the option to crossover and receive PNT2002. Patients will be subject to follow-up for up to 5 years from their first PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival. Key secondary endpoints include overall response rate, overall survival, and pharmacokinetics.

About the FRONTIER Trial

The FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability, and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients with Select Solid Tumors (FRONTIER) trial is an open-label, phase 1 trial to evaluate safety, tolerability, and dosimetry of 177Lu-PNT6555 and 68Ga-PNT6555, the lead assets of the PNT2004 program. The phase 1 clinical trial commenced in summer 2022 in Canada and uses a 68Ga-based PNT6555 molecular imaging agent to select patients to receive a no-carrier-added (n.c.a.) 177Lu-based PNT6555 therapeutic agent. The phase 1 clinical protocol will evaluate PNT6555 in approximately 30 patients in five FAP-avid cancer indications: colorectal, pancreatic, esophageal, melanoma, and soft tissue sarcoma.‍

On November 14, 2022 ProMIS Neurosciences Inc. (TSX: PMN) (Nasdaq: PMN), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic misfolded proteins implicated in the development of neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), reported its third quarter 2022 financial results and recent highlights (Press release, ProMIS Neurosciences, NOV 14, 2022, View Source [SID1234624035]).

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"We continue to progress our therapeutic antibodies selective for toxic oligomers that are associated with the development and progression of neurodegenerative and other misfolded protein diseases. We are excited that our lead compound, PMN310, is advancing toward clinical stage development. Most notably, we recently closed a $7.4 million private placement, which will be used to advance PMN310 into a first-in-human study. We anticipate enrolling the first subject in the first half of 2023," said Gail Farfel, Ph.D., Chief Executive Officer of ProMIS Neurosciences. "We believe our novel discovery platform gives us the potential to advance differentiated next-generation products to address urgent unmet medical needs as in ALS and MSA, and we are excited to continue our transition toward a clinical phase biotechnology company."

Recent Highlights and Anticipated Milestones

Alzheimer’s Disease Program (PMN310)
PMN310, ProMIS’s lead compound, is a novel monoclonal antibody that is highly selective for toxic oligomers of amyloid-beta that are believed to be a major driver of AD.

ProMIS completed pilot toxicology, pharmacokinetics (PK) and tissue cross reactivity (TCR) studies and conducted the formal GLP studies to support an IND application to the U.S. Food and Drug Administration (FDA) and anticipate enrollment of the first subject in our Phase 1a trial in the first half of 2023 subject to FDA’s acceptance of the IND.
ProMIS completed the first stage of development towards a high concentration formulation that could potentially support subcutaneous dosing as a future step to improve overall convenience and patient compliance.
Other programs

Using ProMIS’s discovery platform, the Company generated high-affinity monoclonal antibodies that are selective for the misfolded toxic form of TDP-43. In April 2022, the Company announced that it selected monoclonal antibody PMN267 as the drug candidate for an ALS indication based on its binding profile and activity in cell systems and a mouse model of disease. PMN267 is undergoing humanization in a human IgG1 framework for future clinical testing.
ProMIS has selected monoclonal antibody PMN442 as its alpha-synuclein antibody drug candidate. In vivo testing in mouse disease models is ongoing with results expected in the second half of 2022. PMN442 is currently being humanized in a human IgG1 framework for future clinical testing.
ProMIS continues to advance its amyloid-beta vaccine program with the aim of developing an AD vaccine containing its oligomer target epitopes conjugated to a carrier protein in formulation with an adjuvant. A vaccination study in a mouse model of AD is ongoing.

Corporate

In October 2022, ProMIS executed a securities purchase agreement to sell, through a private investment in public equity (PIPE) financing, 1,383,755 Units of the Company at a price of $5.40 per Unit for aggregate gross proceeds of $7.4 million, before deducting placement agent fees and other offering expenses.
In September 2022, the Board of Directors approved the appointment of Gail Farfel, Ph.D., as the Company’s Chief Executive Officer, effective September 19, 2022.
The Company’s co-founder and former Chief Executive Officer, Eugene Williams, remains as Chairman of the Board.

Third Quarter Financial Highlights

Cash and cash equivalents were $4.0 million as of September 30, 2022, compared to $17.0 million as of December 31, 2021. Net proceeds from the October 2022 financing were $6.4 million.
Research and development expenses were $4.6 million for the third quarter ended September 30, 2022, compared to $0.8 million for the same period in 2021. The increase is primarily attributable to increased spending on the PMN310 program.
General and Administrative expenses were $1.4 million for the third quarter ended September 30, 2022, compared to $1.3 million for the same period in 2021.
Net loss was $6.0 million for the third quarter ended September 30, 2022, compared to $1.2 million for the same period in 2021.

On November 14, 2022 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), a clinical-stage oncology-focused cell therapy company reported financial results for the third quarter ended September 30, 2022 (Press release, Alaunos Therapeutics, NOV 14, 2022, View Source [SID1234624032]).

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"Our team has worked diligently over the past year to transform our promising technology and scientific foundation into meaningful clinical progress. We were excited to present early data from our TCR-T Library Phase 1/2 trial at CICON, where we showed for the very first time, an objective clinical response in a solid tumor using a non-viral TCR-T cell therapy. These initial safety, persistence and efficacy data reinforce the promise of our Sleeping Beauty TCR-T cell therapy to safely achieve measurable regression in solid tumors, even at the lowest dose," commented Kevin S. Boyle, Sr., Chief Executive Officer of Alaunos. "In tandem, we have successfully doubled our manufacturing capacity. We look forward to dosing the next patient in our TCR-T Library Phase 1/2 Trial as well as filing an IND amendment to expand our TCR Library and enhance the speed and flexibility of our manufacturing process using cryopreserved cell products in the fourth quarter."

Recent Developments and Upcoming Milestones

Presented encouraging clinical data from TCR-T Library Phase 1/2 Trial at CRI-ENCI-AACR Sixth International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) (CICON): In September 2022, the Company presented early data from its TCR-T Library Phase 1/2 trial targeting KRAS, TP53, and EGFR mutations across six solid tumor indications. The data represent the first report of a successful TCR-T cell therapy using the non-viral Sleeping Beauty system for solid tumors. The Company expects to dose the next patient in the study in 4Q22.

Key highlights include:

First patient dosed was diagnosed with NSCLC and was treated at dose level 1 with TCR-T cells targeting a KRAS G12D mutation. The patient achieved six-month progression-free survival, with a best overall response of objective, partial regression of greater than 50% of target lesions at 12 weeks post-cell therapy.

Second patient dosed was diagnosed with colorectal cancer and was treated at dose level 2 with TCR-T cells targeting a TP53 R175H mutation. This patient achieved a best overall response of stable disease at six weeks with 12-week progression-free survival.

Persistence of TCR-T cells was evident in both patients. Patient 1 had persistence at 24 weeks with approximately 30% of all T-cells being TCR-T cells in the blood. Patient 2 had persistence at 12 weeks with approximately 20% of all T-cells being TCR-T cells in the blood.

In both patients, the TCR-T cell therapy was well-tolerated and presented a manageable safety profile, with no dose limiting toxicities or immune effector cell-associated neurotoxicity syndrome (ICANS) observed.

Additional information about the trial is available at www.clinicaltrials.gov using the identifier: NCT05194735.

Expanded manufacturing capacity to produce two products simultaneously: The Company continues to execute on its multi-pronged strategy to expand manufacturing capacity. As a result of this initiative, the Company has doubled its existing manufacturing capacity to produce two products simultaneously.

Expect to file IND amendment in 4Q22 to expand its TCR Library and move from a fresh to cryopreserved manufacturing process: Alaunos expects to file an IND amendment in the fourth quarter, which will add two new TCRs to the Company’s TCR Library targeting frequent mutations and HLAs. This should allow the Company to increase the potential addressable market for its T-cell therapies. In addition, the Company has successfully completed process qualification runs using cryopreserved cell products to manufacture TCR-T cells, which reduces manufacturing process time from 30 days to 26 days, a 13% decrease. The IND amendment will enable the Company to move to a cryopreserved manufacturing process and add flexibility for patient scheduling and treatment.

Presented data highlighting potential of the Company’s hunTR platform to expand its TCR Library at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting: In November 2022, the Company presented a poster at the SITC (Free SITC Whitepaper) annual meeting, highlighting its proprietary hunTR (human neoantigen T-cell Receptor) platform. hunTR is a high-throughput screening process that uses state-of-the-art bioinformatics and next generation sequencing to interrogate and deconvolute thousands of single T cells simultaneously. In the study, Alaunos evaluated hundreds of thousands of TCR+HLA+neoantigen permutations in nine patients across colorectal, endometrial and breast cancers. All patients screened had at least one detectable neoantigen-reactive TCR, including one shared KRAS mutation. Further screening of additional patients only for KRAS mutations resulted in discovery of KRAS-G12V reactive TCRs. The Company plans to expand the application of hunTR to screen for additional shared KRAS, TP53, and EGFR mutations in order to rapidly advance new TCR library candidates from the lab through to clinical translation.

Third Quarter Ended September 30, 2022 Financial Results

Collaboration Revenue: Collaboration revenue was $2.9 million for the third quarter of 2022, compared to $0.4 million for the third quarter of 2021, an increase of 631%. The increase was primarily due to the achievement of sales-based milestones of darinaparsin in Japan, which was largely offset by a one-time corresponding $2.5 million Research & Development expense.

Research and Development Expenses: Research and development expenses were $7.9 million for the third quarter of 2022, compared to $14.5 million for the third quarter of 2021, a decrease of approximately 46%. Research and Development expenses during the third quarter of 2022 included a one-time $2.5 million expense as a result of the achievement of sales-based milestones of darinaparsin in Japan.

General and Administrative Expenses: General and administrative expenses were $3.3 million for the third quarter of 2022, compared to $8.2 million for the third quarter of 2021, a decrease of approximately 60%.

Net Loss: Net loss was $8.9 million, or $(0.04) per share, for the third quarter of 2022, compared to a net loss of $22.7 million, or $(0.11) per share, for the same period in 2021.

Cash and Cash Equivalents: As of September 30, 2022, Alaunos had approximately $37.8 million in cash and cash equivalents and restricted cash of $13.9 million. Operating cash burn for the third quarter of 2022 was $6.1 million compared to $9.6 million in the third quarter of 2021, a decrease of $3.4 million or 36%.

Conference Call and Webcast

Alaunos will host a conference call and webcast today, November 14, 2022, at 8:30am ET. Participants may access the live webcast using the link here or by visiting the "Investors" section of the Alaunos website at www.alaunos.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. After the live webcast, the event will be archived on the Company’s website for approximately 30 days after the call.

On November 14, 2022 Yumanity Therapeutics, Inc. ("Yumanity" or the "Company") (Nasdaq: YMTX), a clinical-stage biopharmaceutical company, reported financial results for the third quarter ended September 30, 2022 and provided an overview of the Company’s recent corporate developments (Press release, Yumanity Therapeutics, NOV 14, 2022, View Source [SID1234624031]).

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Recent Corporate Developments

On November 10, 2022, Yumanity announced the effectiveness of a registration statement on Form S-4 (the "Registration Statement") with the U.S. Securities and Exchange Commission (the "SEC") in connection with Yumanity’s previously announced proposed sale of Yumanity’s lead clinical-stage product candidate, YTX-7739, as well as Yumanity’s unpartnered discovery-stage neuroscience product candidates and targets to Janssen Pharmaceutica NV ("Janssen") for $26 million in cash as well as Yumanity’s proposed merger with Kineta, Inc. ("Kineta") under which Kineta will become a wholly-owned subsidiary of Yumanity in an all-stock transaction, resulting in a combined publicly traded company re-named Kineta, Inc. Yumanity subsequently filed a definitive proxy statement and prospectus (the "Proxy Statement") which provides important information about Yumanity and the proposed transactions, both of which were announced on June 6, 2022. Yumanity is mailing the Proxy Statement to stockholders of record as of the close of business on November 4, 2022. The Proxy Statement will be accompanied by a voting instruction form or a proxy card relating to the special meeting of Yumanity’s stockholders to approve the asset sale and merger (the "Special Meeting") which will be held in a virtual-only format via live audio webcast at 10:00 a.m., Eastern Time, on December 13, 2022, at www.virtualshareholdermeeting.com/YMTX2022SM, unless postponed or adjourned to a later date.
Third Quarter 2022 Financial Highlights

Cash position: As of September 30, 2022, cash, cash equivalents and investments were $8.4 million, compared to $36.5 million as of December 31, 2021. The decrease was primarily due to a $12.8 million payment to extinguish the Company’s remaining debt during the first quarter of 2022, spending on the clinical development of YTX-7739 primarily in the first quarter of 2022, and costs related to being a public company. As of the issuance date of the condensed consolidated financial statements for the period ended September 30, 2022, the Company expects that, absent either strategic transaction, its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses early into the first quarter of 2023.

Research and development (R&D) expense: Research and development expense was $0.7 million compared to $6.6 million for the third quarter of 2021. The decrease in R&D expense was primarily due to the elimination of a significant portion of the Company’s R&D personnel in connection with the restructuring announced in February 2022 as well as pausing of clinical development efforts for YTX-7739 while the U.S. Food and Drug Administration partial clinical hold is in effect.

General and administrative expense: General and administrative expense was $4.2 million compared to $4.5 million for the third quarter of 2021. The decrease was primarily attributable to lower personnel costs resulting from the restructuring announced in February 2022, offset by higher legal fees and investment banking fees incurred in connection with the transactions contemplated by the merger agreement with Kineta and the asset purchase agreement with Janssen.

Net loss: The Company reported a net loss of $3.4 million, or $0.31 per basic and diluted share, compared to a net loss of $10.0 million, or $0.97 per basic and diluted share for the third quarter of 2021. The decrease in net loss was due primarily to the decrease in R&D expense as described above. The Company expects to continue to generate operating losses for the foreseeable future, although at reduced expected levels as a result of restructuring actions taken in the nine months ended September 30, 2022.

On November 14, 2022 VBL Therapeutics (Nasdaq: VBLT), a clinical stage biotechnology company developing targeted medicines for immune-inflammatory diseases, reported financial results for the third quarter ended September 30, 2022, and provided a corporate update (Press release, VBL Therapeutics, NOV 14, 2022, View Source [SID1234624030]).

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"VBL’s management team and board continue to make good progress on the evaluation of strategic options for the company’s assets, including the GMP manufacturing facility and VB-601 program, with the goal of maximizing shareholder value," said Dror Harats, M.D., Chief Executive Officer of VBL. "We recently submitted our regulatory filings for a first-in-human clinical trial for the VB-601 program, and expect to initiate this trial in the first quarter of 2023, subject to the outcome of our strategic process."

Third Quarter Highlights

●Filed a regulatory submission to the Israel Ministry of Health and institutional review board to conduct a Phase 1 first-in-human trial for its lead immunology product candidate,VB-601, a targeted antibody for immune-inflammatory applications.
●Retained Chardan Capital to act as financial advisor to explore and evaluate strategic options for maximizing shareholder value.
●Took steps to preserve capital, including the workforce reduction and ceasing internal development of ofra-vec.

Financial Results for the Third Quarter of 2022

●At September 30, 2022, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits of $27.7 million. VBL expects that its cash, cash equivalents, short-term bank deposits, and restricted bank deposits will be sufficient to fund currently planned operating expenses and capital expenditures for at least 12 months. VBL’s ongoing review of its strategic options and any transactions resulting from such review may impact this projection.
●For the quarter ended September 30, 2022, VBL reported a net loss of $9.2 million, or ($0.12) per basic share, compared to a net loss of $6.5 million, or ($0.09) per basic share, in the comparable period in 2021.
●Revenues for the quarter ended September 30, 2022, were $0.5 million, as compared to $0.2 million in the comparable period in 2021.
●For the quarter ended September 30, 2022, total operating expenses were approximately $9.7 million, consisting of $6.0 million in research and development expenses, net, and $3.7 million in general and administrative expenses. This compares with total operating expenses of $6.6 million in the quarter ended September 30, 2021, which was comprised of $5.0 million in research and development expenses, net, and $1.6 million in general and administrative expenses.