On August 11, 2022 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on development of targeted therapies for a number of different cancers, reported financial results for the second quarter ended June 30, 2022 and other recent business developments (Press release, Celcuity, AUG 11, 2022, View Source [SID1234618121]).

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"We made progress on a variety of fronts in the second quarter of 2022. The Breakthrough Therapy Designation recently granted to gedatolisib by the FDA will facilitate close collaboration with the agency as we seek to advance this therapy to the clinic as quickly as possible. Our early phase study evaluating gedatolisib in combination with palbociclib and fulvestrant in patients with advanced breast cancer whose disease progressed on a CDK4/6 inhibitor, reported promising efficacy, with high response rates, and tolerability, with low discontinuation rates due to adverse events. We are now excited to take the next step in the development of this potential first-in-class PI3K/mTOR inhibitor. Our Phase 3 clinical trial, VIKTORIA-1, remains on track to dose the first patient in the next few months," said Brian Sullivan, CEO and Co-Founder of Celcuity.

"We also made great progress strengthening our balance sheet over the past few months to support the clinical development of gedatolisib. The $100 million private placement we signed in May and the amendment we signed just this week increasing our debt financing facility to $75 million is expected to provide the capital we need to fund operations through 2025."

Second Quarter 2022 Business Highlights and Other Recent Developments

●In May, Celcuity entered into a definitive securities purchase agreement with certain institutional and other accredited investors in a private placement for the purchase of common stock, preferred stock that may be convertible into common stock and warrants initially exercisable for preferred stock that is expected to result in aggregate proceeds to the Company of $100 million before deducting placement agent fees and other offering expenses. Investors included Venrock Healthcare Capital Partners, Commodore Capital, New Enterprise Associates (NEA), RA Capital Management, Soleus Capital, and Brian Sullivan, the Company’s Chief Executive Officer. The closing of the private placement is expected to occur shortly after the first patient in VIKTORIA-1 receives their first dose of treatment at a clinical site located in the United States, provided that such date must occur on or before December 31, 2022.

●In July, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Celcuity’s lead drug product candidate gedatolisib, an investigational pan-PI3K/mTOR inhibitor, for the treatment of HR+/HER2- locally advanced, inoperable or metastatic breast cancer that has progressed after treatment with a CDK4/6 inhibitor in combination with a nonsteroidal aromatase inhibitor. This designation allows for more intensive guidance from the FDA and a potentially accelerated review time if relevant criteria are met. Gedatolisib previously received Fast Track designation from the FDA in January 2022.

●This week, Celcuity amended its existing debt financing agreement with an affiliate of Innovatus Capital Partners, LLC ("Innovatus") to provide Celcuity with up to $75 million in term loans, a $50 million increase from the original debt financing agreement. Celcuity received $15 million at the closing of the original agreement in April 2021. Celcuity will be able to draw an additional $20 million tranche following the closing of the $100 million private placement. Celcuity will be able to draw on two additional tranches of $10 million each and one additional tranche of $20 million upon achievement of certain clinical trial and financing milestones. Celcuity is entitled to make interest only payments for the 48-month period from the original agreement date or for the 60-month period from the original agreement date if certain conditions are met. The loans will mature on the sixth anniversary of the initial funding date. Innovatus has the right to convert outstanding principal into shares of Celcuity common stock until the third anniversary of the loan amendment date, with such amount limited to an aggregate of up to $6.6 million assuming all tranches are funded. The loan is secured by all of Celcuity’s assets. Armentum Partners LLC acted as sole advisor to Celcuity for this transaction.

●The VIKTORIA-1 Phase 3 clinical trial remains on track to dose the first patient in the next few months. The operational activities required to initiate the clinical trial at a study site are completed. The clinical trial protocol was updated to include an additional study arm (Arm F) to evaluate gedatolisib plus fulvestrant in 50 patients who have PIK3CA mutations. This update was made in response to a recommendation from the European Medicines Agency (EMA) that the study arms for PIK3CA mutated patients mirror the same study arms for PIK3CA non-mutated patients. No changes were made to the primary endpoints. VIKTORIA-1 will evaluate the safety and efficacy of gedatolisib in combination with fulvestrant with or without palbociclib in adults with HR+/HER2- advanced breast cancer whose disease progressed while receiving prior CDK4/6 therapy.

●Enrollment remains ongoing in the FACT-1 and FACT-2 trials for CELsignia selected patients who have early-stage HR+/HER2- breast cancer with interim results expected in mid-2023.

Second Quarter 2022 Financial Results

Unless otherwise stated, all comparisons are for the second quarter ended June 30, 2022, compared to the second quarter ended June 30, 2021.

The following discussion should be read in conjunction with our unaudited condensed consolidated financial statements and related notes on Form 10-Q for the second quarter ended June 30, 2022. Total operating expenses were $9.6 million for the second quarter of 2022, compared to $13.6 million for the second quarter of 2021.

Research and development (R&D) expenses were $8.4 million for the second quarter of 2022, compared to $13.1 million for the second quarter of 2021. The approximately $4.7 million decrease during the second quarter of 2022, compared to the second quarter of 2021, reflected a $10 million reduction in gedatolisib licensing related expenses, partially offset by increases of $5.3 million in other research and development expenses. Of the $5.3 million increase in research and development expenses, $1.5 million was related to increased employee and consulting expenses, of which $0.5 million was in the form of non-cash stock-based compensation. The remaining $3.8 million increase in research and development expenses is primarily related to costs for existing clinical trials and for activities supporting the initiation of the VIKTORIA-1 pivotal trial.

General and administrative (G&A) expenses were $1.2 million for the second quarter of 2022, compared to $0.6 million for the second quarter of 2021. The approximately $0.6 million increase in G&A expenses during the second quarter of 2022, compared to the second quarter of 2021, arose primarily from approximately $0.5 million in non-cash stock-based compensation.

Net loss for the second quarter of 2022 was $10.0 million, or $0.67 loss per share, compared to a net loss of $14.0 million, or $1.11 loss per share, for the second quarter of 2021. Non-GAAP adjusted net loss for the second quarter of 2022 was $8.3 million, or $0.55 loss per share, compared to non-GAAP adjusted net loss of $8.3 million, or $0.66 loss per share, for the second quarter of 2021. Non-GAAP adjusted net loss excludes stock-based compensation expense, issuance of common stock and non-cash interest. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States (GAAP) to non-GAAP financial measures, please see the financial tables at the end of this press release.

Net cash used in operating activities for the second quarter of 2022 was $11.3 million, compared to $7.6 million for the second quarter of 2021. At June 30, 2022, Celcuity had cash and cash equivalents of $66.9 million, compared to cash and cash equivalents of $84.3 million at December 31, 2021.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the second quarter 2022 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-877-407-0784 and international callers should dial 1-201-689-8560 and reference conference ID: 13731012. A live webcast presentation can also be accessed using this weblink: View Source;tp_key=2043138d9a. A replay of the webcast will be available on the Celcuity website following the live event.

On August 11, 2022 VerImmune, Inc. ("VerImmune"), a biotechnology company developing new oncology therapeutic modalities that redirect the body’s pre-existing immunity toward cancer, reported that it has been accepted into the fully sponsored Assay Cascade characterization and testing program conducted by the Nanotechnology Characterization Laboratory (NCL) at the National Cancer Institute’s, part of the National Institutes of Health, Frederick National Laboratory for Cancer Research (Press release, VerImmune, AUG 11, 2022, View Source [SID1234618120]).

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Nanomedicines accepted into the NCL Assay Cascade program undergo a rigorous evaluation that may include sterility and endotoxin testing, physicochemical characterization, in vitro hemato- and immunotoxicity, and in vivo studies to evaluate safety, efficacy, and pharmacokinetics. The studies are tailored to each individual nanomedicine and are designed to promote the clinical translation of these novel therapies. All studies are funded by the NCI and conducted free of charge for Awardees.

"We are excited to be accepted into this highly competitive program sponsored by the National Cancer Institute" said John Troyer, COO of VerImmune Inc and Principal Investigator. "Acceptance into this program is an important step in validating our strategy since NCL accepts proposals with strong clinical potential. We look forward to this collaboration which will strengthen our existing manufacturing data for FDA submissions."

On August 11, 2022 Promontory Therapeutics Inc., a clinical stage pharmaceutical company focused on oncology therapeutics, reported the peer-reviewed publication of mechanistic studies with lead candidate PT-112 in this month’s issue of Cancers (volume 14, issue 16), an MDPI publication (Press release, Promontory Therapeutics, AUG 11, 2022, View Source [SID1234618119]). The in vitro study, entitled "PT-112 induces mitochondrial stress and immunogenic cell death, targeting tumor cells with mitochondrial deficiencies," showed that PT-112 was selective to cells with defective mitochondria, inducing cancer cell death through non-conventional mechanisms, including increased mitochondrial stress, free radical generation, and immunogenic cell death (ICD), a form of cell death that is reliant upon cellular stresses, and elicits an immune response.

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PT-112, under phase 1/2 clinical development, has shown clinical activity against advanced pretreated solid tumors and has been shown to induce robust ICD. This manuscript reports PT-112’s anti-cancer activity, including mitochondrial stress and selectivity to cancer metabolic processes, specifically mitochondrial dysfunction.

Key findings include:

Mouse tumor cells presenting mitochondrial DNA mutations and the resulting glycolytic phenotype were more sensitive to cell death induced by PT-112 compared to cells with an intact oxidative phosphorylation (OXPHOS) pathway

PT-112 induced mitochondrial stress and initiated autophagy, which is associated with an integrated stress response and with subsequent ICD

PT-112 caused calreticulin exposure, further substantiating PT-112’s ICD effects

HIF-1α expression was higher in cells sensitive to PT-112

Such selectivity of PT-112 has the potential for clinical applications in metabolically aggressive cancers

"Our study published in Cancers provides evidence of PT-112-induced cancer cell organelle stresses, and their relationship to ICD," said Matthew Price, Executive VP & COO of Promontory Therapeutics. "These findings are part of ongoing efforts crossing several research collaborations to define the causes of PT-112’s known immunogenic effects, and are supportive of the uniqueness of its mechanism of action."

The full results are available in the journal Cancers and online here.

About PT-112

PT-112 is the first small-molecule conjugate of pyrophosphate in oncology, and possesses a unique pleiotropic mechanism of action that promotes immunogenic cell death (ICD), through the release of damage associated molecular patterns (DAMPs) that bind to dendritic cells and lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents a highly potent inducer of this immunological form of cancer cell death. Further, PT-112 harbors a property known as osteotropism, or the propensity of the drug to reach its highest concentrations in certain areas of the bone, making it a candidate for treatment of patients with cancers that originate in, or metastasize to, the bone. The first in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients and won "Best Poster" within the Developmental Therapeutics category at the ESMO (Free ESMO Whitepaper) 2018 Annual Congress. The combination Phase 1b dose escalation study of PT-112 with PD-L1 checkpoint inhibitor avelumab in solid tumors was reported in an oral presentation at the ESMO (Free ESMO Whitepaper) 2020 Virtual Congress. The Phase 1 study in patients with relapsed or refractory multiple myeloma presented at ASH (Free ASH Whitepaper) is the third completed Phase 1 study of PT-112. Monotherapy Phase 2 development is ongoing in mCRPC, and now includes the Phase 2 proof of concept study in thymic epithelial tumors under the company’s formal collaboration with the NCI. The PD-L1 combination Phase 2a study is ongoing in a dose confirmation cohort of non-small cell lung cancer (NSCLC) patients.

On August 11, 2022 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the following (Press release, Greenwich LifeSciences, AUG 11, 2022, View Source [SID1234618118]):

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Phase III clinical trial, Flamingo-01, has officially started
Multiple sites have begun the screening and enrolling process
Flamingo-01 is evaluating the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery
CEO Snehal Patel commented, "We are thrilled to begin what we hope will be a successful reproduction of our Phase IIb trial, in which GLSI-100 safely prevented metastatic breast cancer recurrences with 100% disease free survival. The hard work and effort of the GLSI team and our partners have led us to this major milestone. We look forward to sharing more site contact information with patients and their clinicians in the future as we activate more sites and some of the largest oncology networks in the US and Europe, making Flamingo-01 available to as many patients as possible."

The commencement of the Phase III trial transitions the Company into pre-commercialization activities, which include:

Working with the FDA in preparation for a BLA submission and commercial launch
Implementing a global strategy for launching GP2 in international markets outside the US and Europe
Initiating large scale manufacturing, packaging, and marketing
The Company anticipates the following additional activities/milestones:

Phase III clinical trial progress and open label data will be presented at major conferences
Licensing discussions may accelerate as the interim analysis approaches
Other assets may be developed by acquisition or internal research, including T cell therapies that may be discovered in the Phase III trial by studying GP2’s robust immunogenicity
Additional patents for GP2 based on the Phase III trial findings, manufacturing, and pharmacy procedures are planned to be filed to extend patent life
For Patients Seeking to Participate in Flamingo-01

Patients who are interested in participating in the Flamingo-01 Phase III clinical trial can contact the Company by email at [email protected] and can obtain clinical site contact information to contact sites directly on www.clinicaltrials.gov with identifier NCT05232916 (view here).

About Flamingo-01 and GLSI-100

Flamingo-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial will be led by Baylor College of Medicine and will include US and international clinical sites from university-based hospitals and cooperative networks. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 100 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On August 11, 2022 F-star Therapeutics, Inc. (NASDAQ: FSTX) ("F-star" or the "Company"), a clinical-stage biopharmaceutical company pioneering bispecifics in immunotherapy so more people with cancer can live longer and improved lives, reported second quarter 2022 financial results and corporate highlights (Press release, F-star, AUG 11, 2022, View Source [SID1234618117]).

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"During the second quarter, we steadfastly remained focused on advancing our four clinical programs," said Eliot Forster, CEO of F-star Therapeutics, Inc., "We continued the enrollment for the FS118 study in PD-1 acquired resistance head and neck cancer patients and have cleared the initial futility hurdle. The dose-escalation study for FS222 continues to progress well, and we are happy to report that therapy remains well-tolerated and clinically active at pharmacologically active dose levels, including in patients with low levels of PD-L1 expression. We also initiated the combination study of FS120 with KEYTRUDA in patients with advanced cancers and we look forward to evaluating the potential clinical benefits of the combined therapies. Dose escalation of SB 11285 continues. Both the monotherapy and combination with atezolizumab remain well tolerated."

Second Quarter 2022 and Recent Highlights:

F-star planned acquisition by invoX Pharma: As previously disclosed, on June 22, 2022, the Company entered into a definitive agreement to be acquired by invoX Pharma Limited, a wholly owned subsidiary of Sino Biopharmaceutical Limited (HKEX 11771.HK), for $7.12 per share for an approximate total equity value of $161 million in cash. Subject to the satisfaction of customary closing conditions, including regulatory approvals, the transaction is expected to close in the second half of 2022.
License Agreement with Takeda to develop and commercialize a novel next-generation immuno-oncology bispecific antibody therapeutic: Under the terms of the agreement, F-star will grant Takeda a worldwide, exclusive royalty-bearing license to research, develop, and commercialize a bispecific antibody against an immuno-oncology target using F-star’s proprietary Fcab and mAb2 platforms. Takeda will be responsible for all research, development, and commercialization activities under the agreement.
FS118 in acquired resistance head and neck Phase 2 interim update: FS118 appeared to be well tolerated in line with Phase 1 results and has cleared the pre-determined futility hurdle for the initial stage of the head and neck acquired resistance cancer trial. We believe that we are on track to achieve the predefined efficacy levels and are pleased to be observing long-term clinical benefit for patients. The enrollment of the patients for the remainder of the study continues well, paving the way for combination therapy in this hard-to-treat patient population.
FS222 Phase 1 clinical trial update: The monotherapy dose-escalation progresses well. FS222 has demonstrated emerging clinical antitumor activity with a tolerability profile typical of checkpoint inhibitors and elicits dose-dependent increases in soluble CD137 and PD-L1 levels, indicative of target engagement and increases in immune cell activation and proliferation.
FS120 Initiation of KEYTRUDA combination dosing: Pharmacologically active dose levels have been reached and we have initiated dose escalation of FS120 in combination with Keytruda.
FS118 poster presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting demonstrating a novel LAG-3 reduction and shedding mechanism: Data revealed that the unique tetravalent structure of FS118 plays a critical role in evoking LAG-3 shedding, and cell surface reduction, in tumor-infiltrating lymphocytes (TILs), enabling FS118 to overcome compensatory upregulation of LAG-3 induced by PD-(L)1 blockade.
Second Quarter 2022 Financial Summary:

Cash Position
Cash and cash equivalents were $53.0 million as of June 30, 2022, compared to $78.5 million at December 31, 2021.

R&D Expense
R&D expenses were $8.7 million for the quarter ended June 30, 2022, compared to $8.3 million for the corresponding quarter in 2021. The $0.4 million increase is primarily due to an increase of $2.9 million in clinical trial costs, $0.9 million of R&D consulting, staff and other R&D costs, offset by the UK R&D tax credit of $3.4 million, which is treated as a reduction in expense.

G&A Expense
G&A expenses were $7.5 million for the quarter ended June 30, 2022, compared to $6.5 million for the second quarter 2021. This $1.0 million increase is primarily due to $2.5 million in transaction related costs, offset by reductions of $1.0 million of non-transaction related legal and professional fees, $0.4 million in stock-based compensation expense and $0.1 million in other G&A expense.

Net Loss Attributable to Common Shareholders
Net loss was $19.0 million or a loss per share of $0.88 (basic and diluted) for the quarter ended June 30, 2022, as compared to a net loss of $15.5 million or a loss per share of $0.91 (basic and diluted) for the quarter ended June 30, 2021.

Conference Call and Webcast:

F-star will not be hosting a conference call to discuss Q2 2022 financial results or corporate update in light of the pending transaction with invoX Pharma announced on June 23, 2022.