On August 13 2021 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a clinical-stage oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies designed to target p53 mutants, reported financial results for the second quarter ended June 30, 2021 and provided corporate highlights (Press release, PMV Pharma, AUG 13, 2021, View Source [SID1234586519]).

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"We are encouraged by our execution in the clinic, with steady progress in the ongoing Phase 1/2 trial of PC14586," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "We believe PC14586, our first-in-class, tumor agnostic, p53 Y220C reactivator has the potential to transform outcomes for cancer patients. Furthermore, our strong balance sheet leaves us well positioned to continue to translate our deep scientific expertise to deliver benefits to patients."

Corporate Highlights:

Continued enrollment in the Phase 1 portion of a Phase 1/2 clinical trial of PC14586, the Company’s first-in-class, tumor-agnostic, investigational small molecule p53 Y220C reactivator, in patients with advanced solid tumors that have a p53 Y220C mutation (NCT04585750).
Activated twelve clinical trial sites in the United States, consisting of leading oncology centers.
Commenced construction of new corporate headquarters and state-of-the-art laboratories in Princeton, New Jersey.
Second Quarter 2021 Financial Results

PMV Pharma ended the second quarter with $339.0 million in cash, cash equivalents, and marketable securities, compared to $361.4 million as of December 31, 2020. Net cash used in operations was $22.0 million for the six months ended June 30, 2021, compared to $15.0 million for the six months ended June 30, 2020.
Net loss for the six months ended June 30, 2021 was $24.5 million compared to $15.2 million for the six months ended June 30, 2020.
Research and development (R&D) expenses were $15.2 million for the six months ended June 30, 2021 compared to $11.8 million for the six months ended June 30, 2020. The increase in R&D expenses was primarily due to increased headcount and clinical expenses related to development of PC14586, the Company’s lead drug candidate.
General and administrative (G&A) expenses were $9.6 million for the six months ended June 30, 2021 compared to $4.0 million for the six months ended June 30, 2020. The increase in G&A expenses was primarily due to costs relating to building the infrastructure necessary to operate as a public company.
About p53

p53 plays a pivotal role in preventing abnormal cells from becoming a tumor by inducing programmed cell death. Mutant p53 takes on oncogenic properties that endow cancer cells with a growth advantage and resistance to anti-cancer therapy. The p53 Y220C mutation is associated with many cancers, including but not limited to breast, non-small cell lung cancer, colorectal, pancreatic, and ovarian cancers.

About PC14586

PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have the p53 Y220C mutation and has been granted Fast Track designation by the U.S. FDA.

On August 13, 2021 ArcticZymes Technologies reported for the second quarter 2021 on Thursday, 19. August 2021 at 08.30 a.m (Press release, Biotec Pharmacon, AUG 13, 2021, View Source [SID1234586518]).

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Due to the ongoing situation with spread of coronavirus, a number of measures are being implemented to prevent the spread of infection. These measures are being taken to safeguard the health and security of the Company’s shareholders, employees and other stakeholders, and to ensure compliance with applicable national and local restrictions and guidelines. The Company will therefore conduct the presentation only as a webcast over Teams and as a telephone conference.

CEO, Jethro Holter and CFO, Børge Sørvoll will hold the presentation.

Participants who want to participate in the live webcast are asked to send an email to [email protected] for a separate invitation, which will be distributed 1 day prior to the meeting. Participants who want to participate by telephone should dial in on +47 21 40 24 87 with conference id: 235 027 209#. It will be possible to post questions through the webcast and over the phone after the presentation is finished. The report for the second quarter 2021 will be available on www.newsweb.no and on the company’s homepage www.arcticzymes.com from 07.00 a.m. on 19. August 2021.

On August 12, 2021 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported financial results for the second quarter ended June 30, 2021 and provided clinical development and operational highlights (Press release, ALX Oncology, AUG 12, 2021, View Source [SID1234591861]).

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"We are pleased to report on the substantial progress we made since the prior quarter with our lead product candidate, ALX148, and that the United States Adopted Names (USAN) Council has approved ‘evorpacept’ as the nonproprietary (generic) name for ALX148," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "Our highlights include the presentation of additional positive Phase 1b data in second-line or greater HER2 positive gastric or gastroesophageal junction cancer from our ASPEN-01 trial during an oral session at the ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer; these results provide the basis for initiating a randomized Phase 2/3 trial in the same setting (ASPEN-06) scheduled to start in the second half of this year."

"We recently dosed the first patient in our Phase 2 ASPEN-04 trial in first line metastatic or unresectable recurrent head and neck squamous cell carcinoma in combination with KEYTRUDA and chemotherapy, are continuing enrollment in our Phase 2 ASPEN-03 trial in first line metastatic or unresectable, PD-L1 positive recurrent head and neck cancer in combination with KEYTRUDA, and plan to present full results of the Phase 1b study (ASPEN-01) in the fourth quarter of this year. In addition, we plan to present results from our Phase 1 study in myelodysplastic syndromes, to initiate a Phase 2 study in the same setting (ASPEN-02), as well as to initiate a Phase 1 study in acute myeloid leukemia (ASPEN-05)," Dr. Pons continued.

Recent Clinical Developments for Evorpacept (Also known as ALX148)

First Patient Dosed in Phase 2 ASPEN-04 Study
In July 2021, dosed first patient in the Phase 2 ASPEN-04 study evaluating the combination of evorpacept, a next generation CD47 blocker, with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, and standard 5-fluorouracil and platinum chemotherapy for the first line ("1L") treatment of patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma ("HNSCC"). In June 2021, the U.S. Food and Drug Administration ("FDA") informed ALX Oncology that it reviewed its standard non-clinical safety study and has lifted the previously set partial clinical hold and cap on patient enrollment.
First Patient Dosed in Phase 2 ASPEN-03 Study
In May 2021, dosed first patient in the Phase 2 ASPEN-03 study, which is also evaluating the efficacy of evorpacept in combination with KEYTRUDA (pembrolizumab) for the 1L treatment of patients with PD-L1 expressing metastatic or unresectable, recurrent HNSCC with a combined positive score ("CPS") ≥ 1. In June 2021, the FDA informed ALX Oncology that it reviewed its standard non-clinical safety study and has lifted the previously set partial clinical hold and cap on patient enrollment.
Data for Phase 1b ASPEN-01 Study Presented at 23rd ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer
In July 2021, updated clinical data from the Phase 1b ASPEN-01 trial evaluating evorpacept in combination with trastuzumab and CYRAMZA (ramucirumab) for the treatment of gastric or gastroesophageal junction cancer ("G/GEJ") were shared in an oral presentation at the 23rd ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer. Data showed that evorpacept in combination with trastuzumab and ramucirumab is highly active and well-tolerated in patients with second line ("≥2L") or greater HER2 positive G/GEJ cancer.
Collaboration and Supply Agreement Entered with Eli Lilly
In June 2021, ALX Oncology entered into a clinical trial collaboration and supply agreement with Eli Lilly and Company to evaluate the combination of evorpacept with CYRAMZA (ramucirumab), Lilly’s anti-VEGFR2 antibody, for the treatment of patients with HER2 positive G/GEJ. Under the terms of the agreement, ALX Oncology will conduct a Phase 2/3 study to evaluate the efficacy of evorpacept in combination with ramucirumab, trastuzumab, and paclitaxel for the treatment of patients whose tumors have progressed following treatment of HER2 targeted therapy and chemotherapy. Lilly will supply ramucirumab for this trial.
Anticipated Key Milestones for Remainder of 2021

Full results of a Phase 1b study of evorpacept in combination with Merck’s KEYTRUDA (pembrolizumab) and chemotherapy for the treatment of patients with HNSCC (ASPEN-01) are planned to be presented in the fourth quarter of 2021.
Initiation of a Phase 1b clinical trial with evorpacept in combination with Zymeworks’ zanidatamab in patients with advanced HER2-expressing breast cancer and other solid tumors is expected in the second half of 2021.
Initiation of a Phase 1 clinical trial evaluating evorpacept in combination with azacitidine and venetoclax in patients with acute myeloid leukemia ("AML") (ASPEN-05) is planned in the second half of 2021.
Initiation of a randomized Phase 2 trial of evorpacept in combination with Herceptin (trastuzumab), CYRAMZA (ramucirumab) and paclitaxel in second- or third-line treatment of patients with HER2-positive G/GEJ cancer (ASPEN-06) is expected in the second half of 2021.
Results of a Phase 1 clinical trial of evorpacept in combination with azacitidine in patients with myelodysplastic syndromes ("MDS") and the initiation of the Phase 2 clinical trial in MDS (ASPEN-02) are expected in the fourth quarter of 2021.
Second Quarter 2021 Financial Results:

Cash and Cash Equivalents: Cash and cash equivalents as of June 30, 2021, were $410.0 million. ALX Oncology continues to believe its cash and cash equivalents is sufficient to fund planned operations through 2024.
Net Loss: Generally accepted accounting principles (GAAP) net loss attributable to common stockholders was $16.3 million, or $0.40 per basic and diluted share and $14.0 million, or $4.41 per basic and diluted share for the three months ended June 30, 2021 and 2020, respectively. Non-GAAP net loss attributable to common stockholders was $14.0 million for the three months ended June 30, 2021, as compared to $10.7 million for the three months ended June 30, 2020. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.
Related-party Revenue: Related-party revenue for the three months ended June 30, 2021 was nil compared to $0.5 million for the prior-year period. The decrease in related-party revenue relates to the termination of the Tollnine Agreement as of July 1, 2020.
Research and Development ("R&D") Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of evorpacept. These expenses for the three months ended June 30, 2021 were $11.2 million, compared to $7.7 million for the prior-year period. The increase of $3.5 million was primarily attributable to an increase of $3.7 million in clinical and development costs due to higher expenses associated with increased pre-clinical, clinical and other research costs in advancement of our current lead product candidate, evorpacept, an increased personnel-related costs of $1.1 million primarily due to headcount growth, and an increase of $0.3 million other research and development costs primarily driven by milestone payments triggered by the initiation of our Phase 2 trials, offset by a decrease of $1.6 million in stock-based compensation expense primarily resulting from the modification of stock options in the second quarter of 2020 whereas there was no such modification in 2021.
General and Administrative ("G&A") Expenses: G&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the three months ended June 30, 2021 were $5.1 million, compared to $3.2 million for the prior-year period. This increase of $1.9 million was primarily attributable to an increase in stock-based compensation expense of $1.0 million primarily resulting from additional stock option award grants at higher fair values, an increase in personnel-related costs of $0.5 million due to headcount growth, and a $0.4 million increase in other general and administrative costs related to being a public company, including directors and officers liability insurance premiums.

On August 12, 2021 Cardinal Health reported an agreement with TerraPower that will help advance the next generation of cancer treatment (Press release, Cardinal Health, AUG 12, 2021, View Source [SID1234591439]). Working together, the companies will develop and produce Actinium-225, which will be utilized in drug trials involving targeted alpha therapy for diseases such as breast, prostate, colon and neuroendocrine cancers, melanoma and lymphoma. Learn more in today’s press release

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On August 12, 2021 Brooklyn ImmunoTherapeutics, Inc. (NYSE American: BTX) ("Brooklyn"), a biopharmaceutical company focused on exploring the role that gene editing/cell and cytokine therapy can have in treating patients with cancer, blood disorders, and monogenic diseases, reported financial results for the quarter ended June 30, 2021 (Press release, Brooklyn ImmunoTherapeutics, AUG 12, 2021, View Source [SID1234591393]).

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Financial and corporate highlights for the quarter ended June 30, 2021 and subsequently include the following:

Completed the acquisition of Novellus Therapeutics Limited ("Novellus") in July 2021. Novellus is developing next‑generation engineered mesenchymal stem cell ("MSC") therapies using patented mRNA-based cell reprogramming and gene editing technologies licensed from Factor Bioscience ("Factor").

Raised nearly $51 million through equity line sales of common stock for general corporate purposes, including working capital to be used to enhance the development of the mRNA gene editing and cell therapies technology recently licensed from Factor.

Appointed Jay Sial as chief administrative officer and Kevin D’Amour, Ph.D. as chief scientific officer.

Established a research and development center in Cambridge, Massachusetts, to pursue its mRNA-based gene editing and cellular therapies, co-locating with Factor.

Howard Federoff, M.D., Ph.D., Brooklyn’s President and Chief Executive Officer, commented, "The second quarter advanced the evolution of Brooklyn ImmunoTherapeutics from being a cytokine-focused immunotherapeutics company to a platform company with a pipeline of next-generation engineered cellular, gene editing and cytokine products. This was in no small measure due to the acquisition of Novellus, which enables us to utilize the full range of the MSCs they have developed with no restriction on fields of use. By combining these with our licensed mRNA-based cell reprogramming and gene editing technology from Factor Bioscience, we believe we can create a platform technology that will lead to a family of product candidates in varying stages of development from target selection to research and preclinical, including one in the respiratory area that is in the IND-enabling stage."

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"Further, we believe we are positioned to develop a variety of gene-modified products using this platform, which ultimately could help solve problems of treating certain conditions that to date have confounded science, including potential treatments for a set of solid tumors, autoimmune disorders where inflammation is a prominent feature, and addressing multiple issues in the liver, the brain and the eye, as well as applying that technology again to iPSCs for a multitude of applications," continued Dr. Federoff.

"The quarter also resulted in creating a strong balance sheet and a growing in-licensed intellectual property portfolio," said Dr. Federoff. "Following the Novellus acquisition, we had approximately $25 million of cash on hand, which we estimate will fund our operations and expansion through the end of 2023," Dr. Federoff continued. "We are awaiting the readout of our Phase 2b trial for neoadjuvant head and neck cancer with our original asset, IRX-2 human-derived cytokines, during the first half of 2022. Additionally, we have multiple investigator-driven trials in a number of additional cancer types, and additional planned studies in 2022 and 2023."

"We have made a considerable investment in ensuring that we have the right people in place, and with the addition of our new chief scientific officer Dr. Kevin D’Amour and new chief administrative officer Jay Sial. Now it’s time for us to begin to execute on these ambitious plans that this next-generation version of Brooklyn ImmunoTherapeutics promises," concluded Dr. Federoff.

Financial Results for Quarter Ended June 30, 2021

Operating expenses for the quarter ended June 30, 2021 were $10.1 million, as compared to operating expenses for the quarter ended June 30, 2020 of $2.0 million.

Research and development expenses increased to $5.4 million for the quarter ended June 30, 2021 compared to $1.0 million in the quarter ended June 30, 2020. Research and development expenses increased due to upfront payments associated with licensed technology, increased clinical trial expenses, and stock-based compensation for the issuance of equity awards. Brooklyn expects research and development expenses to continue to grow as it expands its clinical trial activities.

General and administrative expenses increased to $4.6 million in the second quarter of 2021 compared to $1.0 million during the same period in 2020. The quarter-over-quarter increase in general and administrative expense was primarily related to increased legal, accounting and consulting fees associated with merger and acquisition activity, costs associated with being a publicly traded company, and increased stock-based compensation resulting from the issuance of equity awards. Brooklyn expects general and administrative expenses to continue to increase in future periods as it increases its business activities and incurs costs associated with being a publicly traded company.

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Net loss for the quarter ended June 30, 2021 was $(27.8) million, as compared to $(3.1) million for the quarter ended June 30, 2020.

As of June 30, 2021, Brooklyn ImmunoTherapeutics had $50.2 million in cash, of which approximately $23.0 million was paid as partial consideration for the acquisition of Novellus on July 16, 2021.