On August 11, 2022 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported financial results for the second quarter 2022 and provided an operational update (Press release, Bellicum Pharmaceuticals, AUG 11, 2022, View Source [SID1234618123]).

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"We have continued to make progress with our patient enrollment efforts in the BPX-601 and BPX-603 trials and I am pleased with our execution," said Rick Fair, President and Chief Executive Officer. "Our team remains focused on generating Phase 1 data that highlight the potential advantages of our GoCAR-T technology."

Program Highlights and Current Updates

BPX-601 GoCAR-T

Enrollment is ongoing in the dose escalation portion of the Phase 1/2 clinical trial for BPX-601 in patients with metastatic castration-resistant prostate cancer (mCRPC). Bellicum plans to present an interim data update on BPX-601 in the first quarter of 2023.
BPX-603 GoCAR-T

Enrollment is ongoing in the dose escalation portion of the Phase 1/2 clinical trial for BPX-603 in patients with solid tumors that express human epidermal growth factor 2 (HER2), including breast, endometrial, ovarian, gastric, and colorectal cancers. Bellicum plans to present an interim data update on BPX-603 in the first half of 2023.
Financial Results for the Second Quarter 2022

R&D Expenses: Research and development expenses were $5.1 million and $9.6 million for the three and six months ended June 30, 2022, respectively, compared to $6.7 million and $13.2 million for the three and six months ended June 30, 2021. The decrease in R&D expenses for the second quarter and the first half of the year 2022 was primarily due to reduced expenses related to rivo-cel activities, a discontinued development program, as well as patient enrollment delays in the BPX-601 and BPX-603 clinical trials.

G&A Expenses: General and administrative expenses were $1.4 million and $2.9 million for the three and six months ended June 30, 2022, respectively, compared to $1.8 million and $3.8 million for the three and six months ended June 30, 2021. The decrease in G&A expenses for the second quarter and the first half of the year 2022 was primarily due to reduced personnel and share-based compensation expenses.

Loss from Operations: Bellicum reported a loss from operations of $6.5 million and $12.5 million for the three and six months ended June 30, 2022, respectively, compared to $7.8 million and $16.7 million for the three and six months ended June 30, 2021, respectively. The results for the six months ended June 30, 2021 included a net loss on early lease termination of $0.5 million as a result of the exit from our South San Francisco office space.

Net Loss: Bellicum reported a net loss of $4.0 million and $11.6 million for the three and six months ended June 30, 2022, respectively, compared to a net loss of $2.2 million and $13.5 million for the three and six months ended June 30, 2021, respectively. The results included a non-cash gain from the change in fair value of warrant derivative liabilities of $2.5 million and $0.9 million for the three and six months ended June 30, 2022, respectively, compared to a non-cash gain from the change in fair value of both warrant and private placement option liabilities of $5.6 million and $3.2 million for the three and six months ended June 30, 2021, respectively. Such gains were primarily driven by a decrease in the Company’s stock price.

Shares Outstanding: As of August 5, 2022, Bellicum had 8,611,829 shares of common stock and 452,000 shares of preferred stock outstanding. Each share of preferred stock is convertible into 10 shares of common stock.

Cash Position: Bellicum reported cash and cash equivalents and restricted cash totaling $34.7 million as of June 30, 2022, compared to $47.7 million as of December 31, 2021.

On August 11, 2022 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported financial results for the second quarter ended June 30, 2022 (Press release, Nkarta, AUG 11, 2022, View Source [SID1234618122]).

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"Nkarta’s performance remained strong in the first half of the year as we announced positive preliminary data for our co-lead NK cell therapy candidates, NKX101 and NKX019, and raised additional capital for advancing these two promising programs through clinical development and regulatory filings," said Paul J. Hastings, President and CEO of Nkarta. "We believe that our progress validates Nkarta’s robust end-to-end platform for CAR NK cell therapy and demonstrates our ability to advance the field of allogeneic cell therapy. We look forward to presenting additional data for both NKX101 and NKX019 later this year."

Anticipated Clinical Milestones

Nkarta plans to present additional clinical data in the second half of 2022 from its ongoing dose escalation monotherapy clinical trials of NKX101 and NKX019. These data are expected to include durability of response in patients who were in response as of the April 2022 data cut-off, safety and activity data from patients who may have received one or more additional cycles of NK cell therapy, and safety and activity data from newly enrolled patients who receive the 3-dose monotherapy treatment at the higher 1.5 billion CAR NK cell dose regimen.
NKX019 Clinical Update

In June 2022, Nkarta filed a protocol amendment with the U.S. Food and Drug Administration (FDA) for the ongoing Phase 1 clinical trial of NKX019 to optimize the trial’s design as the company prepares for potential dose expansion cohorts. The amended protocol, now in effect, allows for an increased dose of cyclophosphamide with lymphodepletion, in line with NKX101, and various expansion cohorts evaluating NKX019 in combination with rituximab.
NKX101 Clinical Data

On April 25, 2022, Nkarta reported preliminary data from its Phase 1 clinical trial evaluating NKX101, an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses NK cells engineered to target NKG2D ligands on cancer cells, as a multi-dose, multi-cycle monotherapy in patients with relapsed / refractory (r/r) acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (MDS). As of data cut-off on April 21, 2022, 21 patients had been enrolled and dosed.
Three of five patients with heavily pre-treated AML treated at the higher dose levels in a three-dose regimen achieved a complete response (60% CR) with hematologic recovery, with two of the three responses MRD (measurable residual disease) negative.
NKX101 was well tolerated. No dose-limiting toxicities were observed. No cytokine release syndrome (CRS), graft-versus-host disease (GvHD), or immune effector cell-associated neurotoxicity syndrome (ICANS) was observed. The most common higher-grade adverse events were myelosuppression and infection, which are common in this patient population following lymphodepletion.
NKX019 Clinical Data

On April 25, 2022, Nkarta reported preliminary data from its Phase 1 clinical trial evaluating NKX019, an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses NK cells engineered to target the B-cell antigen CD19, as a multi-dose, multi-cycle monotherapy in patients with r/r B-cell malignancies. As of data cut-off on April 21, 2022, 13 patients had been enrolled and dosed.
Three of six patients treated at the higher dose level in a three-dose regimen showed a complete response (50% CR), including one patient with aggressive diffuse large B cell lymphoma (DLBCL) and one patient with mantle cell lymphoma (MCL).
NKX019 was well tolerated. No dose-limiting toxicities were observed. No CRS, GvHD, or neurotoxicity (ICANS) was observed. The most common higher-grade adverse events were myelosuppression, which is common in this patient population following lymphodepletion.
Pipeline and Platform

In April 2022, Nkarta presented preclinical data from its engineered NK cell platform in four posters at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The posters included data on the use of CRISPR/Cas9 genome editing to enhance the ability of NK cells to target CD70 antigen (jointly presented with CRISPR Therapeutics); analytical and translational methods to better understand patterns of response to CAR NK cells; analysis of surface antigen expression in preclinical models of multiple myeloma; and immune masking strategies for extending the persistence of allogeneic cell therapies.
Leadership Appointments

In July 2022, Nkarta promoted Ralph Brandenberger, PhD, to Chief Technical Officer. Dr. Brandenberger joined Nkarta in April 2018 and leads technical operations, including process and analytical development, supply chain, manufacturing and quality for Nkarta’s engineered NK cell therapy candidates.
In July 2022, Nkarta promoted Yvonne Li, MBA, to Chief Administrative Officer. Ms. Li joined Nkarta in November 2019 and leads Nkarta’s accounting organization, financial and regulatory compliance, and human resources administration.
In May 2022, Nkarta promoted David R. Shook, MD, to Vice President, Clinical Development to lead all clinical development and regulatory activities at Nkarta. He joined Nkarta in June 2020 and has been responsible for directing Nkarta’s co-lead clinical programs, NKX101 and NKX019. Dr. Shook is a practicing pediatric hematologist, oncologist and transplanter, and an early pioneer of natural killer (NK) cell therapy.
Other Corporate Highlights

In August 2022, Nkarta signed amended lease agreements for its future cell therapy manufacturing facility and company headquarters and for its existing facilities. The amendments provide for approximately $15 million of additional tenant improvement allowances for the future facility, increase the rent for the future facility, and increase the rent and term of the lease for some of Nkarta’s existing facilities. These allowances are in addition to the tenant improvement allowances of $25.2 million included in the original lease agreement for the future facility. Nkarta’s facilities are located in South San Francisco, California.
In April 2022, Nkarta received approximately $215.6 million in net proceeds from a public offering of its common stock. This amount included the exercise in full by the underwriters of their option to purchase additional shares of common stock.
Second Quarter 2022 and Recent Financial Highlights

Cash and Cash Equivalents: As of June 30, 2022, Nkarta had cash, cash equivalents, restricted cash, and short-term investments of $415.0 million. This amount includes net proceeds of approximately $215.6 million from the public offering of common stock in April 2022.
R&D Expenses: Research and development (R&D) expenses were $21.0 million for the second quarter of 2022. Non-cash stock-based compensation expense included in R&D expense was $1.6 million for the second quarter of 2022.
G&A Expenses: General and administrative (G&A) expenses were $6.6 million for the second quarter of 2022. Non-cash stock-based compensation expense included in G&A expense was $2.3 million for the second quarter of 2022.
Net Loss: Net loss was $27.0 million, or $0.61 per basic and diluted share, for the second quarter of 2022. This net loss includes non-cash charges of $5.7 million that consisted primarily of share-based compensation of $3.9 million.
Financial Guidance

Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into 2025.
About NKX101
NKX101 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy donors. It is engineered with a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. NKX101 is also engineered with membrane-bound form of interleukin-15 (IL15) for greater persistence and activity without exogenous cytokine support. To learn more about the NKX101 clinical trial in adults with AML or MDS, please visit ClinicalTrials.gov.

About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed CAR for enhanced tumor cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies. To learn more about the NKX019 clinical trial in adults with advanced B cell malignancies, please visit ClinicalTrials.gov.

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.