On May 17, 2021 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported financial results for the first quarter 2021 and provided an operational update (Press release, Bellicum Pharmaceuticals, MAY 17, 2021, View Source [SID1234580112]).

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"In the first quarter, Bellicum maintained focus on the clinical studies of our next generation CAR-T cell therapies," said Rick Fair, President and Chief Executive Officer. "Our trials of BPX-601 in prostate cancer and BPX-603 in HER2+ solid tumors are well underway, and we look forward to providing future updates on our clinical progress for both programs."

Program Highlights and Current Updates

BPX-601 GoCAR-T

Patient enrollment is ongoing in the Phase 1/2 dose-escalation clinical trial evaluating BPX-601 and rimiducid in patients with previously treated metastatic pancreatic or prostate cancer.
Bellicum plans to present a Phase 1 data update on BPX-601 and rimiducid in patients with metastatic castration-resistant prostate cancer in the first quarter of 2022.
BPX-603 GoCAR-T

Bellicum is conducting its 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. BPX-603 is the company’s first dual-switch GoCAR-T product candidate, which incorporates Bellicum’s iMC activation and CaspaCIDe safety switch technologies. The company expects to present initial Phase 1 data from this trial in the fourth quarter of 2021.
CaspaCIDe

As announced in February, the first reported use of the CaspaCIDe safety switch to mitigate CAR-T cell toxicity was published as an ahead-of-print publication in the digital edition of Blood, a journal published by The American Society of Hematology (ASH) (Free ASH Whitepaper). The report described a case from an investigator-sponsored trial at the University of North Carolina Lineberger Comprehensive Cancer Center of autologous CAR-T cells expressing CD19 and CaspaCIDe. In this patient, grade 3-4 immune effector cell-associated neurotoxicity syndrome (ICANS) refractory to standard therapies was treated with rimiducid to activate CaspaCIDe. Within 12 hours of rimiducid administration, ICANS grade improved from 3 to 1 and was fully resolved after four days.
First Quarter 2021 Financial Results

R&D Expenses: Research and development expenses were $6.5 million for the first quarter of 2021 compared to $10.4 million during the first quarter of 2020. The reduction in expenses in the first quarter 2021 resulted primarily from reduced rivo-cel activities and the corporate restructuring implemented during the fourth quarter of 2020, partially offset by an increase in expenses related to the GoCAR programs.

G&A Expenses: General and administrative expenses were $2.0 million in the first quarter of 2021 compared to $4.2 million in the period a year ago. The reduction in expenses during the first quarter 2021 relative to the comparable period in 2020 was primarily due to the effects of the corporate restructuring that reduced employee-related charges.

Loss from Operations: Bellicum reported a loss from operations of $8.9 million for the first quarter of 2021 compared to a loss from operations of $14.6 million for the comparable period in 2020.

Net Income/Loss: Bellicum reported a net loss of $11.3 million for the first quarter of 2021 compared to net income of $17.6 million for the comparable period in 2020. The results included a non-cash loss of $2.3 million related to the change in fair value of the warrant and private placement option liability for the first quarter of 2021.

Shares Outstanding: As of May 10, 2021, Bellicum had 8,397,803 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 and Guidance: Bellicum reported cash and cash equivalents and restricted cash totaling $29.6 million as of March 31, 2021, compared to $37.0 million as of December 31, 2020. Based on current operating plans, Bellicum expects that current cash resources will be sufficient to meet operating requirements into the second quarter of 2022.

On May 17, 2021 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported that the U.S Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for KIN-2787 and also announced financial results for the quarter ended March 31, 2021 (Press release, Kinnate Biopharma, MAY 17, 2021, View Source [SID1234580128]). Kinnate expects to initiate a first-in-human Phase 1 clinical trial of KIN-2787 in patients with mutant BRAF-driven solid tumors in mid-2021.

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"In the three years since our founding, Kinnate has consistently hit key milestones essential to our mission of delivering new therapies to patients with difficult-to-treat, genomically-defined cancers. The FDA’s clearance of our KIN-2787 IND marks another major achievement for the company and demonstrates the important progress we are making in our transition to becoming a clinical-stage company," said Nima Farzan, Chief Executive Officer of Kinnate. "As we prepare for our first-in-human trial of KIN-2787 later this year, we are also pleased with the rapid advance of our lead FGFR inhibitor candidate, KIN-3248, which we believe may offer a new option for certain patients with cancers like urothelial tumors or intrahepatic cholangiocarcinoma. We anticipate a first half of 2022 IND filing for KIN-3248."

The Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics and anti-cancer activity of KIN-2787 in cancer patients with mutant BRAF-driven solid tumors. The dose escalation portion (Part A) of the trial will determine the recommended dose and schedule of KIN-2787 for further evaluation in patients with BRAF mutations. The dose expansion phase (Part B) of the trial will assess the safety and efficacy of KIN-2787 at the recommended dose and schedule in patients with cancers driven by BRAF Class II or III mutations, including lung cancer, melanoma and other selected adult solid tumors.

Recent Business Highlights and Corporate Update:

In our RAF program, we filed an IND in April 2021 with the FDA to study KIN-2787 in patients with mutant BRAF-driven solid tumors. The FDA cleared the IND in May 2021 and we anticipate initiating a Phase 1 clinical trial for KIN-2787 in mid-2021. KIN-2787, our most advanced product candidate, is a RAF inhibitor we are developing for the treatment of patients with lung cancer, melanoma and other solid tumors. Unlike currently available treatments that target only Class I BRAF kinase mutations, we have designed KIN-2787 to target Class II and Class III BRAF mutations, where it would be a first-line targeted therapy, in addition to covering Class I BRAF mutations.
In May 2021 we closed a $35 million Series A financing of a joint venture in China. Established with OrbiMed Asia Partners, OrbiMed Private Investments and Foresite Capital, the joint venture will be headquartered in Shanghai and the financing will enable the potential development and commercialization by the joint venture of certain Kinnate targeted oncology product candidates across Greater China (mainland China, Hong Kong, Taiwan, and Macau). Kinnate Biopharma will be the majority shareholder in the joint venture. The company has also announced that veteran biopharmaceutical industry executive Wenn Sun, Ph.D., has been appointed as the joint venture’s Executive Chair.
Data from pre-clinical studies of KIN-2787 have been selected for poster presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held virtually June 4-8, 2021. The data to be presented at the ASCO (Free ASCO Whitepaper) annual meeting was derived from pre-clinical studies evaluating the efficacy and tolerability of KIN-2787 in vitro and in vivo in BRAF mutation-driven human cancer models.
In our FGFR program, we selected KIN-3248 as our lead FGFR inhibitor candidate for the treatment of intrahepatic cholangiocarcinoma and urothelial carcinoma and initiated GLP-toxicity studies of KIN-3248. Our FGFR candidates are designed to address clinically observed genomic alterations in FGFR2 and FGFR3 that drive resistance to current therapies. We anticipate filing an IND for KIN-3248 with the FDA in the first half of 2022 and, subject to our planned IND submission taking effect, initiating a Phase 1 clinical trial for KIN-3248 in the first half of 2022.
We continued to advance a number of other small molecule research programs, including a CDK12 inhibitor in our KIN004 program to target the treatment of ovarian carcinoma, triple-negative breast cancer and metastatic castration-resistant prostate cancer.
We expanded our organization to 41 full-time employees at March 31, 2021, of which 30 were engaged in research and development activities.
First Quarter 2021 Financial Results

First quarter net loss for 2021 was $17.5 million, compared to $3.9 million for the same period in 2020.
First quarter research and development expenses for 2021 were $12.7 million, compared to $3.2 million for the same period in 2020.
First quarter general and administrative expenses for 2021 were $4.8 million, compared to $1.0 million for the same period in 2020.
As of March 31, 2021, the total of cash and cash equivalents and investments was $383.1 million.

On May 17, 2021 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, reported financial results for the first quarter ended March 31, 2021 and highlighted recent corporate accomplishments (Press release, Zentalis Pharmaceuticals, MAY 17, 2021, View Source [SID1234580152]).

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"This quarter, we have made tremendous progress advancing the clinical development of one of our lead programs, ZN-c3, underscored by strong data recently presented in a late-breaking session at AACR (Free AACR Whitepaper)," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "These initial results from the Phase 1 monotherapy trial not only demonstrated signals of single-agent efficacy and a superior safety profile compared to other WEE1 inhibitors in development, but also generated multiple confirmed Exceptional Responses across differing solid tumor types. With the recommended dose selected, we look forward to pursuing many planned trials with ZN-c3 this year and exploring its best-in-class potential both as a monotherapy and in combination."

Continued Dr. Sun, "In parallel, we continue to make great headway with the development of our additional differentiated oncology candidates – ZN-c5, ZN-d5 and ZN-e4 – with numerous trials on track to initiate in 2021. Looking ahead to our catalyst-rich year, we remain focused on executing on our clinical strategy and creating value for our stakeholders, in hopes of delivering innovative treatments to help improve the lives of cancer patients."

Program Highlights:

In April 2021, Zentalis reported initial results from the Phase 1 portion of a Phase 1/2 trial of ZN-c3 in advanced solid tumors in a late-breaking session at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which was further discussed at a webcast event with Key Opinion Leaders.
ZN-c3 generated three Exceptional Responses in heavily pretreated patients with ovarian cancer, colorectal cancer and non-small cell lung cancer, as well as two unconfirmed Partial Responses in patients with uterine serous carcinoma;
Showcased favorable safety results with a wide therapeutic window;
A Unique Predictive Biomarker was identified for the Exceptional Responders, with plans to further investigate the biomarker in this patient population;
Selected Recommended Phase 2 Dose for ZN-c3 to be 300 mg QD with continuous dosing.

In April 2021, we entered into a Clinical Trial Collaboration and Supply Agreement with GSK to investigate the combination of ZN-c3, our oral WEE1 inhibitor, and niraparib, GSK’s poly (ADP-ribose) polymerase (PARP) inhibitor, in patients with advanced epithelial ovarian cancer. The Company expects to initiate a Phase 1b trial with this combination in the second half of 2021.

Zentera Therapeutics, Zentalis’ majority-owned joint venture, filed four Clinical Trial Applications (CTAs, China equivalent of IND) and three have been approved in China to date for ZN-c5, ZN-c3, and ZN-c3 in combination. A fourth CTA was submitted earlier this month for ZN-d5.

In February 2021, Zentalis entered into a strategic collaboration with Tempus to leverage its patient-derived organoid biological modeling platform to aid Zentalis in discovering and developing novel oncology therapies. The collaboration will assist in the validation of Zentalis’ mechanistic discoveries, initially focusing on its WEE1 inhibitor, ZN-c3, across patient tumor populations.
Anticipated Milestones:

The Company plans to report interim results from numerous ongoing trials with ZN-c5 and to share guidance on future development plans for this product candidate in the second quarter of 2021.
Zentalis expects to initiate several studies in the coming months, including:
A Phase 2 trial of ZN-c3 in uterine serous carcinoma in the third quarter of 2021;
A Phase 1/2 trial of ZN-c3 in combination with chemotherapy in osteosarcoma in the third quarter of 2021; and
A Phase 1/2 trial of ZN-c3 in combination with GSK’s niraparib in ovarian cancer in the second half of 2021.
Corporate Highlights:

In February 2021, the Company appointed Enoch Kariuki, Pharm.D., to the Board of Directors. Dr. Kariuki most recently served as Chief Financial Officer at VelosBio and has over a decade of experience in life sciences investment banking, strategic advising and business development.
First Quarter 2021 Financial Results

Cash and Marketable Securities Position: As of March 31, 2021, Zentalis had cash, cash equivalents and marketable securities of $298.4 million. Zentalis expects that its existing cash, cash equivalents and marketable securities, which includes the net proceeds of approximately $155.2 million from the August 2020 follow-on offering, will enable the Company to fund its operating expenses and capital expenditure requirements into 2023.

Research and Development Expenses: Research and development expenses for the three months ended March 31, 2021 were $38.4 million, compared to $13.3 million for the three months ended March 31, 2020. The increase of $25.1 million was primarily due to increases in external research and development expenses related to our lead product candidates, as we advanced our Phase 1/2 clinical trials for each of ZN-c5, ZN-c3, ZN-d5 and ZN-e4. In addition, in the three months ended March 31, 2021, we conducted additional preclinical studies, incurred additional manufacturing costs, and incurred increased costs for study and lab materials. Unallocated research and development expenses increased by $14.0 million primarily due to $6.6 million of additional employee related costs, of which $3.0 million was driven by non-cash stock-based compensation from incentive grants and increased headcount to support our platform development. Expenses attributable to collaborations and strategic alliances increased by $3.0 million while allocated expenses, including software, supplies and insurance increased by $2.4 million and outside services increased by $2.0 million to support our growth.

General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2021 were $11.9 million, compared to $3.1 million during the three months ended March 31, 2020. This increase of $8.8 million was primarily attributable to an increase of $8.3 million in employee-related costs, of which $6.4 million was driven by non-cash stock-based compensation from incentive grants, and from increased headcount to support our growth. Consulting and outside services increased by $0.7 million, and fees increased by $0.3 million to support the increased operations of the organization. Insurance costs increased by $0.7 million due to operating as a public company offset by allocated expenses.

Net Loss: Net loss was $50.4 million for three months ended March 31, 2021, compared to $16.2 million for the three months ended March 31, 2020. The increase of $34.2 million was primarily the result of the increases in research and development and general and administrative expenses discussed above.

Impact from COVID-19 Pandemic: Though the impact of the COVID-19 pandemic to our business and operating results presents additional uncertainty and cannot be predicted with confidence, we continue to use the best information available to inform our critical accounting estimates.

On May 17, 2021 GT Biopharma, Inc. ("GT Biopharma" or the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager (TriKE) protein biologic technology platform reported financial results for the first quarter ended March 31, 2021 and provided a general business update (Press release, GT Biopharma, MAY 17, 2021, View Source [SID1234580170]).

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"In the first quarter of 2021, and in the weeks since, we were very pleased to report exciting and encouraging data from our ongoing Phase I/II clinical trial of GTB-3550 in MDS and AML," said Anthony J. Cataldo, GT Biopharma’s Chairman and Chief Executive Officer. "Both from efficacy and safety perspectives, our GTB-3350 TriKE program appears to be delivering the TriKE’s unique therapeutic potential which has been well tolerated in all of our patients. Our differentiated approach stimulating NK cell activity, reinforces our rationale to proceed with additional programs in solid tumor and hematologic cancers. In addition, with our $28.7M financing completed and a key strategic manufacturing partnership in place, we are well equipped and positioned to capitalize on the potential we are already seeing from these innovative new therapies. We again thank the patients and their families for their contribution, as we advance towards the prospect of an off-the-shelf monotherapy cancer therapeutic that can be therapeutically effective without supplemental engineered NK cells or the need for any combination drugs."

Clinical Highlights

Updated Interim Results from First-in-Human GTB-3550 TriKE Phase I/II Clinical Trial for the Treatment of High-Risk Myelodysplastic Syndromes (MDS) and Refractory/Relapsed Acute Myeloid Leukemia (AML): In March and April 2021, GT Biopharma announced updated interim results from the Phase I dose-escalation portion of the Phase I/II expansion clinical trial of GTB-3550 TriKE from 9 patients with MDS and AML. Results demonstrated up to 63.7% reduction in bone marrow blast levels, restoration of endogenous NK cell function, proliferation and immune surveillance. All patients treated displayed no signs of any grade of cytokine release syndrome (CRS) across all dose cohorts. GTB-3550 TriKE is currently being administered to patients at doses significantly higher than the reported maximum tolerated dose (MTD) for continuous infusion of recombinant human interleukin-15 (IL-15).
Enrollment in Phase I Portion of GTB-3550 TriKE Phase I/II Clinical Trial in MDS and AML Continues: In April 2021, GT Biopharma announced the enrollment of patient 10 in its GTB-3550 TriKE Phase I/II Clinical Trial in high-risk MDS and AML patients. The patient was dosed at 100mcg/kg/day.
Additional New Findings Supporting GTB-3550 TriKE Monotherapy: In April 2021, GT Biopharma announced additional interim results demonstrating that GTB-3550 TriKE monotherapy is able to rescue the patient’s otherwise exhausted/inhibited/non-functional endogenous NK cell population, and target direct killing of the patient’s AML and MDS cancer cells without the need for the co-administration addition of supplemental progenitor-derived or autologous/allogenic engineered NK cells.
Announced Preliminary Phase II Clinical Trial Design: In May 2021, GT Biopharma announced updates to the Phase 2 design of the ongoing Phase I/II clinical trial of GTB-3550 TriKE monotherapy. The Phase II portion intends to enroll patients with CD33 expression ≥50% in independent cohorts (higher-risk MDS and AML); treat patients with two cycles of GTB-3550 therapy with a rest period between cycles as opposed to the single-cycle used during Phase 1; enroll patients with fewer prior treatment lines; and, (evaluate the potential use of minimal residual disease (MRD) based endpoints that may allow for accelerated approval.
Corporate Highlights

Closed $28.7 Million Public Offering and Successful Nasdaq Listing: In February 2021, GT Biopharma announced the closing of an underwritten public offering extending GT Biopharma’s cash runway through 2022. The Company also retired over $32 million in debt and consolidated capital structure to 28,637,000 shares issued and outstanding.
Strengthened Leadership Team with Key Appointments: In April 2021, GT Biopharma announced the appointment of Gregory Berk, M.D., as Chief Medical Officer and the transition of Jeffrey S. Miller, M.D., from Consulting Chief Medical Officer to Consulting Chief Scientific Officer. Additionally, in January 2021, GT Biopharma announced the appointments of Michael Breen and Rajesh Shrotriya, M.D., as independent directors to the Company’s Board of Directors.
Expanded GMP Manufacturing Agreement with Cytovance Biologics: In February 2021, GT Biopharma announced that it signed an expanded GMP manufacturing agreement with Cytovance Biologics for the manufacturing of all TriKE product candidates.
First Quarter 2021 Financial Results:

Cash Position: As of March 31, 2021, cash, cash equivalents and investments were $27.6 million, compared to $5.3 million as of December 31, 2020. The increase in cash, cash equivalents and investments was primarily due to the completed public offering of 4,945,000 shares of common stock for net proceeds of $24,679,000 after deducting underwriting discounts, commissions and other direct offering expenses. As of May 14th, current cash position of $35,000,000.
Research and Development Expenses: Research and development expenses were $1.6 million for the first quarter of 2021, compared to $.3 million for the same period in 2020. The increase in research and development expenses for the first quarter 2021 was primarily due to the issuance of 189,753 shares of common stock as payment of a fee valued at $1,355,000. We anticipate our direct clinical costs to increase in the remainder of 2021 upon the continuation of a phase one/two clinical trial of our most advanced TriKE product candidate, GTB-3550.
General Administrative Expenses: General administrative expenses were $27.3 million for first quarter 2021, compared to $.7 million for the same period in 2020. The increase in selling, general and administrative expenses is primarily attributable the increase in stock-based compensation. In the period ended March 31, 2021 we incurred $21,535,000 of stock-based compensation, we incurred no such expenses during 2020.
Net Loss: Net loss was $29.7million for the first quarter of 2021, resulting in basic and diluted net loss per share of $1.83. Net loss was $1.7 million for the same period in 2020, resulting in basic and diluted net loss per share of $0.41.
About GTB-3550 TriKE

GTB-3550 is the Company’s first TriKE product candidate being initially developed for the treatment AML. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The natural killer (NK) cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. We intend to study GTB-3550 in CD33 positive leukemias such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies.

On May 17, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune T-cell activating technology, reported the receipt of $4.5 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2020 (Press release, PDS Biotechnology, MAY 17, 2021, View Source [SID1234580192]).

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"We are pleased to receive an allocation from the New Jersey NOL program," said Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. "The funding will be beneficial to us as we continue to efficiently utilize our resources to advance our immuno-oncology pipeline through development."

The NOL program enables qualified, unprofitable NJ-based technology or biotechnology companies with fewer than 225 U.S. employees (including parent company and all subsidiaries) to sell a percentage of net operating losses and research and development (R&D) tax credits to unrelated profitable corporations. This allows qualifying technology and biotechnology companies with NOLs to turn their tax losses and credits into cash proceeds to fund growth and operations, including research and development or other allowable expenditures. PDS Biotech is one of 49 early-stage companies to share in approximately $54.5 million of tax credit transfers approved by NJEDA for the 2020 period.