On April 29, 2021 Blueprint Medicines Corporation (NASDAQ: BPMC) reported its financial results and provided a business update for the first quarter ended March 31, 2021 (Press release, Blueprint Medicines, APR 29, 2021, View Source [SID1234578806]).

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"In recent months, we made significant progress toward achieving our key 2021 portfolio goals, illustrating our clinical leadership in systemic mastocytosis and the rapid advancement of our next wave of therapeutic candidates with first- or best-in-class potential," said Jeff Albers, Chief Executive Officer of Blueprint Medicines. "With a potential U.S. approval for AYVAKIT in advanced systemic mastocytosis in the second quarter, we are looking forward to welcoming a new era of precision medicines care for people living with this debilitating disease. In parallel, we are initiating multiple clinical trials across our pipeline, beginning with the Phase 1 trial of BLU-945 and Phase 2/3 HARBOR trial of BLU-263, as we continue to translate our research productivity and precision therapy expertise to address patient need across cancers and hematologic malignancies. Taken together, these accomplishments position Blueprint Medicines to help an increasing number of patients globally as we advance our robust portfolio."

First Quarter 2021 Highlights and Recent Progress

AYVAKIT/AYVAKYT (avapritinib): systemic mastocytosis (SM)

● Reported data at the virtual American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, including registrational PATHFINDER trial data in advanced systemic mastocytosis (SM), which demonstrated an overall confirmed response rate of 75 percent, as well as PIONEER Part 1 data highlighting the impact of AYVAKIT on skin manifestations in non-advanced SM. Read the full data here.
● Received European Medicines Agency (EMA) validation of the Type II variation marketing authorization application (MAA) for AYVAKYT for the treatment of advanced SM. Validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. Read the press release here.

AYVAKIT/AYVAKYT (avapritinib): gastrointestinal stromal tumor (GIST)

● Recorded $7.1 million in net product revenue during the first quarter of 2021 for AYVAKIT/AYVAKYT, which was approved by the U.S. Food and Drug Administration (FDA) in January 2020 for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations, and by the European Commission in September 2020 as a monotherapy for the treatment of adult patients with unresectable or metastatic GIST harboring the PDGFRA D842V mutation.
● Received National Medical Products Administration (NMPA) approval in China, via our collaboration with CStone Pharmaceuticals, for the treatment of adults with unresectable or metastatic PDGFRA exon 18 mutant GIST, the first approved precision therapy for this patient population in China.

GAVRETO (pralsetinib): RET-altered cancers

● Recorded $1.8 million in net product revenue during the first quarter of 2021 for GAVRETO, which was approved by the FDA in September 2020 for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test and in December 2020 for the treatment of patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer. Blueprint Medicines is commercializing GAVRETO in the U.S. together with Genentech, Inc., a member of the Roche Group.
● Received approval in China, via our collaboration with CStone Pharmaceuticals, for the treatment of adults with locally advanced or metastatic RET fusion-positive NSCLC after platinum-based chemotherapy, the first approved selective RET inhibitor in China.

BLU-263: SM

● Reported new data at AACR (Free AACR Whitepaper) from a Phase 1 trial in healthy volunteers, showing that BLU-263 was generally well-tolerated across a range of single- and multiple-ascending doses, with a half-life supporting once-daily dosing. Based on these data, Blueprint Medicines plans to evaluate BLU-263 at doses ranging from 25 to 100 mg once daily in Part 1 of the Phase 2/3 HARBOR trial in non-advanced SM. Read the full data here.

BLU-945 and BLU-701: treatment-resistant EGFR-driven NSCLC

● Reported new preclinical data at AACR (Free AACR Whitepaper) showing the potential for the company’s potent and selective double-mutant EGFR inhibitor, BLU-701, and potent and selective triple-mutant EGFR inhibitor, BLU-945, to be used alone or in combination, together or with other agents, to overcome or prevent on-target resistance across multiple lines of treatment. Read the full data here.
● Received clearance from the FDA for an investigational new drug (IND) application for BLU-945 for the treatment of patients with EGFR-driven NSCLC.

BLU-222: Cyclin E-aberrant cancers

● Nominated BLU-222, a potentially best-in-class selective and potent CDK2 inhibitor development candidate, for the treatment of cyclin E-aberrant cancers.
● Reported new preclinical data at AACR (Free AACR Whitepaper) for a set of CDK2 inhibitors, showing that selective CDK2 inhibition arrested the cell cycle and blocked tumor proliferation in cyclin E (CCNE)-amplified cell lines and demonstrated robust and sustained anti-tumor activity in vivo in models of CCNE-amplified ovarian, breast and gastric cancer, with improved tolerability compared to a pan-CDK inhibitor and chemotherapy. Read the full data here.

BLU-852: Cancer immunotherapy

● Nominated BLU-852, a potentially best-in-class selective and potent MAP4K1 inhibitor development candidate, developed under the company’s cancer immunotherapy collaboration with Roche.
● Reported new preclinical data at AACR (Free AACR Whitepaper) for a set of MAP4K1 inhibitors, including BLU-852, which were shown to enhance intratumoral immune cell activation, overcome T cell suppression, and reduce tumor burden both as a monotherapy and in combination with checkpoint inhibition. Read the full data here.

Key Upcoming Milestones

The company expects to achieve the following near-term milestones:

● Obtain regulatory approval from the FDA and, if approved, launch AYVAKIT for the treatment of patients with advanced SM in the second quarter of 2021.
● Present clinical data from the ARROW trial of pralsetinib in patients with RET fusion‒positive non-small cell lung cancer and in patients with solid tumors at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in the second quarter of 2021.
● Initiate a global Phase 1 trial of BLU-945 in patients with treatment-resistant EGFR-driven NSCLC in the second quarter of 2021.
● Complete enrollment of the registration-enabling Part 2 of the PIONEER trial of AYVAKIT in non-advanced SM in mid-2021.
● Initiate the Phase 2/3 HARBOR trial of BLU-263 in patients with non-advanced SM in mid-2021.
● Initiate a Phase 1 trial of BLU-701 in patients with treatment-resistant EGFR-driven NSCLC in the second half of 2021.
● Present preclinical data supporting combination of BLU-945 and BLU-701 in treatment-naïve EGFR-driven NSCLC in the second half of 2021.

First Quarter 2021 Financial Results

● Revenues: Revenues were $21.6 million for the first quarter of 2021, including $7.1 million of net product revenues from sales of AYVAKIT/AYVAKYT, $1.8 million of net product revenues from sales of GAVRETO and $12.6 million in collaboration revenues. Blueprint Medicines recorded revenues of $6.2 million in the first quarter of 2020, including $3.5 million of net product revenues from sales of AYVAKIT and $2.7 million in collaboration revenues.
● Cost of Sales: Cost of sales was $0.1 million for the first quarter of 2021, as compared to less than $0.1 million for the first quarter of 2020.
● R&D Expenses: Research and development expenses were $79.7 million for the first quarter of 2021, as compared to $84.1 million for the first quarter of 2020. This decrease was primarily due to reimbursement from the global development cost sharing arrangement under our collaboration with Roche for pralsetinib. Research and development expenses included $8.9 million in stock-based compensation expenses for the first quarter of 2021.
● SG&A Expenses: Selling, general and administrative expenses were $42.0 million for the first quarter of 2021, as compared to $35.7 million for the first quarter of 2020. This increase was primarily due to increased costs associated with building our commercial infrastructure for commercialization of AYVAKIT/AYVAKYT and GAVRETO, partially offset by reimbursement under our collaboration with Roche for pralsetinib. General and administrative expenses included $11.7 million in stock-based compensation expenses for the first quarter of 2021.
● Net Loss: Net loss was $99.7 million for the first quarter of 2021, or a net loss per share of $1.72, as compared to a net loss of $111.0 million for the first quarter of 2020, or a net loss per share of $2.11.
● Cash Position: As of March 31, 2021, cash, cash equivalents and investments were $1,430.1 million, as compared to $1,549.7 million as of December 31, 2020.

Conference Call Information

Blueprint Medicines will host a live conference call and webcast at 8:30 a.m. ET today to discuss first quarter 2021 financial results and recent business activities. The conference call may be accessed by dialing (855) 728-4793 (domestic) or (503) 343-6666 (international), and referring to conference ID 9292306. A webcast of the call will be available under "Events and Presentations" in the Investors & Media section of the Blueprint Medicines website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

On April 29, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, reported that it will host a conference call and live webcast on Thursday, May 6, 2021 at 8:30 a.m. EDT to report financial results for the first quarter 2021 and provide business updates (Press release, ADC Therapeutics, APR 29, 2021, View Source [SID1234578801]).

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To access the live call, please dial 888-771-4371 (domestic) or +1 847-585-4405 (international) and provide confirmation number 50158735. A live webcast of the presentation will be available under "Events and Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

On April 29, 2021 Novocure (NASDAQ: NVCR) reported financial results for the quarter ended March 31, 2021, highlighting continued commercial strength despite changes in patterns of care in some regions driven by COVID-19, as well as continued progress across the company’s clinical and product development programs (Press release, NovoCure, APR 29, 2021, View Source [SID1234578832]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields). TTFields are electric fields that disrupt cancer cell division.

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(1) Adjusted EBITDA is a non-U.S. GAAP measurement of earnings before interest, taxes, depreciation, amortization and share-based compensation.

(2) An "active patient" is a patient who is receiving treatment under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.

(3) A "prescription received" is a commercial order for Optune or Optune Lua that is received from a physician certified to treat patients for a patient not previously on Optune or Optune Lua. Orders to renew or extend treatment are not included in this total.

"Over the last several months, we have made progress across multiple clinical development programs intended to determine Tumor Treating Fields’ optimal use," said William Doyle, Novocure’s Executive Chairman. "We continued to increase our understanding of the potential benefits of Tumor Treating Fields when used together with immunotherapies and continued to enroll patients in five late-stage clinical trials in multiple solid tumor types. The accelerated interim analysis of the LUNAR trial and the upcoming HEPANOVA data presentation represent the beginning of what we expect to be an exciting few years of data readouts from our pipeline."

"Our track record of consistent execution and financial strength continued in the first quarter of 2021," added Asaf Danziger, Novocure’s Chief Executive Officer. "We generated $135 million in net revenues with an 80% gross margin, and we invested $46 million in research and development intended to fuel future growth. With 3,454 active patients on therapy at the end of the quarter, we have treated nearly 20,000 patients globally, to date."

First quarter 2021 financial update

For the quarter ended March 31, 2021, net revenues were $134.7 million, representing 32% growth compared to the first quarter 2020.

In the United States, net revenues totaled $85.9 million in the quarter ended March 31, 2021, representing 24% growth compared to the same period in 2020.
In Germany and other EMEA markets, net revenues totaled $35.0 million in the quarter ended March 31, 2021, representing 43% growth compared to the same period in 2020.
In Japan, net revenues totaled $8.3 million in the quarter ended March 31, 2021, representing 28% growth compared to the same period in 2020.
In Greater China, net revenues totaled $5.5 million in the quarter ended March 31, 2021, representing 237% growth compared to the same period in 2020.
For the three months ended March 31, 2021, the increase in net revenues from the first quarter of 2020 resulted primarily from an increase of 359 active patients in our currently active markets and a durable improvement in the net revenues booked per active patient.

We recorded $9.4 million in revenues from Medicare fee-for-service beneficiaries billed under the coverage policy effective on September 1, 2019 in the first quarter 2021, an increase of 32% from the $7.1 million recognized in the same period in 2020. We have gained a good understanding of how to ensure timely processing of Medicare claims and we believe that we have sufficient experience to recognize approximately two-thirds of the expected contribution from Medicare beneficiaries. In the first quarter of 2021, incremental net revenues resulting from the successful appeal of previously denied claims for Medicare fee-for-service beneficiaries billed prior to established coverage reverted to normalized levels from the first half of 2020.

Cost of revenues for the three months ended March 31, 2021 was $26.4 million compared to $24.5 million for the same period in 2020, representing an increase of 8%. The increase in cost of revenues was primarily due to the cost of shipping transducer arrays to a higher volume of commercial patients and increasing shipments of equipment to Zai Lab. Gross margin was 80% for the three months ended March 31, 2021 compared to 76% for the three months ended March 31, 2020.

Research, development and clinical trials expenses for the three months ended March 31, 2021 were $45.9 million compared to $25.3 million for the same period in 2020, representing an increase of 82%. This was primarily due to an increase in clinical trial and personnel expenses for our phase 3 pivotal and post-marketing trials, an increase in development and personnel expenses to support our product development programs, increased investments in preclinical research and the expansion of our medical affairs activities.

Sales and marketing expenses for the three months ended March 31, 2021 were $31.4 million compared to $28.8 million for the same period in 2020, representing an increase of 9%. This was primarily due to an increase in personnel and professional services costs to support our growing commercial business and reimbursement efforts.

General and administrative expenses for the three months ended March 31, 2021 were $31.1 million compared to $26.6 million for the same period in 2020, representing an increase of 17%. This was primarily due to an increase in personnel costs and professional services.

Net loss for the three months ended March 31, 2021 was $4.1 million compared to net income of $4.0 million for the same period in 2020.

At March 31, 2021, we had $864.4 million in cash and cash equivalents and short-term investments, an increase of $21.8 million compared to $842.6 million at December 31, 2020. The increase in our cash, cash equivalents and short-term investments was primarily due to the cash flow from operations and the exercise of options.

First quarter 2021 operating statistics

There were 3,454 active patients at March 31, 2021, representing 12% growth compared to March 31, 2020, and 1% growth compared to December 31, 2020.

In the United States, there were 2,183 active patients at March 31, 2021, representing 8% growth compared to March 31, 2020.
In Germany and other EMEA markets, there were 1,000 active patients at March 31, 2021, representing 18% growth compared to March 31, 2020.
In Japan, there were 271 active patients at March 31, 2021, representing 22% growth compared to March 31, 2020.
Additionally, 1,402 prescriptions were received in the quarter ended March 31, 2021, representing no change compared to the same period in 2020, and a 1% decrease compared to the quarter ended December 31, 2020. We believe the prolonged disruption caused by COVID-19 is resulting in increased volatility across global health care systems, such as fluctuations in patient volumes and changes in patterns of care in certain regions, which had some impact on our business in the first quarter.

In the United States, 917 prescriptions were received in the quarter ended March 31, 2021, representing a 7% decrease compared to the same period in 2020.
In Germany and other EMEA markets, 382 prescriptions were received in the quarter ended March 31, 2021, representing 16% growth compared to the same period in 2020.
In Japan, 103 prescriptions were received in the quarter ended March 31, 2021, representing 10% growth compared to the same period in 2020.
First quarter 2021 non-U.S. GAAP measures

We also measure our performance based upon a non-U.S. GAAP measurement of earnings before interest, taxes, depreciation, amortization and shared-based compensation ("Adjusted EBITDA"). We believe Adjusted EBITDA is useful to investors in evaluating our operating performance because it helps investors compare the results of our operations from period to period by removing the impact of earnings attributable to our capital structure, tax rate and material non-cash items, specifically share-based compensation.

Adjusted EBITDA was $21.1 million for the three months ended March 31, 2021, an increase of $6.1 million, or 40%, from $15.1 million for the three months ended March 31, 2020. This improvement in fundamental financial performance was driven by net revenue growth coupled with an ongoing commitment to disciplined management of expenses.

Recent clinical milestones

Earlier this April, we disclosed that an independent data monitoring committee (DMC) informed Novocure that the pre-specified interim analysis for the phase 3 pivotal LUNAR trial for the treatment of non-small cell lung cancer (NSCLC) was accelerated given the length of accrual and the number of events observed, to date. The interim analysis included data from 210 patients accrued through February 2021. After review of the interim analysis, the DMC concluded that the LUNAR trial should continue with no evidence of increased systemic toxicity. The DMC went on to comment that the continued accrual to 534 patients as proposed in the original protocol, given the current rate of accrual and the interim data presented, is likely unnecessary and possibly unethical for patients randomized to control. For this reason, the DMC recommended an adjustment of accrual to approximately 276 patients with a 12-month follow-up following the enrollment of the last patient. The DMC believes this amended protocol would provide adequate data regarding toxicity and efficacy, providing sufficient overall power, as well as potentially providing important information regarding efficacy within treatment subgroups.

In April, we concluded our phase 2 pilot HEPANOVA trial investigating TTFields together with sorafenib, a kinase inhibitor, in 25 patients with advanced liver cancer. We have submitted an abstract for presentation at an upcoming medical conference in late June and look forward to discussing the full data set with clinicians, investigators and investors in the future.

In April, the U.S. Food and Drug Administration (FDA) approved our investigational device exemption (IDE) application to initiate the KEYNOTE-B36 phase 2 pilot trial to study TTFields with pembrolizumab in first-line NSCLC through our clinical collaboration with MSD (Merck & Co., Inc., Kenilworth, NJ, USA). We are currently evaluating clinical trial sites for initiation.

Anticipated clinical milestones

FDA response to IDE supplement incorporating recommended protocol changes to phase 3 pivotal LUNAR trial in NSCLC (Q2 2021)
Presentation of full data from phase 2 pilot HEPANOVA trial in advanced liver cancer (Q2 2021)
Interim analysis of phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (Q3 2021)
Data from phase 2 pilot EF-31 trial in gastric cancer (2022)
Interim analysis of phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2022)
Data from phase 3 pivotal METIS trial in brain metastases (2022)
Data from phase 2 pilot EF-33 trial with high-intensity arrays in recurrent glioblastoma (2022)
Final data from phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2023)
Final data from phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2023)
Final data from phase 3 pivotal LUNAR trial in NSCLC (to be determined pending FDA approval of IDE supplement)
Conference call details

Novocure will host a conference call and webcast to discuss first quarter 2021 financial results at 8 a.m. EDT today, Thursday, April 29, 2021. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 2286525.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On April 29, 2021 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported a business update for the first quarter ended March 31, 2021 (Press release, Genocea Biosciences, APR 29, 2021, View Source [SID1234578800]).

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"Genocea continues to accumulate evidence that our ATLAS platform may enable immunotherapies that preferentially attack the surface-presented antigens driving anti-tumor responses or as we say, ‘Targets Matter’," said Chip Clark, Genocea’s President and Chief Executive Officer. "Whether through our ongoing clinical trials with GEN-011, our neoantigen-targeted peripheral T cell ("NPT") therapy and GEN-009, our neoantigen vaccine, or through our research efforts with Inhibigens and SARS-CoV-2 antigen discovery, we look forward to providing updates consistent with this thesis throughout the year."
Clinical updates
GEN-011 Phase 1/2a clinical trial (the "TITAN study")
•GEN-011 is in development to treat checkpoint inhibitor-refractory patients. Genocea believes using patient T cells taken from easily accessible peripheral blood and expanding the T cells only on tumor neoantigens prioritized by our ATLAS platform may give GEN-011 efficacy, accessibility and cost advantages over other T cell therapies. The TITAN study is designed to explore safety, biomarkers of activity and anti-tumor efficacy. During the first quarter, Genocea continued to add clinical sites and accrue patients. The company expects to have initial efficacy data from a patient subset late in the fourth quarter of 2021 or the first quarter of 2022.
GEN-009 Phase 1/2a clinical trial
•The Company will provide long-term follow-up clinical and immunogenicity data from the ongoing Phase 1/2a clinical study at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") 2021 Annual Meeting from June 4 – June 8.
Research updates
Inhibigens
•At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting 2021 in April, the Company presented novel preclinical Inhibigen data highlighting that the presence of a single Inhibigen in an otherwise protective immunotherapy can completely reverse the therapy’s intended anti-tumor responses and the Inhibigen effect can be seen as early as 4 days post-dosing.

SARS-CoV-2
•The Company continues its SARS-CoV-2 research efforts to identify conserved antigens of protective T cell responses that may enable a next-generation vaccine protecting against a wide range of strains.
Other business updates
Strengthened executive leadership team
•Genocea appointed Jacquelyn Sumer as Chief Legal and Compliance Officer. Jackie brings over fifteen years of legal experience, including roles at several biopharmaceutical companies with a focus in oncology and cell therapy experience development and commercialization.
Financial and other updates
First quarter 2021 financial results
•Cash position: As of March 31, 2021, cash and cash equivalents were $66.0 million compared to $79.8 million as of December 31, 2020.
•Research and Development (R&D) expenses: R&D expenses were $8.8 million for the quarter ended March 31, 2021, compared to $10.0 million for the same period in 2020.
•General and Administrative (G&A) expenses: G&A expenses were $3.7 million for the quarter ended March 31, 2021, compared to $3.4 million for the same period in 2020.
•Net loss: Net loss was $12.0 million for the quarter ended March 31, 2021, compared to $12.9 million for the same period in 2020.
Debt Refinancing
•In February 2021, the Company entered into an agreement with Silicon Valley Bank for a $10 million term loan. The proceeds from the loan were used to repay the Company’s outstanding loan from Hercules Capital, Inc., and for general corporate purposes.
Guidance
•Genocea’s operating plan extends its cash runway to the end of 2022.

Conference Call
Genocea will host a conference call and webcast today at 8:30 a.m. E.T. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 2191366. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

On April 29, 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 that initial efficacy and safety data from the National Cancer Institute’s (NCI) Phase 2 clinical study of PDS0101 for the treatment of advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment (NCT04287868) has been accepted for oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting taking place June 4-8.

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The accepted abstract summarizes initial findings from the ongoing trial, which studies PDS0101 in combination with two investigational immune-modulating agents: bintrafusp alfa (M7824), a bifunctional "trap" fusion protein targeting TGF-β and PD-L1, and NHS-IL12 (M9241), a tumor-targeting immunocytokine. Earlier this year, it was announced that the trial had achieved its preliminary efficacy threshold of an objective response in 3 or more of the first 8 patients as measured by RECIST 1.1. The trial subsequently expanded enrollment to both checkpoint inhibitor naïve patients and patients who have failed prior therapy with checkpoint inhibitors. "We are encouraged by the data and look forward to the presentation of initial findings from the study," said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "ASCO provides an important opportunity to share the potential of both PDS0101 and the Versamune platform with the research and medical community."

Abstract Number: 2501
Abstract Title: Phase II evaluation of the triple combination of PDS0101, M9241, and bintrafusp alfa in patients with HPV 16 positive malignancies.

Presenting Author: Julius Strauss, MD, National Cancer Institute
Session: Developmental Therapeutics—Immunotherapy
Date: June 7, 2021
Time: 3:00 PM-6:00 PM EDT

The abstract will be available on Wednesday, May 19 at 5:00 PM EDT on ASCO (Free ASCO Whitepaper).org.