On May 7, 2020 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq: ZIOP), reported its financial results for the first quarter ended March 31, 2020 and provided a corporate update (Press release, Ziopharm, MAY 7, 2020, View Source [SID1234557279]).

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"We anticipate reporting milestones across all of our programs this year, even when factoring in the effects of the pandemic on our global community, and we are working to minimize the uncertainty around some of of our timelines," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer. "We continue to make progress toward initiating our TCR-T clinical trial at MD Anderson Cancer Center based on the Sleeping Beauty platform and look forward to providing an update on the status of this trial later this year. In our Controlled IL-12 platform for recurrent glioblastoma (rGBM), clinicians and healthcare workers continue to treat patients and facilitate patient enrollment and our anticipated milestones in this program are on track. The National Cancer Institute (NCI) and MD Anderson have limited nonclinical and clinical research in response to COVID-19 which impacts their partners, and which will temporarily delay the initiation of our clinical trials with each institution. We are working closely with them to undertake our trials once the restrictions ease; however, the timing is not under our control."

"The Company is in a strong financial position, having completed a financing during the first quarter prior to the impact of the pandemic in the United States," added Sath Shukla, Chief Financial Officer. "With over $170 million in cash and investments available to support our programs, we are well positioned to weather this storm and continue executing on our strategic objectives."

Recent Corporate Highlights

Sleeping Beauty TCR-T Program

NCI Phase 2 TCR-T Study. During the quarter, the Ziopharm team worked with the NCI to advance preparations for dosing the first patient, including work on screening patients and final engineering

runs. As a result of COVID-19, the NCI has instituted significant work restrictions which unavoidably impacts research with its partners and have in turn delayed the dosing of the first patient in our TCR-T trial under the CRADA. Ziopharm is able to use its expanded laboratories in Houston to help complete the engineering runs and reduce future delays for this trial. The study is the first-in-human non-viral TCR-T study to be conducted at the NCI and details on the protocol are available on clinicaltrials.gov (NCT0402436).

Personalized and Library TCR-T Clinical Trial with MD Anderson. Based on instructive feedback from the U.S. Food and Drug Administration (FDA), the Company continues to make progress toward initiating its TCR-T clinical trial at MD Anderson based on the Sleeping Beauty platform. As previously guided, the Company plans to evaluate both its personalized TCR-T and its library TCR-T therapies and, in preparation for this trial, the Company has increased its R&D footprint at MD Anderson by leasing additional research and development facilities.

Controlled IL-12 Program

Phase 2 Combination Study. Under the Controlled IL-12 program, Ziopharm is actively enrolling patients in a phase 2 combination trial with Regeneron’s Libtayo to treat patients with rGBM. Per the study protocol, the Company expects to enroll at least 36 patients at approximately 10 sites. Enrollment for this study is anticipated to be completed in H1 2020. Accrual to the phase 1 monotherapy expansion protocol (NCT03679754) and combination study with OPDIVO were completed in 2019 (NCT03636477). The Company anticipates providing clinical updates at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) virtual annual meeting in late May.

Sleeping Beauty CAR-T Program

Eden BioCell CAR-T Study. The Company’s joint venture partner, Eden BioCell, continued to make progress toward filing an IND this year for a clinical trial in Taiwan to assess patient-derived (autologous) CD19-specific CAR-T therapies, produced using a technology we refer to as Rapid Personalized Manufacturing (RPM).

Ziopharm CAR-T Study. The Company’s planned clinical trial infusing donor-derived (allogeneic) CD19-specific CAR-T therapies produced using RPM has been impacted by MD Anderson’s response to COVID-19, which impacts all their partners. This will unavoidably delay the dosing of the first patient in this trial. Institutional and federal regulatory documents are complete, manufacturing has been verified, but the site initiation visit is delayed due to the current work restrictions at MD Anderson. In response to COVID-19 and other considerations, the Company is prioritizing the work with Eden BioCell to develop autologous CAR-T under RPM given Eden BioCell’s technical progress and the favorable work environment in Taiwan, despite the pandemic. This helps conserve the Company’s financial resources while preserving Ziopharm’s rights to advance the technology in the U.S. and leverage clinical data from Greater China. Data from Eden BioCell and Ziopharm will collectively support the development of RPM technology.

Operational

Expanded Team, Board, and Capabilities. Ziopharm selectively expanded its team with new employees in cell therapy, manufacturing and clinical operations to further advance its programs, expand its capabilities and support its growth especially in Houston. The Company is recruiting additional personnel, including a Chief Medical Officer, and strengthening its business development and investor relations capabilities. Ziopharm also plans to selectively add to its Board of Directors, complementing its existing leadership in drug development, financing, and business development.

Strengthened Balance Sheet. The Company successfully raised over $100 million in net proceeds during the first quarter, extending its funding horizon into mid-2022. The additional funding provides for an accelerated buildout of its TCR-T program in Houston and the launch of Ziopharm-led TCR clinical trials for patients with solid tumors. The Company ended the first quarter of 2020 with approximately $171 million in cash, and another $18 million in capital pre-funded by MD Anderson available for the Company’s programs.

First Quarter 2020 Financial Results

Research and development expenses were $12.7 million for the first quarter of 2020, compared to $9.5 million for the first quarter of 2019, primarily reflecting increased clinical trial activity.

General and administrative expenses were $6.0 million for the first quarter of 2020, compared to $4.1 million for the first quarter of 2019. The increase in general and administrative expenses for the first quarter of 2020 is primarily due to increased headcount, legal costs associated with its expanded patent portfolio and facility costs.

Net loss for the first quarter of 2020, was $18.3 million, or $(0.09) per share, compared to a net loss of $13.4 million, or $(0.08) per share, for the first quarter of 2019.

Cash and cash equivalents, as of March 31, 2020 were $171.0 million.

A prepayment of approximately $18.0 million remains for work to be conducted by the Company at MD Anderson under the Company’s research and development agreements.

Conference Call and Webcast

Ziopharm will host a conference call and webcast for the investment community today, May 7, 2020, at 4:30 p.m. EDT. The conference call can be accessed by dialing 1-877-451-6152 (U.S. and Canada) or 1-201-389-0879 (international). The passcode for the conference call is 13701877. To access the live webcast or the subsequent archived recording, click here or visit the "Investors" section of the Ziopharm website at www.ziopharm.com. The webcast will be recorded and available for replay on the company’s website for two weeks.

On May 7, 2020 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, reported results for the first quarter of 2020 in addition to providing an update on the company’s recent activities (Press release, Five Prime Therapeutics, MAY 7, 2020, View Source [SID1234557278]).

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"Five Prime is in a solid position with near-term data readouts for our two lead programs and a strong cash runway, which is a result of our financial discipline," said Tom Civik, Chief Executive Officer of Five Prime Therapeutics. "I am immensely proud of our employees who continue to show resolve and agility during this challenging time of the coronavirus pandemic. The team has kept our clinical trials on track bringing us closer to potentially having a significant impact on some of the most devastating cancers."

First Quarter 2020 Milestones

Clinical Pipeline:

Bemarituzumab (anti-FGFR2b) is a first-in-class isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) being studied in the FIGHT trial as a targeted cancer therapy for tumors that overexpress FGFR2b.

The FIGHT trial is being converted from a Phase 3 to a randomized, double-blind, Phase 2 trial based on the approximately 150 patients enrolled.

The Phase 2 FIGHT study is expected to have a sufficient number of PFS and OS events to generate clinically meaningful and actionable data by the end of the year or early 2021.

Converting to a Phase 2 trial is the fastest path to generating informative data about bemarituzumab: the first agent to target FGFR2b overexpressing gastric and gastroesophageal junction cancer (GEJ).

FPT155 (CD80-Fc) is a first-in-class CD80-Fc fusion protein that directly engages CD28 and binds to CTLA-4, promoting T cell activation in the tumor microenvironment.

In the ongoing Phase 1 dose escalation study, a dose-dependent expansion of memory T-cells has been identified, consistent with the mechanism of action of FPT155 observed in preclinical studies.

In parallel with continued dose escalation, patients with warm/hot tumor types are being enrolled with the aim to generate early clinical evidence of FPT155 single-agent activity by the end of 2020.

An arm has been added in the ongoing trial to test the combination of escalating doses of FPT155 and pembrolizumab in patients with PD-1 treated non-small cell lung cancer. Five Prime expects to begin enrolling patients in this cohort in the third quarter of 2020.

FPA150 (anti-B7-H4) is a first-in-class antibody being studied as a treatment for patients with B7-H4 overexpressing tumors in a Phase 1a/1b clinical trial. Five Prime is in the process of completing the Phase 1a/1b study. The company does not currently plan to independently advance the clinical development of FPA150 as either a monotherapy or in combination with pembrolizumab.

BMS-986258 (anti-TIM-3) is a fully-human monoclonal antibody targeting TIM-3 (T cell immunoglobulin and mucin domain-3), the first clinical candidate from the discovery collaboration between Five Prime and Bristol-Myers Squibb (BMS) that includes targets in three immune checkpoint pathways. In light of the coronavirus pandemic, Five Prime is withdrawing its guidance that this trial may advance from Phase 1 to Phase 2 in 2020.

2020 Corporate Highlights

In April 2020, Five Prime announced the appointment of Thomas Civik as President and Chief Executive Officer and a member of the Board of Directors of the company. Mr. Civik joins Five Prime from Foundation Medicine, where he served as Chief Commercial Officer. Prior to that, Mr. Civik most recently served as Vice President and Oncology Franchise Head at Genentech.

In February 2020, the company announced a global license agreement with Seattle Genetics, Inc. to develop and commercialize novel ADC therapies using monoclonal antibodies, developed by Five Prime, that are directed to a single target. Under the terms of the agreement, the company received a $5 million upfront payment and is eligible to receive progress-dependent development and regulatory milestone payments as well as cumulative commercial milestone payments. Cumulative milestone payments may reach up to $525 million for the first two ADC product candidates.

Summary of First Quarter 2020 Financial Results and Cash Guidance:

Cash Position: Cash, cash equivalents and marketable securities totaled $142.7 million as of March 31, 2020, compared to $157.9 million as of December 31, 2019. The decrease in cash, cash equivalents and marketable securities was primarily attributed to quarterly operating expenses that exceeded quarterly revenues.

Revenue: Collaboration and license revenue for the first quarter of 2020 increased by $3.1 million, or 58%, to $8.4 million from $5.3 million for the first quarter of 2019. The increase was primarily related to license revenues earned from the Seattle Genetics license agreement, signed in February 2020, and revenue from the collaboration with Zai Lab. These increases were partially offset by the completion of the immuno-oncology research collaboration with BMS and progress pursuant to the company’s performance obligation under the original cabiralizumab collaboration with BMS.

R&D Expenses: Research and development expenses for the first quarter of 2020 decreased by $13.2 million, or 42%, to $18.6 million from $31.8 million for first quarter of 2019. The decrease was primarily related to lower compensation costs resulting from the October 2019 restructuring, lower clinical services and specialty lab services related to clinical studies of cabiriluzumab and FPA150, reduced companion diagnostics expenses directed toward the bemarituzumab development program and a decrease in miscellaneous research and development expenses. These decreases were partially offset by increased clinical trial expenses primarily related to bemarituzumab.

G&A Expenses: General and administrative expenses for both the first quarter of 2020 and the first quarter of 2019 were $10.5 million.

Net Loss: Net loss for the first quarter of 2020 was $20.1 million, or $0.57 per basic and diluted share, compared to a net loss of $35.4 million, or $1.02 per basic and diluted share, for the first quarter of 2019.

Shares Outstanding: Total shares outstanding were 35,324,056 as of March 31, 2020.

Cash Guidance: Five Prime expects full-year 2020 net cash used in operating activities to be between $77 and $82 million and affirms previously issued guidance to end 2020 with cash, cash equivalents and marketable securities between $77 and $82 million.

Conference Call Information

Five Prime will host a conference call and live audio webcast today at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss its financial results and provide a corporate update. To participate in the conference call, please dial (253) 237-1188 (domestic) or (877) 878-2269 (international) and refer to conference ID 5376706. To access the live webcast please visit the "Events & Presentations" page under the "Investors" tab on Five Prime’s website at www.fiveprime.com. An archived copy of the webcast will be available on Five Prime’s website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

On May 7, 2020 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported financial results for the first quarter of 2020 (Press release, Dynavax Technologies, MAY 7, 2020, View Source [SID1234557277]).

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"Now more than ever, the world is acutely aware of the crucial role vaccines play in protecting our families, communities, and those at high risk for infectious disease," commented Ryan Spencer, Chief Executive Officer of Dynavax. "Hepatitis B is a highly infectious deadly virus which, thankfully, can be prevented with effective vaccination. Our first product, HEPLISAV-B, provides adults higher levels of protection from hepatitis B in one month, compared to other hepatitis B vaccines that require six months. We believe that HEPLISAV-B has the potential to become the standard of care for adult hepatitis B vaccination in the U.S."

Mr. Spencer added, "With uncertainty spawned by the current pandemic, our focus in 2020 remains driving revenue growth of HEPLISAV-B, generating data to support a unique dosing regimen for patients on hemodialysis, and supporting policy initiatives aimed at protecting more adults through adoption of a two-dose regimen, all of which position HEPLISAV-B for substantial long-term growth. Additionally, we have established multiple research collaborations leveraging our proprietary vaccine adjuvant, CpG 1018, to support the development of coronavirus vaccines. Despite the short-term disruptions of this year, Dynavax’s long-term value proposition remains intact with the added potential to accelerate the utilization of CpG 1018 globally."

HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]

Despite sales reductions at the end of March due to coronavirus pandemic response, Dynavax achieved first quarter 2020 net product revenue of $10.5 million compared to $5.6 million for the first quarter of 2019.
Dynavax has exceeded the HEPLISAV-B minimum product revenue covenant in its Term Loan Agreement of $30 million for the annual measurement period ending June 30, 2020.
On-going clinical trial evaluating immunogenicity and safety of 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease (ESRD) who are initiating or undergoing hemodialysis:
Seroprotection rate of 86.4% demonstrated in interim analysis of 44 patients
Safety and efficacy have not been established in this population; full study data anticipated in the second half of 2020
COVID-19 Response
Dynavax has focused on four key areas in addressing uncertainty related to the COVID-19 pandemic:

Protecting the health and safety of Dynavax’s employees and customers
Ensuring access to HEPLISAV-B with a secure supply chain able to meet U.S. market demand
Continuing to advance the Company’s on-going clinical trials of HEPLISAV-B
Leveraging the Company’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018, in collaborations to develop additional adjuvanted vaccines. Dynavax has established multiple such research collaborations to develop a coronavirus (COVID-19) vaccine:
Vaccine Approach Collaborator Country
Protein Subunit University of Queensland Australia
Clover Biopharmaceuticals China
Inactivated Virus Sinovac Biotech China
Valneva France

2020 Milestones

Interim data from ongoing study of HEPLISAV-B in patients on hemodialysis reported in April 2020; final immunogenicity data anticipated in the second half of 2020
Completion of Phase 1-enabling animal studies and toxicology for an improved pertussis vaccine with CpG 1018
Inclusion of CpG 1018 in at least one coronavirus vaccine advanced to Phase 1 clinical evaluation
Entrance into multiple strategic relationships focused on initial research in a variety of vaccine candidates to establish CpG 1018 as a leading adjuvant
Completion of safety follow-up for HEPLISAV-B post-marketing studies in Q4 2020
Financial Results
Product Revenue, Net. Product revenue, net increased to $10.5 million in the first quarter of 2020 compared to $5.6 million in the same period in 2019 due to higher sales volume as additional healthcare providers completed operational activities required to switch to HEPLISAV-B and existing customers placed repeat orders. Although there was a modest impact from COVID-19 on HEPLISAV-B net product sales in the first quarter, most medical centers restricted access to their facilities and focused on providing care to only the most severely affected patients by mid-March. This has resulted in significantly reduced utilization of vaccines, including HEPLISAV-B, which is likely to continue until the U.S. returns to more normal conditions.

Cost of Sales – Product. Cost of sales – product for the first quarter 2020 was $2.4 million, compared to $1.8 million for the first quarter of 2019. The increase is due to higher sales volume and higher unit costs as we produce and then sell finished product inventory that includes components for which a portion of the cost has previously been expensed to research and development prior to approval of the pre-filled syringe presentation in March 2018.

Research and Development Expenses. Research and development expenses for the first quarter of 2020 were $4.7 million, compared to $21.2 million for the first quarter of 2019. Excluding non-cash stock-based compensation, R&D expenses decreased to $6.2 million in the first quarter of 2020, compared to $19.0 million in the first quarter of 2019. Stock-based compensation for the three months ended March 31, 2020 included reversal of expenses related to cancellation of certain equity grants.

SG&A Expenses. Selling, general and administrative (SG&A) expenses for the first quarter of 2020 were $20.9 million, compared to $18.3 million for the first quarter of 2019. The increase for the three months ended March 31, 2020 compared to 2019, was primarily related to costs related to the HEPLISAV-B post-marketing study, an increase in facility costs due to higher overhead allocation to SG&A functions and changes in non-cash stock-based compensation resulting from the restructuring.

Net Loss. Net loss allocable for the first quarter of 2020 was $12.6 million, or $0.15 per basic share and $0.25 per diluted share, compared to a net loss of $39.7 million, or $0.62 per basic and diluted share, for the first quarter of 2019.

Cash Position. Cash, cash equivalents and marketable securities totaled $129.5 million at March 31, 2020.

Conference Call and Webcast Information
Dynavax will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT. The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at www.dynavax.com. Alternatively, participants may dial (866) 420-4066 (domestic) or (409) 217-8237 (international) and refer to conference ID 1178679. A replay of the webcast will be available for 30 days following the live event.

Please see Important Safety Information below.

For more information about HEPLISAV-B, visit View Source

About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,I and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.II Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician’s discretion.III Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.IV

About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

Indication and Use
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

Important Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B. Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

On May 7, 2020 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported first quarter 2020 financial results and provides a business update (Press release, CytomX Therapeutics, MAY 7, 2020, View Source/news-releases/news-release-details/cytomx-therapeutics-announces-first-quarter-2020-financial" target="_blank" title="View Source/news-releases/news-release-details/cytomx-therapeutics-announces-first-quarter-2020-financial" rel="nofollow">View Source [SID1234557276]).

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"The first quarter of 2020 presented unique challenges as we navigated the early stages of the COVID-19 pandemic, but through a strategic pipeline reprioritization and excellent progress with new and existing research and development partnerships, we entered the second quarter well positioned for the remainder of the year and beyond," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "Our continued achievements reflect our long-term strategic vision for CytomX and include the progression of multiple wholly-owned and partnered programs into or towards Phase 2 clinical trials alongside a major new collaboration with Astellas that further validates our Probody platform. Our intensified focus on the application of Probody technology to undruggable targets is aimed at making the biggest difference for patients with cancer."

First Quarter Business Highlights and Recent Developments

COVID 19 Pandemic and Business Continuity

CytomX is committed to ensuring the health, safety and well-being of its clinical study participants, staff at our study sites and our employees. CytomX continues to closely monitor the COVID-19 pandemic situation and is following local, state, and federal guidelines, including, with respect to the conduct of our worldwide clinical trials, emerging Health Authority guidance and IRB/Ethics Committee recommendations.

STRATEGIC REPRIORITIZATION OF WHOLLY OWNED CLINICAL PIPELINE INCREASES FOCUS ON UNDRUGGABLE TARGETS AND FIRST-IN-CLASS DRUG DEVELOPMENT

PROCLAIM-CX-2009-001

CytomX made the decision in March 2020 to temporarily pause new patient enrollment and new site activation in the PROCLAIM-CX-2009-001 study evaluating the CD166-targeting Probody drug conjugate CX-2009. This study includes the Phase 2 expansion study evaluating CX-2009 as monotherapy in patients with hormone receptor (ER, PR) positive, HER2 negative breast cancer. This decision followed the assessment of the evolving COVID-19 pandemic, and the emerging challenges for clinical trial execution within our studies and across the industry. CytomX intends to resume the CX-2009 clinical program as soon as practicable.
PROCLAIM-CX-072-002

CytomX also made the strategic decision in March 2020 to terminate the PROCLAIM-CX-072-002 study evaluating the anti-PD-L1 Probody CX-072 in combination with ipilimumab in melanoma. This follows a re-evaluation of the evolving clinical, competitive, and commercial landscapes in immuno-oncology, taken together with impact of the COVID-19 pandemic.
This strategic decision allows CytomX to focus its resources on its potential first-in-class assets, CX-2009 and CX-2029, to the future evaluation of a combination of CX-072 and CX-2009, and to the generation of additional clinical candidates for advancement to IND filing and clinical trials.
SIGNIFICANT PROGRESS WITHIN NEW AND EXISTING STRATEGIC COLLABORATIONS

Astellas Collaboration – Newly Formed Alliance Expands Research and Development in the Field of T-Cell Engaging Bispecifics

CytomX announced a strategic collaboration with Astellas Pharma Inc. focusing on the discovery, development, and commercialization of novel CD3 targeting T-cell engaging bispecific antibodies for the treatment of cancer. Astellas paid CytomX an upfront cash payment of $80 million, that was received in April, with CytomX eligible to receive future preclinical, clinical, and commercial milestones of over $1.6 billion. CytomX is also eligible to receive tiered royalties on global net sales that range from high-single digits to mid-teens.
AbbVie Collaboration – Phase 2 Expansion Stage Study Advances CX-2029, A First-in-Class Anti-CD71 Probody Drug Conjugate

CytomX announced a $40 million milestone payment, to be received by CytomX from AbbVie in the second quarter, through the achievement of pre-specified criteria for the dose escalation phase of the ongoing Phase 1/2 clinical trial, PROCLAIM-CX-2029. CytomX and AbbVie are finalizing plans for the advancement of CX-2029 to Phase 2 expansion cohorts in select tumor types. Additional information is available at ClinicalTrials.gov using the Identifier NCT003543813.
Bristol Myers Squibb Collaboration – Advancement of ipilimumab Probody into Randomized Phase 2 Study

Bristol Myers Squibb initiated a Phase 2 randomized cohort expansion in its ongoing first-in-human Phase 1/2a trial of the anti-CTLA-4 Probody BMS-986249, a Probody version of the anti-CTLA-4 antibody Yervoy (ipilimumab), in combination with Opdivo (nivolumab) in patients with metastatic melanoma. This advancement triggered a milestone payment of $10 million that was received by CytomX in April. Additional information is available at ClinicalTrials.gov using the Identifier NCT03369223.
Amgen Collaboration – Advancement of Lead T-Cell Bispecific Candidate into IND Enabling Studies

CytomX, in partnership with Amgen, has recently advanced CX-904, a lead T-cell engaging bispecific Probody candidate against Epidermal Growth Factor Receptor (EGFR) and CD3, into IND-enabling studies. CytomX is responsible for the IND filing, targeted for late 2021, and for early clinical development
ASCO 2020 PRESENTATIONS TO HIGHLIGHT MULTIPLE PROBODY CLINICAL-STAGE PROGRAMS

CytomX and its partners announced presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program

CytomX and its partner AbbVie will present data from Phase 1 dose escalation study of the PROCLAIM-CX-2029 Phase 1/2 study of the anti CD71 Probody CX-2029
Bristol Myers Squibb will present data from the Phase 1 dose escalation study of the Phase 1/2a trial of the anti-CTLA-4 Probody BMS-986249
CytomX will present updated data from the Phase 1 dose escalation and dose ranging studies of the PROCLAIM-CX-2009 Phase 1/2 study of the anti CD166 Probody CX-2009
CytomX will present updated data from the Phase 1 dose escalation study, monotherapy expansion studies and combination with ipilimumab studies of PROCLAIM-CX-072 Phase 1/2 study of the anti PD-L1 Probody CX-072
Executive Appointments

Announced the appointments of Carlos Campoy, as senior vice president and chief financial officer and Alison Hannah, M.D., as senior vice president and chief medical officer.
First Quarter 2020 Financial Results

Cash, cash equivalents and short-term investments totaled $247.9 million as of March 31, 2020, compared to $296.1 million as of December 31, 2019.

Revenue was $49.6 million for the three months ended March 31, 2020, compared to $29.5 million for the three months ended March 31, 2019. The net increase in revenue of $20.1 million was primarily due to an increase in revenue of $26.6 million relating to the partial revenue recognition of the $40 million milestone earned from AbbVie associated with the PROCLAIM-CX-2029 project in the first quarter of 2020, an increase of $10 million relating to the milestone earned from Bristol Myers Squibb associated with the initiation of the Phase 2 randomized cohort expansion in the first quarter of 2020, partially offset by a decrease in revenue of $17.4 million relating to the accelerated recognition of revenue in the first quarter of 2019 due to reprioritization within our alliance with Bristol Myers Squibb.

Research and development expenses increased by $6.4 million during the three months ended March 31, 2020 compared to the corresponding period in 2019. The increase was largely attributed to $9.1 million of sublicense fees paid to the University of California, Santa Barbara associated with the milestones and upfront payments earned in the first quarter of 2020 and a $3.0 million license fee to ImmunoGen associated with the first dosing of a patient in the CX-2009 Phase 2 clinical trial during the first quarter of 2020. These increases were partially offset by a $5.0 million decrease associated with the acquisition of technical know-how related to drug conjugate linker-toxin and CD3-based bispecific technologies during the first quarter of 2019.

General and administrative expenses were essentially flat during the three months ended March 31, 2020 compared to the corresponding period in 2019.

Teleconference Scheduled Today at 5:00 p.m. ET
Conference Call/Webcast Information

CytomX management will host a conference call today at 5:00 p.m. ET. Interested parties may access the live audio webcast of the teleconference through the "Investor & News" section of CytomX’s website at View Source or by dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International) and using the passcode 6282129. An archive of the webcast will be available on the CytomX website from May 7, 2020, until May 14, 2020.

On May 7, 2020 Athersys, Inc. (NASDAQ: ATHX) reported its financial results for the three months ended March 31, 2020 (Press release, Athersys, MAY 7, 2020, View Source [SID1234557275]).

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Highlights of the first quarter of 2020 and recent events include:

Received authorization from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2/3 COVID-19 induced acute respiratory distress syndrome (ARDS) clinical trial; completed site initiation and began enrolling patients in this trial referred to as the MACOVIA study;

Received FDA authorization to initiate a Phase 2 clinical trial with The University of Texas Health Science Center at Houston (UTHealth) titled MultiStem Administration for Trauma Related Inflammation and Complications (MATRICS-1); funded by a grant from the Medical Technology Enterprise Consortium (MTEC) and the Memorial Hermann Foundation;

Announced positive one-year results from our exploratory clinical study of MultiStem cell therapy for ARDS; MultiStem treated patients reported consistent improvement in quality of life over the one-year evaluation period and showed marked improvements in key clinical metrics, including intensive care unit-free days, ventilator-free days and mortality compared to placebo, especially in patients with pneumonia-induced ARDS;

Furthered discussions with the Biomedical Advanced Research and Development Authority (BARDA) to establish a collaboration to advance our MultiStem program;

Appointed Mr. Ivor Macleod as our Chief Financial Officer and Ms. Maia Hansen as Senior Vice President, Operations and Supply Chain, adding their expertise to our leadership team to help plan and execute our strategy as we approach potential product commercialization;

Initiated new sites for the MASTERS-2 ischemic stroke study while continuing to enroll new patients into the trial;

Advanced through our Japanese partner, HEALIOS K.K. (Healios), its ARDS and ischemic stroke programs, with Healios disclosing its intent to finish enrollment of both its ONE-BRIDGE ARDS study and its TREASURE stroke study this year;

Engaged in partnering discussions with companies interested in MultiStem commercialization rights in Europe and other regions;

Received an additional $7.0 million investment from Healios resulting from its exercise in full of a warrant to purchase additional shares of Athersys common stock;

Raised gross proceeds of approximately $57.6 million, before deducting the underwriting discount and offering expenses, through an underwritten public offering of 25,587,500 shares of common stock, providing additional working capital for general corporate purposes, including the initiation of the MACOVIA trial, further advancement of process development and manufacturing projects, and other key initiatives;

Recognized net loss of $15.6 million, or $0.10 net loss per share, for the quarter ended March 31, 2020; and

Ended the first quarter with $32.7 million of cash and cash equivalents, which excludes the impact of the Healios warrant exercise and proceeds from the recent underwritten public offering.

"We have achieved a number of important milestones recently, including obtaining FDA authorization to move two important trials forward. The first of these, the MACOVIA study for treating patients suffering from COVID-19 induced ARDS and related complications, represents our second pivotal trial, alongside our ongoing MASTERS-2 trial evaluating the administration of MultiStem for treating ischemic stroke. Working in collaboration with the FDA and our clinical partners, we were able to get the MACOVIA trial designed, authorized and up and running very quickly, and we thank everyone for their tremendous commitment and effort over the past several months, " commented Dr. Gil Van Bokkelen, Chairman and CEO of Athersys. "In addition, we recently announced authorization to initiate the MATRICS-1 trial for evaluating administration of MultiStem to patients suffering from serious traumatic injury, which is being supported by MTEC, the funding arm of the

Department of Defense, and UTHealth. We thank the FDA, MTEC and our clinical collaborators for their support in these advancements.

"Following the successful completion of the recent fundraising and the full exercise of the outstanding warrant by our partner, Healios, we have strengthened our financial position, and are focused on making further progress in our important programs and core capabilities. Despite the challenging and chaotic environment created by the COVID-19 pandemic, we have maintained our commitment to the advancement of our portfolio of critical care programs and to helping patients in areas of significant unmet clinical need. I’d like to thank each of our employees for their dedication, determination and extraordinary effort," concluded Dr. Van Bokkelen.

First Quarter Results
There were no revenues for the three months ended March 31, 2020 compared to $1.4 million for the three months ended March 31, 2019. The revenues in the prior period were generated from our collaboration with Healios related to manufacturing services performed. We expect our collaboration revenues to vary over time as we contract with Healios to perform manufacturing services and as we potentially enter into new collaborations.
Research and development expenses increased to $12.1 million for the three months ended March 31, 2020 from $11.4 million for the comparable period in 2019. The $0.7 million net increase is associated with increases in research supplies of $0.7 million, personnel costs of $0.3 million, outside services of $0.2 million, consulting costs of $0.1 million, stock compensation costs of $0.1 million and other research and development costs of $0.2 million with such increases partially offset by decreases in clinical trial and manufacturing process development costs of $0.9 million. Our clinical development, clinical manufacturing and manufacturing process development expenses vary over time based on the timing and stage of clinical trials underway, manufacturing campaigns for clinical trials and manufacturing process development projects.
General and administrative expenses increased to $3.5 million for the three months ended March 31, 2020 compared to $3.1 million in the comparable period in 2019. The $0.4 million increase was primarily due to increased personnel costs, outside services and stock compensation costs.
Net loss for the first quarter of 2020 was $15.6 million compared to a net loss of $13.0 million in the first quarter of 2019. The difference primarily results from the above variances.
During the three months ended March 31, 2020, net cash used in operating activities was $12.1 million compared to $5.5 million in the three months ended March 31, 2019. At March 31, 2020, we had $32.7 million in cash and cash equivalents, compared to $35.0 million at December 31, 2019.

Conference Call
Gil Van Bokkelen, Chairman and Chief Executive Officer, Ivor Macleod, Chief Financial Officer, and Karen Hunady, Director of Corporate Communications and Investor Relations will host a conference call today to review the results as follows:
Date

May 7, 2020
Time

4:30 p.m. (Eastern Time)
Telephone access: U.S. and Canada

(877) 396-3286
Telephone access: International

(647) 689-5528
Access code

6575418
Live webcast

www.athersys.com under the Investors section

We encourage shareholders to listen using the webcast link and to use the phone line if you intend to ask a question. A replay will be available on the webcast at www.athersys.com under the Investors section approximately two hours after the call has ended. Shareholders may also call in for on-demand listening shortly after the completion of the call until 11:59 PM Eastern Time on May 14, 2020 by dialing (800) 585-8367 or (416) 621-4642 and entering Encore passcode 6575418.