[Ip-health] Bernie v Trump and Examples of companies disclosing the costs of trials, in SEC reports

James Love james.love at keionline.org
Sun May 26 11:18:13 PDT 2019


One more thing.  If you lie about the numbers in the SEC reports, you can
literally end up in Jail.

On Sun, May 26, 2019 at 8:13 PM James Love <james.love at keionline.org> wrote:

> For the past four months, the US government has been blocking language in
> a WHO resolution on transparency, that would make the costs of clinical
> trials public.
>
> On Friday, Senator Bernie Sanders sent a tweet to 8.3 million followers,
> that read as follows:
>
> "I understand President Trump is blocking a resolution at the @WHO that
> would require drug companies to disclose actual R&D costs for
> pharmaceutical drugs. Nobody should believe Mr. Trump when he talks about
> taking on Big Pharma."
> Source: https://twitter.com/SenSanders/status/1132054320063614976
>
>
> Bernie also linked to this Reuters article that included an interview with
> Secretary Azar (until Jan 2017, president of Lilly USA).
> https://t.co/2XaXURjjlv
>
> Sophie Kasimow, Bernie Sander's Poverty & Inequality Advisor, then
> retweeted the Sanders tweet, with her
>
> The US is one of a few countries pushing secrecy over transparency in a
> key WHO resolution on clinical trial and R&D costs. This administration is
> in pharma's pocket so deep they are coming out the pant leg.
> #TransparencyResolution #WHA72
>
> Source: https://twitter.com/sophiekasimow/status/1132125195060359168
>
> Here in Geneva, the US government has disputed that companies already
> disclose the costs of clinical trials, when they are material to share
> prices.
>
> Luis Gil Abinader put together this list of examples, which such
> disclosures are in fact made.
>
> https://www.keionline.org/sec-disclosures
>
>
> https://www.sec.gov/Archives/edgar/data/849043/000084904306000002/f8k021606.htm
>
> 8-K 1 f8k021606.htm
>
> FORM 8-K
>
> February 16, 2006
>
> NEUROGEN CORPORATION
>
> VR1 PHASE I CLINICAL TRIALS $2 MILLION FROM MERCK
>
> On February 16, 2006, Neurogen Corporation issued a press release
> announcing that Merck & Co., Inc. has commenced Phase I clinical trials of
> NGD-8243, a leading drug candidate for treating pain, and one of several
> drug candidates being developed as the result of the companies’ exclusive
> worldwide alliance to develop oral therapeutics targeting the VR1 receptor.
> The Phase I clinical trial being conducted by Merck in Europe is a
> randomized, double-blind, placebo-controlled evaluation of the safety and
> pharmacokinetics of single ascending oral doses of NGD-8243 in healthy
> volunteers. The initiation of Phase I studies triggers a milestone
> payment of $2 million from Merck to Neurogen.
>
>
> https://www.sec.gov/Archives/edgar/data/352747/000143774911005563/ex99-1.htm
>
> EX-99.1 2 ex99-1.htm EXHIBIT 99.1
>
> Exhibit 99.1
>
> August 8, 2011
>
> Unigene Laboratories, Inc
>
> Unigene and GSK Enter Development Services and Clinical Supply Agreement
> in Preparation of Potential Phase 3 Study of Oral PTH for the Treatment of
> Osteoporosis in Postmenopausal Women
>
> On December 10, 2010, Unigene entered into an amended and restated
> exclusive worldwide license agreement with GSK to develop and commercialize
> an oral formulation of a recombinantly produced PTH analog for the
> treatment of osteoporosis in postmenopausal women. Under the terms of the
> amended and restated agreement, Unigene is responsible for the manufacture
> of the PTH and the conduct of the Phase 2 study. The Company received an
> upfront payment of $4 million in December to cover costs associated with
> the Phase 2 study, and also received an additional $4 million payment in
> May upon completion of Phase 2 patient enrollment, and is eligible to
> receive further payments of up to approximately $140 million based on the
> achievement of regulatory and commercialization milestones. In addition,
> Unigene is eligible to receive tiered double-digit royalties in the
> low-to-mid teens on global sales.  Once the Phase 2 study has been
> completed and based on a review of the data, GSK may elect to assume
> responsibility for all future development and commercialization of the
> product.
>
>
> https://www.sec.gov/Archives/edgar/data/1399250/000114420413050290/v354767_ex99-6.htm
>
> EX-99.6 7 v354767_ex99-6.htm LETTER TO SHAREHOLDERS
>
> Exhibit 99.6
>
> September 9, 2011
>
> Transition
>
> UNTITLED
>
> In exercising the option to assume all TT-401 rights, Lilly also paid
> Transition a US$7 million milestone payment. Under the option exercise, Lilly
> will perform and fund all future development and commercialization
> activities. Transition will provide one-time funding of US$14 million
> during the performance of the TT-401 Phase 2 study by Lilly. If TT-401 is
> successfully commercialized, Transition will be eligible to receive
> approximately US$240 million in additional milestone payments. Transition
> will also be eligible to receive a double-digit royalty on sales of TT-401
> products and a low single digit royalty on related compounds.
>
>
> https://www.sec.gov/Archives/edgar/data/1070698/000107069811000148/raptorpressrelease121911.htm
>
> EX-99.1 2 raptorpressrelease121911.htm EXHIBIT 99.1
>
> PRESS RELEASE
>
> December 19, 2011
>
> Raptor Pharmaceutical Corp.
>
> Raptor Pharmaceutical Corp. Signs Collaborative Research and Development
> Agreement with NIDDK on Phase 2b Clinical Trial of RP104 (DR Cysteamine
> Tablets) in Non-alcoholic Steatohepatitis (“NASH”)
>
> Raptor estimates the total cost of the CyNCh trial to be in the range of
> $14-$16 million. Under the CRADA agreement, Raptor will fund a total of
> $6 million of the cost of the trial, in addition to providing clinical
> trial materials and drug manufacturing/quality support estimated at
> approximately $1 million.  The remainder of the funding will come from
> NIDDK. Raptor holds worldwide, exclusive licenses from UC San Diego to
> patents relating to use of cysteamine in NAFLD and NASH. Under this CRADA
> collaboration, Raptor will retain exclusive development and commercial
> rights to the clinical data resulting from the CyNCh trial.
>
>
> https://www.sec.gov/Archives/edgar/data/1034842/000110465912016254/a12-6714_1ex99d1.htm
>
> EX-99.1 2 a12-6714_1ex99d1.htm
>
> EX-99.1
>
> March 6, 2012
>
> Rigel Pharmaceuticals, Inc
>
> Rigel Announces Fourth Quarter and Year End 2011 Financial Results
>
>
> The decrease in contract revenue from collaborations in 2011 was mainly
> due to the $100.0 million upfront payment received in 2010 pursuant to the
> exclusive worldwide license agreement with AstraZeneca AB (AZ) for
> fostamatinib, as well as $25.0 million in revenues earned from AZ in 2010
> for the initiation of the Phase 3 clinical trial program with fostamatinib
> in patients with rheumatoid arthritis (RA) and the completion of the
> transfer of the fostamatinib open label extension study to AZ.
>
> https://www.sec.gov/Archives/edgar/data/1000694/000114420414014965/R17.htm
>
> XML 77 R17.htm IDEA: XBRL DOCUMENT
>
> Dec. 31, 2013
>
> Novavax
>
> U.S. Government Agreement, Joint Venture and Collaborations [Abstract],
> Note 8 - U.S. Government Agreement, Joint Venture and Collaborations
>
> In February 2011, the Company was awarded a contract from HHS BARDA valued
> at $97 million for the first three-year base-period, which was extended in
> February 2014 by seven months to September 2014, with an HHS BARDA option
> for an additional two-year period valued at $79 million. This extension
> is intended to allow the Company to continue to access the remainder of the
> base-period funding. The HHS BARDA contract award provides significant
> funding for the Company's ongoing clinical development and product scale-up
> of both its seasonal and pandemic influenza vaccine candidates.
>
> The Company recognized revenue of approximately $17.4 million in 2013, and
> has recognized approximately $52 million in revenue since the inception of
> the contract. In connection with the recent amendment of the HHS BARDA
> contract, the Company recorded revenue of $2.7 million in the fourth
> quarter of 2013 relating to manufacturing and other activities that support
> the Phase 1/2 clinical trial of its H7N9 candidate and Matrix-M adjuvant,
> which began in the first quarter of 2014.
>
> Under certain circumstances, HHS BARDA reimbursements may be delayed or
> even potentially withheld. In March 2012, the Company decided to conduct a
> Phase 2 clinical trial of its quadrivalent seasonal influenza vaccine
> candidate ("205 Trial") under its existing U.S. investigational new drug
> application ("IND") for its trivalent seasonal influenza vaccine candidate
> as opposed to waiting to conduct this clinical trial under a new IND for
> its quadrivalent vaccine candidate ("Quadrivalent IND"). Based on the
> Company's discussions with HHS BARDA in 2012, the outside clinical trial
> costs for the 205 Trial may only be submitted for reimbursement to HHS
> BARDA and recorded as revenue by the Company after it submits the clinical
> trial data in a future Quadrivalent IND. The submission of the Quadrivalent
> IND is expected shortly before the Company initiates the next Phase 2
> dose-confirmatory clinical trial, which is currently expected in the fourth
> quarter of 2014. The outside clinical trial costs of the 205 Trial
> conducted in 2012 total $2.9 million. These costs have been recorded as
> an expense and are included in cost of government contracts revenue.
>
>
>
> https://www.sec.gov/Archives/edgar/data/946486/000114036114030646/ex99_1.htm
>
> EX-99.1 2 ex99_1.htm EXHIBIT 99.1
>
> Exhibit 99.1
>
> August 5, 2014
>
> Discovery Laboratories, Inc.
>
> Discovery Labs Reports Second Quarter 2014 Financial Results
>
> During the second quarter of 2014, sales of SURFAXIN to the Company’s
> specialty distributor were approximately $114,000 and demand sales into
> hospitals were $72,000. In accordance with the Company’s revenue
> recognition policy, for the second quarter of 2014, the Company recognized
> $42,000 in revenue for sales of SURFAXIN. The Company also recognized
> $1.1 million in grant revenue under a $1.9 million Fast Track SBIR Grant
> from the NHLBI of the NIH to provide support for the ongoing phase 2a
> clinical trial for AEROSURF. The remaining $0.8 million available under
> the grant is expected to be received by the end of 2014.
>
>
> https://www.sec.gov/Archives/edgar/data/832489/000143774914014670/ex99-1.htm
>
> EX-99 2 ex99-1.htm EXHIBIT 99.1
>
> Exhibit 99.1
>
> August 7, 2014
>
> GeoVax Labs, Inc.
>
> GeoVax Reports 2014 Second Quarter Financial Results and Provides
> Corporate Update
>
> Preventive HIV Vaccine Program: All of the human clinical trials of
> GeoVax’s preventive HIV vaccines have been conducted by the HIV Vaccine
> Trials Network (HVTN) with funding from the NIH. The most recent of these
> clinical trials (HVTN 094), a Phase 1 study of GOVX-B21, was completed in
> late 2013. Based on analysis of all available data generated to date,
> GeoVax is advancing GOVX-B11 to the next stage of human clinical testing,
> and is in planning discussions with the HVTN and NIH for a Phase 2b
> efficacy trial. GeoVax expects the Phase 2b trial to involve as many as
> 4,000 subjects (vaccine + placebo) with an estimated cost in excess of $50
> million. While GeoVax expects the NIH to fund this trial, any formal
> commitment may not occur until 2015. In advance of this commitment, GeoVax
> has requested approximately $3 million for the production of the DNA
> component of its vaccine regimen in sufficient quantities for the proposed
> Phase 2b trial. The Company expects a response from the NIH to this request
> during the third quarter of 2014. Should this funding be unavailable,
> GeoVax will seek other sources for funding vaccine production.
>
>
>
> https://www.sec.gov/Archives/edgar/data/1567514/000119312514305711/d774909dex991.htm
>
> EX-99.1 2 d774909dex991.htm
>
> EX-99.1
>
> August 12, 2014
>
> Intra-Cellular Therapies, Inc.
>
> Intra-Cellular Therapies Reports Financial Results for Second Quarter
> Ended June 30, 2014
>
> Research and development (R&D) expenses for the second quarter of 2014
> were $2.7 million, compared to $7.8 million for the second quarter of 2013. The
> decrease of $5.1 million is due almost exclusively to costs associated with
> outside clinical testing for our Phase 2 clinical trials of ITI-007 that
> was completed in late 2013, with no related costs incurred in 2014.
> Partially offsetting this decrease were expenses of approximately $1.0
> million relating to manufacturing and other clinical and non-clinical
> testing of our ITI-007 product candidate.
>
>
> https://www.sec.gov/Archives/edgar/data/1621443/000110465917068241/a17-27035_1ex99d1.htm
>
> EX-99.1 2 a17-27035_1ex99d1.htm
>
> EX-99.1
>
> November 14, 2014
>
> Zynerba Pharmaceuticals, Inc
>
> Zynerba Pharmaceuticals Reports Third Quarter 2017 Financial Results and
> Operational Highlights
>
> The Company believes that the cash and cash equivalent position of $66.3
> million as of September 30, 2017 is sufficient to develop five Phase
> 3-ready programs and initiate at least one pivotal program and fund
> operations and capital requirements into 2019.
>
>
> https://www.sec.gov/Archives/edgar/data/1553846/000117184315001738/newsrelease.htm
>
> EX-99 2 newsrelease.htm PRESS RELEASE
>
> EXHIBIT 99.1
>
> March 31, 2015
>
> RedHill Biopharma Ltd.
>
> RedHill Biopharma Acquires Phase II First-in-Class Oral Small Molecule SK2
> Inhibitor From Apogee Biotech
>
> Apogee received cumulative funding exceeding $14 million to support the
> development of ABC294640, primarily through grants and contracts from U.S.
> federal and state government agencies such as the NIH Small Business
> Innovation Research/Small Business Technology Transfer (SBIR/STTR) program,
> including funding from the National Cancer Institute (NCI), the U.S.
> Department of Health and Human Services' Biomedical Advanced Research and
> Development Authority (BARDA), the Department of Defense (DoD), the FDA
> Office of Orphan Products Development and the Pennsylvania Department of
> Health.
>
> A Phase Ib/II clinical study with ABC294640 for refractory/relapsed
> diffuse large B cell
>
> lymphoma (DLBCL) is planned to commence in the second quarter of 2015 and
> will be funded by a $1.5 million grant awarded by the National Cancer
> Institute under the NIH SBIR/STTR program to Apogee in conjunction with the
> Louisiana State University Health Science Center. The study will include
> approximately 30 patients and is intended to assess the tolerability of
> ABC294640 within the DLBCL population, as well as provide a preliminary
> evaluation of efficacy. A second Phase II clinical study of ABC294640 for
> the treatment of multiple myeloma is planned, subject to funding by a
> pending grant from the National Cancer Institute. A third Phase II clinical
> study is being planned by RedHill in order to evaluate ABC294640 as a
> radio-protectant and radiation enhancer in cancer patients undergoing
> radiotherapy.
>
>
> https://www.sec.gov/Archives/edgar/data/1419600/000119312515280981/d56782dex991.htm
>
> EX-99.1 2 d56782dex991.htm EX-99.1
>
> August 6, 2015
>
> Flexion Therapeutics, Inc.
>
> Flexion Therapeutics Reports Second-Quarter 2015 Financial Results
>
> In April 2015, we announced that the DoD awarded us a grant worth
> approximately $2 million and that, in connection with the DoD grant, we
> initiated a Phase 2 clinical trial investigating FX006 as a treatment for
> OA pain in active military and medically retired veterans with
> post-traumatic OA of the knee.
>
> https://www.sec.gov/Archives/edgar/data/882796/000117184315006102/R8.htm
>
> XML 27 R8.htm IDEA: XBRL DOCUMENT
>
> September 30, 2015
>
> BIOCRYST PHARMACEUTICALS INC
>
> Note 3 — Collaborative and Other Research and Development Contracts
>
> On March 31, 2015, the Company announced that the Biomedical Research and
> Development Authority within the U.S. Department of Health and Human
> Services’ Office of the Assistant Secretary for Preparedness and Response
> awarded BioCryst a contract for the continued development of BCX4430 as a
> potential treatment for diseases caused by RNA pathogens, including
> filoviruses. This BARDA/HHS contract includes a base contract of $13,314
> to support BCX4430 drug manufacturing, as well as $22,855 in additional
> development options that can be exercised by the government, bringing the
> potential value of the contract to $36,169. As of September 30, 2015, a
> total of $16,300 has been awarded under exercised options within this
> contract.
>
> National Institute of Allergy and Infectious Diseases (“NIAID/HHS”). In
> September 2013, NIAID/HHS contracted with the Company for the development
> of BCX4430 as a treatment for Marburg virus disease. NIAID/HHS, part of
> the National Institutes of Health, made an initial award of $5,000 to the
> Company. The total funding under this contract as of September 30, 2015
> could be up to $34,002, if all contract options are exercised by NIAID/HHS,
> over a five year period. The goals of this contract, including
> amendments, are to file IND applications for intravenous and intramuscular
> BCX4430 for the treatment of Marburg virus disease, to study BCX4430 as a
> treatment for Ebola virus disease and to conduct an initial Phase 1 human
> clinical trial. As of September 30, 2015, a total of $29,875 has been
> awarded under exercised options within this contract. BCX4430 is the lead
> compound in the Company’s BSAV research program.
>
>
> https://www.sec.gov/Archives/edgar/data/1133869/000114420415064859/v424618_ex99-1.htm
>
> EX-99.1 2 v424618_ex99-1.htm EXHIBIT 99.1
>
> Exhibit 99.1
>
> November 12, 2015
>
> Capricor Therapeutics, Inc.
>
> Capricor Therapeutics Reports Third Quarter 2015 Business & Financial
> Highlights
>
> The Phase I DYNAMIC trial is evaluating CDCs (CAP-1002) in patients with
> advanced heart failure. The trial enrolled 14 patients with either ischemic
> or non-ischemic dilated cardiomyopathy with left ventricular ejection
> fraction (LVEF) of 35% or below and New York Heart Association (NYHA) Class
> III or Ambulatory Class IV heart failure. Suitable patients underwent
> sequential intracoronary infusion of CAP-1002 in up to three coronary
> territories. The triple vessel infusion was designed to deliver cells to
> wide areas of myocardium since patients with advanced heart failure have
> significant fibrosis in all areas of the heart. The Phase I trial is
> being funded in part through a grant of approximately $3.0 million from the
> National Institutes of Health (NIH).
>
>
> https://www.sec.gov/Archives/edgar/data/1600620/000115752315003852/a51224700ex99_1.htm
>
>
> EX-99.1 2 a51224700ex99_1.htm
>
> EXHIBIT 99.1
>
> November 13, 2015
>
> Aurinia Pharmaceuticals Inc.
>
> Aurinia Reports Third Quarter 2015 Financial Results
>
> For the third quarter ended September 30, 2015, the Company reported a
> consolidated net loss of $5.2 million or $0.16 per common share, as
> compared to a restated consolidated net income of $2.8 million or $0.08 per
> fully diluted common share for the same period in 2014. The change was
> primarily attributable to an increase of $2.2 million in Phase 2b LN
> clinical trial costs and a decrease of $4.1 million in the non-cash gain
> on the quarterly fair value revaluation of the derivative warrant liability
> for the three months ended September 30, 2015 compared to the same period
> in 2014. In addition the 2014 comparative figure reflected a gain on
> extinguishment of warrant liability of $1.75 million. There was no similar
> item in 2015.
>
>
> https://www.sec.gov/Archives/edgar/data/1293971/000156459015011237/blue-ex991_46.htm
>
> EX-99.1 2 blue-ex991_46.htm EX-99.1
>
> Exhibit 99.1
>
> December 3, 2015
>
> bluebird bio
>
> bluebird bio and ViroMed Enter into License Agreement for Novel Antibodies
> to Develop Chimeric Antigen Receptor T Cell Therapy
>
> Under the terms of the agreement, ViroMed will provide bluebird bio
> exclusive rights to its novel humanized antibody to the target, and
> bluebird bio will leverage its proprietary lentiviral gene therapy platform
> and CAR T capabilities to develop CAR T therapies against the target.  Financial
> terms of the agreement include a $1 million upfront payment and subsequent
> milestone payments to ViroMed, which together could total over $48 million
> per licensed product if certain development and regulatory milestones are
> achieved.  ViroMed is also eligible to receive tiered royalties on
> product sales. bluebird bio will conduct and fund clinical development as
> well as regulatory and commercial activities.
>
> https://www.sec.gov/Archives/edgar/data/1301501/000130150116000080/R12.htm
>
> XML 27 R12.htm IDEA: XBRL DOCUMENT
>
> June 30, 2016
>
> Achaogen Inc
>
> Government Contracts
>
> In August 2010, the Company was awarded a contract with the Biomedical
> Advanced Research and Development Authority (“BARDA”) for the development,
> manufacturing, nonclinical and clinical evaluation of, and regulatory
> filings for, plazomicin as a countermeasure for disease caused by
> antibiotic-resistant pathogens and biothreats. The original contract
> included committed funding of $27,600,000 for the first two years of the
> contract and subsequent options exercisable by BARDA to provide
> additional funding. In September 2012, BARDA exercised an additional
> $15,798,000 contract option ("Option 1"), which increased the total
> contract committed funding to $43,398,000 through March 2014. In April
> 2013, the Company was awarded an additional $60,410,000 under the contract
> to support its Phase 3 clinical trial of plazomicin ("Option 2") to
> increase the total committed funding under this contract to $103,808,000.
> On May 26, 2016, the Company was awarded an additional $20 million ("Option
> 3") under the contract to support its Phase 3 EPIC trial of plazomicin.
> This brings the total committed funding under the contract to $123,808,000.
> The Company recorded contract revenue of $8,510,000 and $4,876,000 under
> this agreement during the three-month periods ended June 30, 2016 and 2015,
> respectively, and $13,780,000 and $9,717,000 during the six-month periods
> ended June 30, 2016 and 2015, respectively
>
>
> https://www.sec.gov/Archives/edgar/data/1534120/000155837016006680/cerc-20160720ex9911b330d.htm
>
> EX-99.1 2 cerc-20160720ex9911b330d.htm EX-99.1
>
> Exhibit 99.1
>
> July 20, 2016
>
> Cerecor
>
> Grant to Fund CERC-501 Development for Alcohol Use Disorder
>
> Cerecor Inc. (NASDAQ: CERC), a clinical-stage biopharmaceutical company
> developing treatments to make a difference in the lives of patients with
> neurological and psychiatric disorders, today announced that it has been
> awarded a grant (award number U44AA025253) from the National Institute on
> Alcohol Abuse and Alcoholism (NIAAA) at the National Institutes of Health
> (NIH).  The grant of $1.0 million provides Cerecor with additional
> resources to progress the development of CERC-501 for the treatment of
> alcohol use disorder (AUD).  Upon successful completion of the
> development activities covered under this grant, Cerecor will have the
> opportunity to apply for continued funding.
>
> Cerecor is a biopharmaceutical company that is developing innovative drugs
> that make a difference in the lives of patients with neurological and
> psychiatric diseases. Cerecor is currently pursuing the development of
> two clinical Phase 2-stage product candidates:  CERC-501 and CERC-301, an
> oral, NR2B-specific, NMDA receptor antagonist. Cerecor is currently
> conducting a Phase 2 study of CERC-301 as an adjunctive treatment of MDD
> and expects to announce results from that study in the first half of 2017.
> In addition, Cerecor is conducting preclinical testing of CERC-406, a brain
> penetrant COMT inhibitor with potential procognitive activity. For more
> information about the company and its products, please visit
> www.cerecor.com or contact Mariam E. Morris, Chief Financial Officer, at
> (443) 304-8002.
>
>
> https://www.sec.gov/Archives/edgar/data/1094038/000119312516710452/d259737dex992.htm
>
> EX-99.2 4 d259737dex992.htm PRESS RELEASE
>
> Exhibit 99.2
>
> September 6, 2016
>
> TapImmune Issues
>
> Multiple Phase 2 Trials, over $9 Million in New Funding & NASDAQ Uplisting
> Application
>
> The $9 million cash influx, combined with the elimination of the
> derivative liability creates a balance sheet for TapImmune that enabled us
> to apply for an uplisting of our common stock to the NASDAQ Capital Market. It
> also provides available cash to execute on the 4 Phase 2 trials of our lead
> clinical candidate TPIV 200, while also providing funding for the continued
> advancement of our second clinical candidate TPIV 110, slated to enter
> Phase 2.
>
> We anticipate this Phase 2 study of TPIV 200 in the treatment of triple
> negative breast cancer, conducted by the Mayo Clinic and sponsored by the
> U.S. Department of Defense (DOD), will begin to enroll patients in the
> fourth quarter of this year. The anticipated 280 patient study will be
> led by Dr. Keith Knutson of the Mayo Clinic in Jacksonville, Florida. Dr.
> Knutson is the inventor of the technology and an advisor to TapImmune. While
> TapImmune is supplying doses of TPIV 200 for the trial, the remaining costs
> associated with conducting this study will be funded by a $13.3 million
> grant made by the DOD to the Mayo Clinic.
>
> https://www.sec.gov/Archives/edgar/data/725363/000165495416004905/R16.htm
>
> XML 25 R16.htm IDEA: XBRL DOCUMENT
>
> September 30, 2016
>
> Cel-Sci Corporation
>
> Commitments and Contingencies Disclosure [Abstract]
>
> The Company estimates that the total remaining cash cost of the Phase 3
> clinical trial, excluding any costs that will be paid by CEL’SCI’s
> partners, would be approximately $12.1 million after September 30, 2016.
> This is based on the executed contract costs with the CROs only and does
> not include other related costs, e.g. the manufacturing of the drug. The
> Company has filed an amendment to the original Phase 3 protocol for it head
> and neck cancer study with the FDA to allow for this expansion in patient
> enrollment. Should the FDA allow the amended protocol filed with them to
> proceed, the remaining cost of the Phase 3 clinical trial will be higher.
>
>
> https://www.sec.gov/Archives/edgar/data/1301501/000119312514020548/d623715dex107h.htm
>
> EX-10.7H 26 d623715dex107h.htm
>
> EX-10.7H
>
> January 24, 2017
>
> ACHAOGEN, INC
>
> CONTINUATION SHEET
>
> Option Period 2: Stage 2 Non-clinical studies, Phase 3 Clinical Study.
>
> Obligated Amount: $60,410,398.00
>
>
> https://www.sec.gov/Archives/edgar/data/1638287/000110465917016633/a17-7290_4ex99d1.htm
>
> EX-99.1 2 a17-7290_4ex99d1.htm EX-99.1
>
> Exhibit 99.1
>
> March 15, 2017
>
> Gemphire
>
> Gemphire Announces Fiscal Year 2016 Financial Results and Provides
> Corporate Update
>
> In March 2017, we closed on a $12.5 million private placement that
> provides funding for the AZURE-1 Phase 2 trial investigating gemcabene in
> NASH patients, manufacturing activities, and general corporate purposes.
> This extends the Company’s cash runway until at least late 2018.
>
>
>
>
>
>
>
>
>
>
>
>
> https://www.sec.gov/Archives/edgar/data/1680048/000114420417017831/v462107_10k.htm
>
> 10-K 1 v462107_10k.htm
>
> FORM 10-K
>
> March 30, 2017
>
> Mustang Bio, Inc
>
> The information below provides estimates regarding the costs associated
> with the completion of the current development phase and our current
> estimated range of the time that will be necessary to complete that
> development phase for our product candidates. For a description of the risk
> factors that could significantly affect our ability to meet these cost and
> time estimates, see Item 1A of this Form 10-K.
>
> Product
>
> Target Indication
>
> Development
>
> Stage
>
> Estimated time to
>
> complete phase
>
> Estimated cost to
>
> complete phase
>
> IL13Ra2-CAR- T
>
> Glioblastoma
>
> Phase 1/2
>
> First half 2018
>
> $2.5-5 Million
>
> CD123 CAR-T
>
> AML
>
> Phase 1/2
>
> Second half 2018
>
> $2.5-5 Million
>
>
> https://www.sec.gov/Archives/edgar/data/1624658/000119312518155283/d570609dex991.htm
>
> EX-99.1 2 d570609dex991.htm EX-99.1
>
> May 8, 2018
>
> Allena Pharmaceuticals, Inc.
>
> Allena Pharmaceuticals Reports First Quarter 2018 Financial Results and
> Provides Business Update
>
> R&D Expenses: R&D expenses were $5.9 million for the first quarter of 2018
> as compared to $4.4 million for the first quarter of 2017. The increase
> was primarily due to costs incurred for URIROX-1 and Study 206, which were
> initiated during the first quarter of 2018, as well as manufacturing
> costs for engineering and clinical batch production to support Allena’s
> planned Phase 3 program. R&D expenses for the first quarter of 2017
> included close-out related costs for Allena’s Study 713 and Study 204.
>
>
> https://www.sec.gov/Archives/edgar/data/1579428/000110465917031163/a17-12769_1ex99d1.htm
>
> EX-99.1 2 a17-12769_1ex99d1.htm
>
> EX-99.1
>
> May 09, 2017
>
> Axsome Therapeutics, Inc.
>
> Axsome Therapeutics Reports First Quarter 2017 Financial Results
>
> Research and development (R&D) expenses: R&D expenses were $6.0 million
> for the quarter ended March 31, 2017 compared to $4.5 million for the
> comparable period in 2016. The increase in R&D expenses was primarily due
> to the conduct of the CREATE-1, STRIDE-1, and COAST-1 Phase 3 clinical
> trials, as well as product candidate manufacturing costs.
>
>
>
> https://www.sec.gov/Archives/edgar/data/1579428/000110465917031163/a17-12769_1ex99d1.htm
>
> EX-99.1 2 a17-12769_1ex99d1.htm
>
> EX-99.1
>
> May 09, 2017 (Globe Newswire)
>
> Axsome Therapeutics, Inc.
>
> Axsome Therapeutics Reports First Quarter 2017 Financial Results
>
> Research and development (R&D) expenses: R&D expenses were $6.0 million
> for the quarter ended March 31, 2017 compared to $4.5 million for the
> comparable period in 2016. The increase in R&D expenses was primarily due
> to the conduct of the CREATE-1, STRIDE-1, and COAST-1 Phase 3 clinical
> trials, as well as product candidate manufacturing costs.
>
>
>
> https://www.sec.gov/Archives/edgar/data/832489/000143774917013926/ex99-1.htm
>
> EX-99.1 2 ex99-1.htm EXHIBIT 99.1
>
> Exhibit 99.1
>
> August 7, 2017
>
> GeoVax
>
> GeoVax Reports 2017 Second Quarter Financial Results and Provides
> Corporate Update
>
> During 2017, GeoVax continued its work under a NIAID contract of up to
> $7.8 million for production of the DNA component of GOVX-B11 intended for
> later-stage clinical trials. The Company also continued work under two
> SBIR grants from NIAID for both its clade B HIV vaccine, and for its
> vaccine for the clade C HIV subtype prevalent in Africa.
>
>
> https://www.sec.gov/Archives/edgar/data/1626971/000117184317006576/exh_991.htm
>
> EX-99.1 2 exh_991.htm PRESS RELEASE
>
> EXHIBIT 99.1
>
> Nov. 02, 2017
>
> Corvus Pharmaceuticals, Inc.
>
> Corvus Pharmaceuticals Reports Third Quarter 2017 Financial Results and
> Clinical Program Update
>
> Research and development expenses for the three months ended September 30,
> 2017, totaled $10.7 million compared to $7.7 million for the same period in
> 2016. The increase of $3.0 million was primarily due to an increase of
> $2.8 million in outside clinical trial costs associated with the Phase 1/1b
> clinical trial for CPI-444.
>
>
> https://www.sec.gov/Archives/edgar/data/1235007/000155837018004411/ex-99d1.htm
>
> EX-99.1 2 ex-99d1.htm EX-99.1
>
> Exhibit 99.1
>
> May 9, 2018
>
> Endocyte, Inc
>
> Endocyte Provides First Quarter 2018 Financial Results and Operational
> Update
>
> Research and development expenses were $5.3 million for the first quarter
> of 2018, compared to $8.0 million for the same period in 2017. The decrease
> was primarily attributable to a strategic portfolio review announced in
> June 2017 which led to a reduction in workforce and the discontinuation of
> certain research and development activities, including: a decrease of
> $1.4 million in expenses related to pre-clinical work and general research,
> including the development of EC2629; a decrease of $0.8 million in EC1169
> trial expenses; a decrease of $0.6 million in EC1456 trial expenses; a
> decrease of $0.5 million in compensation expense as a result of employee
> terminations since March 31, 2017, and a decrease of $0.4 million in
> manufacturing expense for EC1169 and EC1456. These decreases were partially
> offset by: an increase of $0.8 million in expenses related to development
> of PSMA-617; and an increase of $0.2 million related to our CAR T-cell
> therapy program.
>
>
> https://www.sec.gov/Archives/edgar/data/1630212/000161577418011426/s113520_8k.htm
>
> 8-K 1 s113520_8k.htm 8-K
>
> FORM 8-K
>
> October 23, 2018
>
> Avalon GloboCare Corp
>
> On October 23, 2018, Avactis Biosciences, Inc. (“Avactis”), a wholly-owned
> subsidiary of Avalon GloboCare Corp. (the “Company”), and Arbele Limited
> (“Arbele”) for the establishment of AVAR BioTherapeutics (China) Co. Ltd.
> (“AVAR”), a Sino-foreign equity joint venture, pursuant to an Equity Joint
> Venture Agreement (the “AVAR Agreement”), which will be owned 60% by
> Avactis and 40% by Arbele. The purpose and business scope of the Joint
> Venture is to research, develop, produce, sell, distribute and generally
> commercialize CAR-T/CAR-NK/TCR-T/universal cellular immunotherapy in China.
> Avactis is required to contribute USD $10 million (or equivalent in RMB) in
> cash and/or services, which shall be contributed in tranches based on
> milestones to be determined jointly by AVAR and Avactis in writing subject
> to Avactis’ cash reserves. Within 30 days, Arbele shall make contribution
> of USD $6.66 million in the form of entering into a License Agreement with
> AVAR granting AVAR with an exclusive right and license in China to its
> technology and intellectual property pertaining to
> CAR-T/CAR-NK/TCR-T/universal cellular immunotherapy technology and any
> additional technology developed in the future with terms and conditions to
> be mutually agreed upon Avactis and AVAR and services.
>
>
> https://www.sec.gov/Archives/edgar/data/1372299/000119312518321813/d649260dex991.htm
>
> EX-99.1 2 d649260dex991.htm
>
> EX-99.1
>
> November 8, 2018
>
> Histogenics Corporation
>
> HISTOGENICS CORPORATION ANNOUNCES THIRD QUARTER 2018 FINANCIAL AND
> OPERATING RESULTS
>
> Research and development expenses were $4.6 million in the third quarter
> of 2018, compared to $3.5 million in the third quarter of 2017. The
> increase was primarily due to increases in consulting and compensation
> related expenses in connection with the preparation and evaluation of the
> data from the NeoCart Phase 3 clinical trial and the potential submission
> of a BLA for NeoCart with the FDA. General and administrative expenses
> were $2.4 million in the third quarter of 2018, compared to $2.2 million in
> the third quarter of 2017. The increase was primarily due to higher
> salaries and consulting expenses related to increased activities to support
> the potential commercialization of NeoCart.
>
>
> https://www.sec.gov/Archives/edgar/data/1701108/000119312518322565/d633511dex991.htm
>
> EX-99.1 2 d633511dex991.htm
>
> EX-99.1
>
> November 8, 2018
>
> Spero Therapeutics, Inc.
>
> Spero Therapeutics Announces Third Quarter 2018 Financial Results and
> Pipeline Overview
>
> Following a scheduled pre-Phase 3 meeting with the U.S. Food and Drug
> Administration in the fourth quarter of 2018, Spero expects to submit an
> investigational new drug application (IND) and initiate a pivotal Phase 3
> clinical trial of SPR994 for the treatment of cUTI around year-end 2018. To
> support clinical development of SPR994, in July 2018 the Biomedical
> Advanced Research and Development Authority (BARDA) and the Defense Threat
> Reduction Agency (DTRA) awarded the Company up to $54 million in
> non-dilutive funding and support over a five-year period.
>
>
> https://www.sec.gov/Archives/edgar/data/1527599/000115752317003087/a51715759ex99_1.htm
>
> EX-99.1 2 a51715759ex99_1.htm
>
> EXHIBIT 99.1
>
> November 13, 2017
>
> Synlogic, Inc.
>
> Synlogic Reports Third Quarter 2017 Financial Results and Recent Progress
>
> Research and development expenses were $9.0 million for the three months
> ended September 30, 2017 compared to $4.1 million in the corresponding
> period in 2016. The increase was primarily due to an increase in external
> costs associated with our Phase 1 clinical trial, preclinical studies,
> formulation development and consulting fees as well as increased internal
> research costs and increased compensation-related expenses associated with
> increased headcount.
>
>
> https://www.sec.gov/Archives/edgar/data/1069530/000117184318000861/exh_991.htm
>
> EX-99.1 2 exh_991.htm PRESS RELEASE
>
> EXHIBIT 99.1
>
> February 05, 2018
>
> Pain Therapeutics
>
> Pain Therapeutics Reports 2017 Financial Results and Corporate Update
>
> Throughout 2017, we announced that the National Institutes of Health (NIH)
> had awarded us research grants following a competitive, peer-reviewed
> evaluation of our technology for scientific and technical merit.  Research
> awards included a grant to develop a simple blood-test to detect
> Alzheimer’s disease; a grant to study PTI-125, our clinical drug candidate
> to treat Alzheimer’s disease; and a grant to further develop FENROCK, an
> abuse-deterrent transdermal patch.
>
> We received $1.4 million in research grant funding in the year ended
> December 31, 2017 from the National Institutes of Health (NIH) that we
> recorded as a reduction to our research and development expenses.
>
> PTI-125 – Proprietary small molecule drug for the treatment of Alzheimer’s
> disease.  Phase I clinical-stage program, substantially funded by a
> research grant award from the National Institutes of Health (NIH).
>
>
> https://www.sec.gov/Archives/edgar/data/1597264/000155837018000828/ex-99d1.htm
>
> EX-99.1 2 ex-99d1.htm EX-99.1
>
> Exhibit 99.1
>
> February 21, 2018
>
> Blueprint Medicines
>
> Blueprint Medicines Reports Fourth Quarter and Full Year 2017 Financial
> Results
>
> R&D Expenses: Research and development expenses were $43.6 million for the
> fourth quarter of 2017 and $144.7 million for the year ended December 31,
> 2017, as compared to $24.1 million for the fourth quarter of 2016 and $81.1
> million for the year ended December 31, 2016. This increase was primarily
> attributable to increased clinical and manufacturing expenses associated
> with advancing avapritinib, BLU-554, and BLU-667 further through Phase 1
> clinical trials and increased personnel-related expenses. Research and
> development expenses included $1.9 million in stock-based compensation
> expenses for the fourth quarter of 2017 and $6.3 million in stock-based
> compensation expenses for the year ended December 31, 2017.
>
>
> https://www.sec.gov/Archives/edgar/data/1689813/000110465918016085/a18-7861_1ex99d1.htm
>
> EX-99.1 2 a18-7861_1ex99d1.htm EX-99.1
>
> Exhibit 99.1
>
> March 6, 2018
>
> BIOHAVEN PHARMACEUTICALS
>
> BIOHAVEN PHARMACEUTICALS REPORTS FOURTH QUARTER AND FULL YEAR 2017
> FINANCIAL AND BUSINESS RESULTS
>
> The increase in direct program costs reflects continued investment in
> clinical development and product supply.  Development costs related to
> rimegepant increased $23.0 million in support of two Phase 3 clinical
> trials, a long-term safety study, drug supply and a development milestone
> paid to Bristol-Myers Squibb.  BHV-3500 program spending increased $5.7
> million related to formulation development and toxicology efforts, while
> BHV-0223 program development increased $3.6 million to advance a
> bioequivalence study.
>
>
> https://www.sec.gov/Archives/edgar/data/1267813/000155837018001594/mrns-20180306ex991a538cd.htm
>
> EX-99.1 2 mrns-20180306ex991a538cd.htm
>
> EX-99.1
>
> March 6, 2018
>
> Marinus Pharmaceuticals, Inc.
>
> MARINUS PHARMACEUTICALS PROVIDES BUSINESS UPDATE AND 2017 FINANCIAL RESULTS
>
> Additionally, we sold $0.4 million in state research and development tax
> credits which we used to offset research and development expenses.  The
> decrease was partially offset by an increase of $2.3 million associated
> with our IV programs in PPD, for which a Phase 2 clinical trial was
> initiated in June 2017.
>
>
> https://www.sec.gov/Archives/edgar/data/1694665/000119312518179502/d592167dex991.htm
>
> EX-99.1 2 d592167dex991.htm EX-99.1
>
> Exhibit 99.1
>
> May 31, 2018
>
> Evelo Biosciences
>
> Evelo Biosciences Reports First Quarter 2018 Financial Results and Recent
> Business Highlights
>
> The increase of $3.3 million was due primarily to an increase of $1.6
> million in costs for Evelo’s inflammation programs, driven by external
> preclinical research, manufacturing costs and licensing expense, an
> increase of $1.3 million in gut-body network platform expenses in line with
> Evelo’s strategy to maximize the potential of its platform and an increase
> of $0.8 million in personnel costs, including increases in salaries and
> bonuses of $0.5 million and an increase of $0.2 million in stock-based
> compensation expense. Oncology and other program expenses decreased
> slightly due to the timing of activities supporting the expected start of
> Evelo’s clinical trial with EDP1503 in the second half of 2018.
>
>
> https://www.sec.gov/Archives/edgar/data/1701108/000119312518244366/d599143dex991.htm
>
> EX-99.1 2 d599143dex991.htm
>
> EX-99.1
>
> August 9, 2018
>
> Spero Therapeutics, Inc.
>
> Spero Therapeutics Announces Second Quarter 2018 Financial Results and
> Pipeline Overview
>
> Revenue from government awards totaled $463,000 for the second quarter of
> 2018, higher than second quarter 2017 awards of $249,000, and were
> comprised of reimbursement for SPR741, SPR206 and SPR720 program expenses. Research
> and development expenses were $7.4 million for the second quarter of 2018,
> largely in line with second quarter of 2017 expenses of $7.5 million, with
> spending primarily attributed to the SPR994 and SPR206 development programs.
> General and administrative expenses were $3.1 million for the second
> quarter of 2018, generally in line with second quarter of 2017 expenses of
> $3.0 million with increased headcount and personnel related costs offset by
> lower professional and consultant fees.
>
> As of June 30, 2018, the Company’s cash, cash equivalents and marketable
> securities totaled $66.6 million. In early July, Spero completed a
> follow-on offering in which it issued 3,780,000 shares of common stock at a
> price of $12.50 per share, and 2,220 shares of Series A Convertible
> Preferred Stock at a price of $12,500 per share, for net proceeds before
> expenses of $70.5 million after deducting underwriting discounts and
> commissions. Spero believes that its existing cash, cash equivalents and
> marketable securities, together with the proceeds from the follow-on
> offering and initial committed funding of $15.7 million under the BARDA
> award, will fund operations into the second half of 2020, including through
> top-line data readout of the planned pivotal Phase 3 clinical trial of
> SPR994. A portion of the funding from our BARDA award is scheduled to
> support the development of SPR994 beyond 2020, provided we achieve the
> specified milestones and BARDA exercises all of its options under the
> agreement.
>
>
> https://www.sec.gov/Archives/edgar/data/1175151/000114420418046276/tv501695_ex99-1.htm
>
> EX-99.1 2 tv501695_ex99-1.htm EXHIBIT 99.1
>
> Exhibit 99.1
>
> August 21, 2018
>
> CytoSorbents Corporation
>
> CytoSorbents Awarded up to $3M in SBIR Phase IIB Bridge Funding by
>  NIH/NHLBI to Accelerate U.S. Approval and Commercialization of the
> HemoDefend™ Blood Transfusion Filter
>
> CytoSorbents Corporation (NASDAQ:CTSO) a critical care immunotherapy
> leader specializing in blood purification, announced today that the
> National Heart, Lung, and Blood Institute (NHLBI), a division of the
> National Institutes of Health (NIH), has awarded the company a three-year
> Phase IIB Bridge SBIR (Small Business Innovation Research) award, valued at
> up to $3 million, to facilitate and accelerate the commercialization of
> its HemoDefend™ red blood cell (RBC) transfusion filter.
>
> Dr. Phillip Chan, Chief Executive Officer stated, “The HemoDefend-RBC
> filter development has been generously supported by NHLBI and U.S.
> Special Operations Command (USSOCOM) with approximately $1.7 million in
> non-dilutive SBIR Phase I and II funding. In this next phase, NHLBI will
> match company funds dollar-for-dollar up to approximately $1 million each
> year for three years, for total funding of approximately $3 million,
> subject to the availability of funds and satisfactory progress of the
> project. This funding will be used to help finance the costs of the
> HemoDefend pRBC pivotal clinical trial that is expected to begin in Q1 2019
> and support U.S. FDA regulatory approval, as well as initial
> commercialization activities including manufacturing scale-up. We thank
> NHLBI for their continued support.”
>
>
> https://www.sec.gov/Archives/edgar/data/1425205/000114420418057617/tv506486_ex99-1.htm
>
> EX-99.1 2 tv506486_ex99-1.htm EXHIBIT 99.1
>
> Exhibit 99.1
>
> November 6, 2018
>
> Iovance Biotherapeutics
>
> Iovance Biotherapeutics Reports Third Quarter 2018 Financial Results and
> Provides Corporate Update
>
> The increase was primarily attributable to a $4.8 million increase in
> clinical trial costs due to; higher patient enrollment and an increase in
> the number of sites in the clinical trial of lifileucel for the treatment
> of metastatic melanoma, increased enrollment in the cervical and head and
> neck LN-145 clinical trials and the initiation of clinical trials in 2018
> for new indications.
>
>
> https://www.sec.gov/Archives/edgar/data/1107421/000119312519003789/d687534dex991.htm
>
> EX-99.1 2 d687534dex991.htm EX-99.1
>
> Exhibit 99.1
>
> Jan. 7, 2019
>
> Ziopharm Oncology
>
> Ziopharm Oncology Posts Letter to Stockholders
>
> As of October 2018, we have a simplified relationship with Intrexon, with
> exclusive rights for the assets we desired most, and we eliminated $157
> million of preferred stock held by Intrexon. The new license agreement
> helped pave the way for us to raise $50 million in a private placement from
> existing investors, secure a clinical collaboration with Regeneron
> Pharmaceuticals for Controlled IL-12 and announce a joint venture with
> committed funding of up to $35 million to bring our Sleeping Beauty
> platform for CD19-specific CAR-T to China.
>
> Using our Sleeping Beauty platform, we believe we can solve ongoing
> commercialization hurdles by manufacturing CAR-T faster and at a fraction
> of the expense compared to viral vectors, thereby dramatically expanding
> patient access. We have made considerable progress in achieving T-cell
> viability needed to obtain regulatory clearance for our clinical trial. We
> plan to begin using this approach to treat patients at MD Anderson in the
> second half of 2019 with CD19-specific CAR-T therapies (with mbIL15 and a
> kill switch) manufactured in two days or less following gene transfer.
> Also, our new joint venture, Eden BioCell, will appropriate the same
> Sleeping Beauty platform to undertake very rapid manufacturing in the
> Greater China markets to help solve production issues of CD19 CAR-T cell
> therapy. We own 50 percent of Eden BioCell with our partner, TriArm
> Therapeutics, which committed up to $35 million to this joint venture.
> TriArm was formed by Panacea Venture Healthcare, a fund co-founded and
> managed by James Huang, Managing Partner of Kleiner Perkins Caufield &
> Byers China (KPCB China). As our CAR-T efforts are now well funded both at
> MD Anderson and Eden BioCell, there is considerable upside for our
> investors in this program with minimal impact to our bottom-line.
>
>
> https://www.sec.gov/Archives/edgar/data/1640455/000164045519000017/jnce12312018exhibit991.htm
>
>
> EX-99.1 2 jnce12312018exhibit991.htm
>
> EXHIBIT 99.1
>
> March 6, 2019
>
> Jounce Therapeutics, Inc.
>
> Jounce Therapeutics Reports Fourth Quarter and Full Year 2018 Financial
> Results
>
> The decrease in R&D expenses for the fourth quarter of 2018 was primarily
> due to $2.8 million of decreased external research and development costs,
> offset by $1.7 million of increased external clinical and regulatory
> costs associated with vopratelimab as well as the initiation of the
> JTX-4014 Phase 1 clinical trial during the fourth quarter of 2018.
>
>
> https://www.sec.gov/Archives/edgar/data/1654151/000119312519074785/d720514dex991.htm
>
> EX-99.1 2 d720514dex991.htm EX-99.1
>
> Exhibit 99.1
>
> March 14, 2019
>
> Deciphera Pharmaceuticals
>
> Deciphera Pharmaceuticals, Inc. Announces Fourth Quarter and Year-end 2018
> Financial Results
>
> R&D Expenses: Research and development expenses for the fourth quarter of
> 2018 were $27.4 million, compared to $15.7 million for the same period in
> 2017. The increase was primarily due to an increase in spending on the
> ripretinib (DCC-2618) program of $5.8 million as a result of clinical trial
> start-up activities related to the Phase 3 INTRIGUE study in second-line
> GIST, which the Company initiated in December 2018. Expenses related to
> the rebastinib program increased $1.8 million, primarily due to the Phase
> 1b/2 study of rebastinib in combination with paclitaxel, which the
> Company initiated in October 2018, and start-up activities related to the
> second Phase 1b/2 clinical trial of rebastinib in combination with
> carboplatin, which the Company initiated in January 2019.
>
>
> https://www.sec.gov/Archives/edgar/data/1453687/000145368719000028/exhibit991_earningsrelease.htm
>
> EX-99.1 2 exhibit991_earningsrelease.htm
>
> EXHIBIT 99.1
>
> March 15, 2019
>
> Selecta Biosciences, Inc.
>
> Selecta Biosciences Announces Fourth Quarter and Year End 2018
>
> Financial Results and Provides Corporate Update
>
> Research and Development Expenses: Research and development expenses for
> the fourth quarter of 2018 were $10.3 million, which compares with $13.6
> million for the fourth quarter of 2017. The decrease was driven by
> reduced expenditures for our preclinical product candidates combined with
> the winding down of the Phase 2 clinical trial of SEL-212 in the second
> half of 2018.
>
>
>
> https://www.sec.gov/Archives/edgar/data/1708688/000114036119005785/ex99_1.htm
>
> EX-99.1 2 ex99_1.htm
>
> EXHIBIT 99.1
>
> 28 March 2019
>
> InflaRx
>
> InflaRx Full Year 2018 Financial & Operating Results
>
> This increase is primarily attributable to a €7.1 million increase in CRO
> and CMO expenses for IFX-1 in connection with preparation to commence the
> clinical trial Phase IIb in patients with HS and the Phase II clinical
> program in patients with AAV, as well as with the ongoing manufacturing
> activities for clinical trial material for these clinical trials with
> IFRX-1 and to a €3.4 million increase in employee-related costs associated
> with salaries, bonus, benefits and non-cash share-based compensation.
>
>
> https://www.sec.gov/Archives/edgar/data/1611747/000121390019006836/f6k042219ex99-1_biondvax.htm
>
> EX-99.1 2 f6k042219ex99-1_biondvax.htm
>
> PRESS RELEASE
>
> April 22, 2019
>
> BiondVax Pharmaceuticals Ltd.
>
> European Investment Bank (EIB) extends financing agreement to €24 million
> total in support of BiondVax’s universal flu vaccine ongoing pivotal Phase
> 3 clinical trial
>
> BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), announced today that the
> Management Committee of the European Investment Bank (EIB) agreed to extend
> the 2017 financing agreement with BiondVax by an additional €4 million.
> The funds will be used in support of the ongoing pivotal, clinical
> efficacy, Phase 3 trial of BiondVax’s M-001 Universal Flu Vaccine
> candidate in Europe.
>
>
> https://www.sec.gov/Archives/edgar/data/1576263/000162828019004929/ex991mrtx_q12019earningsre.htm
>
> EX-99.1 2 ex991mrtx_q12019earningsre.htm EXHIBIT 99.1
>
> Exhibit 99.1
>
> April 29, 2019
>
> Mirati Therapeutics, Inc
>
> MIRATI THERAPEUTICS REPORTS FIRST QUARTER 2019 FINANCIAL RESULTS
>
> Research and development expenses for the first quarter of 2019 were $34.2
> million, compared to $19.7 million for the same period in 2018. The
> increase in research and development expenses is due to an increase in
> expense associated with sitravatinib and MRTX849, as well as an increase in
> salaries and related expense, including an increase in share-based
> compensation expense. The increase in sitravatinib expense is due to
> increased costs to support the expansion of existing and new clinical
> trials, and the increase in MRTX849 expense relates to the Phase 1 clinical
> trial, which was initiated in the first quarter of 2019. The Company
> recognized research and development-related share-based compensation
> expense of $5.2 million during the first quarter of 2019, compared to $1.5
> million for the same period in 2018.
>
>
> https://www.sec.gov/Archives/edgar/data/1655759/000119312519141625/d744383dex991.htm
>
> EX-99.1 2 d744383dex991.htm
>
> EX-99.1
>
> May 8, 2019
>
> Arvinas
>
> Arvinas Reports First Quarter Financial Results and Provides Corporate
> Update
>
> Research and development expenses were $14.2 million for the quarter ended
> March 31, 2019, as compared to $7.1 million for the quarter ended March 31,
> 2018. The increase in research and development expenses for the quarter
> primarily related to expenses associated with the initiation of our Phase 1
> clinical trial of ARV-110 and IND-enabling expenses associated with ARV-471
> as well as increased personnel and other expenses related to our platform
> research and exploratory programs research.
>
>
>
> https://www.sec.gov/Archives/edgar/data/1579428/000110465919027994/a19-9691_1ex99d1.htm
>
> EX-99.1 2 a19-9691_1ex99d1.htm EX-99.1
>
> Exhibit 99.1
>
> May 9, 2019
>
> Axsome Therapeutics
>
> Axsome Therapeutics Reports First Quarter 2019 Financial Results and
> Provides Business Update
>
> Research and development (R&D) expenses: R&D expenses were $7.6 million
> for the quarter ended March 31, 2019 and $4.8 million for the comparable
> period in 2018. The increase was primarily due to the initiation and
> rapid progress of the MOMENTUM study, progress of our STRIDE-1, ADVANCE-1
> and smoking cessation studies, and manufacturing costs related to our
> AXS-07 product candidate, which was partially offset by a reduction in the
> costs of previously completed clinical trials and nonclinical work.
>
>
>
>
>
>
> --
> James Love.  Knowledge Ecology International
> U.S. Mobile +1.202.361.3040
> U.S. office phone +1.202.332.2670
> http://www.keionline.org <http://www.keionline.org/donate.html>
> twitter.com/jamie_love
>


-- 
James Love.  Knowledge Ecology International
U.S. Mobile +1.202.361.3040
U.S. office phone +1.202.332.2670
http://www.keionline.org <http://www.keionline.org/donate.html>
twitter.com/jamie_love


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