[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 11:13:50 PDT 2019


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

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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

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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
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U.S. office phone +1.202.332.2670
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