This Quarterly Report on Form 10-Q contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as amended, Section
21E of the Securities Exchange Act of 1934, as amended, and the Private
Securities Litigation Reform Act of 1995, and such statements are subject to the
"safe harbor" created by those sections. Forward-looking statements are based on
our management's beliefs and assumptions and on information available to our
management as of the date hereof. In some cases, you can identify
forward-looking statements by terms such as "may," "will," "should," "could,"
"would," "expect," "plans," "anticipates," "believes," "estimates," "projects,"
"predicts," "potential" and similar expressions intended to identify
forward-looking statements. Examples of these statements include, but are not
limited to, statements regarding: the development plan for the Company's product
candidate LUM-201 (ibutamoren) ("LUM-201"); the development plan for our
existing pipeline and potential partnership and out-licensing opportunities; the
timing of planned preclinical studies and clinical trials; the timing of and our
ability to obtain regulatory approvals for our product candidates; the clinical
utility of our product candidates; our plans to leverage our existing
technologies to discover and develop additional product candidates; our
intellectual property position; our ability to enter into strategic
collaborations, licensing or other arrangements; our estimates regarding
expenses, future revenues, capital requirements and needs for additional
financing; plans to develop and commercialize our product candidates; and other
risks and uncertainties, including those described in Part II, Item 1A, "Risk
Factors" of this Quarterly Report and in our other periodic reports filed from
time to time with the Securities and Exchange Commission, or SEC, including our
Annual Report on Form 10-K for the year ended December 31, 2019 and Private
Lumos's audited consolidated financial statements and notes thereto and
management's discussion and analysis of financial condition and results of
operations for the year ended December 31, 2019 included in our Current Report
on Form 8-K/A, filed with the SEC on May 29, 2020. Our actual results could
differ materially from those discussed in our forward-looking statements for
many reasons, including those risks. You should not place undue reliance on
these forward-looking statements, which apply only as of the date of this
Quarterly Report on Form 10-Q. You should read this Quarterly Report on Form
10-Q completely. Except as required by law, we assume no obligation to update
these forward-looking statements publicly, or to update the reasons actual
results could differ materially from those anticipated in these forward-looking
statements, even if new information becomes available in the future. Such
factors may be amplified by the COVID-19 pandemic and its potential impact on
our business and the global economy.
The following discussion and analysis should be read in conjunction with the
unaudited financial statements and notes thereto included in Part I, Item 1 of
this Quarterly Report on Form 10-Q.
Overview
Lumos is a clinical-stage biopharmaceutical company focused on the
identification, acquisition and in-license, development, and commercialization
of novel products for the treatment of rare diseases. The Company's mission is
to develop new therapies for people with rare diseases, prioritizing its focus
where the medical need is high and the pathophysiology is clear.
In March 2020, the World Health Organization declared the outbreak of COVID-19,
a novel strain of Coronavirus, a global pandemic. This outbreak is causing major
disruptions to businesses and markets worldwide as the virus spreads. The extent
of the effect on the Company's operational and financial performance will depend
on future developments, including the duration, spread and intensity of the
pandemic, and governmental, regulatory and private sector responses, all of
which are uncertain and difficult to predict. Although the Company is unable to
estimate the financial effect of the pandemic at this time, if the pandemic
continues to evolve into a severe worldwide crisis, it could have a material
adverse effect on the Company's business, results of operations, financial
condition and cash flows. The financial statements do not reflect any
adjustments as a result of the pandemic.
Recent Events
On March 18, 2020, the Company, formerly known as NewLink, completed a merger in
accordance with the terms of the Merger Agreement, pursuant to which Merger Sub
merged with and into Private Lumos, with Private Lumos surviving as a
wholly-owned subsidiary of NewLink.
Also on March 18, 2020, and prior to the Effective Time, the Company effected a
1-for-9 Reverse Stock Split and, following the Merger, changed its name to
"Lumos Pharma, Inc." Unless otherwise noted herein, all references to share
amounts give effect to the Reverse Stock Split. Following the completion of the
Merger, the business being conducted by the Company became primarily the
business conducted by Private Lumos, which is a biopharmaceutical company
focused on the identification, acquisition, in-license, development, and
commercialization of novel products for the treatment of rare diseases.
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Lumos' current pipeline is focused on the future development of an orally
administered small molecule, the growth hormone secretagogue ibutamoren, for
three rare endocrine disorders.
For accounting purposes, Private Lumos is considered to have acquired NewLink in
the Merger. NewLink's shares of common stock listed on The Nasdaq Capital
Market, previously trading through the Merger Date under the ticker symbol
"NLNK", commenced trading on The Nasdaq Capital Market, under the ticker symbol
"LUMO", on Thursday, March 19, 2020. The accompanying results of operations give
retroactive effect to the exchange ratio and change in par value for all periods
presented.

The Merger was accounted for as a reverse merger with Lumos deemed the accounting acquiror for accounting purposes. Further, the Merger is to be accounted for as an asset acquisition rather than a business combination because the assets acquired and liabilities assumed from NewLink do not meet the definition of a business as defined by ASC 805, Business Combinations as NewLink does not contain the processes in place to generate outputs.



The results of operations and cash flows prior to the Merger Date, relate to
Private Lumos. Subsequent to the Merger Date the information in these unaudited
quarterly financial statements relates to the Company and its consolidated
entities. All share and per share amounts in the financial statements and
related notes have been retroactively adjusted, where applicable, for all
periods presented to give effect to the exchange ratio applied in connection
with the Merger and the Reverse Stock Split.
LUM-201 Growth Hormone Secretagogue
Our pipeline is focused on the development of an orally administered small
molecule, the growth hormone secretagogue LUM-201 for rare endocrine disorders
where injectable recombinant human growth hormone ("rhGH") is currently
approved. A secretagogue is a substance that stimulates the secretion or release
of another substance. LUM-201 stimulates the release of growth hormone ("GH")
and is referred to as a GH secretagogue. The current targeted indications for
LUM-201 are Pediatric Growth Hormone Deficiency ("PGHD"), Turner Syndrome and
Children Born Small for Gestational Age ("SGA"), in each case in a certain
subset of affected patients. Lumos is planning to initiate a clinical
development program to study the effects of LUM-201 in PGHD prior to the end of
2020 with a Phase 2b clinical trial (the "Phase 2b Trial"). The coronavirus
pandemic has caused pervasive interruptions to clinical trials industrywide.
Facing similar near-term impediments, the Company has experienced some delays
related to the pandemic and may experience further delays should significant
pandemic related disruptions persist. Depending on the outcome of data developed
in the Phase 2b Trial and the timing of such data, Lumos plans to conduct
separate Phase 2 clinical trials to study the effects of LUM-201 for Turner
Syndrome and SGA in a certain subset of affected patients. The graphic below
depicts these indications with their respective development status.

[[Image Removed: nlnk-20200331_g2.jpg]]


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LUM-201 stimulates GH via the GH secretagogue receptor, also known as the
ghrelin receptor, thus providing a differentiated mechanism of action to treat
some rare endocrine disorders (involving a deficiency of GH) by increasing the
amplitude of endogenous, pulsatile GH secretion. LUM-201's stimulatory effect is
regulated by insulin-like growth factor feedback, hence protecting against
hyperstimulation of GH. LUM-201 has been observed to stimulate endogenous GH in
patients who have a functional but reduced hypothalamic pituitary GH axis.
LUM-201 is a tablet formulation that will be administered orally once daily and
provides a new therapeutic approach to the 35-year old standard of care
(subcutaneous injectable rhGH) for treating rare endocrine disorders associated
with GH deficiencies.
If approved, LUM-201 has the potential to become the first approved oral GH
secretagogue to treat rare endocrine disorders associated with GH deficiencies,
starting with PGHD, providing an alternative to the current standard regimen of
daily injections.
LUM-201 for the Treatment of a Subset of PGHD Patients
Lumos is initially developing LUM-201 for a subset of patients with PGHD. PGHD
is a rare endocrine disorder occurring in approximately one in 3,500 persons
aged birth to 17 years. Causes of PGHD can be: congenital (children are born
with the condition), acquired (brain tumor, head injuries or other causes),
iatrogenic (induced by medical treatment) or idiopathic (of unknown cause).
Children with untreated PGHD will have significant growth failure (potential
adult heights significantly less than five feet and may have abnormal body
composition with decreased bone mineralization, decreased lean body mass and
increased fat mass).
The main therapeutic goal in PGHD is to restore growth, enabling short children
to achieve normal height and prevent complications that could involve metabolic
abnormalities, cognitive deficiencies and reduced quality of life. Current
treatment of PGHD is limited to daily subcutaneous injections of rhGH with a
treatment cycle lasting up to an average of seven years. Poor compliance in
daily rhGH injections for an average seven-year treatment regime results in an
adverse impact on overall health efficacy.
LUM-201 is intended to provide an oral treatment to stimulate the release of
endogenous GH in PGHD patients who have a functional but reduced hypothalamic
pituitary GH axis and are expected to respond to LUM-201. Lumos believes this
group represents 50% to 60% of PGHD patients. Lumos is planning to initiate a
clinical development program to study the effects of LUM-201 in PGHD by the end
of 2020 with a Phase 2b study. Lumos has received a Study May Proceed letter
from FDA after their review of our study protocol. As trial initiation is
currently delayed by the COVID-19 pandemic, Lumos is evaluating whether there is
opportunity within the proposed Phase 2b study to address additional FDA
comments that could increase Phase 3 registration readiness. The submitted trial
is a randomized study testing three doses of LUM-201 in a parallel enrollment
approach versus the current standard dose of injectable rhGH with the twin goals
of dose selection and refinement of patient selection for a Phase 3 study.
Potential expansion of LUM-201 into additional endocrine indications
Lumos is also in the planning stages for developing LUM-201 for patients with
Turner Syndrome. Turner Syndrome is a sex-linked developmental disorder that
affects females only (one normal x chromosome, and the other x chromosome is
either missing or structurally changed). It causes growth failure that begins
before birth and continues into infancy and childhood, where it can be
accentuated by the absence of puberty. If left untreated, girls with Turner
Syndrome will usually achieve an average adult height that is significantly
shorter than their peers.
Lumos is also in the planning stages for developing LUM-201 for the indication
of SGA. SGA is a child born with birth weight and/or length under two standard
deviations ("SDS") for the gestational age and sex of the population.
Approximately five percent of all newborn children are SGA and a spectrum of
factors are found to be causative: maternal, placental, fetal, metabolic, and
genetic. In the newborn period, SGA children are at greater risk of
life-threatening conditions: hypoglycemia, hypercoagulability, necrotic
enterocolitis, direct hyperbilirubinemia, and hypotension. Approximately 10% of
SGA children do not achieve catch-up growth and remain short (?-2 SDS) into
adulthood.
Lumos acquired LUM-201 from Ammonett Pharma LLC ("Ammonett") in July 2018.
LUM-201 received Orphan Drug Designation ("ODD") in the United States and the
European Union for GHD in 2017. The United States patent "Detecting and Treating
Growth Hormone Deficiency" has been issued with an expiration in 2036. Other
patent applications are pending in multiple jurisdictions.
Since its inception, Private Lumos' operations have focused on organizing and
staffing, business planning, raising capital, acquiring its technology and
assets, and conducting preclinical and clinical development of its product
candidates. Private Lumos has devoted substantial effort and resources to
acquiring its current product candidate, LUM-201, as well as its previous
product candidate, LUM-001, which it ceased developing in 2019. Private Lumos
acquired LUM-201 through its acquisition of substantially all of the assets
related to LUM-201 from Ammonett which had licensed LUM-201 in October 2013 from
Merck. Private Lumos has not generated any revenue from product sales. Prior to
the Merger, Private Lumos funded its operations
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primarily through the sale and issuance of preferred stock, as well as through
in-kind support pursuant to a collaborative research and development agreement
with the NIH from 2012 to February 2020.
The following relates to products in development by NewLink prior to the Merger:
IDO Pathway Inhibitors
In cancer, the IDO (indoleamine-2, 3-dioxygenase) pathway regulates immune
response by suppressing T-cell activation, which enables cancer to avoid immune
response. IDO is overexpressed in many cancers, both within tumor cells as a
direct defense against T-cell attack, and also within antigen presenting cells
in tumor-draining lymph nodes, thereby promoting peripheral tolerance to tumor
associated antigens ("TAAs"). When hijacked by developing cancers in this
manner, the IDO pathway may facilitate the survival, growth, invasion and
metastasis of malignant cells whose expression of TAAs might otherwise be
recognized and attacked by the immune system.
Currently, we have a small molecule portfolio primarily focused on the IDO
pathway. Our small-molecule IDO pathway inhibitor product candidates that have
previously been advanced into the clinic include indoximod and NLG802. Our
product candidates are designed to counteract the above described
immunosuppressive effects of the IDO pathway in cancer. Preclinical evidence
supports the premise that indoximod stimulates the activation of antitumor
T-cells through activation of mammalian target of rapamycin and modulation of
signaling through the aryl hydrocarbon receptor.
To date, our IDO focused small molecules have been well tolerated in clinical
trials. They are orally bioavailable and we believe they offer the potential to
be synergistic with other cancer therapies such as radiation, chemotherapy,
vaccination and immunotherapies involving other checkpoint inhibitors such as
anti-PD-1, anti-programmed cell death ligand-1, or anti-cytotoxic T-lymphocyte
antigen 4. Clinical data suggest an increase in clinical activity without adding
significant toxicity.
More than 900 patients have been treated with indoximod to date and it has
generally been well-tolerated, including in combination with PD-1 checkpoint
inhibitors, various chemotherapy agents, radiation, and a cancer vaccine. A
tablet formulation of indoximod hydrochloride for adult patients and a sprinkle
formulation for pediatric indications have been developed. Both of these
formulations of indoximod could be used in future clinical trials.
NLG802 is a prodrug of indoximod. NLG802 is intended to increase bioavailability
and exposure to indoximod above levels currently achievable by direct oral
administration of indoximod. Based on data from a Phase 1 dose escalation trial,
presented in May 2019 at the Immuno-Oncology 2019 World Congress, the treatment
regimen was well tolerated with no NLG802-related serious adverse events
reported. The recommended Phase 2 dose was established at 1452 mg BID based on
achieving preclinical exposure levels required for pharmacodynamic effects of
indoximod.
Two U.S. patents covering both the salt and prodrug formulations of indoximod
were issued in the United States on August 15, 2017 and February 19, 2019,
respectively, providing exclusivity until at least 2036. We are continuing to
pursue international patent coverage for these formulations in some countries,
and we are exploring the potential for further development and licensing
opportunities but do not have an active program for the drug product candidate
as of March 31, 2020.
Ebola Vaccine
In November 2014, NewLink entered into the NewLink Merck Agreement to develop
and potentially commercialize our rVSV?G-ZEBOV GP vaccine product candidate and
other aspects of the vaccine technology. The rVSV?G-ZEBOV GP vaccine product
candidate was originally developed by the PHAC and is designed to utilize the
rVSV vector to induce immunity against Ebola virus when replacing the VSV
glycoprotein with corresponding glycoproteins from filoviruses. Under the
NewLink Merck Agreement, NewLink received an upfront payment of $30.0 million in
October 2014, and in February 2015, NewLink received a milestone payment of
$20.0 million.
In addition to milestone payments from Merck, NewLink was awarded contracts for
development of the rVSV?G-ZEBOV GP from the BARDA and the DTRA totaling $52.1
million during 2016 and $67.0 million during 2014 and 2015. Funds of $2.1
million were de-obligated from the DTRA grant awards in 2017. NewLink received
total awards of $118.8 million. On April 26, 2018 NewLink entered into an
agreement with Merck, DTRA and BARDA to transfer the government grants from
BARDA and DTRA to Merck. The transfer was completed in June 2018 and Merck
replaced NewLink as the prime contractor on all such grants.
On December 20, 2019, Merck announced that the FDA approved its application for
ERVEBO® (Ebola Zaire Vaccine, Live) for the prevention of disease caused by
Zaire Ebola virus in individuals 18 years of age and older. On January 3, 2020,
Merck notified NewLink that they had been issued a PRV. Under the terms of the
NewLink Merck Agreement, on February 4, 2020, Merck assigned all of its rights
and interests in connection with the PRV to NewLink, and upon the Merger, the
Company
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is entitled to 60% of the value of the PRV obtained through sale, transfer or
other disposition of the PRV. We also have the potential to earn royalties on
sales of the vaccine in certain countries, if the vaccine is successfully
commercialized by Merck. However, we believe that the market for the vaccine
will be limited primarily to areas in the developing world that are excluded
from royalty payment or where the vaccine is donated or sold at low or no margin
and therefore we do not expect to receive material royalty payments from Merck
in the foreseeable future.
Restructuring Charges
On September 30, 2019, prior to the Merger, NewLink adopted a restructuring plan
to reduce its headcount by approximately 60%, which consisted primarily of
clinical and research and development staff and made several changes to senior
leadership in order to conserve resources.
In addition to the restructuring, effective August 3, 2019, Charles J. Link, Jr,
M.D. retired from his position as the Chairman, Chief Executive Officer and
Chief Scientific Officer and a member of the board of directors of NewLink, and
Nicholas Vahanian retired from his position as the President and member of the
board of NewLink, effective September 27, 2019, and his employment with NewLink
ended on November 11, 2019.
As of March 31, 2020, the Company has $2.7 million accrued relating to remaining
payments expected to be paid out over the next twelve months. No expense was
recorded during the three months ended March 31, 2020.
Corporate Information
Our executive offices are located at 4200 Marathon Blvd., Suite 200, Austin
Texas. We have additional executive and administrative space in Ames, Iowa, with
the lease ending in March 2021.
We incurred a net loss of $340,000 for the three months ended March 31, 2020. We
expect to continue to incur losses over the next several years as we incur
expenses to complete our clinical trial programs, expand our pipeline and pursue
regulatory approval of our product candidates.
Critical Accounting Policies and Significant Judgments and Estimates
We have prepared our financial statements in accordance with U.S. GAAP which
requires us to make estimates, assumptions and judgments that affect the
reported amount of assets, liabilities, expenses and related disclosures at the
date of the financial statements, as well as revenues and expenses during the
reporting periods. As such, to understand our financial statements, it is
important to understand our critical accounting policies. A critical accounting
policy is one that is both important to the portrayal of our financial condition
and results of operation and requires management's most difficult, subjective or
complex judgments, often as a result of the need to make estimates about the
effect of matters that are inherently uncertain. Actual results could,
therefore, differ materially from these estimates under different assumptions or
conditions.
While our significant accounting policies are described in more detail in Note 4
to our condensed consolidated financial statements, we believe the following
accounting policies to be critical in the preparation of our financial
statements.
Asset acquisitions
Accounting for transactions as asset acquisitions is significantly different
than business combinations. For example, acquired in-process research and
development is expensed for asset acquisitions and capitalized for business
combinations. Goodwill is only recognized in business combination transactions.
As a result, it is important to determine whether a business or an asset or a
group of assets is acquired. A business is defined in ASC 805, Business
Combinations, as an integrated set of inputs and processes that are capable of
generating outputs that have the ability to provide a return to its investors or
owners. Typical inputs include long-lived assets (including intangible assets or
rights to use long-lived assets), intellectual property and the ability to
obtain access to required resources. Typical processes include strategic,
operational and resource management processes that are typically documented or
evident through an organized workforce.
We considered all of the above factors when determining whether a business was
acquired. In evaluating the Merger, we concluded that NewLink did not meet the
definition of a business as it does not have the processes in place to generate
outputs.
There are several methods that can be used to determine the fair value of
acquired intangibles. We used the precedent transaction method under the market
approach to estimate the value of the PRV. We relied on purchase prices
indicated by actual precedent priority review voucher transactions that were
reasonably comparable to the PRV owned by NewLink. The Market Approach requires
several judgments and assumptions to determine the fair value including discount
rates, probability assumption of sale, expected transaction sales price, and tax
rates. A change in these assumptions would impact the
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consideration received and capitalized as part of the Merger. The change could
be material. For example, a 3% change in the discount rate used would increase
(decrease) the fair value of the equity issued by approximately 2 to 4%.
The fair value assigned to the acquired in-process research and development
assets was estimated based on the estimated expected net proceeds from the sales
of these assets as intellectual property. These assets are no longer being
actively pursued in further clinical development by the Company.
Acquired in-process research and development
Acquired in-process research and development expense consists of the initial
up-front payments incurred in connection with the acquisition or licensing of
product candidates that do not meet the definition of a business under ASC 805,
Business Combinations.
Recent Accounting Pronouncements
We do not believe that any recently issued effective pronouncements, or
pronouncements issued but not yet effective, if adopted, would have a material
effect on the accompanying financial statements.
Results of Operations
Comparison of the Three Months Ended March 31, 2020 and 2019
Revenues. Revenues for the three months ended March 31, 2020 were $21,000, an
increase of $21,000 from zero for the same period in 2019. The increase in
revenue is attributable to $21,000 in licensing billings to Merck. We recognized
licensing revenue during the three months ended March 31, 2020 for work we
performed as a subcontractor of Merck.
Research and Development Expenses. Research and development expenses for the
three months ended March 31, 2020 were $1.9 million, an increase of $450,000
from $1.5 million for the same period in 2019. The increase is primarily due to
additional expenses incurred as a result of the Merger including the write-off
of the acquired NewLink in-process research and development of $426,000,
increase of $84,000 in personnel-related and stock compensation expense, and an
increase of $68,000 in equipment and supplies expense, offset by a decrease in
research and development consulting of $128,000.
General and Administrative Expenses. General and administrative expenses for the
three months ended March 31, 2020 were $3.3 million, an increase of $2.6 million
from $683,000 for the same period in 2019. The increase was due primarily to
increases of $1.6 million in legal and professional fees incurred primarily due
to the Merger, $663,000 in personnel-related expense, $295,000 due to increased
operating expenses for rent, supplies, and depreciation and $91,000 due to
insurance.
Income Tax Benefit. We recorded an income tax benefit of $5.5 million for the
three months ended March 31, 2020. We recorded no income tax benefit for the
three months ended March 31, 2019. The income tax benefit as of March 31, 2020
differs from the three months ended March 31, 2019 primarily due to the benefit
recorded as a result of our ability to carryback NOLs to the tax years beginning
before December 31, 2017, specifically to the years ended December 31, 2014 and
2015, the release of the valuation allowance relating to Private Lumos NOL
carryforwards, and current tax benefit that management anticipates will be
utilized in the current year.
Net Loss. Net income for the three months ended March 31, 2020 was $340,000
compared to a net loss of $2.1 million for the same period in 2019. The net loss
available to common shareholders for the three months ended March 31, 2020 was
$311,000 compared to a net loss available to common shareholders of $2.9 million
for the same period in 2019. The increase in net loss attributable to common
shareholders compared to net loss is due to the accretion of preferred stock
dividends of $651,000 and $750,000 for the three months ended March 31, 2020 and
2019, respectively. The basic and diluted weighted-average shares of common
stock outstanding for the three months ended March 31, 2020 were 2,189,758,
resulting in a basic and diluted loss per share available to common shareholders
of $0.14. For the three months ended March 31, 2019, the basic and diluted
weighted-average shares of common stock outstanding were 1,339,289, resulting in
basic and diluted loss per share of $2.13.

Liquidity and Capital Resources As of March 31, 2020, we had cash and cash equivalents of $85.8 million. We have historically funded our operations principally through the private placement of equity securities, public offerings of common stock, and license and milestone payments received under our collaboration agreements. We believe that our cash and cash equivalents on hand will be sufficient to fund our current operations through at least 2022.


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We anticipate that we will continue to generate operating losses to the extent
that we incur expenses to complete our clinical trial programs for our product
candidates, develop our pipeline and pursue regulatory approval of our product
candidates.
We may seek to sell additional equity or debt securities or obtain a credit
facility if our available cash and cash equivalents are insufficient to satisfy
our liquidity requirements or if we develop additional opportunities to do so.
The sale of additional equity and debt securities may result in additional
dilution to our stockholders. If we raise additional funds through the issuance
of debt securities or preferred stock, these securities could have rights senior
to those of our common stock and could contain covenants that would restrict our
operations. We may require additional capital beyond our currently forecasted
amounts. Any such required additional capital may not be available on reasonable
terms, if at all. If we were unable to obtain additional financing, we may be
required to reduce the scope of, delay or eliminate some or all of our planned
research and development activities, which could harm our business.
Because of the numerous risks and uncertainties associated with the research and
development of our product candidates, we are unable to estimate the exact
amounts of our working capital requirements. Our future funding requirements
will depend on many factors, including, but not limited to:
•the scope, progress, results, and costs of clinical trials for our product
candidates, and discovery and development activities related to new product
candidates;
•the timing of, and the costs involved in, obtaining regulatory approvals for
our product candidates;
•the cost of commercialization activities if any of our product candidates are
approved for sale, including marketing, sales, facilities, and distribution
costs;
•the cost of manufacturing our product candidates and any products we
commercialize;
•our ability to establish and maintain strategic collaborations, licensing or
other arrangements and the financial terms of such agreements;
•whether, and to what extent, we are required to repay our outstanding
government provided loans;
•the costs involved in preparing, filing, prosecuting, maintaining, defending
and enforcing patent claims, including litigation costs and the outcome of such
litigation;
•the impact of public health crises such as the current COVID-19 pandemic or
similar outbreaks, and
•the timing, receipt and amount of sales of, or royalties on, our future
products, if any.
Cash Flows
The following table sets forth the primary sources and uses of cash for each of
the periods set forth below:
                                                                 Three Months Ended March 31,
                                                                  2020                    2019
      Net cash used in operating activities                $       (3,310)          $      (2,186)
      Net cash provided by investing activities                    84,179                       -
      Net cash used in financing activities                             -                       -
      Net increase (decrease) in cash and equivalents      $       80,869           $      (2,186)

For the three months ended March 31, 2020 and 2019, we used cash of $3.3 million and $2.2 million, respectively, for our operating activities. The increase in cash used in operating activities was primarily due to the Merger activity and changes in working capital for the three months ended March 31, 2020 as compared to the three months ended March 31, 2019. For the three months ended March 31, 2020 our investing activities provided cash of $84.2 million and none for the three months ended March 31, 2019. The cash provided by investing activities during the three months ended March 31, 2020 was due to $84.2 million in cash acquired in connection with the Merger.




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