Notes to Condensed Consolidated Financial
Statements
(Unaudited)
1. Nature of Operations
Description of the Business
The Company was incorporated on March 15,
2000 in California and reincorporated as a Delaware corporation in September 2001 under the name KaloBios Pharmaceuticals, Inc.
Effective August 7, 2017, the Company changed its legal name to Humanigen, Inc. During February
2018, the Company completed the restructuring transactions announced in December 2017 and continued its transformation into a clinical-stage
biopharmaceutical company by further developing its clinical stage immuno-oncology and immunology portfolio of monoclonal
antibodies. The Company is currently focused on developing its novel human granulocyte-macrophage colony-stimulating factor (“GM-CSF”)
neutralization and gene-knockout platforms and its portfolio of next-generation cell and gene therapies.
The Company’s lead product candidate
is lenzilumab, a proprietary Humaneered® monoclonal antibody (a biologic) that has been demonstrated to neutralize a naturally
occurring inflammatory factor (GM-CSF). GM-CSF is a cytokine which acts directly on myeloid cells to cause expansion, activation,
and to initiate and promote the production of other chemokines, including MCP-1, MIP-1a, and IP-10, and cytokines, including TNFa,
IL-6 and IL-1 as part of the body’s immune response. GM-CSF is thought of as a communication conduit between the innate and
adaptive immune systems. Once initiated, the inflammatory cascade in certain cases may quickly evolve into a self-perpetuating
“storm” as the production of chemokines increases expansion and trafficking of myeloid cells. This, in turn, leads
to abnormally high levels of inflammatory cytokines, endothelial activation, vascular permeability, disseminated intravascular
coagulation, and neurologic inflammation. This “cytokine storm” is frequently referred to as cytokine release syndrome,
or CRS. The neutralization of GM-CSF has been shown to prevent and potentially treat cytokine storm through a decrease in levels
of IL-6, MCP-1, MIP1a, IP-10, VEGF, TNFα and other factors and reduce levels of inflammatory myeloid cells. Reduction of these
factors demonstrates that GM-CSF is a critical upstream and early regulator of many inflammatory cytokines known to be important
in the pathophysiology of CRS (Sterner RM et al. Blood 2019. 133(7): 697–709).
During 2019 and throughout the early portion
of the first quarter of 2020, the Company continued to pursue its anti-GM-CSF programs to prevent or reduce the serious and potentially
life-threatening side effects associated with chimeric antigen receptor T-cell (“CAR-T”) therapy and to prevent or
treat graft-versus-host disease (“GvHD”) in patients undergoing allogeneic hematopoietic stem cell transplantation
(“HSCT”). In collaboration with Kite Pharmaceuticals, Inc., a Gilead company (“Kite or the “Kite Collaboration”),
the Company seeks to study the effect of lenzilumab on the safety of Yescarta®, axicabtagene ciloleucel (“Yescarta”),
Kite’s FDA-approved CAR-T therapy. A clinical trial is underway to measure the effect of lenzilumab in reducing CRS and neurotoxicity
(NT), with a secondary endpoint of increased efficacy of Yescarta.
The recent coronavirus pandemic, which is
due to the SARS-CoV-2 virus and leads to the condition referred to as COVID-19, is frequently characterized in the later and sometimes
fatal stages by severe, progressive viral pneumonia that can progress to acute respiratory distress syndrome (“ARDS”),
respiratory failure and death. Recent publications indicate that ARDS in this setting is caused by the body’s autoimmune
response to CRS. Published data point to GM-CSF being a key triggering cytokine, with elevated levels especially in those patients
who transition to the Intensive Care Unit (“ICU”).
In response to this published data indicating
that GM-CSF inhibition may play a role in treating patients with COVID-19, the Company is developing lenzilumab in COVID-19 in
a Phase III potential registration study. The Company has commenced enrollment in a multicenter randomized, placebo-controlled,
double-blind clinical trial with lenzilumab for the prevention of respiratory failure and/or death in hospitalized patients with
severe pneumonia associated with SARS-CoV-2 infection (Clinicaltrials.gov # NCT04351152).
The Company has generated compassionate
use data with lenzilumab in patients hospitalized with severe pneumonia associated with COVID-19 and is working with stakeholders
to share these data.
See Management’s Discussion and Analysis
of Financial Condition and Results of Operations in Item 2 of this Quarterly Report on Form 10-Q for additional information regarding
the business.
Liquidity and Going Concern
The Company has incurred significant losses
since its inception in March 2000 and had an accumulated deficit of $287.4 million
as of March 31, 2020. At March 31, 2020, the Company had a working capital deficit of $15.1
million. To date, none of the Company’s product candidates has been approved for sale and therefore the Company has not generated
any revenue from product sales. Management expects operating losses to continue for the foreseeable future. The Company will require
additional financing in order to meet its anticipated cash flow needs, which are expected to increase as the Company’s clinical
trial activities accelerate during the next twelve months. As a result, the Company will continue to require additional capital
through equity offerings, debt financing and/or payments under new or existing licensing or collaboration agreements. If sufficient
funds are not available on acceptable terms when needed, the Company could be required to significantly reduce its operating expenses
and delay, reduce the scope of, or eliminate one or more of its development programs. The Company’s ability to access capital
when needed is not assured and, if not achieved on a timely basis, could materially harm its business, financial condition and
results of operations. These conditions raise substantial doubt about the Company’s ability to continue as a going concern.
The Condensed Consolidated Financial Statements
for the three months ended March 31, 2020 were prepared on the basis of a going concern, which contemplates that the Company will
be able to realize assets and discharge liabilities in the normal course of business. The ability of the Company to meet its total
liabilities of $16.7 million at March 31, 2020 and to continue as a going concern
is dependent upon the availability of future funding. The financial statements do not include any adjustments that might be necessary
if the Company is unable to continue as a going concern.
Basis of Presentation
The accompanying interim unaudited Condensed
Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S.
GAAP”) for interim financial information and on a basis consistent with the annual consolidated financial statements and
include all adjustments necessary for the presentation of the Company’s condensed consolidated financial position, results
of operations and cash flows for the periods presented. The Condensed Consolidated Financial Statements include the accounts of
the Company and its wholly owned subsidiaries. These financial statements have been prepared on a basis that assumes that the Company
will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments
in the normal course of business. The December 31, 2019 Condensed Consolidated Balance Sheet was derived from the audited financial
statements but does not include all disclosures required by U.S. GAAP. These interim financial results are not necessarily indicative
of the results to be expected for the year ending December 31, 2020, or for any other future annual or interim period. The accompanying
unaudited Condensed Consolidated Financial Statements should be read in conjunction with the audited consolidated financial statements
and the related notes thereto included in the Company’s 2019 Form 10-K.
The preparation of financial statements
in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported
in the Condensed Consolidated Financial Statements and accompanying notes. Actual results could differ materially from those estimates.
The Company believes judgment is involved in determining the valuation of the fair value-based measurement of stock-based compensation
and warrant valuations. The Company evaluates its estimates and assumptions as facts and circumstances dictate. As future events
and their effects cannot be determined with precision, actual results could differ from these estimates and assumptions, and those
differences could be material to the Condensed Consolidated Financial Statements.
Certain prior year amounts have been reclassified
to conform to the current year presentation. Such reclassifications had no effect on prior years’ Net loss or Stockholders’
deficit.
2. Summary of Significant Accounting Policies
There have been no material changes in the
Company’s significant accounting policies since those previously disclosed in the 2019 Form 10-K.
Derivative Financial Instruments
The Company has equity conversion features
within its 2020 Convertible Redeemable Notes that qualify as embedded derivatives under the guidance of FASB ASC Topic 815, Derivatives
and Hedging. As part of that guidance, an analysis is performed on each embedded derivative to determine whether it should
be bifurcated from the host instrument and recorded separately within the Consolidated Balance Sheet at its fair value. Changes
in fair value are recorded in other income (expense) within the Consolidated Statement of Operations. Refer to Note 4 - Debt
and Note -5 – Derivative Instruments for further discussion of the Company’s embedded derivatives.
3. Potentially Dilutive Securities
The Company’s potentially dilutive
securities, which include stock options, restricted stock units and warrants, have been excluded from the computation of diluted
net loss per common share as the effect of including those securities would be to reduce the net loss per common share and be antidilutive.
Therefore, the denominator used to calculate both basic and diluted net loss per common share is the same in each period presented.
The following outstanding potentially dilutive
securities have been excluded from the computations of diluted net loss per common share:
|
|
As of March 31,
|
|
|
|
2020
|
|
|
2019
|
|
Options to purchase common stock
|
|
|
17,104,649
|
|
|
|
16,062,922
|
|
Warrants to purchase common stock
|
|
|
331,193
|
|
|
|
331,193
|
|
|
|
|
17,435,842
|
|
|
|
16,394,115
|
|
4. Debt
Notes Payable to Vendors
On June 30, 2016, the Company issued promissory
notes in an aggregate principal amount of approximately $1.2 million to certain claimants in accordance with the Company’s
Plan of Reorganization (the “Plan”) filed with the United States Bankruptcy Court for the District of Delaware (the
“Bankruptcy Court”) (Case No. 15-12628 (LSS) (the “Bankruptcy Case”) which became effective June 30, 2016,
at which time the Company emerged from its Chapter 11 bankruptcy proceedings. The notes are unsecured, bear interest at 10% per
annum and became due and payable in full, including principal and accrued interest on June 30, 2019. In July and August, 2019,
following the receipt of proceeds from the 2019 Bridge Notes, the Company used approximately $0.5 million of the proceeds to retire
a portion of these notes, including accrued interest. After giving effect to these payments, the aggregate principal amount and
accrued but unpaid interest on these notes approximates $1.1 million as of March 31, 2020. As of March 31, 2020 and December 31,
2019, the Company has accrued $0.3 million and $0.3 million in interest related to these promissory notes, respectively. The outstanding
principal amount and accrued but unpaid interest on these notes is currently payable to the respective holders without demand,
notice or declaration, and the holders, without demand or notice of any kind, may exercise any and all other rights and remedies
available to them under the notes, the Plan, at law or in equity. We do not have sufficient funds to repay the principal and accrued
but unpaid interest on these notes in their entirety.
Advance Notes
In June, July and August, 2018 the Company
received an aggregate of $0.9 million of proceeds from advances made to the Company (the “Advance Notes”) by four different
lenders including Dr. Cameron Durrant, the Company’s Chairman and Chief Executive Officer; Cheval Holdings, Ltd., an affiliate
of Black Horse Capital, L.P., the Company’s controlling stockholder; and Ronald Barliant, a director of the Company (collectively
the “Lenders”). The Advance Notes accrued interest at a rate of 7% per year, compounded annually.
In accordance with their terms, on May 30,
2019, in connection with the Company’s announcement of the Collaboration Agreement with Kite, the lenders converted the amounts
due under the Advance Notes into the Company’s common stock at the conversion price of $0.45 per share. The Company issued
a total of 2,179,622 shares of common stock in connection with the conversion.
2018 Convertible Notes
Commencing September 19, 2018, the Company
delivered a series of convertible promissory notes (the “2018 Notes”) evidencing an aggregate of $2.5 million of loans
made to the Company by six different lenders, including an affiliate of Black Horse Capital, L.P., the Company’s controlling
stockholder. The 2018 Notes bear interest at a rate of 7% per annum and will mature on the earliest of (i) twenty-four months from
the date the 2018 Notes were signed, (ii) the occurrence of any customary event of default, or (iii) the certain liquidation events
including any dissolution or winding up of the Company or merger or sale by the Company of all or substantially all of its assets
(in any case, a “Liquidation Event”). The Company used the proceeds from the 2018 Notes for working capital.
Following the end of the quarter ended March
31, 2020, holders of the 2018 Notes notified us of their exercise of their conversion rights. Please see Note 11 – Subsequent
Events for additional information.
As of March 31, 2020 and December 31, 2019,
the Company has accrued $0.3 million and $0.2 million in interest related to these promissory notes, respectively.
2019 Convertible Notes
Commencing on April
23, 2019, the Company delivered a series of convertible promissory notes (the “2019 Notes”) evidencing an aggregate
of $1.3 million of loans made to the Company.
The 2019 Notes bear interest at a rate of 7.5% per annum and
will mature on the earliest of (i) twenty-four months from the date the 2019 Notes are signed (the “Stated Maturity Date”),
(ii) the occurrence of any customary event of default, or (iii) the certain liquidation events including any dissolution or winding
up of the Company or merger or sale by the Company of all or substantially all of its assets (in any case, a “Liquidation
Event”). The Company used the proceeds from the 2019 Notes for working capital.
Following the end
of the quarter ended March 31, 2020, holders of the 2019 Notes notified us of their exercise of their conversion rights. Please
see Note 11 – Subsequent Events for additional information.
As of March 31, 2020 and December 31, 2019,
the Company had accrued $0.1 million and $0.1 million in interest related to these promissory notes, respectively.
The Advance Notes, the 2018 Notes and the
2019 Notes have an optional voluntary conversion feature in which the holder could convert the notes in the Company’s common
stock at maturity at a conversion rate of $0.45 per share for the Advance Notes and the 2018 Notes and at a conversion rate of
$1.25 for the 2019 Notes. The intrinsic value of this beneficial conversion feature was $1.8 million upon the issuance of the Advance
Notes, the 2018 Notes and the 2019 Notes and was recorded as additional paid-in capital and as a debt discount which is accreted
to interest expense over the term of the Advance Notes and Notes. Interest expense includes debt discount amortization of $0.2
million for the three months ended March 31, 2020.
The Company evaluated the embedded features
within the Advance Notes, the 2018 Notes and the 2019 Notes to determine if the embedded features are required to be bifurcated
and recognized as derivative instruments. The Company determined that the Advance Notes, the 2018 Notes and the 2019 Notes contain
contingent beneficial conversion features (“CBCF”) that allow or require the holder to convert the Advance Notes, the
2018 Notes and the 2019 Notes, as applicable, to Company common stock at a conversion rate of $0.45 per share for the Advance Notes
and the 2018 Notes and $1.25 for the 2019 Notes, but did not contain embedded features requiring bifurcation and recognition as
derivative instruments. Upon the occurrence of a CBCF that results in conversion of the Advance Notes, the 2018 Notes or the 2019
Notes to Company common stock, the remaining unamortized discount will be charged to interest expense. Upon conversion of the Advance
Notes on May 30, 2019, the remaining unamortized discount was charged to interest expense. The remaining debt discount for the
2018 and 2019 will be charged to interest expense in the second quarter of 2020 with their conversion in April 2020.
2020 Convertible Redeemable Notes
On
March 13, 2020 and March 19, 2020 (the “Issuance Dates”), the Company delivered two convertible redeemable promissory
notes (the “2020 Notes”) evidencing loans with an aggregate principal amount of $518,333 made to the Company.
The
2020 Notes bear interest at a rate of 7.0% per annum and will mature on March 13, 2021 and March 19, 2021, respectively. The 2020
Notes contain an original issue discount of $33,000 and $18,833, respectively. The Company used the proceeds from the 2020 Notes
for working capital.
Beginning
on the six month anniversary of the Issuance Dates, unless earlier redeemed by the Company, the holders are entitled, at their
option, to convert all or any amount of the principal amount of the 2020 Notes then outstanding, together with the accrued and
unpaid interest on such portion of the 2020 Notes proposed to be converted, into shares of the Company’s common stock (the
"Common Stock") at a conversion price equal to $0.25 per share (the “Fixed Price”). After the nine month
anniversary of the Issuance Dates, the conversion price shall be equal to the lower of (i) the Fixed Price or (ii) 68% of the lowest
of either the trading price or closing bid of the Common Stock, for the ten prior trading days including the day upon which a Notice
of Conversion is received (the “Variable Conversion Price”).
In
the event our Common Stock has a closing price equal to $0.30 or less for 5 consecutive days prior to the 9 month anniversary of
the Issuance Date, then, beginning on the 6 month anniversary of the Issuance Date, the holders may elect in their respective Notice
of Conversion to use the lower of the Fixed Price or the Variable Conversion Price set forth above.
Commencing
on the 6 month anniversary of the Issuance Dates, the Company will have the right, but not the obligation, to elect to make fixed
monthly amortizing payments to the holders in the amount of $25,000 and $14,250, respectively. If we elect to make such payments,
the holders shall not be entitled to convert all or any amount of the principal amount of the 2020 Notes then outstanding if and
for so long as we are current in respect of the amortizing payments.
The 2020 Notes may be redeemed by us at
any time before the 270th day following their issuance, at a redemption price equal to (i) 110% of the principal plus
accrued but unpaid interest on the 2020 Notes to the date of redemption, if the redemption occurs in the first 60 days following
the Issuance Dates; (ii) 120% of the principal plus accrued but unpaid interest on the 2020 Notes to the date of redemption, if
the redemption occurs from day 61 through day 120 following the Issuance Dates; or (iii) 130% of the principal plus accrued but
unpaid interest on the 2020 Notes to the date of redemption, if the redemption occurs from day 121 through day 270 following the
Issuance Dates. The 2020 Notes contain customary default and remedies provisions for convertible note financings of this nature.
As of March 31, 2020, the Company has accrued
$1,600 in interest related to the 2020 Notes.
The Company evaluated the embedded features
within the 2020 Notes and determined that the embedded features are required to be bifurcated and recognized as stand-alone derivative
instruments. The variable-share settlement features within the 2020 Notes qualify as redemption features and meet the net settlement
criterion for qualification as a stand-alone derivative. In determining the fair value of the bifurcated derivative, the Company
evaluated the likelihood of conversion of the 2020 Notes to Company stock. As the Company believes it will have adequate
funding prior to the six month anniversary of the 2020 Notes, the first conversion option for the holders of the 2020 Notes, and
it has the intent to either begin making amortizing payments or to pay off the 2020 Notes in their entirety prior to that date,
the fair value was determined to be $0 as of March 31, 2020. The original issue discount
is being accreted to interest expense over the term of the 2020 Notes. Interest expense includes the original issue discount amortization
of approximately $4,000 for the three months ended March 31, 2020. The remaining debt discount will be amortized over approximately
11 months for the 2020 Notes.
2019 Bridge
Notes
On June 28, 2019, the
Company issued three short-term, secured bridge notes (the “June Bridge Notes”) evidencing an aggregate of $1.7 million
of loans made to the Company by three parties: Cheval Holdings, Ltd., an affiliate of Black Horse Capital, L.P., the Company’s
controlling stockholder, lent $750,000; Nomis Bay LTD, the Company’s second largest stockholder, lent $750,000; and Dr. Cameron
Durrant, the Company’s Chief Executive Officer and Chairman of the Board of Directors, lent $200,000. The proceeds from the
June Bridge Notes were used to satisfy a portion of the unsecured obligations incurred in connection with the Company’s emergence
from bankruptcy in 2016 and for working capital and general corporate purposes. Of the $1.7 million in proceeds received, $950,000
was received on June 28, 2019 and was recorded as Advance notes in the Condensed Consolidated Balance Sheet as of June 30, 2019.
The remaining proceeds of $750,000 were received July 1, 2019 and recorded accordingly.
The June Bridge Notes
bear interest at a rate of 7.0% per annum and had an original maturity date of October 1, 2019, which the Company and the lenders
agreed to extend until December 31, 2020. No other changes to the terms of the June Bridge Notes were made in connection with the
extension of the maturity date. The June Bridge Notes may become due and payable at such earlier time as the Company raises more
than $3,000,000 in a bona fide financing transaction or upon a change in control. The June Bridge Notes are secured by liens on
substantially all of the Company’s assets.
On November 12, 2019, the Company issued
two short-term, secured bridge notes (the “November Bridge Notes” and together with the June Bridge Notes, the “2019
Bridge Notes”) evidencing an aggregate of $350,000 of loans made to the Company by two parties: Cheval Holdings, Ltd.,
an affiliate of Black Horse Capital, L.P., our controlling stockholder, lent $250,000; and Dr. Cameron
Durrant, our Chief Executive Officer and Chairman of our Board of Directors, lent $100,000. The proceeds from the November
Bridge Notes were used for working capital and general corporate purposes.
The November Bridge Notes rank on par with
the June Bridge Notes, and possess other terms and conditions substantially consistent with those notes. The November Bridge Notes
bear interest at a rate of 7.0% per annum and had an original maturity date of December 31, 2019, which the Company and the lenders
agreed to extend until December 31, 2020. No other changes to the terms of the November Bridge Notes were made in connection with
the extension of the maturity date. The November Bridge Notes may become due and payable at such earlier time as the Company raises
more than $3,000,000 in a bona fide financing transaction or upon a change in control. The November Bridge Notes also are secured
by a lien on substantially all of the Company’s assets.
Upon an event of default,
which events include, but are not limited to, (1) the Company’s failure to timely pay any monetary obligation under the 2019
Bridge Notes; (2) our failure to pay our debts generally as they become due and (3) our commencing any proceeding relating to the
Company under any bankruptcy reorganization, arrangement, insolvency, readjustment of debt, dissolution or liquidation or similar
laws of any jurisdiction now or hereafter in effect, the interest payable on the 2019 Bridge Notes increases to 10.0% per annum.
Further, upon certain events of default, all payments and obligations due and owed under the 2019 Bridge Notes shall immediately
become due and payable without demand and without notice to the Company.
As of March 31, 2020 and December 31, 2019,
the Company has accrued $0.1 million and $0.1 million in interest related to these promissory notes, respectively.
As of March 31, 2020, the maturities of
the debt of the Company by year is as follows:
|
|
Total
|
|
|
2020
|
|
|
2021
|
|
Principal payments on Notes payable to vendors
|
|
$
|
774
|
|
|
$
|
774
|
|
|
$
|
-
|
|
Interest payments on Notes payable to vendors
|
|
|
348
|
|
|
|
348
|
|
|
|
-
|
|
Principal payments on 2019 Bridge notes
|
|
|
2,050
|
|
|
|
2,050
|
|
|
|
-
|
|
Interest payments on 2019 Bridge notes
|
|
|
99
|
|
|
|
99
|
|
|
|
-
|
|
Principal payments on Convertible notes
|
|
|
4,293
|
|
|
|
3,018
|
|
|
|
1,275
|
|
Interest payments on Convertible notes
|
|
|
358
|
|
|
|
270
|
|
|
|
88
|
|
Gross debt before unamortized discount
|
|
|
7,922
|
|
|
|
6,559
|
|
|
|
1,363
|
|
Unamortized debt discount on convertible debt
|
|
|
(607
|
)
|
|
|
(532
|
)
|
|
|
(75
|
)
|
Total Debt
|
|
$
|
7,315
|
|
|
$
|
6,027
|
|
|
$
|
1,288
|
|
5. Derivative Instruments
The Company has certain embedded equity
conversion features within its 2020 Notes that require bifurcation and recognition as stand-alone derivatives. See Note 4 –
Debt for additional information and discussion on the bifurcated derivatives.
6. Commitments and Contingencies
Contractual Obligations and Commitments
As of March 31, 2020, other than the debt
issuances described in Note 4 and the license agreements described in Note 8, there were no material changes to the Company’s
contractual obligations from those set forth in the 2019 Form 10-K.
Guarantees and Indemnifications
The Company has certain agreements with
service providers with which it does business that contain indemnification provisions pursuant to which the Company typically agrees
to indemnify the party against certain types of third-party claims. The Company accrues for known indemnification issues when a
loss is probable and can be reasonably estimated. The Company would also accrue for estimated incurred but unidentified indemnification
issues based on historical activity. As the Company has not incurred any indemnification losses to date, there were no accruals
for or expenses related to indemnification issues for any period presented.
7. Stockholders’ Equity
Lincoln Park Capital Purchase Agreement
On November 8, 2019, the Company entered
into a purchase agreement (the “Purchase Agreement”) and a registration rights agreement (the “Registration Rights
Agreement”) with Lincoln Park Capital Fund, LLC (“LPC”), pursuant to which the Company has the right to sell
to LPC up to $20,000,000 in shares of the Company’s common stock, $0.001 par value per share (the “Common Stock”),
subject to certain limitations and conditions set forth in the Purchase Agreement.
Under the Purchase Agreement, the Company
has the right, from time to time at its sole discretion and subject to certain conditions, to direct LPC to purchase up to 100,000
shares of Common Stock, with such amounts increasing based on certain threshold prices but not to exceed $750,000 in total proceeds
on any purchase date. The purchase price of shares of Common Stock pursuant to the Purchase Agreement will be based on the market
prices of the Common Stock at the time of such purchases as set forth in the Purchase Agreement. Such sales of Common Stock by
the Company, if any, may occur from time to time, at the Company’s option, over the 36-month period expiring in December
2022.
In connection with the signing of the Purchase
Agreement on November 8, 2019, the Company issued 706,592 shares of its common stock to LPC. The issuance of the shares were recorded
as debt issuance costs in Common stock and Additional paid-in capital with no net effect on Stockholders’ deficit.
In addition to regular purchases, as described
above, the Company may also direct LPC to purchase additional amounts as accelerated purchases if the closing sale price of the
Common Stock is not below certain threshold prices, as set forth in the Purchase Agreement. In all instances, the Company may not
sell shares of its Common Stock to LPC under the Purchase Agreement if it would result in LPC beneficially owning more than 4.99%
of the Common Stock then outstanding.
LPC represented to the Company, among other
things, that it was an “accredited investor” (as such term is defined in Rule 501(a) of Regulation D under
the Securities Act of 1933, as amended (the “Securities Act”)), and the Company sold the securities to LPC pursuant
to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of, and Regulation
D under, the Securities Act.
The Purchase Agreement and the Registration
Rights Agreement contain customary representations, warranties, agreements and conditions to completing future sale transactions,
indemnification rights and obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time,
at no cost or penalty. During any “event of default” under the Purchase Agreement, all of which are outside of LPC’s
control, LPC does not have the right to terminate the Purchase Agreement; however, the Company may not initiate any regular or
other sale of shares to LPC until such event of default is cured.
Actual sales of shares of Common Stock to
LPC under the Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including,
among others, market conditions, the trading price of the Common Stock and determinations by the Company as to the appropriate
sources of funding for the Company and its operations. In consideration for entering in the Purchase Agreement, the Company paid
LPC a commitment fee in shares of Common Stock. The Company did not receive any cash proceeds from the issuance of these shares.
The net proceeds under the Purchase Agreement
to the Company will depend on the frequency and prices at which the Company sells shares of its stock to LPC. The Company expects
that any proceeds received by the Company from such sales to LPC will be used for working capital and general corporate purposes.
During the months of December 2019 and January
2020, the Company issued a total of 700,000 shares for aggregate proceeds of $0.3 million under the Purchase Agreement.
Equity Financings
During the month of December 2019, the Company
issued 500,000 shares of its common stock for aggregate proceeds of $0.2 million under the Purchase Agreement.
During the month of January 2020, the Company
issued 200,000 shares of its common stock for aggregate proceeds of $0.1 million under the Purchase Agreement.
2012 Equity Incentive Plan
Under the Company’s 2012 Equity Incentive
Plan, the Company may grant shares, stock units, stock appreciation rights, performance cash awards and/or options to employees,
directors, consultants, and other service providers. For options, the per share exercise price may not be less than the fair market
value of a Company common share on the date of grant. Awards generally vest and become exercisable over three to four years and
expire 10 years from the date of grant. Options generally become exercisable as they vest following the date of grant.
A summary of stock option activity for the
three months ended March 31, 2020 under all of the Company’s options plans is as follows:
|
|
Options
|
|
|
Weighted
Average
Exercise
Price
|
|
Outstanding at January 1, 2020
|
|
|
15,881,721
|
|
|
$
|
0.95
|
|
Granted
|
|
|
1,223,033
|
|
|
|
0.40
|
|
Exercised
|
|
|
-
|
|
|
|
-
|
|
Cancelled (forfeited)
|
|
|
-
|
|
|
|
-
|
|
Cancelled (expired)
|
|
|
(105
|
)
|
|
|
11.68
|
|
Outstanding at March 31, 2020
|
|
|
17,104,649
|
|
|
$
|
0.91
|
|
The weighted average fair value of options
granted during the three months ended March 31, 2020 was $0.40 per share.
The
Company valued the options granted using the Black-Scholes options pricing model and the following weighted-average assumption
terms for the three months ended March 31, 2020:
|
Three
months ended
March
31, 2020
|
Exercise price
|
$0.38 - $0.40
|
Market value
|
$0.38 - $0.40
|
Expected term
|
5 years
|
Expected volatility
|
95%
|
Risk-free interest rate
|
1.47% - 1.57%
|
Expected dividend yield
|
0%
|
Stock-Based Compensation
The Company recorded stock-based compensation
expense in the Condensed Consolidated Statements of Operations as follows:
|
|
Three months ended March 31,
|
|
|
|
2020
|
|
|
2019
|
|
General and administrative
|
|
$
|
211
|
|
|
$
|
697
|
|
Research and development
|
|
|
54
|
|
|
|
-
|
|
Total stock-based compensation
|
|
$
|
265
|
|
|
$
|
697
|
|
At March 31, 2020, the Company had $0.7
million of total unrecognized stock-based compensation expense, net of estimated forfeitures, related to outstanding stock options
that will be recognized over a weighted-average period of 1.6 years.
8. License and Collaboration Agreements
Kite Agreement
On May 30, 2019, the Company entered into
a collaboration agreement (the “Kite Agreement”) with Kite Pharmaceuticals, Inc., pursuant to which the Company and
Kite areconducting a multi-center Phase 1b/2 study of lenzilumab with Kite’s Yescarta in patients with relapsed or refractory
B-cell lymphoma, including diffuse large B-cell lymphoma (“DLBCL”). The primary objective of the Study is to determine
the effect of lenzilumab on the safety of Yescarta.
Pursuant to the Kite Agreement, the Company
shall supply lenzilumab to the collaboration for use in the study and will contribute up to approximately $8.0 million towards
the out-of-pocket costs of the study, depending on the number of patients enrolled into the study.
Mayo Agreement
On June 19, 2019 the
Company entered into an exclusive worldwide license agreement (the “Mayo Agreement”) with the Mayo Foundation for Medical
Education and Research (“Mayo”) for certain technologies used to create CAR-T cells lacking GM-CSF expression through
various gene-editing tools including CRISPR-Cas9 (GM-CSF knock-out). The license covers various patent applications and know-how
developed by Mayo in collaboration with the Company. These licensed technologies complement and broaden the Company’s position
in the GM-CSF neutralization space and expand the Company’s discovery platform aimed at improving CAR-T to include gene-edited
CAR-T cells.
Pursuant to the Mayo
Agreement, the Company will pay $200,000 to Mayo within six months of the effective date, or upon completion of a qualified financing,
whichever is earlier. The Mayo Agreement also requires the payment of milestones and royalties upon the achievement of certain
regulatory and commercialization milestones. The Company accrued the initial payment and interest through March 31, 2020 in Accrued
expenses in the accompanying Condensed Consolidated Balance Sheets as of December 31, 2019 and March 31, 2020.
Zurich Agreement
On July 19, 2019 the
Company entered into an exclusive worldwide license agreement (the “Zurich Agreement”) with the University of Zurich
(“UZH”) for technology used to prevent or treat Graft versus Host Disease (“GvHD”) through GM-CSF neutralization.
The Zurich Agreement covers various patent applications filed by UZH which complement and broaden the Company’s position
in the application of GM-CSF and expands the Company’s development platform to include improving allogeneic Hematopoietic
Stem Cell Transplantation (“HSCT”).
Pursuant to the Zurich
Agreement, the Company paid $100,000 to UZH in July 2019. The Zurich Agreement also requires the payment of milestones and royalties
upon the achievement of certain regulatory and commercialization milestones. The license payment of $100,000 was recorded as expense
in Research and development in July 2019.
9. Savant Arrangements
On June 30, 2016 the Company and Savant
Neglected Diseases, LLC (“Savant”) entered into an Agreement for the Manufacture, Development and Commercialization
of Benznidazole for Human Use (the “MDC Agreement”), pursuant to which the Company acquired certain worldwide rights
relating to benznidazole (the “Compound”).
In addition, on the Effective Date the Company
and Savant also entered into a Security Agreement (the “Security Agreement”), pursuant to which the Company granted
Savant a continuing senior security interest in the assets and rights acquired by the Company pursuant to the MDC Agreement and
certain future assets developed from those acquired assets.
On the Effective Date, the Company issued
to Savant a five year warrant (the “Warrant”) to purchase 200,000 shares of the Company’s Common Stock, at an
exercise price of $2.25 per share, subject to adjustment. The Warrant is exercisable for 25% of the shares immediately and exercisable
for the remaining shares upon reaching certain regulatory related milestones. As of March 31, 2020 the number of shares for which
the Warrant is currently exercisable totals 100,000 shares at an exercise price of $2.25 per share.
As a result of the FDA granting accelerated
and conditional approval of a benznidazole therapy manufactured by a competitor for the treatment of Chagas disease and awarding
such competitor a neglected tropical disease PRV in August 2017, the Company ceased development of benznidazole and re-evaluated
the final two vesting milestones and concluded that the probability of achievement of these milestones had decreased to 0%.
In July 2017, the Company commenced litigation
against Savant alleging that Savant breached the MDC Agreement and seeking a declaratory judgement. Savant has asserted counterclaims
for breaches of contract under the MDC Agreement and the Security Agreement. The dispute primarily concerns the Company’s
right under the MDC Agreement to offset certain costs incurred by the Company in excess of the agreed upon budget against payments
due Savant. See Note 10, below, for more information regarding the Savant litigation. The aggregate cost overages as of June 30,
2017 that the Company asserts are Savant’s responsibility total approximately $3.4 million, net of a $0.5 million deductible.
The Company asserts that it is entitled to offset $2.0 million in milestone payments due Savant against the cost overages, such
that as of June 30, 2017, Savant owed the Company approximately $1.4 million. As of June 30, 2019, the cost overages totaled $4.1
million such that Savant owed the Company approximately $2.1 million in cost overages. Such cost overages have been charged to
Research and development expense as incurred. Recovery of such cost overages, if any, will be recorded as a reduction of Research
and development expense in the period received.
The $2.0 million in milestone payments due
Savant are included in Accrued expenses in the accompanying Condensed Consolidated Balance Sheet as of March 31, 2020 and December
31, 2019.
10. Litigation
Savant Litigation
On July 10, 2017, the Company filed a complaint
against Savant in the Superior Court for the State of Delaware, New Castle County (the “Delaware Court”). KaloBios
Pharmaceuticals, Inc. v. Savant Neglected Diseases, LLC, No. N17C-07-068 PRW-CCLD. The Company asserted breach of contract
and declaratory judgment claims against Savant arising under the MDC Agreement. See Note 9 - “Savant Arrangements”
for more information about the MDC Agreement. The Company alleges that Savant has breached its MDC Agreement obligations to pay
cost overages that exceed a budgetary threshold as well as other related MDC Agreement representations and obligations. In the
litigation, the Company has alleged that as of June 30, 2017, Savant was responsible for aggregate cost overages of approximately
$3.4 million, net of a $0.5 million deductible under the MDC. The Company asserts that it is entitled to offset $2.0 million in
milestone payments due Savant against the cost overages, such that as of June 30, 2017 Savant owed the Company approximately $1.4
million.
On July 12, 2017, Savant removed the case
to the Bankruptcy Court, claiming that the action is related to or arises under the Bankruptcy Case from which we emerged in July
2016. In re KaloBios Pharmaceuticals, Inc., No. 15-12628 (LSS) (Bankr. D. Del.). On July 27, 2017, Savant filed an Answer
and Counterclaims. Savant’s filing alleges breaches of contracts under the MDC Agreement and the Security Agreement, claiming
that the Company breached its obligations to pay the milestone payments and other related representations and obligations. On August
1, 2017, the Company moved to remand the case back to the Delaware Court (the “Motion to Remand”).
On August 2, 2017, Savant sent a foreclosure
notice to the Company, demanding that it provide the Collateral as defined in the Security Agreement for inspection and possession
on August 9, 2017, with a public sale to be held on September 1, 2017. The Company moved for a Temporary Restraining Order (the
“TRO”) and Preliminary Injunction in the Bankruptcy Court on August 4, 2017. Savant responded on August 7, 2017. On
August 7, 2017, the Bankruptcy Court granted the Company’s motion for a TRO, entering an order prohibiting Savant from collecting
on or selling the Collateral, entering our premises, issuing any default notices to us, or attempting to exercise any other remedies
under the MDC Agreement or the Security Agreement. On August 9, 2017, the parties have stipulated to continue the provisions of
the TRO in full force and effect until further order of the appropriate court, which the Bankruptcy Court signed that same day
(the “Stipulated Order”).
On January 22, 2018, Savant wrote to the
Bankruptcy Court requesting dissolution of the TRO and the Stipulated Order. On January 29, 2018, the Bankruptcy Court granted
the Motion to Remand and denied Savant’s request to dissolve the TRO and Stipulated Order, ordering that any request to dissolve
the TRO and Stipulated Order be made to the Delaware Court.
On February 13, 2018 Savant made a letter
request to the Delaware Court to dissolve the TRO and Stipulated Order. Also on February 13, 2018, the Company filed its Answer
and Affirmative defenses to Savant’s Counterclaims. On February 15, 2018 the Company filed a letter opposition to Savant’s
request to dissolve the TRO and Stipulated Order and requesting a status conference. A hearing on Savant’s request to dissolve
the TRO and Stipulated Order was held before the Delaware Court on March 19, 2018. The Delaware Court denied Savant’s request
to dissolve the TRO and Stipulated order, which remain in effect.
On April 11, 2018, the Company advised the
Delaware Court that it would meet and confer with Savant regarding a proposed case management order and date for trial. On April
26, 2018 the Delaware Court so-ordered a proposed case management order submitted by the Company and Savant. The schedule in the
case management order was modified by stipulation on August 24, 2018.
On April 8, 2019, the Company moved to compel
Savant to produce documents in response to the Company’s document requests. The parties thereafter agreed to a discovery
schedule through June 30, 2019, which the Superior Court so-ordered, and the parties produced documents to each other.
On June 4, 2019, Savant filed a complaint
against the Company and Madison in the Delaware Court of Chancery (the “Chancery Action”) seeking to “recover
as damages that amounts owed to it under the MDC Agreement, and to reclaim Savant’s intellectual property,” among other
things. Savant also requested leave to move to dismiss the Company’s complaint on the grounds that the Company’s
transfer of assets to Madison was champertous. On June 10, 2019, the Company requested by letter that the Superior Court
hold a contempt hearing because the Chancery Action violated the TRO entered by the Bankruptcy Court, the terms of which have been
extended by stipulation of the parties. On June 18, 2019, the Superior Court held a telephonic status conference. The
parties agreed that the Chancery Action should be consolidated with the Superior Court action, after which the Superior Court would
address the parties’ motions.
On July 22, 2019, the Company moved for
contempt against Savant. Savant filed its opposition on July 29, 2019. On August 12, 2019, the Superior Court denied
the Company’s motion for contempt.
On July 23, 2019, Savant moved for summary
judgment on the issue of champerty. The Company filed its response and cross-motion for summary judgment on August 27, 2019.
Savant filed its reply on September 10, 2019 and the Company filed its cross-reply on September 20, 2019. The motion is fully
briefed, and was argued at a hearing on February 3, 2020. The court has not yet ruled on the motion.
On July 26, 2019, the Company moved to modify
the previously agreed-upon discovery schedule to extend discovery through December 31, 2019, which the Superior Court granted.
In subsequent orders, the discovery schedule was further extended until the end of June 2020.
On July 30, 2019, the Company filed a motion
to dismiss Savant’s Chancery Action. Savant filed an amended complaint on September 4, 2019, and the Company filed
its opening brief in support of its motion to dismiss on October 11, 2019. That motion is fully briefed and was argued at
a hearing on February 3, 2020. The court has not yet ruled on the motion.
On August 19, 2019, Savant moved to dismiss
the Company’s amended Superior Court complaint. On September 27, 2019, the Company filed an opposition to Savant’s
motion and, in the alternative, requested leave to file a second amended complaint against Savant. Savant consented to the
filing of the second amended complaint and withdrew their motion to dismiss. Savant filed a partial motion to dismiss against
a co-defendant on October 30, 2019. That motion is fully briefed and was argued at a hearing on February 3, 2020. At the
February 3, 2020 hearing, the Court reserved judgment on the parties’ reciprocal motions.
On November 18, 2019, the Court granted Savant’s Motion
to Schedule a Preliminary Injunction hearing concerning the August 2017 TRO and Stipulated Order that are still in effect.
At a hearing on April 28, 2020, the Court granted the application for a preliminary injunction to the Company, and the parties
are preparing a proposed order to effectuate the Court’s rulings at the hearing. The Stipulated Order will no longer
be in effect upon the entry of the preliminary injunction order.
A trial is scheduled for October 2020.
11. Subsequent Events
Conversion
of Outstanding 2018 and 2019 Convertible Notes
As
described in the Company’s 2019 Annual Report on Form 10-K, holders of the Company’s outstanding convertible notes
issued in 2018 and 2019 are entitled to convert the principal and unpaid interest on such notes into shares of the Company’s
common stock under various scenarios, including if the Company were to sell its equity securities on or before the date of repayment
of the 2018 and 2019 Notes in any financing transaction that results in gross proceeds to the Company of less than $10 million
(a “Non-Qualified Financing”). A Non-Qualified Financing occurred as a result of sales of our common stock to Lincoln
Park Capital Fund, LLC starting on December 11, 2019 and concluding on January 7, 2020, pursuant to the Purchase Agreement described
in Note 7, Stockholders’ Equity above. Commencing on April 2, 2020, the holders of such notes, including Cheval Holdings,
Ltd. (“Cheval”), an affiliate of Black Horse Capital, L.P., our controlling stockholder, notified us of their exercise
of such conversion rights. Pursuant to the exemption from registration afforded by Section 3(a)(9) under the Securities Act of
1933, we issued an aggregate of 11,989,578 shares of our common stock upon the conversion of $4.3 million in aggregate principal
and interest on the notes converted, which obligations were retired. Of these, we issued 1,583,333 shares to Cheval. Dr. Dale Chappell,
our ex-officio chief scientific officer, controls Black Horse Capital, L.P. and reports beneficial ownership of all shares held
by it and its affiliates, including Cheval.
After
giving effect to the shares issued upon such conversions, as of May 14, 2020, no
convertible notes issued in 2018 or 2019 were outstanding.
April 2020 Bridge Notes
On April 27, 2020, the Company issued two
short-term, secured bridge notes (the “2020 Bridge Notes”) evidencing an aggregate of $350,000 of loans made to the
Company by two parties: Cheval Holdings, Ltd., an affiliate of Black Horse Capital, L.P., the Company’s controlling
stockholder, lent $100,000; and Nomis Bay LTD, the Company’s second largest
stockholder, lent $250,000. The proceeds from the 2020 Bridge Notes were used for
working capital and general corporate purposes.
The 2020 Bridge Notes rank on par with the
2019 Bridge Notes, and possess other terms and conditions substantially consistent with those notes. The 2020 Bridge Notes bear
interest at a rate of 7.0% per annum and have a maturity date of December 31, 2020. The 2020 Bridge Notes may become due and payable
at such earlier time as the Company raises more than $10,000,000 in a bona fide financing transaction or upon a change in control.
The 2020 Bridge Notes also are secured by a lien on substantially all of the Company’s assets.
Upon an event of default,
which events include, but are not limited to, (1) the Company’s failure to timely pay any monetary obligation under the 2020
Bridge Notes; (2) our failure to pay our debts generally as they become due and (3) our commencing any proceeding relating to the
Company under any bankruptcy reorganization, arrangement, insolvency, readjustment of debt, dissolution or liquidation or similar
laws of any jurisdiction now or hereafter in effect, the interest payable on the 2020 Bridge Notes increases to 10.0% per annum.
Further, upon certain events of default, all payments and obligations due and owed under the 2020 Bridge Notes shall immediately
become due and payable without demand and without notice to the Company.
Paycheck Protection Plan Loan
On May 5, 2020, the
Company received a Paycheck Protection Plan loan under the 2020 CARES Act in the amount of $83 thousand (the “PPP Loan”).
The PPP Loan bears interest at a rate of 1% per annum and matures on the second anniversary of the date of the applicable loan
documents. The PPP loan may be prepaid at any time and may be forgiven under certain circumstances. Assuming the PPP Loan is not
forgiven, the Company will be required to make monthly amortizing payments beginning November 1, 2020 to fully repay the PPP Loan
and accrued interest through the maturity date. Upon an event of default, which events include, but are not limited to, (1) the
Company’s failure to timely pay any monetary obligation under the PPP Loan; (2) our failure to pay our debts generally as
they become due and (3) our commencing any proceeding relating to the Company under any bankruptcy reorganization, arrangement,
insolvency, readjustment of debt, dissolution or liquidation or similar laws of any jurisdiction now or hereafter in effect, the
PPP Loan shall immediately become due and payable without demand and without notice to the Company. The Company intends to
use the proceeds of the PPP Loan for payroll costs.