Item 1. Financial Statements
Item 1.
Financial Statements
ETERNA THERAPEUTICS INC.
CONDENSED CONSOLIDATED
BALANCE SHEETS
(In thousands, except par value amount)
(unaudited)
March 31,
December 31,
2023
2022
ASSETS
Current assets:
Cash
$
5,397
$
11,446
Other receivables
647
951
Prepaid expenses and other current assets
471
1,284
Total current assets
6,515
13,681
Restricted cash
4,095
4,095
Property and equipment, net
215
236
Right-of-use assets - operating leases
989
1,030
Goodwill
2,044
2,044
Investment in non-controlling interest
8
59
Other assets
1,242
1,134
Total assets
$
15,108
$
22,279
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
1,461
$
1,620
Accrued expenses
2,012
3,626
Income taxes payable
7
-
Operating lease liabilities, current
168
295
Due to related party, current
1,750
1,750
Other current liabilities
8
363
Total current liabilities
5,406
7,654
Warrant liabilities
376
331
Operating lease liabilities, non-current
841
887
Due to related party, non-current
768
1,206
Deferred revenue
250
-
Other liabilities
87
94
Total liabilities
7,728
10,172
Stockholders’ equity:
Preferred stock, $ 0.005 par value, 1,000 shares authorized, 156
designated and outstanding of Series A convertible preferred stock at March 31 , 2023 and December 31 , 2022 , $ 156 liquidation
preference
1
1
Common stock, $ 0.005 par value, 100,000 shares authorized at March 31, 2023 and December 31, 2022; 5,127 issued and outstanding at both March 31 , 2023 and December 31 , 2022
26
26
Additional paid-in capital
178,066
177,377
Accumulated deficit
( 170,713
)
( 165,297
)
Total stockholders’ equity
7,380
12,107
Total liabilities and stockholders’ equity
$
15,108
$
22,279
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ETERNA THERAPEUTICS INC.
CONDENSED CONSOLIDATED
STATEMENTS OF
OPERATIONS
(In thousands, except per share amounts)
(unaudited)
Three months
ended March 31,
2023
2022
Operating expenses:
License costs
$
50
$
-
Research and development
1,674
1,782
General and administrative
3,592
4,514
Total operating expenses
5,316
6,296
Loss from operations
( 5,316
)
( 6,296
)
Other expense, net:
Change in fair value of warrant liabilities
( 45
)
( 1,322
)
Loss on non-controlling investment
( 51
)
( 615
)
Other income (expense), net
1
( 1,142
)
Total other expense, net
( 95
)
( 3,079
)
Loss before income taxes
( 5,411
)
( 9,375
)
Provision for income taxes
( 5
)
-
Net loss
$
( 5,416
)
$
( 9,375
)
Net loss per common share - basic and diluted
$
( 1.06
)
$
( 3.50
)
Weighted average shares outstanding - basic and diluted
5,127
2,681
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ETERNA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
STOCKHOLDERS’ EQUITY
For the three months ended March 31, 2023 and 2022 (unaudited)
(in thousands)
Series A Preferred
Additional Paid-
Stock
Common Stock
in
Accumulated
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Balances at January 1, 2023
156
$
1
5,127
$
26
$
177,377
$
( 165,297
)
$
12,107
Stock-based compensation
-
-
-
-
689
-
689
Net loss
-
-
-
-
( 5,416
)
( 5,416
)
Balances at March 31, 2023
156
$
1
5,127
$
26
$
178,066
$
( 170,713
)
$
7,380
Balances at January 1, 2022
156
$
1
2,601
$
13
$
166,191
$
( 140,702
)
$
25,503
Issuance of common stock and pre-funded warrants in connection with private offering, net.
-
-
275
1
( 1
)
-
-
Forfeiture of unvested restricted stock
-
-
( 4
)
-
-
-
-
Issuance of common stock from vested restricted stock units
-
-
-
-
-
-
-
Stock-based compensation
-
-
-
-
1,183
-
1,183
Net loss
-
-
-
-
-
( 9,375
)
( 9,375
)
Balances at March 31, 2022
156
$
1
2,872
$
14
$
167,373
$
( 150,077
)
$
17,311
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ETERNA THERAPEUTICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF
CASH FLOWS
(in thousands)
(unaudited)
For the three
months ended
March 31,
2023
2022
Cash flows used in operating activities:
Net loss
$
( 5,416
)
$
( 9,375
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
21
36
Stock-based compensation
689
1,183
Amortization of right-of-use asset
41
102
Loss on disposal of fixed assets
-
371
Gain on lease termination
-
( 85
)
Loss on change in warrant liabilities
45
1,322
Loss on non-controlling investment
51
615
Changes in operating assets and liabilities:
Other receivables
304
( 146
)
Prepaid expenses and other current assets
813
298
Other non-current assets
( 108
)
66
Accounts payable and accrued expenses
( 1,766
)
486
Operating lease liability
( 173
)
( 103
)
Due to related party
( 438
)
-
Deferred revenue
250
-
Other liabilities
( 362
)
( 202
)
Net cash used in operating activities
( 6,049
)
( 5,432
)
Cash flows used in investing activities:
Purchase of property and equipment
-
( 46
)
Net cash used in investing activities
-
( 46
)
Cash flows provided by financing activities:
Proceeds from issuance of common stock and warrants in connection with private offering
-
11,993
Net cash provided by financing activities
-
11,993
Net (decrease) increase in cash and cash equivalents
( 6,049
)
6,515
Cash, cash equivalents and restricted cash at beginning of period
15,541
16,985
Cash, cash equivalents and restricted cash at end of period
$
9,492
$
23,500
Supplemental disclosures of cash flow information:
Cash paid during the period for:
Interest
$
1
$
1
Income taxes
$
-
$
-
Reconciliation of cash, cash equivalents and restricted cash at end of period:
Cash and cash equivalents
$
5,397
$
23,500
Restricted cash
4,095
-
Total Cash, cash equivalents and restriced cash at end of period
$
9,492
$
23,500
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ETERNA THERAPEUTICS INC.
NOTES TO CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
(Unaudited)
1)
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
Description of Business
Eterna Therapeutics Inc. (“Eterna”), together with its subsidiaries including Eterna Therapeutics LLC (“Eterna LLC”), Novellus, Inc. (“Novellus”) and Novellus Therapeutics Limited (“Novellus
Limited”), is a life science company committed to realizing the potential of mRNA cell engineering to provide patients with transformational new medicines. Eterna has in-licensed a portfolio of over 100 patents covering key mRNA cell engineering technologies, including technologies for mRNA cell reprogramming, mRNA gene editing, the NoveSliceTM and UltraSliceTM
gene-editing proteins, and the ToRNAdoTM mRNA delivery system. Eterna plans to develop and advance a pipeline of therapeutic products both internally and through strategic partnerships, with the near-term focus on strategic partnerships.
Eterna licenses its mRNA technology platform from Factor Bioscience Limited (“Factor Limited”) under an exclusive license agreement. As used herein, the “Company” refers collectively to Eterna and its subsidiaries.
Basis of Presentation
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial statements and with the
instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited financial
statements include all the normal recurring adjustments that are necessary for a fair presentation of the financial position, results of operations and cash flows for the periods presented.
These condensed consolidated financial statements should be read together with the audited consolidated financial statements and notes thereto contained in Eterna’s Annual Report on Form 10-K for the year ended December 31, 2022 filed
with the Securities and Exchange Commission (the “SEC”) on March 20, 2023 (the “2022 10-K”). The accompanying condensed consolidated balance sheet as of December 31, 2022 has been derived from the audited financial statements contained in the
2022 10-K but does not include all of the information and footnotes required by GAAP for complete financial statements. The results of operations for the three months ended March 31, 2023 are not necessarily indicative of the results to be
anticipated for the entire year ending December 31, 2023, or any other period.
2)
LIQUIDITY AND CAPITAL RESOURCES
The Company has incurred significant operating losses and has an accumulated deficit as a result of its efforts to develop product candidates, including conducting clinical trials and providing general and
administrative support for operations. As of March 31, 2023, the Company had an unrestricted cash balance of approximately $ 5.4
million and an accumulated deficit of approximately $ 170.7 million. For the three months ended March 31, 2023, the Company incurred
a net loss of $ 5.4 million, and the Company used cash in operating activities of $ 6.0 million.
In October 2022, the Company entered
into a facility sublease agreement (the “Sublease”) for approximately 45,500 square feet of office and laboratory space in
Somerville, Massachusetts. Pursuant to the Sublease, the Company delivered to the sublessor a security deposit in the form of a letter of credit in the amount of $ 4.1 million, which will be reduced on an incremental basis throughout the term of the lease. The letter of credit was issued by the Company’s commercial bank, which required that
the Company cash collateralize the letter of credit by depositing $ 4.1 million in a restricted cash account with such bank. The
amount of required restricted cash collateral will decline in parallel with the reduction in the amount of the letter of credit over the term of the Subleas e.
On April 5, 2023, the Company entered into a purchase agreement and a registration rights agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed
to purchase up to $ 10.0 million of the Company’s common stock in an “equity line” financing arrangement. See Note 14.
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In connection with preparing the accompanying condensed consolidated financial statements as of and for the three months ended March 31, 2023, the Company’s management concluded that there is
substantial doubt regarding the Company’s ability to continue as a going concern because it does not expect to have sufficient cash or working capital resources to fund operations for the twelve-month period subsequent to the issuance date
of these financial statements. The Company will need to raise additional capital, which could be through public or private equity offerings, debt financings, strategic partnerships or other means. Other than the two-year purchase agreement with the investment group discussed above, the Company currently has no arrangements for such capital, and no
assurances can be given that it will be able to raise such capital when needed, on acceptable terms, or at all.
The accompanying condensed consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the
normal course of business. The accompanying condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and
classifications of liabilities that may result from uncertainty related to the Company’s ability to continue as a going concern.
3)
CONTRACT WITH CUSTOMER
On February 21, 2023, the Company and Lineage Cell Therapeutics, Inc. (“Lineage”)
entered into an exclusive option and license agreement (the “Lineage Agreement”), pursuant to which, prior to August 22, 2023, Lineage may request that the Company develop for, and deliver to, Lineage certain
induced pluripotent stem cell lines, which Lineage would use to evaluate the possible development of cell transplant therapies for treatment of diseases of the central nervous system in humans, excluding certain indications. The Lineage
Agreement also provides Lineage with the option (the “Option Right”) to obtain an exclusive sublicense to certain related technology for preclinical, clinical and commercial purposes, which would permit Lineage to sublicense such intellectual
property, subject to payment of certain sublicense royalty fees. Lineage has six months from our delivery to Lineage of such induced pluripotent stem cell lines to exercise such option. Upon entry into the Lineage Agreement, Lineage paid the
Company a $ 250 ,000 non-refundable up-front payment (the “Option Fee”) for the Option Right. The Company is also entitled to
certain cell line customization fees with respect to cell lines that Lineage may request that it develop for Lineage, and royalty payments with respect to any such licensed products, certain sublicense fees and certain milestone payments under the
Lineage Agreement.
The Company recognizes revenue under ASC 606, Revenue
from Contracts with Customers (“ASC 606”), when a customer obtains control of promised goods or services in an amount that reflect the consideration that the Company expects to receive in exchange for those goods or services. The Company
performs the following five steps in order to recognize revenue:
1.
Identify the contract with a customer;
2.
Identify the performance obligations in the contracts;
3.
Determine the transaction price;
4.
Allocate the transaction price to the performance obligations; and
5.
Recognize revenue when (or as) the performance obligations are satisfied.
The Company has determined that as of contract inception, the Option Right contains a
material right because by entering into the agreement, the Option Right allows the customer to obtain a license that no other customer can receive. As a result, the Option Right is a separate performance obligation under the agreement. The cell
line customization activities that the Company may perform and the granting of the license that the Company may provide to the customer are not considered performance obligations as of contract inception, as these are goods and services that the
customer may request in the future and will be accounted for as separate contracts when the customer exercises the Option Right or provides its request to the Company to perform the cell line customization activities. As a result, the Option Right
performance obligation is the only performance obligation as of contract inceptions, and 100 % of the Option Fee is allocated to the
Option Right. Revenue from the Option Right will be recognized when the customer enters into the sublicense or when the Option Right expires. As of March 31, 2023, the Company has recorded $ 250 ,000 as deferred revenue related to the upfront, nonrefundable Option Fee.
As provided for in the Exclusive Factor License Agreement discussed in Note 9, the
Company is obligated to pay Factor Limited 20 % of the Option Fee when the Company received payment from the customer in February 2023.
Accordingly, the Company recognized a license cost of $ 50 ,000 during the three months ended March 31, 2023.
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4)
FAIR VALUE OF FINANCIAL INSTRUMENTS
Fair value is defined as the price that would be received to sell an asset, or paid to transfer a liability, in an orderly transaction between
willing market participants. A fair value hierarchy has been established for valuation inputs that gives the highest priority to quoted prices in active markets for identical assets or liabilities and the lowest priority to unobservable
inputs. The fair value hierarchy is as follows:
•
Level 1 Inputs – Valued based on quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement
date.
•
Level 2 Inputs – Valued based on inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. These might
include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or
liability (such as interest rates, volatilities, prepayment speeds, credit risks, etc.) or inputs that are derived principally from or corroborated by market data by correlation or other means.
•
Level 3 Inputs – Valued based on inputs for which there is little or no market value, which require the reporting entity to develop its own assumptions.
The carrying amounts reported on the balance sheet for cash and cash equivalents, accounts receivable, prepaid assets and other current assets,
restricted cash, accounts payable and accrued expenses, other current liabilities and other liabilities approximate fair value based due to their short maturities.
The following tables summarize the liabilities that are measured at fair value as of March 31, 2023 and December 31,2022 (in thousands):
Description
Level
March 31,
2023
December 31,
2022
Liabilities:
Warrant liabilities - Common Warrants
3
$
376
$
331
The Company uses a Black-Scholes option pricing model to
estimate the fair value of the Common Warrants, which is considered a Level 3 fair value measurement. Certain inputs used in this Black-Scholes pricing model may fluctuate in future periods based upon factors that are outside of the
Company’s control. A significant change in one or more of these inputs used in the calculation of the fair value may cause a significant change to the fair value of the Company’s warrant liabilities, which could also result in material
non-cash gains or losses being reported in the Company’s consolidated statement of operations.
The Company remeasured the fair value of
the Common Warrants
as of March 31, 2023. The
following table presents the changes in the warrant liabilities from January 1, 2023 (in thousands):
Fair value at January 1, 2023
$
331
Change in fair value of warrant liabilities
45
Fair value at March 31, 2023
$
376
5)
LEASES
The Company has
operating leases for office and laboratory space in the borough of Manhattan in New York, New York, in Cambridge, Massachusetts and in Somerville, Massachusetts, which expire in 2026, 2028, and 2032, respectively.
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In March 2022, the Company entered into a facility lease in San Diego, California (the “San Diego Lease”) with Torrey Pines Science Center Limited Partnership for approximately 5,200 square feet of laboratory and office space. The term of the San Diego Lease was 62 months and the lease
commencement date was April 19, 2022 . The
Company recorded a $ 1.7 million right of use (“ROU’) asset and a $ 1.7 million lease liability for the San Diego Lease .
During 2022, the Company decided to consolidate its
research and development efforts in Cambridge, Massachusetts, and the Company determined to sublease the San Diego laboratory and office space. On January 31, 2023, the Company terminated its lease in San Diego, California pursuant to a
lease termination agreement entered into with the lessor in November 2022 and amended in December 2022. The Company paid a $ 0.1
million lease termination fee in January 2023. The lease termination was accounted for as a modification because the Company did not contemporaneously terminate the lease when it entered into the lease termination agreement on November 30,
2022 (the “Modification Date”) and had a continued right-of-use of the facility through January 31, 2023. As a result, on the Modification Date, the Company remeasured the remaining lease payments, including the $ 0.1 million termination fee, and reduced the lease liability the Company had on its balance sheet on the Modification Date by approximately $ 1.4 million to the present value of the remeasured lease liability of approximately $ 0.2 million and reduced the ROU asset by approximately $ 0.8 million to zero . As of March 31, 2023, the Company had no
remaining lease liabilities associated with this lease.
In October 2022, the Company entered into the Sublease
with E.R. Squibb & Sons, L.L.C., a subsidiary of Bristol-Myers Squibb Company (“Sublessor”), for office, laboratory and research and development space (the “Premises”). The Premises consist of approximately 45,500 square feet on the ninth floor of a building currently under construction located in Somerville, Massachusetts.
Payments of the Sublease rent commence on the date that is
the earlier of (i) the date that the Company commences business operations from the Premises and (ii) the one-year anniversary of the date that Sublessor obtained the primary landlord’s consent for the Sublease, which was November 29, 2022
(such applicable date, the “Rent Commencement Date”). The Sublease has a term of 10 years from the Rent Commencement Date (the
“Term”), subject to a five-year extension in accordance with the terms of the Sublease.
Pursuant to the Sublease, the Company paid the Sublessor a
security deposit in the form of a letter of credit in the amount of approximately $ 4.1 million. Provided there are no events of
default by the Company under the Sublease, the letter of credit will be reduced on an incremental basis throughout the Term. Pursuant to the Sublease, the Company has agreed to pay base rent of approximately $ 0.5 million per month during the first year of the Term, increasing on an incremental basis each subsequent year of the Term for a total of
approximately $ 63.0 million in base rental payments, as well as parking and traditional lease expenses, including certain taxes,
operating expenses and utilities.
The Sublessor has agreed to provide the Company with a
tenant improvement allowance of $ 190 per rentable square foot, or $ 8.6 million. Tenant improvements to the Premises in excess of this amount, if any, will be at the Company’s own cost. As of March 31, 2023, the Premises had not been made available
for the Company to begin the construction of the tenant improvements. It is expected that the Premises will be made available to begin the construction during the second quarter of 2023, and it is anticipated that the construction will be
substantially complete during the fourth quarter of 2023. As a result, the commencement date of the Sublease did not occur as of March 31, 2023, and accordingly, the Company did not recognize a lease liability and corresponding ROU asset for
the Sublease as of March 31, 2023.
As of March 31, 2023, the Company had incurred
approximately $ 0.7 million in costs in connection with the Sublease, which consisted of approximately $ 0.6 million for the architect to design the tenant improvements to the Premises and for a project manager to manage the construction of the tenant
improvements as well as approximately $ 0.1 million in bank fees related to the issuance of the letter of credit discussed above.
These costs are recorded in other assets in the accompanying condensed consolidated balance sheet as of March 31, 2023.
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For the three months ended March 31, 2023 and 2022, the net operating lease expenses were as follows (in thousands):
Three months ended
2023
2022
Operating lease expense
$
68
$
186
Sublease income
( 21
)
( 21
)
Variable lease expense
5
3
Total lease expense
$
52
$
168
The tables below show the beginning balances of the operating ROU assets and lease liabilities as of January 1, 2023 and the ending balances
as of March 31, 2023, including the changes during the period (in thousands).
Operating Lease ROU Assets
Operating lease ROU assets at January 1, 2023
$
1,030
Amortization of operating lease ROU assets
( 41
)
Operating lease ROU assets at March 31, 2023
$
989
Operating Lease Liabilities
Operating lease liabilities at January 1, 2023
$
1,182
Principal payments on operating lease liabilties
( 173
)
Operating lease liabilities at March 31, 2023
1,009
Less non-current portion
841
Current portion at March 31, 2023
$
168
As of March 31, 2023, the Company’s operating leases had a weighted-average remaining life of 4.8 years with a weighted-average discount rate of 10.23 %.
The maturities of the
operating lease liabilities are as follows (in thousands):
As of
March 31,
2023
2023
$
203
2024
272
2025
274
2026
267
2027
163
Thereafter
82
Total payments
1,261
Less imputed interest
( 252
)
Total operating lease liabilities
$
1,009
The weighted-average remaining life, the weighted-average discount rate and the maturities of the operating lease liabilities shown above do not include the Sublease, as the commencement date of the Sublease had not
begun as of March 31, 2023, and therefore, the Company did not record a corresponding lease liability and ROU asset.
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6)
GOODWILL
In 2018, the Company acquired IRX Therapeutics (“IRX”), which was accounted for as a business combination. The Company recorded goodwill in the
amount of $ 2.0 million related to the IRX acquisition . Goodwill is not amortized but is
tested for impairment annually, or more frequently if the Company becomes aware of any events occurring or changes in circumstances that indicate that the fair value of the entity is less than its carrying value. Because management evaluates
the Company as a single reporting unit, goodwill is tested for impairment at the entity level by first performing a qualitative assessment to determine whether it is more likely than not that the fair value of the entity is less than its
carrying value. Such qualitative factors include macroeconomic conditions, industry and market considerations, cost factors, overall financial performance and other relevant events. If the entity does not pass the qualitative assessment,
then the entity’s carrying value is compared to its fair value. Goodwill is considered impaired if the carrying value of the entity exceeds its fair value .
As of
March 31, 2023, the Company evaluated potential triggering events that could indicate that the fair value of the entity is less than its carrying value and determined there were no such events that occurred.
7)
RELATED PARTY TRANSACTIONS
The agreements described below have been
deemed related party transactions, as the Company’s Chief Executive Officer, Dr. Matthew Angel, is also the Chairman and Chief Executive Officer of Factor Bioscience and a Director of Factor Limited.
As of March 31, 2023, the following
agreements were in place related to Factor Bioscience Inc. (including its affiliates, “Factor Bioscience”) and Dr. Matthew Angel:
In September
2022, the Company entered into a Master Services Agreement (the “MSA”) with Factor Bioscience, pursuant to which Factor Bioscience has agreed to provide services to the Company as agreed between the Company and Factor Bioscience and as set
forth in one or more work orders under the MSA, including the first work order included in the MSA (“WO1”). Under WO1, Factor Bioscience has agreed to provide the Company with mRNA cell engineering research support services, including access to
certain facilities, equipment, materials and training, and the Company has agreed to pay Factor Bioscience an initial fee of $ 5.0
million, payable in twelve equal monthly installments of approximately $ 0.4 million. Of the $ 5.0 million, the Company allocated $ 3.5 million to the License Fee Obligation (as defined below). Following the initial 12-month period, the Company has agreed to pay Factor Bioscience
a monthly fee of $ 0.4 million until such time as WO1 is terminated. The Company paid a deposit of $ 0.4 million, which will be applied to the last month of the first work order.
The
Company may terminate WO1 under the MSA on or after the second anniversary of the date of the MSA, subject to providing Factor Bioscience with 120
days’ prior notice. Factor Bioscience may terminate such work order only on and after the fourth anniversary of the date of the MSA, su bject to providing the Company with 120 days’ prior notice. The MSA contains customary confidentiality provisions and representations and warranties of the parties, and the MSA may be
terminated by ether party upon 30 days’ prior notice, subject to any superseding termination provisions contained in a particular work
order.
In connection with entering into the MSA, Factor Bioscience’s subsidiary , Factor Limited, entered into a waiver
agreement (the “Waiver Agreement”) with Eterna LLC, pursuant to which Factor Limited agreed to waive payment of $ 3.5 million
otherwise payable to it (the “License Fee Obligation”) in October 2022 by Eterna LLC under the exclusive license agreement entered into in April 2021 by and among Eterna LLC, Novellus Limited and Factor Limited, as amended in November
2022 (the “Original Factor License Agreement”). Under the terms of the Waiver Agreement, the License Fee Obligation is waived conditionally on the Company paying Factor Bioscience amounts due under the MSA .
Because the License Fee Obligation was conditionally waived until such amount
has been paid under the MSA, the Company recorded a liability of $ 3.5 million. As of March 31 2023, there was approximately $ 2.5 million of the License Fee Obligation remaining, which is recorded on the accompanying condensed consolidated balance sheet in the “due to
related party” line items.
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On February 20, 2023, the Company and
Factor Limited entered into an exclusive license agreement (the “Exclusive Factor License Agreement”) , which terminated and superseded the Original Factor License Agreement. Subject to certain exclusive licenses or other rights granted by
Factor Limited to other third parties as of the effective date of the Exclusive Factor License Agreement, Factor granted the Company the exclusive, sublicensable license under certain patents owned by Factor Limited (the “Factor Patents”).
The term of the Exclusive Factor License Agreement expires on November 22, 2027, but will be automatically extended for an additional two and a half years (such period, the “Renewal Term”) if the Company receives at least $ 100 million in fees from sublicenses
to the Factor Patents (“Sublicense Fees”) granted by the Company pursuant to the Exclusive Factor License Agreement. The Company will pay to Factor Limited 20 % of any Sublicense Fee received by the Company before the initial expiration date of such license and 30 %
of any Sublicense Fees received by the Company during the Renewal Term. The Company may terminate the Exclusive Factor License Agreement upon 120
days’ written notice to Factor Limited, and both parties otherwise have additional customary termination rights. Under the Exclusive Factor License Agreement, the Company is obligated to pay the expenses incurred by Factor Limited in
preparing, filing, prosecuting and maintaining the Factor Patents and has agreed to bear all costs and expenses associated with enforcing and defending the Factor Patents in any action or proceeding arising from pursuit of sublicensing
opportunities under the license granted under the Exclusive Factor License Agreement.
In
September 2022, Novellus and Eterna entered into a Second Amendment to the Limited Waiver and Assignment Agreement (the “Waiver and Assignment Agreement”) with Drs. Matthew Angel and Christopher Rohde (the “Founders”) whereby the Company has
agreed to be responsible for all future, reasonable and substantiated legal fees, costs, settlements and judgments incurred by the Founders, the Company or Novellus for certain claims and actions and any pending or future litigation brought
against the Founders, Novellus and/or the Company by or on behalf of the Westman and Sowyrda legal matters described in Note 9 (the “Covered Claims”). The Founders will continue to be solely responsible for any payments made to satisfy a
judgement or settlement of any pending or future wage act claims. Under the Waiver and Assignment Agreement, the Founders agreed that they are not entitled to, and waived any right to, indemnification or advancement of past, present or future
legal fees, costs, judgments, settlement or other liabilities they may have been entitled to receive from the Company or Novellus in respect of the Covered Claims. The Company and the Founders will share in any recoveries up to the point at
which the parties have been fully compensated for legal fees, costs and expenses incurred, with the Company retaining any excess recoveries. The Company has the sole authority to direct and control the prosecution, defense and settlement of the
Covered Claims.
8)
ACCRUED EXPENSES
Accrued expenses consisted of the following (in thousands):
March 31,
2023
December 31,
2022
Legal fees and settlements
$
595
$
1,138
Clinical
510
570
Professional fees
389
333
Accrued compensation
205
1,065
Other
313
520
Total accrued expenses
$
2,012
$
3,626
9)
COMMITMENTS AND CONTINGENCIES
Litigation Matters
The Company is involved in litigation and arbitrations from time to time in the ordinary course of business. Legal fees and other costs
associated with such actions are expensed as incurred. In addition, the Company assesses the need to record a liability for litigation and contingencies. The Company reserves for costs relating to these matters when a loss is probable, and the
amount can be reasonably estimated.
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Novellus, Inc . v. Sowyrda et al ., C.A. No.
2184CV02436-BLS2
On October 25, 2021 Novellus, Inc. filed a complaint in the Superior Court of Massachusetts, Suffolk County, against former Novellus, Inc.
employees Paul Sowyrda and John Westman and certain other former investors in Novellus LLC (Novellus, Inc.’s former parent company prior to our acquisition of Novellus, Inc.), alleging breach of fiduciary duty, breach of
contract and civil conspiracy. Eterna acquired Novellus, Inc. on July 16, 2021. On May 27, 2022 Novellus, Inc. amended the complaint to withdraw all claims against all defendants except Paul Sowyrda and John Westman. On
July 1, 2022, Westman filed a motion to compel arbitration or in the alternative, to stay the litigation pending the disposition of certain litigation in the Court of Chancery for the State of Delaware filed by Mr. Sowyrda
against Novellus LLC, Dr. Christopher Rohde, Dr. Matthew Angel, Leonard Mazur and Factor Bioscience, Inc. captioned Zelickson et al., v. Angel et al., C.A. 2021-1014-JRS and by Westman against Novellus LLC captioned Westman
v. Novellus LLC, C.A. No. 2021-0882-NAC (the “Delaware Actions”). On July 1, 2022, Sowyrda answered the complaint and asserted counterclaims against Novellus, Inc, and third-party defendants Dr. Matthew Angel and Dr.
Christopher Rohde alleging violations of the Massachusetts Wage Act, Massachusetts Minimum Fair Wage Law, the Fair Labor Standards Act, breach of contract, unjust enrichment and quantum meruit. Sowyrda also joined in
Westman’s motion to stay the case pending the Delaware Actions. Novellus, Inc.’s claims and Mr. Sowyrda’s counterclaims relate to alleged conduct that took place before Eterna acquired Novellus, Inc.
On November 15, 2022, prior to a decision on Westman’s and Sowyrda’s motion to compel or stay, the Parties agreed to voluntarily dismiss and
consolidate the Delaware Actions with this action. On December 15, 2022, Sowyrda filed an Amended Answer to the Amended Complaint, asserted affirmative defenses and filed Amended Counterclaims against Dr. Angel, Dr. Rohde,
Novellus LLC, Novellus Inc., Factor Bioscience Inc., and Eterna Therapeutics Inc. (“Counterclaim Defendants”) alleging against various Counterclaim Defendants breach of contract, breaches of the implied duty of good faith
and fair dealing, breaches of fiduciary duty, breaches of the operating agreement, aiding and abetting breaches of fiduciary duty, tortious interference with contract, equitable accounting, violations of the Massachusetts
Wage Act, Massachusetts Minimum Fair Wage Law, the Fair Labor Standards Act, unjust enrichment, and quantum meruit. Also on December 15, 2022, Westman filed an answer to the Amended Complaint and asserted similar
counterclaims against the same Counterclaim Defendants. Westman and Sowyrda each asserted claims for indemnification and/or advancement against Novellus, Inc. On January 11, 2023, Westman and Sowyrda served a joint motion
to enforce their advancement and/or indemnification rights against Novellus Inc. Novellus Inc. vigorously opposes this motion and served its opposition on January 27, 2023. On February 8, 2023, Westman and Sowyrda served a
reply in support of their motion to enforce indemnification/advancement rights, and submitted the motion to the Court. Novellus Inc. answered Westman and Sowyrda’s counterclaims on January 27, 2023, denying liability. The
remaining Counterclaim Defendants served a motion to dismiss most of the remaining counterclaims on January 27, 2023. The motion to dismiss is now fully briefed, and the Court has scheduled oral argument for May 23, 2023 on
(a) the Counterclaim Defendants’ motion to dismiss, and (b) Sowyrda’s and Westman’s motion to enforce.
Under applicable Delaware law and Novellus Inc.’s organizational documents, the Company may be required to advance or
reimburse certain legal expenses incurred by former officers and directors of Novellus, Inc. in connection with the foregoing Westman and Sowyrda matters. However, a future advance or reimbursement is not currently probable
nor can it be reasonably estimated.
Licensing Agreements
Exclusive Factor License Agreement.
On February 20, 2023, the Company and Factor Limited entered into the
Exclusive Factor License Agreement, which terminated and superseded the Original Factor License Agreement. See Note 7 for details of this agreement.
Retirement Savings Plan
The
Company established a defined contribution plan, organized under Section 401(k) of the Internal Revenue Code, which allows employees to defer up to 90 % of their pay on a pre-tax basis. Beginning on January 1, 2023, the Company began matching employees’ contributions at a rate of 100 % of the first 3 % of the employee’s
contribution and 50 % of the next 2 % of the employee’s contribution, for a maximum Company match of 4 %.
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10)
STOCK-BASED COMPENSATION
Stock Options
During the three months ended March 31, 2023 and 2022, the Company granted the
following stock options (in thousands):
Three months ended March 31,
2023
2022
Stock options granted
212
63
The Company recognizes
stock-based compensation expense for stock options granted to employees, directors and certain consultants. The Company estimates the fair value of stock options using the Black-Scholes option pricing model. The fair value of stock options
granted is recognized as expense over the requisite service period on a straight-lined basis.
The following weighted-average assumptions were used for stock options granted during the three months ended March 31,
2023 and 2022:
Three months ended March 31,
2023
2022
Weighted average risk-free rate
38.60
%
1.92
%
Weighted average volatility
95.04
%
93.00
%
Dividend yield
0
%
0
%
Expected term
5.36 years
5.78 years
The
per-share weighted average grant-date fair value of stock options granted during the three months ended March 31, 2023 and 2022 was $ 3.15
and $ 31.55 , respectively. Vesting of all stock option grants is subject to continuous service with the Company through such vesting
dates. As of March 31, 2023, there were approximately 560,000 stock options outstanding.
Restricted Stock Units
During
the three months ended March 31, 2022, the Company granted approximately 55,000 performance-based restricted stock units (“RSUs”), all
of which were forfeited during 2022, as the applicable performance goals were not met. The Company did no t grant any RSUs during the
three months ended March 31, 2023.
The
Company recognizes the fair value of RSUs as expense on a straight-line basis over the requisite service period. For performance-based RSUs, the Company begins recognizing the expense once the achievement of the related performance goal is
determined to be probable.
Outstanding
RSUs are settled in an equal number of shares of common stock on the vesting date of the award. An RSU award is settled only to the extent vested. Vesting generally requires the continued employment or service by the award recipient through the
respective vesting date. Because RSUs are settled in an equal number of shares of common stock without any offsetting payment by the recipient, the measurement of cost is based on the quoted market price of the stock at the measurement date,
which is the grant date.
In
lieu of paying cash to satisfy withholding taxes due upon the settlement of vested RSUs, at the Company’s discretion, an employee may elect to have shares of common stock withheld that would otherwise be issued at settlement, the value of which
is equal to the amount of withholding taxes payable. There were no RSUs that vested and were settled during the three months
ended March 31, 2023 and 2022
As of
March 31, 2023, there were approximately 1,000 RSUs outstanding.
Stock-Based Compensation Expense
For the three months ended March 31, 2023 and 2022, the Company
recognized stock-based compensation expense as follows (in thousands):
Three months ended March 31,
2023
2022
Research and development
$
64
$
422
General and administrative
625
761
Total
$
689
$
1,183
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11)
WARRANTS
On March 6, 2022, the Company entered into the March Purchase Agreement with an investor for a private placement of equity (the “March
PIPE”), pursuant to which, the Company issued 275,000 shares of common stock, approximately 68,000 Pre-Funded Warrants and approximately 343,000
Common Warrants for an aggregate gross purchase price of approximately $ 12.0 million. The transaction closed on March 9, 2022.
Each Pre-Funded Warrant had an exercise price of $ 0.10 per share of common stock, was immediately exercisable, could be
exercised at any time, had no expiration date and was subject to customary adjustments. Each Common Warrant has an exercise price of $ 38.20
per share, became exercisable six months following the closing of the transaction, expires five-and-one-half years from the date of issuance and is subject to customary adjustments. The Common Warrants may not be exercised if the
aggregate number of shares of common stock beneficially owned by the holder thereof would exceed 4.99 % immediately after exercise
thereof, subject to increase to 9.99 % at the option of the holder.
The Common Warrants and Pre-Funded Warrants were accounted for as liabilities under ASC 815-40, as these warrants provide for a cashless
settlement provision that does not meet the requirements of the indexation guidance under ASC 815-40. These warrant liabilities are measured at fair value at inception and on a recurring basis, with changes in fair value presented within the
statement of operations. (See Note 4 for more information related to changes in fair value.) Upon exercise of the Common Warrants and Pre-Funded Warrants, the fair value on the exercise date is reclassified from warrant liabilities to
equity.
The fair values of the Common Warrants and the Pre-Funded Warrants at the issuance date totaled $ 12.6 million in the aggregate, which was $ 0.6 million more
than the Subscription Amount. The excess $ 0.6 million represents
an inducement to the investor to enter into the transaction and was recorded in warrant liabilities expense in the accompanying condensed consolidated statement of operations for the three months ended March 31, 2022.
On July 12, 2022, the investor exercised its 68,000
Pre-Funded Warrants at an exercise price of $ 0.10 per share for an aggregate exercise price of approximately $ 7,000 , in cash. The Company issued 68,000
shares of common stock to the investor on July 14, 2022 upon receipt of the cash proceeds and reclassified approximately $ 0.7
million of the fair value of the exercised warrants as of the exercise date from warrant liabilities to equity. Subsequent to the exercise, no
Pre-Funded Warrants remained outstanding.
The Company incurred fees of approximately $ 1.0 million related to the transaction, which were allocated to the fair value of the Common Warrants and the Pre-Funded Warrants and recorded in other expense, net on the accompanying
condensed consolidated statement of operations for the three months ended March 31, 2021.
As of March 31, 2023, the Company has the following warrants outstanding that were issued in connection with private placement discussed above as well as a private placement with other investors from November
2022:
Private Placement
Warrants
Outstanding
(in thousands)
Exercise
Price
Date
Exerciseable
Expiration
Date
Classification
March 2022 PIPE
343
$
38.20
September 9, 2022
September 9, 2027
Liability
November 2022 PIPE
4,370
$
3.28
June 2, 2023
June 2, 2028
Equity
4,713
As
of March 31, 2023, the weighted average remaining contractual life of the warrants outstanding was 5.12 years and the weighted
average exercise price was $ 5.82 .
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12)
EARNINGS PER SHARE
Basic net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period. Diluted
net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding plus dilutive securities. Shares of common stock issuable upon exercise, conversion or vesting of stock options, RSUs, warrants and
other convertible securities, including our outstanding Series A Convertible Preferred Stock, are considered potential common shares and are included in the calculation of diluted net loss per share using the treasury method when their effect is
dilutive. Diluted net loss per share is the same as basic net loss per share for periods in which the effect of potentially dilutive shares of common stock is antidilutive. The following table presents the amount of warrants, stock options,
convertible preferred stock and RSUs that were excluded from the computation of diluted net loss per common share for the three months ended March 31, 2023 and 2022, as their effect was anti-dilutive (in thousands):
Three months ended March 31,
2023
2022
Warrants
4,713
343
Stock options
560
259
Preferred stock converted into common stock
7
2
RSUs
1
66
Total potential common shares excluded from computation
5,281
670
13)
RECENT ACCOUNTING PRONOUNCEMENTS
There have been no recent Accounting Standards Updates (“ASUs”) issued by the Financial Accounting Standards Board that would apply to the Company since the ASUs disclosed in the 2022 10-K .
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14)
SUBSEQUENT EVENTS
Exacis Asset Purchase
On April 26, 2023, the Company entered into an asset purchase agreement (the “Exacis Purchase Agreement”), together with Exacis Biotherapeutics Inc. (“Exacis”), the stockholders party thereto (the “Exacis Stockholders”) and, with
respect to specified provisions therein, Factor Limited. Pursuant to the Exacis Purchase Agreement, the Company acquired from Exacis substantially all of Exacis’ intellectual property assets (the “Purchased Assets”), including all of
Exacis’ right, title and interest in and to an exclusive license agreement by and between Exacis and Factor Limited (the “Purchased License”). The Company assumed none of Exacis’ liabilities, other than liabilities under the Purchased
License that accrue subsequent to the Closing Date.
In consideration for the Purchased Assets, on the closing date of the transaction, the Company issued to Exacis an aggregate of 69,343
shares of common stock, which shares are subject to a 12-month lockup, pursuant to which Exacis may not sell or otherwise
transfer such shares. The Company additionally agreed to make the following contingent payments: (i) if, at any time during the three-year
period commencing on such closing date and ending on the three-year anniversary of the closing date, the Company’s market
capitalization equals or exceeds $ 100.0 million for at least ten consecutive trading days, then the Company will issue to Exacis a number of shares of common stock equal to (x) $ 2.0 million divided by (y) the quotient of $ 100.00
million divided by the number of the Company’s then issued and outstanding shares of common stock; (ii) if, at any time during the three-year
period commencing on such closing date and ending on the three-year anniversary of the closing date, the Company’s market capitalization equals or exceeds $ 200.0 million for at least ten consecutive trading days, then the Company will issue to Exacis
a number of additional shares of common stock equal to (x) $ 2.0 million divided by (y) the quotient of $ 200.00 million divided by the number of the Company’s then issued and outstanding shares of common stock; and (iii) during the five-year period commencing on the closing date and ending on the five-year anniversary of the closing date (the “Five-Year Period”), the
Company will pay or deliver to Exacis 20 % of all cash or other consideration (collectively, “License Consideration”) actually
received by the Company during the Five-Year Period from (i) third-party licensees or sublicensees of the intellectual property rights acquired by the Company from Exacis pursuant to the Exacis Purchase Agreement, or (ii) subject to certain
exceptions, the sale of such intellectual property rights; provided, that the License Consideration shall not in any event exceed $ 45.0
million.
Standby Securities Purchase Agreement
On April 5, 2023, the Company entered into a purchase agreement and a registration rights agreement Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase up to $ 10.0 million of the Company’s common stock, subject to the terms and conditions contained in the appliable agreements. Such sales of common
stock by the Company, if any, are subject to certain limitations set forth in the purchase agreement, and may occur from time to time, at the Company’s sole discretion, over a period of up to 24-months, commencing April 25, 2025, which was
the date on which each of the conditions to the Lincoln Park’s purchase obligations set forth in the purchase agreement were initially satisfied. In consideration of Lincoln Park’s entry into the purchase agreement, the Company issued to
Lincoln Park 73,659 shares of common stock (the “ELOC Consideration Shares”). Pursuant to such registration rights agreement,
the Company filed a registration statement with the SEC on April 17, 2023 to register for resale shares of common stock issuable pursuant to such purchase agreement and the ELOC Consideration Shares, and the SEC declared such registration
statement effective on April 24, 2023.
In connection with entry into such purchase agreement, the Company terminated its prior purchase agreements with Lincoln Park entered into during 2021.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.