Immunic, Inc. Reports Third Quarter 2019 Financial Results and Highlights Recent Activity
NEW YORK, Nov. 7, 2019 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced financial results for the third quarter ended September 30, 2019 and highlighted recent activity.
"The third quarter was marked by several key clinical milestones. Chief among them was the early completion of enrollment for our phase 2 EMPhASIS trial for IMU-838 in relapsing-remitting multiple sclerosis, nine months ahead of initial expectation," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "This achievement demonstrates our ability to execute on the program and highlights patients' urgent need for a safer oral treatment option for this progressive, debilitating disease. We also reported positive results from the interim dosing analysis of the CALDOSE-1 trial of IMU-838 in moderate-to-severe ulcerative colitis. Specifically, the data indicated a potentially broader active dose range than originally thought, and the trial is continuing with all three dosing arms. Based partially on these interim results, we anticipate beginning the phase 2 CALDOSE-2 trial in Crohn's disease next year. Additionally, during the third quarter, our Australian subsidiary dosed the first healthy volunteer, on schedule, in the phase 1 clinical program of IMU-935, which we believe holds tremendous promise in multiple indications.
"On the operational side, I am pleased to announce that during the first week of November, we opened an office in New York City which is planned to serve as our U.S. corporate headquarters. The office is headed by our Chief Financial Officer, Sanjay S. Patel, who joined the company in July of this year. Additionally, we announced the appointment of highly regarded industry veteran, Tamar Howson, to our Board of Directors in October. Tamar has immediately begun contributing her knowledge and expertise and we are delighted to welcome her to Immunic's growing team," Dr. Vitt added.
Third Quarter 2019 and Subsequent Highlights
-- October 2019: Expanded Board of Directors to six members, with
appointment of industry veteran, Tamar Howson.
-- October 2019: Announced early completion of enrollment for phase 2
EMPhASIS trial of lead compound, IMU-838, in patients with
relapsing-remitting multiple sclerosis (RRMS).
-- September 2019: Announced dosing of first healthy volunteer in phase 1
clinical program of IMU-935, a potentially best-in-class ROR t inverse
agonist which holds promise as a treatment for various inflammatory and
autoimmune diseases.
-- September 2019: Presented selected available and previously unpublished
preclinical data confirming the favorable profile of IMU-838, as
compared to the DHODH inhibitor, teriflunomide, at the Congress of the
European Committee for the Treatment and Research in Multiple Sclerosis
(ECTRIMS) 2019, held in Stockholm, Sweden.
-- September 2019: Reported positive interim dosing analysis results from
phase 2 CALDOSE-1 study of IMU-838 in patients with moderate-to-severe
ulcerative colitis (UC). Results showed that the study's lowest, 10 mg
dose was not likely ineffective, that the highest, 45 mg dose was not
intolerable and that no safety signal was identified for any of the
trial's three doses. The study is continuing with all three dosing arms
and the overall number of anticipated patients in the trial has been
expanded to 240 from 195.
-- August 2019: Announced first patient enrolled in an
investigator-sponsored proof-of-concept clinical trial of IMU-838 for
the treatment of patients with primary sclerosing cholangitis (PSC),
being conducted in collaboration with investigators at Arizona State
University and the Mayo Clinic.
-- August 2019: Awarded research grant from the German Federal Ministry of
Education and Research of up to approximately $730,000 in support of the
InnoMuNiCH project. The grant funds will be used to fund a three-year
research project by the company and three partners to study the effect
of small molecule compounds on cellular metabolism and their impact on
the development of T helper cells and the corresponding regulation of
relevant proteins.
-- July 2019: Appointed Sanjay S. Patel, CFA, as Chief Financial Officer,
succeeding Interim Chief Financial Officer, Tamara A. Seymour, MBA.
Anticipated Clinical Milestones
-- Top-line data from Immunic's phase 2 EMPhASIS trial of IMU-838 in RRMS
is expected to be available in the third quarter of 2020.
-- Phase 2 CALDOSE-1 trial of IMU-838 in patients with moderate-to-severe
UC is ongoing with expanded number of patients; top-line data is
expected during the fourth quarter of 2021.
-- Initiation of the phase 2 CALDOSE-2 trial of IMU-838 for the treatment
of Crohn's disease (CD) is expected to begin in 2020, after (i)
completion of a full review of the interim dosing analysis from
CALDOSE-1 (which will guide the definition of suitable dose strengths
for CALDOSE-2), and (ii) consulting with the appropriate regulatory
authorities.
-- Proof-of-concept trial underway for IMU-838 in PSC at the Mayo Clinic in
Arizona and Minnesota. Positive data may enable Immunic to immediately
begin a pivotal trial, especially given IMU-838's best-in-class DHODH
inhibitor safety profile and IND already established in intestinal bowel
disease.
-- Subsequent to the ongoing phase 1, double-blind, placebo-controlled,
single ascending dose trial of IMU-935 in healthy volunteers, Immunic
plans to initiate a second phase 1, multiple ascending dose,
double-blind, placebo-controlled trial in healthy volunteers. An
extension of the studies, in patients with psoriasis, is anticipated to
begin in the first half of 2020.
-- Phase 1 clinical trials of IMU-856, aimed at restoring the intestinal
barrier function without impairing the immune system, are expected to
begin during the first half of 2020.
Financial and Operating Results
-- Research and Development (R&D) Expenses were $7.1 million for the three
months ended September 30, 2019, as compared to $1.4 million for the
same period ended September 30, 2018. The increase was primarily
attributable to (i) higher external development costs for the company's
IMU-838 program for the phase 2 clinical trials in patients with
relapsing-remitting multiple sclerosis and ulcerative colitis and
preparation costs related to the phase 2 clinical trial for patients
with Crohn's disease, totaling $4.4 million and (ii) preclinical and
drug supply costs related to the IMU-856 program of $0.8 million.For the
nine months ended September 30, 2019, R&D expenses were $16.5 million,
as compared to $5.4 million for the same period ended September 30,
2018. The increase is primarily due to (i) higher external development
costs for the company's IMU-838 program for the phase 2 clinical trials
in patients with relapsing-remitting multiple sclerosis and ulcerative
colitis and preparation costs related to a phase 2 clinical trial in
patients with Crohn's disease totaling $7.4 million, (ii) preclinical
and drug supply costs related to the IMU-856 program of $1.2 million,
(iii) a contingent payment under the asset purchase agreement with 4SC
AG, triggered by the stock-for-stock exchange transaction completed on
April 12, 2019 (Exchange Transaction), settled in stock, valued at $1.5
million and (iv) an increase in drug supply costs to support clinical
development of $0.7 million.
-- General and Administrative (G&A) Expenses were $2.1 million for the
three months ended September 30, 2019, as compared to $0.4 million for
the same period ended September 30, 2018. The increase is primarily
attributable to (i) an increase of personnel expenses of $0.2 million in
the company's German offices, (ii) an increase of legal and consulting
costs of $0.2 million and (iii) $1.1 million related to becoming a
public company, including directors and officers liability insurance and
personnel costs for executives and staff in the U.S. corporate
headquarters.For the nine months ended September 30, 2019, G&A expenses
were $12.4 million, as compared to $1.4 million for the same period
ended September 30, 2018. The increase is primarily due to (i) one-time
costs related to the completion of the Exchange Transaction, including
$6.4 million of stock-based compensation for executives, key employees
and members of the Board and $1.7 million in investment bank and legal
fees and (ii) $1.7 million related to becoming a public company
including directors and officers liability insurance and personnel costs
for executives and staff in the U.S. corporate headquarters.
-- Other Income for the three months ended September 30, 2019 was $1.0
million, as compared to $8,000 for the same period ended September 30,
2018. The increase is primarily due to (i) a $0.6 million reimbursement
of R&D expenses in connection with the option and license agreement with
Daiichi Sankyo Co., Ltd., and (ii) the $0.4 million difference between
the face value and fair value of the promissory note collected in full
in September 2019 in connection with the sale of certain clinical
development-related assets and related intellectual property rights
("ELAD Assets"), offset by a $0.1 million write-off of the equity
interest in Vital Therapies (Beijing) Company Limited (VTL China)
included in the ELAD Assets sale.Other income for the nine months ended
September 30, 2019 was $1.6 million, as compared to $32,000 for the same
period ended September 30, 2018. The increase is primarily due to (i) a
$1.1 million reimbursement of R&D expenses in connection with the option
and license agreement with Daiichi Sankyo Co., Ltd., and (ii) the $0.4
million difference between the face value and fair value of the
promissory note collected in full in September 2019 in connection with
the sale of ELAD Assets, offset by a $0.1 million write-off of the
equity interest in VTL China included in the ELAD Assets sale.
-- Net Loss for the three months ended September 30, 2019 was approximately
$8.2 million, or $0.82 per basic and diluted share, based on 10,022,856
weighted average common shares outstanding, compared to a net loss of
approximately $1.8 million, or $2.12 per basic and diluted share, based
on 846,953 weighted average common shares outstanding for the same
period ended September 30, 2018.Net loss for the nine months ended
September 30, 2019 was approximately $27.2 million, or $3.96 per basic
and diluted share, based on 6,880,057 weighted average common shares
outstanding, compared to a net loss of approximately $6.7 million, or
$7.95 per basic and diluted share, based on 846,953 weighted average
common shares outstanding for the same period ended September 30, 2018.
Substantially all of the company's operating losses have resulted from
expenses incurred in connection with its R&D programs and from general
and administrative costs associated with operations.
-- Cash and Cash Equivalents, as of September 30, 2019, of $30.5 million is
expected to fund the company's operations into the fourth quarter of
2020.
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, including relapsing-remitting multiple sclerosis, ulcerative colitis, Crohn's disease, and psoriasis. The company is developing three small molecule products: IMU-838 is a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH; IMU-935 is an inverse agonist of ROR t; and IMU-856 targets the restoration of the intestinal barrier function. Immunic's lead development program, IMU-838, is in phase 2 clinical development for relapsing-remitting multiple sclerosis and ulcerative colitis, with an additional phase 2 trial planned in Crohn's disease. An investigator-sponsored proof-of-concept clinical trial for IMU-838 in primary sclerosing cholangitis is ongoing at the Mayo Clinic. For further information, please visit: www.immunic-therapeutics.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's three development programs and the targeted diseases; the potential for IMU-838, IMU-935 and IMU-856 to safely and effectively target diseases; the timing of future clinical trials and expected results of such trials; the nature, strategy and focus of the company; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to meet business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made.
Contact Information
Immunic, Inc.
Jessica Breu
Manager IR and Communications
+49 89 250 0794 69
jessica.breu@immunic.de
Or
Rx Communications Group
Melody Carey
+1-917-322-2571
immunic@rxir.com
Financials
Immunic, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
Three Months Nine Months
Ended September 30, Ended September 30,
2019 2018 2019 2018
Operating expenses:
Research and development $
7,102 $
1,410 $
16,486 $
5,350
General and administrative 2,075 395 12,360 1,412
Total operating expenses 9,177 1,805 28,846 6,762
Loss from operations (9,177) (1,805) (28,846) (6,762)
Other income (expense):
Interest income (expense) 58 92 (1)
Other income, net 904 8 1,512 33
Total other income 962 8 1,604 32
Net loss $
(8,215) $
(1,797) $
(27,242) $
(6,730)
Net loss per share, basic and
diluted $
(0.82) $
(2.12) $
(3.96) $
(7.95)
Weighted-average common shares
outstanding, basic and diluted 10,022,856 846,953 6,880,057 846,953
===
Immunic, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
September 30, December 31,
2019 2018
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $
30,460 $
13,072
Other current assets and prepaid
expenses 4,059 259
Total current assets 34,519 13,331
Property and equipment, net 44 40
Goodwill 32,970
Right of use assets, net 71
Total assets $
67,604 $
13,371
Liabilities, Preferred Stock and Stockholders'
Equity (Deficit)
Current liabilities:
Accounts payable $
3,718 $
1,400
Accrued expenses 3,236 416
Other current liabilities 82 104
Total current liabilities 7,036 1,920
Long-term liabilities:
Other long-term liabilities 41
Total long-term liabilities 41
Total liabilities 7,077 1,920
Commitments and contingencies (Note 6)
Series A-2 Convertible
preferred stock, EUR1.00 par
value, 299,456 shares
authorized, issued and
outstanding at December 31,
2018 - 34,313
Series A-1 Convertible
preferred stock, EUR1.00 par
value, 13,541 shares
authorized, issued and
outstanding at December 31,
2018 - 2,879
Stockholders' equity (deficit):
Preferred stock, $0.0001 par
value; 20,000,000 authorized
and no shares issued or
outstanding at September 30,
2019 and December 31, 2018 -
Common stock, $0.0001 par value;
130,000,000 and 846,953 shares
authorized and 10,070,680 and
846,953 shares issued and
outstanding at September 30,
2019 and December 31, 2018,
respectively 1
Additional paid-in capital 114,550 56
Accumulated other comprehensive
loss (1,804) (819)
Accumulated deficit (52,220) (24,978)
Total stockholders' equity
(deficit) 60,527 (25,741)
Total liabilities, preferred
stock and stockholders' equity
(deficit) $
67,604 $
13,371
===
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SOURCE Immunic, Inc.
