– Demonstrated Potent Neutralization Activity of IMM-BCP-01 Against SARS-CoV-2 Delta Variant in Preclinical Pseudovirus Testing –
– IMM-BCP-01: Selected Antibody Cocktail, Progressing Towards IND Filing –
– Awarded an Additional $4.3 million by the U.S. Department of Defense –
– Raised $27 million in Gross Proceeds in a Private Placement –
EXTON, Pa.–(BUSINESS WIRE)–Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, today reported financial results for the second quarter ended June 30, 2021 and provided a corporate update.
“We made strong progress during Q2 in the development of IMM-BCP-01, our antibody cocktail to combat SARS-CoV-2. We finalized the selection of antibodies for the cocktail, secured increased funding for the program from the Department of Defense, and demonstrated IMM-BCP-01’s potent neutralization activity against all SARS-CoV-2 variants of concern, including the Delta variant, in preclinical testing. We believe we are well-positioned for an IND filing for this program in the third quarter,” said Purnanand Sarma, Ph.D., President and CEO of Immunome. “We have continued to strengthen the company through a number of executive and non-executive appointments, in addition to a successful fundraising. We believe these activities set us up for value-creating events in the near-term, including a planned IND filing for our IL-38 immuno-oncology program in the fourth quarter. I look forward to updating you further on our progress in the coming months.”
Second Quarter and Subsequent Highlights
- Demonstrated Potent Neutralization Activity of IMM-BCP-01 Against SARS-CoV-2 Delta Variant. In July 2021, Immunome announced that its three-antibody cocktail (IMM-BCP-01) has demonstrated potent neutralizing activity against the SARS-CoV-2 Delta variant in pre-clinical pseudovirus testing. An Investigational New Drug (IND) filing for IMM-BCP-001 is planned for 3Q 2021.
- Selected Antibodies for IMM-BCP-001 Antibody Cocktail. In April 2021, the company announced antibody selection for its IMM-BCP-01 cocktail and shared data showing that IMM-BCP-01 neutralizes CDC SARS-CoV-2 “Variants of Concern” in preclinical testing. The cocktail was efficacious in Syrian hamsters infected with SARS-CoV-2 (USA-WA1/2020) in both prophylactic and treatment schedules. Further, the cocktail neutralized Alpha and Beta variants in live virus testing and Gamma and Epsilon variants in pseudovirus testing.
- Completed a $27 million Private Placement. In April 2021, the company announced a private placement of its common stock for gross proceeds to Immunome of approximately $27 million, before deducting placement agent commissions and other offering expenses.
- Awarded $4.3 million by the U.S. Department of Defense (DoD). In May 2021, Immunome announced that the DoD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense had awarded the company $4.3 million. These funds were in addition to Immunome’s original $13.3 million award provided by the DoD in July 2020. (Contract number: W911QY2090019)
- Appointed Corleen Roche as Chief Financial Officer. In April 2021, Immunome announced that it had appointed Corleen Roche as its Chief Financial Officer. Ms. Roche is a highly accomplished CFO with over 30 years of industry experience.
- Appointed Franklyn G. Prendergast, M.D., Ph.D., to Board of Directors. In June 2021, the company announced that it had appointed Dr. Prendergast to its Board of Directors. Dr. Prendergast is a renowned medical and academic research professional who received the 2019 Mayo Distinguished Alumni award and has over 45 years of association with the Mayo Foundation. Over the past 20 years, Dr. Prendergast has served on the Board of Directors or Scientific Advisory Board of several biotechnology companies.
- Appointed Andrew Badley, M.D., to COVID-19 Advisory Board. In June 2021, Immunome announced the appointment of Andrew D. Badley, M.D., to the company’s COVID-19 Advisory Board. Dr. Badley is a renowned infectious disease expert who has spent 19 years with the Mayo Clinic in various roles. He currently serves as the Chair of Mayo Clinic’s COVID-19 Research Taskforce.
Financial Highlights
- Research and development (R&D) expenses: R&D expenses for the three months ended June 30, 2021 were $3.2 million.
- General and administrative (G&A) expenses: G&A expenses for the three months ended June 30, 2021 were $2.5 million.
- Net loss: Net loss for the three months ended June 30, 2021 was $5.2 million.
- Cash and cash equivalents: As of June 30, 2021, cash and cash equivalents totaled $59.8 million.
About Immunome
Immunome is a biopharmaceutical company that utilizes its proprietary human memory B cell platform to discover and develop first-in-class antibody therapeutics that are designed to change the way diseases are treated. The company’s initial focus is on developing therapeutics to treat oncology and infectious diseases, including COVID-19. Immunome’s proprietary discovery engine identifies novel therapeutic antibodies and their targets by leveraging the highly educated components of the immune system, memory B cells, from patients whose bodies have learned to fight off their disease. For more information, please visit www.immunome.com.
Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements” intended to qualify for the “safe harbor” from liability established by the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding Immunome’s beliefs and expectations regarding the advancement of its oncology and COVID-19 therapeutic antibody programs, execution of its clinical and strategic plans, anticipated upcoming milestones for IMM-BCP-01 and IMM‐ONC‐01, including expectations regarding therapeutic potential and benefits thereof, and IND filings. Forward-looking statements may be identified by the words “anticipate,” believe,” “estimate,” “expect,” “intend,” “plan,” “project,” “may,” “will,” “could,” “should,” “seek,” “potential” and similar expressions. Forward-looking statements are based on Immunome’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, those risks and uncertainties associated with: the impact of the COVID-19 pandemic on Immunome’s business, operations, strategy, goals and anticipated milestones; the uncertainties inherent in research and development, including Immunome’s ability to execute on its strategy with respect to its R&D efforts, IND filings, initiation of clinical studies and other anticipated milestones as and when anticipated; the effectiveness of Immunome’s product candidates including the possibility that further preclinical data and any clinical trial data may be inconsistent with the data used for advancing the product candidates; Immunome’s ability to fund operations; the competitive landscape; and the additional risks and uncertainties set forth more fully under the caption “Risk Factors” in Immunome’s Form 10-K filed with the United States Securities and Exchange Commission (SEC) on March 25, 2021, and elsewhere in Immunome’s filings and reports with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Immunome undertakes no duty to publicly update or revise any forward looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable law.
|
IMMUNOME, INC. Condensed Statements of Operations (Unaudited; In thousands, except share and per share data) |
||||||||||||||||
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
||||||||||||
|
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
||||||||
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Research and development |
|
$ |
3,233 |
|
|
$ |
1,892 |
|
|
$ |
5,212 |
|
|
$ |
4,007 |
|
|
General and administrative |
|
|
2,507 |
|
|
|
823 |
|
|
|
4,425 |
|
|
|
1,363 |
|
|
Total operating expenses |
|
|
5,740 |
|
|
|
2,715 |
|
|
|
9,637 |
|
|
|
5,370 |
|
|
Loss from operations |
|
|
(5,740 |
) |
|
|
(2,715 |
) |
|
|
(9,637 |
) |
|
|
(5,370 |
) |
|
Other income |
|
|
500 |
|
|
|
— |
|
|
|
500 |
|
|
|
— |
|
|
Interest income (expense), net |
|
|
(1 |
) |
|
|
5 |
|
|
|
(2 |
) |
|
|
(17 |
) |
|
Net loss |
|
$ |
(5,241 |
) |
|
$ |
(2,710 |
) |
|
$ |
(9,139 |
) |
|
$ |
(5,387 |
) |
|
Per share information: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Net loss per share of common stock, basic and diluted |
|
$ |
(0.46 |
) |
|
$ |
(2.47 |
) |
|
$ |
(0.83 |
) |
|
$ |
(4.89 |
) |
|
Weighted-average common shares outstanding, basic and diluted |
|
|
11,456,991 |
|
|
|
1,099,270 |
|
|
|
11,051,185 |
|
|
|
1,101,798 |
|
|
IMMUNOME, INC. Condensed Balance Sheets (Unaudited; In thousands, except share data) |
|||||||||
|
|
|
June 30, 2021 |
|
December 31, 2020 |
|
||||
|
Assets |
|
|
|
|
|
|
|
||
|
Current assets: |
|
|
|
|
|
|
|
||
|
Cash |
|
$ |
59,829 |
|
|
$ |
39,766 |
|
|
|
Prepaid expenses and other current assets |
|
|
2,986 |
|
|
|
3,128 |
|
|
|
Total current assets |
|
|
62,815 |
|
|
|
42,894 |
|
|
|
Property and equipment, net |
|
|
1,226 |
|
|
|
1,531 |
|
|
|
Restricted cash |
|
|
100 |
|
|
|
100 |
|
|
|
Total assets |
|
$ |
64,141 |
|
|
$ |
44,525 |
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
||
|
Current liabilities: |
|
|
|
|
|
|
|
||
|
Accounts payable |
|
|
1,790 |
|
|
|
1,187 |
|
|
|
Accrued expenses and other current liabilities |
|
|
1,687 |
|
|
|
1,372 |
|
|
|
Equipment loan payable |
|
|
44 |
|
|
|
113 |
|
|
|
Current portion of long-term debt |
|
|
— |
|
|
|
366 |
|
|
|
Total current liabilities |
|
|
3,521 |
|
|
|
3,038 |
|
|
|
Long-term debt, net of current portion |
|
|
— |
|
|
|
134 |
|
|
|
Deferred rent |
|
|
3 |
|
|
|
8 |
|
|
|
Total liabilities |
|
|
3,524 |
|
|
|
3,180 |
|
|
|
Commitments and contingencies (Note 6) |
|
|
|
|
|
|
|
||
|
Stockholders’ equity: |
|
|
|
|
|
|
|
||
|
Common stock, $0.0001 par value; 200,000,000 shares authorized at June 30, 2021 and December 31, 2020; 11,812,792 shares issued and outstanding at June 30, 2021; 10,634,245 shares issued and outstanding at December 31, 2020 |
|
|
1 |
|
|
|
1 |
|
|
|
Additional paid-in capital |
|
|
124,149 |
|
|
|
95,738 |
|
|
|
Accumulated deficit |
|
|
(63,533 |
) |
|
|
(54,394 |
) |
|
|
Total stockholders’ equity |
|
|
60,617 |
|
|
|
41,345 |
|
|
|
Total liabilities and stockholders’ equity |
|
$ |
64,141 |
|
|
$ |
44,525 |
|
|
Contacts
Immunome Contact
Corleen Roche
Chief Financial Officer
Immunome, Inc.
investors@immunome.com
Investor Contact
Laurence Watts
Managing Director
Gilmartin, LLC
laurence@gilmartinir.com