Keros Therapeutics Reports Recent Business Highlights and First Quarter 2020 Financial Results
“Keros continued to make meaningful strides in the first quarter of 2020 as we continued our transition from a private company to a public company,” said
Recent Corporate Highlights:
- Completed Series C financing: In
March 2020 , Keros closed a Series C financing for total gross proceeds of$56.0 million , bringing the total venture funding for the company to approximately$78.5 million in gross proceeds.
- Completed upsized initial public offering: In
April 2020 , Keros completed its initial public offering of 6,900,000 shares of common stock, which included the exercise in full by the underwriters of their option to purchase up to 900,000 additional shares at a public offering price of$16.00 per share, for aggregate gross proceeds to Keros of$110.4 million . Keros received approximately$99.8 million in net proceeds after deducting underwriting discounts and commissions and offering costs.
- Leadership team strengthened and board of directors expanded to support growth: In
February 2020 , Keros appointedKeith Regnante as its Chief Financial Officer.Mr. Regnante will lead the finance and information technology functions, together with overseeing investor relations and fundraising efforts. Additionally, inMarch 2020 , Keros appointedNima Farzan , the Chief Executive Officer ofKinnate Biopharma Inc. , andCarl Gordon , Managing Partner and Co-Head of Global Private Equity atOrbiMed Advisors LLC , to its board of directors.
Recent Program Highlights:
- KER-050 for the treatment of ineffective hematopoiesis to address cytopenias:
- In
January 2020 , Keros completed a randomized, double-blind, placebo-controlled, two-part, dose-escalation Phase 1 clinical trial of KER-050 in 48 healthy post-menopausal women. Keros plans to report the positive topline data from this trial at the virtual 25thCongress of theEuropean Hematology Association (EHA) taking placeJune 11-14 2020 . In addition, two abstracts outlining data from preclinical studies of KER-050 in multiple animal models have been accepted for presentation at the 25thCongress of the EHA taking place fromJune 11 to 14, 2020 . - Commencement of an open-label Phase 2 clinical trial of KER-050 evaluating the treatment of cytopenias, including anemia and thrombocytopenia, in patients with very low-, low- or intermediate-risk myelodysplastic syndromes is expected in the second half of 2020, subject to any delays related to the COVID-19 pandemic.
- In
- KER-047 for the treatment of anemia arising from high hepcidin levels and for the treatment of fibrodysplasia ossificans progressiva:
- Keros expects to complete its Phase 1 clinical trial of KER-047 in mid-2020, and to subsequently report data from this trial in the second half of 2020, subject to any delays related to the COVID-19 pandemic.
- Keros expects to complete its Phase 1 clinical trial of KER-047 in mid-2020, and to subsequently report data from this trial in the second half of 2020, subject to any delays related to the COVID-19 pandemic.
- KER-012 for the treatment of disorders associated with bone loss and for the treatment of pulmonary arterial hypertension
- Keros has selected KER-012 as a product candidate for further preclinical and clinical development.
First Quarter 2020 Financial Results
Keros reported a net loss of $11.9 million in the first quarter of 2020 as compared to a net loss of $3.2 million in the first quarter of 2019. The increase in net loss for the first quarter was largely due to increased research and development efforts as well as investments to enable the company transition to a publicly traded company.
Research and development expenses were $8.5 million for the first quarter of 2020 as compared to $4.9 million for the same period in 2019. The increase of
General and administrative expenses were $2.0 million for the first quarter of 2020 as compared to $0.5 million for the same period in the prior year. The increase of
Keros’ cash and cash equivalents as of March 31, 2020 was $54.5 million compared to $7.0 million as of December 31, 2019. Total cash and cash equivalents as of
About
Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the transforming growth factor-Beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros’ lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros’ lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from elevated levels of hepcidin, the key regulator of iron absorption and recycling, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros’ third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.
Cautionary Note Regarding Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," “plans,” “potential,” "projects,” “would” and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros’ expectations regarding its growth, strategy, progress and timing of its preclinical studies and clinical trials for KER-050, KER-047 and KER-012, including its regulatory plans; the potential impact of COVID-19 on Keros’ ongoing and planned preclinical studies, clinical trials, business and operations; Keros’ plans to present preclinical and clinical data at upcoming conferences; and Keros’ expected cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros’ limited operating history and historical losses; Keros’ ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros’ dependence on the success of its lead product candidates, KER-050 and KER-047; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros’ ability to obtain, maintain and protect its intellectual property; Keros’ dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.
These and other risks are described more fully in Keros’ filings with the
Investor Contact:
Julia Balanova
jbalanova@soleburytrout.com
646-378-2936
Condensed Consolidated Statements of Operations (In thousands, except share and per share data) (Unaudited) |
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THREE MONTHS ENDED |
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2020 | 2019 | ||||||
REVENUE: | |||||||
Research collaboration revenue | $ | — | $ | 2,500 | |||
Total revenue | — | 2,500 | |||||
OPERATING EXPENSES: | |||||||
Research and development | (8,527 | ) | (4,867 | ) | |||
General and administrative | (1,977 | ) | (491 | ) | |||
Total operating expenses | (10,504 | ) | (5,358 | ) | |||
LOSS FROM OPERATIONS | (10,504 | ) | (2,858 | ) | |||
OTHER EXPENSE, NET: | |||||||
Interest expense, net | (2 | ) | (2 | ) | |||
Research and development incentive income | — | 180 | |||||
Change in fair value of preferred stock tranche obligation | (1,490 | ) | (604 | ) | |||
Other (expense) income, net | (68 | ) | 101 | ||||
Total other expense, net | (1,560 | ) | (325 | ) | |||
Loss before income taxes | (12,064 | ) | (3,183 | ) | |||
Income tax benefit | 172 | — | |||||
Net loss | $ | (11,892 | ) | $ | (3,183 | ) | |
Net loss attributable to common stockholders—basic and diluted (Note 10) | $ | (12,698 | ) | $ | (3,633 | ) | |
Net loss per share attributable to common stockholders—basic and diluted | $ | (5.11 | ) | $ | (1.61 | ) | |
Weighted-average common stock outstanding—basic and diluted | 2,484,057 | 2,258,335 | |||||
Condensed Consolidated Balance Sheets (In thousands, except share and per share data) (Unaudited) |
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2020 |
2019 |
||||||
ASSETS | |||||||
CURRENT ASSETS: | |||||||
Cash and cash equivalents | $ | 54,518 | $ | 7,020 | |||
Prepaid expenses and other current assets | 1,197 | 381 | |||||
Deferred IPO costs | 2,019 | 604 | |||||
Research and development incentive receivable | 805 | 922 | |||||
Total current assets | 58,539 | 8,927 | |||||
Operating lease right-of-use assets | 1,116 | 1,205 | |||||
Property and equipment, net | 822 | 708 | |||||
Restricted cash | 115 | 115 | |||||
TOTAL ASSETS | $ | 60,592 | $ | 10,955 | |||
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' DEFICIT | |||||||
CURRENT LIABILITIES: | |||||||
Accounts payable | $ | 2,426 | $ | 2,088 | |||
Current portion of operating lease liabilities | 388 | 376 | |||||
Accrued expenses and other current liabilities | 6,022 | 2,022 | |||||
Total current liabilities | 8,836 | 4,486 | |||||
Operating lease liabilities, net of current portion | 797 | 899 | |||||
Preferred stock tranche liability | — | 4,956 | |||||
Other liabilities | 104 | 119 | |||||
Total liabilities | 9,737 | 10,460 | |||||
COMMITMENTS AND CONTINGENCIES | |||||||
Series A convertible preferred stock, par value of |
|||||||
as of |
9,891 | 9,891 | |||||
Series A-1 convertible preferred stock, par value of |
|||||||
as of |
944 | 944 | |||||
Series B-1 convertible preferred stock, par value of |
|||||||
as of |
9,106 | 9,106 | |||||
Series C convertible preferred stock, par value of |
|||||||
authorized as of issued and outstanding as of and redemption value of |
55,781 | — | |||||
STOCKHOLDERS' DEFICIT: | |||||||
Common stock, par value of |
|||||||
of issued and outstanding as of |
1 | 1 | |||||
Additional paid-in capital | 6,674 | 203 | |||||
Accumulated deficit | (31,542 | ) | (19,650 | ) | |||
Total stockholders' deficit | (24,867 | ) | (19,446 | ) | |||
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' DEFICIT | $ | 60,592 | $ | 10,955 |
Source: Keros Therapeutics, Inc.