ALLK Allakos Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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Lirentelimab (ENIGMA 2)
Eosinophilic Gastritis and/or eosinophilic duodenitis (EoD)
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Phase 3
Phase 3
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Lirentelimab (KRYPTOS)
Eosinophilic esophagitis
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Phase 2/3
Phase 2/3
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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Lirentelimab
Non-eosinophilic gastrointestinal disease
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Phase 2
Phase 2
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Phase 3 trial to be initiated 2H 2021.
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Lirentelimab (subcutaneous)
Eosinophilic gastritis (EG) / eosinophilic duodenitis (EoD)
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Phase 2/3
Phase 2/3
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Phase 2/3 trial to be initiated 2H 2021.
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|
AK002
Severe Allergic Conjunctivitis
|
Phase 1b
Phase 1b
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Phase 1b presentation at ASCRS May 16, 2020.
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Latest News
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REDWOOD CITY, Calif., Aug. 09, 2021 (GLOBE NEWSWIRE) -- Allakos Inc. (the "Company") (NASDAQ:ALLK), a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, today provided a business update and reported financial results for the second quarter ended June 30, 2021.
Recent Accomplishments
- Presented new data at Digestive Disease Week (DDW) 2021 suggesting eosinophilic gastritis and/or eosinophilic duodenitis (EG/EoD) is significantly underdiagnosed and may be a common cause of moderate-to-severe gastrointestinal symptoms. Forty-five percent (45%, 181/405) of patients with chronic functional gastrointestinal symptoms who underwent upper endoscopy with biopsy met the diagnostic criteria for EG/EoD.
- Completed patient enrollment in Phase 3 EG/EoD and Phase 2/3 eosinophilic esophagitis (EoE) clinical trials of lirentelimab (AK002).
Upcoming 2021 Milestones
- Topline data from a randomized, double-blind, placebo-controlled Phase 3 study of lirentelimab in patients with EG/EoD expected in the fourth quarter of 2021.
- Topline data from a randomized, double-blind, placebo-controlled Phase 2/3 study of lirentelimab in patients with EoE expected in the fourth quarter of 2021.
- Initiation of a randomized, double-blind, placebo-controlled Phase 2/3 study of subcutaneous lirentelimab in patients with EG and/or EoD expected in the second half of 2021.
- Initiation of a Phase 2 study in a non-eosinophilic gastrointestinal disease in the second half of 2021.
Second Quarter 2021 Financial Results
Research and development expenses were $41.0 million in the second quarter of 2021 as compared to $28.3 million in the same period in 2020, an increase of $12.7 million.
General and administrative expenses were $16.2 million in the second quarter of 2021 as compared to $12.1 million in the same period in 2020, an increase of $4.1 million.
Allakos reported a net loss of $57.2 million in the second quarter of 2021 as compared to $39.3 million in the same period in 2020, an increase of $17.9 million. Net loss per basic and diluted share was $1.07 for the second quarter of 2021 compared to $0.80 in the same period in 2020.
Allakos ended the second quarter of 2021 with $559.7 million in cash, cash equivalents and marketable securities.
About Allakos
Allakos is a clinical stage biotechnology company developing antibodies that target immunomodulatory receptors present on immune effector cells involved in allergic, inflammatory, and proliferative diseases. The Company's lead antibody, lirentelimab (AK002), is being evaluated in a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE). Lirentelimab targets Siglec-8, an inhibitory receptor selectively expressed on human mast cells and eosinophils. Inappropriately activated eosinophils and mast cells have been identified as key drivers in a number of severe diseases affecting the gastrointestinal tract, eyes, skin, lungs and other organs. Lirentelimab has been tested in multiple clinical studies. In these studies, lirentelimab eliminated blood and tissue eosinophils, inhibited mast cells and improved disease symptoms in patients with EG and/or EoD, EoE, mast cell gastrointestinal disease, severe allergic conjunctivitis, chronic urticaria and indolent systemic mastocytosis. For more information, please visit the Company's website at www.allakos.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements include, but are not limited to, Allakos' progress and business plans, the expected timing of anticipated study results and plans relating to its future clinical trials. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to: Allakos' stages of clinical drug development; Allakos' ability to timely complete clinical trials for, and if approved, commercialize lirentelimab (AK002), its lead compound; Allakos' ability to obtain required regulatory approvals for its product candidates; uncertainties related to the enrollment of patients in its clinical trials; Allakos' ability to demonstrate sufficient safety and efficacy of its product candidates in its clinical trials; uncertainties related to the success of later-stage clinical trials, regardless of the outcomes of preclinical testing and early-stage trials; market acceptance of Allakos' product candidates; uncertainties related to the projections of the size of patient populations suffering from the diseases Allakos is targeting; Allakos' ability to advance additional product candidates beyond lirentelimab; Allakos' ability to obtain additional capital to finance its operations; and other important risk factors set forth in Allakos' most recent Annual Report on Form 10-K filed with the SEC on March 1, 2021, Quarterly Report on Form 10-Q filed with the SEC on August 9, 2021, and future reports to be filed with the SEC. These documents contain and identify important factors that could cause the actual results for Allakos to differ materially from those contained in Allakos' forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Allakos specifically disclaims any obligation to update any forward-looking statement, except as required by law. These forward-looking statements should not be relied upon as representing Allakos' views as of any date subsequent to the date of this press release.
Source: Allakos Inc.
ALLAKOS INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share data)
(Unaudited)Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 Operating expenses Research and development $ 40,985 $ 28,346 $ 79,900 $ 46,631 General and administrative 16,210 12,058 32,880 23,646 Total operating expenses 57,195 40,404 112,780 70,277 Loss from operations (57,195 ) (40,404 ) (112,780 ) (70,277 ) Interest income 103 1,284 233 3,273 Other expense, net (117 ) (172 ) (220 ) (112 ) Net loss (57,209 ) (39,292 ) (112,767 ) (67,116 ) Unrealized gain (loss) on marketable
securities(56 ) (1,219 ) 24 650 Comprehensive loss $ (57,265 ) $ (40,511 ) $ (112,743 ) $ (66,466 ) Net loss per common share: Basic and diluted $ (1.07 ) $ (0.80 ) $ (2.11 ) $ (1.38 ) Weighted-average number of common
shares outstanding:Basic and diluted 53,669 48,816 53,429 48,753
ALLAKOS INC.
CONDENSED BALANCE SHEETS
(in thousands)June 30, December 31, 2021 2020 (Unaudited) Assets Current assets: Cash and cash equivalents $ 203,956 $ 207,177 Investments in marketable securities 355,739 451,820 Prepaid expenses and other current assets 16,363 10,270 Total current assets 576,058 669,267 Property and equipment, net 25,034 8,345 Operating lease right-of-use assets 37,736 39,731 Other long-term assets 16,119 2,275 Total assets $ 654,947 $ 719,618 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 15,663 $ 13,960 Accrued expenses and other current liabilities 18,335 8,490 Total current liabilities 33,998 22,450 Operating lease liabilities, net of current portion 49,963 42,773 Total liabilities 83,961 65,223 Stockholders' equity: Common stock 53 53 Additional paid-in capital 1,026,632 997,298 Accumulated other comprehensive gain 32 8 Accumulated deficit (455,731 ) (342,964 ) Total stockholders' equity 570,986 654,395 Total liabilities and stockholders' equity $ 654,947 $ 719,618 
Investor Contact: Adam Tomasi, President and COO ir@allakos.com Media Contact: Denise Powell denise@redhousecomms.com
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-- Results from both clinical trials expected in the fourth quarter of 2021 --
-- CMO Dr. Henrik Rasmussen to retire; Dr. Craig Paterson, SVP of Clinical Development and Medical Affairs, promoted to CMO --
REDWOOD CITY, Calif., June 07, 2021 (GLOBE NEWSWIRE) -- Allakos Inc. (the "Company" or "Allakos") (NASDAQ:ALLK), a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, today announced that it has completed enrollment in its Phase 3 study of lirentelimab in patients with eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD), and its Phase 2/3 study of lirentelimab in patients with eosinophilic esophagitis (EoE). Clinical trial results from both randomized, double-blind, placebo-controlled studies are expected in the fourth quarter of 2021.
The Company also announced the retirement of Henrik Rasmussen, M.D., Ph.D., Allakos' chief medical officer (CMO). Dr. Rasmussen will step down on June 11, 2021, after which he will continue to serve as a strategic advisor to the Company. Craig Paterson, M.D., Allakos' Senior Vice President of Clinical Development and Medical Affairs, will be promoted to CMO.
"We thank Henrik for his many contributions to the lirentelimab development program," said Robert Alexander, Ph.D., chief executive officer of Allakos. "Under Henrik's watch, lirentelimab has shown activity across multiple therapeutic areas and, importantly, the data suggest lirentelimab could be an important therapy for patients with EG, EoD and EoE. I also look forward to Craig's leadership as we further expand the lirentelimab development program."
"It has been a distinct pleasure working at Allakos and deeply rewarding to lay the groundwork for the lirentelimab development program, and with our registrational studies fully enrolled, it is an ideal time for my transition," stated Dr. Rasmussen. "Craig is exceptionally qualified to continue the momentum that the team has created—he is a talented gastrointestinal surgeon with clinical, regulatory and academic experience in the field of gastroenterology and immunology, areas that are critical for the continued successful development of lirentelimab."
Dr. Paterson joined Allakos as SVP of clinical development and medical affairs in March 2021, reporting to Dr. Rasmussen. Prior to Allakos, he was the Lead Program Physician for Immunodermatology at UCB, CMO at Vivelex Pharmaceuticals, and was Senior Vice President of Medical and Clinical Development at Salix Pharmaceuticals where he was responsible for the development of Xifaxin550, Relistor and other gastrointestinal drugs. Dr. Paterson also held roles of increasing responsibility at Endo International, King Pharmaceuticals and GlaxoSmithKline. Dr. Paterson previously served as Chief, Colon and Rectal Surgery, Associate Professor of Surgery at University of Massachusetts Medical School and Assistant Professor of Surgery at McMaster University Medical Center where he was responsible for direct patient care as well as supervision of fellows, surgical residents and medical students. Dr. Paterson holds a medical degree as well as an M.Sc. in physiology and pharmacology from McMaster University, Ontario, Canada and an M.B.A. from the University of Tennessee.
About Allakos
Allakos is a clinical stage biotechnology company developing antibodies that target immunomodulatory receptors present on immune effector cells involved in allergic, inflammatory, and proliferative diseases. The Company's lead antibody, lirentelimab (AK002), is being evaluated in a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE). Lirentelimab targets Siglec-8, an inhibitory receptor selectively expressed on human mast cells and eosinophils. Inappropriately activated eosinophils and mast cells have been identified as key drivers in a number of severe diseases affecting the gastrointestinal tract, eyes, skin, lungs and other organs. Lirentelimab has been tested in multiple clinical studies. In these studies, lirentelimab eliminated blood and tissue eosinophils, inhibited mast cells and improved disease symptoms in patients with EG and/or EoD, EoE, mast cell gastrointestinal disease, severe allergic conjunctivitis, chronic urticaria and indolent systemic mastocytosis. For more information, please visit the Company's website at www.allakos.com.Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements include, but are not limited to, Allakos' progress and business plans, the expected timing of anticipated study results and plans relating to its future clinical trials. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to: Allakos' stages of clinical drug development; Allakos' ability to timely complete clinical trials for, and if approved, commercialize lirentelimab (AK002), its lead compound; Allakos' ability to obtain required regulatory approvals for its product candidates; uncertainties related to the enrollment of patients in its clinical trials; Allakos' ability to demonstrate sufficient safety and efficacy of its product candidates in its clinical trials; uncertainties related to the success of later-stage clinical trials, regardless of the outcomes of preclinical testing and early-stage trials; market acceptance of Allakos' product candidates; uncertainties related to the projections of the size of patient populations suffering from the diseases Allakos is targeting; Allakos' ability to advance additional product candidates beyond lirentelimab; Allakos' ability to obtain additional capital to finance its operations; and other important risk factors set forth in Allakos' most recent Annual Report on Form 10-K filed with the SEC on March 1, 2021, Quarterly Report on Form 10-Q filed with the SEC on May 10, 2021, and future reports to be filed with the SEC. These documents contain and identify important factors that could cause the actual results for Allakos to differ materially from those contained in Allakos' forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Allakos specifically disclaims any obligation to update any forward-looking statement, except as required by law. These forward-looking statements should not be relied upon as representing Allakos' views as of any date subsequent to the date of this press release.
Source: Allakos Inc.
Investor Contact: Adam Tomasi, President & COO ir@allakos.com Media Contact: Denise Powell denise@redhousecomms.com
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REDWOOD CITY, Calif., May 24, 2021 (GLOBE NEWSWIRE) -- Allakos Inc. (the "Company") (NASDAQ:ALLK), a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, reported data at Digestive Disease Week (DDW) 2021. Results from a prospective study examined the rates of elevated tissue eosinophils in patients with chronic unexplained gastrointestinal (GI) symptoms or functional gastrointestinal disorders (FGIDs) such as irritable bowel syndrome (IBS) and functional dyspepsia (FD). The results suggest that eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) may be an underrecognized cause of chronic unexplained GI symptoms in these patients, and that EG/EoD is highly underdiagnosed.
"Chronic functional GI symptoms such as early satiety, bloating, nausea/vomiting, loss of appetite, diarrhea and abdominal pain/cramping, affect millions of adults in the United States. Indeed, IBS and functional dyspepsia are among the most common diagnoses made by gastroenterologists," said Dr. Anthony Lembo, Associate Professor of Medicine at Harvard Medical School. "These data suggest that EG/EoD may be associated with these unexplained chronic GI symptoms in these patients and that targeted EG/EoD therapies could provide a benefit."
"The results of this study indicate that EG/EoD is highly underdiagnosed, likely due to the lack of a standardized approach to evaluating patients with chronic non-specific symptoms," said Dr. Nicholas Talley, Pro Vice-Chancellor, Global Research at the University of Newcastle, Australia and Adjunct Professor of Medicine, Division of Gastroenterology and Hepatology Department of Medicine, University of North Carolina at Chapel Hill. "In practice, gastroenterologists may not always take enough biopsies during upper endoscopy (EGD), especially in the absence of obvious mucosal abnormalities. This study shows that systematic collection of at least 12 biopsies from the stomach and duodenum during EGD is important to detect EG/EoD. In addition, close collaboration between gastroenterologists and pathologists is essential to ensure tissue eosinophils are counted and reported, so that patients who meet the diagnostic threshold for EG/EoD are not missed. We anticipate these findings will be critical in shaping future diagnostic guidelines for how patients with chronic, unexplained moderate-to-severe GI symptoms are evaluated."
Prevalence Study Design
This prospective, multi-center study assessed eosinophil and mast cell levels in biopsies obtained from patients with active, chronic unexplained gastrointestinal symptoms or FGIDs. Inclusion in the study required patients to have ≥6-month history of abdominal pain, abdominal cramping, nausea, vomiting, diarrhea, bloating and/or early satiety without an identifiable cause and be unresponsive to pharmacologic or dietary intervention, or have a diagnosis of IBS or FD. Gastric and duodenal biopsies were collected in patients who had an average weekly single symptom severity score ≥3 (0-10 scale) for abdominal pain, abdominal cramping, nausea, vomiting, diarrhea, bloating or early satiety and a total symptom severity score ≥10 as assessed by the patient reported outcome (PRO) questionnaire used in the Company's Phase 2 (ENIGMA) and Phase 3 EG/EoD (ENIGMA 2) studies. A key primary endpoint of the Prevalence Study was:- The proportion of symptomatic patients that underwent biopsy and met the histologic criteria for EG/EoD (≥30 eosinophils/ high-power field [HPF] in five HPFs of the stomach or ≥30 eosinophils/HPF in three HPFs of the duodenum, respectively).
Prevalence Study Results
73% (405 of 556) of patients screened met the symptom severity criteria and underwent upper endoscopy with biopsy. Of the patients biopsied, 45% (181 of 405) met the histologic criteria for EG/EoD, representing 33% (181 of 556) of all the patients who entered screening.The presentation at DDW 2021 included details related to the EG/EoD prevalence results and the eosinophil endpoints assessed in this study. Full results from the prevalence study will be presented at future meetings and in publications.
About Eosinophilic Gastritis and/or Eosinophilic Duodenitis
Eosinophilic gastritis and/or eosinophilic duodenitis (EG/EoD) is a chronic, often severe, inflammatory disease characterized by persistent gastrointestinal symptoms and elevated and activated eosinophils in the stomach and/or, duodenum, respectively. Emerging data suggests that activated mast cells also contribute to disease pathogenesis. Common symptoms include abdominal pain, nausea, diarrhea, bloating, cramping, early satiety, loss of appetite, vomiting and weight loss. Published literature reports the prevalence of eosinophilic gastritis and/or eosinophilic duodenitis in the United States to be approximately 50,000 people. The Company believes that EG/EoD may be significantly underdiagnosed or misdiagnosed as other gastrointestinal diseases. The results from this study suggest that EG/EoD may be more common than documented in the literature. There are no treatments approved specifically for EG/EoD. Treatment with systemic steroids can provide symptomatic improvement. However, long-term treatment with steroids is generally not possible due to the numerous side effects.About Lirentelimab Development in EG/EoD
Lirentelimab (AK002), targets Siglec-8, an inhibitory receptor selectively expressed on human mast cells and eosinophils. Lirentelimab has been studied in a prospective, multi-center, randomized, double-blind, placebo controlled, Phase 2 Study in patients with EG/EoD (ENIGMA). In ENIGMA, all lirentelimab dose arms showed clinically meaningful and statistically significant benefits when compared to placebo across all prespecified primary and secondary endpoints, including reductions in gastrointestinal tissue eosinophil counts and patient-reported disease symptoms. Detailed results were published in the New England Journal of Medicine on October 22, 2020. Lirentelimab has received orphan disease designation for eosinophilic gastritis, eosinophilic duodenitis/eosinophilic gastroenteritis and eosinophilic esophagitis. A Phase 3 Study of lirentelimab in patients with EG/EoD (NCT04322604) and a Phase 2/3 Study in patients with eosinophilic esophagitis (NCT04322708) are currently underway. Data from these studies are expected in the fourth quarter of 2021.About Allakos
Allakos is a clinical stage biotechnology company developing antibodies that target immunomodulatory receptors present on immune effector cells involved in allergic, inflammatory, and proliferative diseases. The Company's lead antibody, lirentelimab (AK002), targets Siglec-8, an inhibitory receptor selectively expressed on human mast cells and eosinophils. Lirentelimab has been shown to inhibit mast cells and deplete eosinophils. Inappropriately activated eosinophils and mast cells have been identified as key drivers in a number of severe diseases affecting the gastrointestinal tract, eyes, skin, lungs and other organs. Lirentelimab has been tested in multiple clinical studies. In these studies, lirentelimab eliminated blood and tissue eosinophils, inhibited mast cells and improved disease symptoms in patients with eosinophilic gastritis and/or eosinophilic duodenitis, eosinophilic esophagitis, mast cell gastrointestinal disease, severe allergic conjunctivitis, chronic urticaria, and indolent systemic mastocytosis. For more information, please visit the Company's website at www.allakos.com.Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements include, but are not limited to, Allakos' progress and business plans, the expected timing of anticipated study results and plans relating to its future clinical trials. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to: Allakos' stages of clinical drug development; Allakos' ability to timely complete clinical trials for, and if approved, commercialize lirentelimab (AK002), its lead compound; Allakos' ability to obtain required regulatory approvals for its product candidates; uncertainties related to the enrollment of patients in its clinical trials; Allakos' ability to demonstrate sufficient safety and efficacy of its product candidates in its clinical trials; uncertainties related to the success of later-stage clinical trials, regardless of the outcomes of preclinical testing and early-stage trials; market acceptance of Allakos' product candidates; uncertainties related to the projections of the size of patient populations suffering from the diseases Allakos is targeting; Allakos' ability to advance additional product candidates beyond lirentelimab; Allakos' ability to obtain additional capital to finance its operations; and other important risk factors set forth in Allakos' most recent Annual Report on Form 10-K filed with the SEC on March 1, 2021, Quarterly Report on Form 10-Q filed with the SEC on May 10, 2021 and future reports to be filed with the SEC. These documents contain and identify important factors that could cause the actual results for Allakos to differ materially from those contained in Allakos' forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Allakos specifically disclaims any obligation to update any forward-looking statement, except as required by law. These forward-looking statements should not be relied upon as representing Allakos' views as of any date subsequent to the date of this press release.Source: Allakos Inc.
Investor Contact: Adam Tomasi, President & COO ir@allakos.com Media Contact: Denise Powell denise@redhousecomms.com
- The proportion of symptomatic patients that underwent biopsy and met the histologic criteria for EG/EoD (≥30 eosinophils/ high-power field [HPF] in five HPFs of the stomach or ≥30 eosinophils/HPF in three HPFs of the duodenum, respectively).
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REDWOOD CITY, Calif., May 10, 2021 (GLOBE NEWSWIRE) -- Allakos Inc. (the "Company") (NASDAQ:ALLK), a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, today reported financial results for the first quarter ended March 31, 2021 and provided a business update.
Recent Accomplishments
- Announced the acceptance of two oral and five poster presentations at the Digestive Disease Week (DDW) Annual Meeting taking place May 21 to 23, 2021. ePosters and ePapers will be available from the DDW ePosters and ePapers website. Abstracts can now be found here.
- Initiated a randomized, double-blind, placebo-controlled Phase 3 study of lirentelimab in patients with eosinophilic duodenitis.
Upcoming 2021 Milestones
- Topline data from a randomized, double-blind, placebo-controlled Phase 3 study of lirentelimab in patients with eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) expected in the fourth quarter of 2021.
- Topline data from a randomized, double-blind, placebo-controlled Phase 2/3 study of lirentelimab in patients with eosinophilic esophagitis (EoE) expected in the fourth quarter of 2021.
- Initiation of a randomized, double-blind, placebo-controlled Phase 2/3 study of subcutaneous lirentelimab in patients with EG and/or EoD expected in the second half of 2021.
- Initiation of a Phase 2 study in a non eosinophilic gastrointestinal disease in the second half of 2021.
First Quarter 2021 Financial Results
Research and development expenses were $38.9 million in the first quarter of 2021 as compared to $18.3 million in the same period in 2020, an increase of $20.6 million.
General and administrative expenses were $16.7 million in the first quarter of 2021 as compared to $11.6 million in the same period in 2020, an increase of $5.1 million.
Allakos reported a net loss of $55.6 million in the first quarter of 2021 as compared to $27.8 million in the same period in 2020, an increase of $27.8 million. Net loss per basic and diluted share was $1.04 for the first quarter of 2021 compared to $0.57 in the same period in 2020.
Allakos ended the first quarter of 2021 with $615.9 million in cash, cash equivalents and marketable securities.
About Allakos
Allakos is a clinical stage biotechnology company developing antibodies that target immunomodulatory receptors present on immune effector cells involved in allergic, inflammatory, and proliferative diseases. The Company's lead antibody, lirentelimab (AK002), is being evaluated in a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE). Lirentelimab targets Siglec-8, an inhibitory receptor selectively expressed on human mast cells and eosinophils. Inappropriately activated eosinophils and mast cells have been identified as key drivers in a number of severe diseases affecting the gastrointestinal tract, eyes, skin, lungs and other organs. Lirentelimab has been tested in multiple clinical studies. In these studies, lirentelimab eliminated blood and tissue eosinophils, inhibited mast cells and improved disease symptoms in patients with EG and/or EoD, EoE, mast cell gastrointestinal disease, severe allergic conjunctivitis, chronic urticaria and indolent systemic mastocytosis. For more information, please visit the Company's website at www.allakos.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements include, but are not limited to, Allakos' progress and business plans, the expected timing of anticipated study results and plans relating to its future clinical trials. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to: Allakos' stages of clinical drug development; Allakos' ability to timely complete clinical trials for, and if approved, commercialize lirentelimab (AK002), its lead compound; Allakos' ability to obtain required regulatory approvals for its product candidates; uncertainties related to the enrollment of patients in its clinical trials; Allakos' ability to demonstrate sufficient safety and efficacy of its product candidates in its clinical trials; uncertainties related to the success of later-stage clinical trials, regardless of the outcomes of preclinical testing and early-stage trials; market acceptance of Allakos' product candidates; uncertainties related to the projections of the size of patient populations suffering from the diseases Allakos is targeting; Allakos' ability to advance additional product candidates beyond lirentelimab; Allakos' ability to obtain additional capital to finance its operations; and other important risk factors set forth in Allakos' most recent Annual Report on Form 10-K filed with the SEC on March 1, 2021, Quarterly Report on Form 10-Q filed with the SEC on May 10, 2021, and future reports to be filed with the SEC. These documents contain and identify important factors that could cause the actual results for Allakos to differ materially from those contained in Allakos' forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Allakos specifically disclaims any obligation to update any forward-looking statement, except as required by law. These forward-looking statements should not be relied upon as representing Allakos' views as of any date subsequent to the date of this press release.
Source: Allakos Inc.
Investor Contact: Media Contact: Adam Tomasi, President and COO Denise Powell ir@allakos.com denise@redhousecomms.com ALLAKOS INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share data)Three Months Ended March 31, 2021 2020 Operating expenses Research and development $ 38,915 $ 18,285 General and administrative 16,670 11,588 Total operating expenses 55,585 29,873 Loss from operations (55,585 ) (29,873 ) Interest income 130 1,989 Other income (expense), net (103 ) 60 Net loss (55,558 ) (27,824 ) Unrealized gain on marketable securities 80 1,869 Comprehensive loss $ (55,478 ) $ (25,955 ) Net loss per common share: Basic and diluted $ (1.04 ) $ (0.57 ) Weighted-average number of common shares outstanding: Basic and diluted 53,186 48,691 ALLAKOS INC.
CONDENSED BALANCE SHEETS
(in thousands)March 31, December 31, 2021 2020 Assets Current assets: Cash and cash equivalents $ 169,989 $ 207,177 Investments in marketable securities 445,945 451,820 Prepaid expenses and other current assets 13,015 10,270 Total current assets 628,949 669,267 Property and equipment, net 13,620 8,345 Operating lease right-of-use assets 38,924 39,731 Other long-term assets 2,275 2,275 Total assets $ 683,768 $ 719,618 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 9,911 $ 13,960 Accrued expenses and other current liabilities 12,976 8,490 Total current liabilities 22,887 22,450 Operating lease liabilities, net of current portion 44,827 42,773 Total liabilities 67,714 65,223 Stockholders' equity: Common stock 53 53 Additional paid-in capital 1,014,435 997,298 Accumulated other comprehensive gain 88 8 Accumulated deficit (398,522 ) (342,964 ) Total stockholders' equity 616,054 654,395 Total liabilities and stockholders' equity $ 683,768 $ 719,618 -
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REDWOOD CITY, Calif., April 19, 2021 (GLOBE NEWSWIRE) -- Allakos Inc. (the "Company" or "Allakos") (NASDAQ:ALLK), a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, today announced that Baird Radford has been appointed Chief Financial Officer. As CFO, Mr. Radford will lead Allakos' finance organization while working with the Company's leadership team to drive its strategic initiatives and operating principles.
Mr. Radford has over 25 years of finance and leadership experience at public companies in multiple industries and various stages of growth. Prior to joining Allakos, Mr. Radford served as Senior Vice President of Finance at Aimmune Therapeutics where he was responsible for all aspects of strategic and operational finance activities supporting the launch of its first approved product, including financial planning, controllership, tax and treasury functions. Prior to working at Aimmune Therapeutics, he served as the Chief Financial Officer at HeartFlow and held senior finance positions at Intuitive Surgical, eBay and PricewaterhouseCoopers. Mr. Radford received his Bachelor of Business Administration from Ohio University.
"We are extremely pleased to have Baird join the Allakos team–he is a proven executive who has shaped and led successful teams. Baird brings broad experience and a track record of success at commercial-stage companies as we position Allakos for growth and potential commercialization of our first product candidate," said Robert Alexander, PhD, chief executive officer of Allakos. "We look forward to leveraging Baird's expertise as we enter the next critical phase of our growth."
"With lirentelimab in a Phase 3 pivotal study, this is an exciting time to be joining Allakos," said Mr. Radford. "I am honored to be part of the Allakos team and look forward to helping the company achieve its strategic objectives and financial goals as we work together to address the need for safe and effective therapies for eosinophil and mast cell-related diseases."
About Allakos
Allakos is a clinical stage biotechnology company developing antibodies that target immunomodulatory receptors present on immune effector cells involved in allergic, inflammatory, and proliferative diseases. The Company's lead antibody, lirentelimab (AK002), is being evaluated in a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE). Lirentelimab targets Siglec-8, an inhibitory receptor selectively expressed on human mast cells and eosinophils. Inappropriately activated eosinophils and mast cells have been identified as key drivers in a number of severe diseases affecting the gastrointestinal tract, eyes, skin, lungs and other organs. Lirentelimab has been tested in multiple clinical studies. In these studies, lirentelimab eliminated blood and tissue eosinophils, inhibited mast cells and improved disease symptoms in patients with EG and/or EoD, EoE, mast cell gastrointestinal disease, severe allergic conjunctivitis, chronic urticaria and indolent systemic mastocytosis. For more information, please visit the Company's website at www.allakos.com.Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements include, but are not limited to, Allakos' progress and business plans, the expected timing of anticipated study results and plans relating to its future clinical trials. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to: Allakos' stages of clinical drug development; Allakos' ability to timely complete clinical trials for, and if approved, commercialize lirentelimab (AK002), its lead compound; Allakos' ability to obtain required regulatory approvals for its product candidates; uncertainties related to the enrollment of patients in its clinical trials; Allakos' ability to demonstrate sufficient safety and efficacy of its product candidates in its clinical trials; uncertainties related to the success of later-stage clinical trials, regardless of the outcomes of preclinical testing and early-stage trials; market acceptance of Allakos' product candidates; uncertainties related to the projections of the size of patient populations suffering from the diseases Allakos is targeting; Allakos' ability to advance additional product candidates beyond lirentelimab; Allakos' ability to obtain additional capital to finance its operations; and other important risk factors set forth in Allakos' most recent Annual Report on Form 10-K filed with the SEC on March 1, 2021, and future reports to be filed with the SEC. These documents contain and identify important factors that could cause the actual results for Allakos to differ materially from those contained in Allakos' forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Allakos specifically disclaims any obligation to update any forward-looking statement, except as required by law. These forward-looking statements should not be relied upon as representing Allakos' views as of any date subsequent to the date of this press release.
Source: Allakos Inc.
Investor Contact: Adam Tomasi, President & COO ir@allakos.com Media Contact: Denise Powell denise@redhousecomms.com