All City Baby
3月前
NMRC Advances Bacteriophage Therapy to Phase 3 Clinical Trial
https://www.med.navy.mil/Media/News/Article/4438022/nmrc-advances-bacteriophage-therapy-to-phase-3-clinical-trial/
18 March 2026
From Aleece Williams - Naval Medical Research Command
SILVER SPRING, Md. – Naval Medical Research Command (NMRC), in partnership with Armata Pharmaceuticals, has completed a phase 2 clinical trial on a Staphylococcus aureus (Staph A) bacteriophage therapy.
The therapy, AP-SA02, used for the treatment of complicated bacteremia caused by S. aureus, including multidrug resistant (MDR) strains, is expected to continue to phase 3 of clinical trials in the second half of 2026.
NMRC and Armata combined efforts for the development of a bacteriophage therapy designed to provide protection against MDR bacterial infections. Following the successful completion of these trials, researchers anticipate it will arm warfighters with a readily available, faster acting treatment, as compared to traditional antibiotics.
“This collaboration accelerates the development of innovative medical treatments with military applications that require cutting edge medical research,” explained Thomas Dunn, NMRC’s acting program manager for Naval Advanced Medical Development. “Burden sharing the development of innovative antimicrobials that can be used to minimize the impact of such infections, requires industrial partner capabilities (especially in biological manufacture) such as those provided by Armata Pharmaceuticals.”
Phase 3 of the clinical trials is projected to last 3-4 years, with the trial projected to be completed before or during fiscal year 2030.
Providing warfighters with this alternative to traditional antibiotics is intended to minimize lost duty days and increase force readiness, by providing a more effective, faster-acting solution to MDR bacteremia caused by Staph A, including methicillin-sensitive S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA) strains.
NMRC and Walter Reed Army Institute of Research members contributed shared efforts towards bacteriophage research when developing this bacteriophage therapy. Throughout Phase 3, NMRC will provide technical oversight and continue contributing funding.
This partnership allows Armata to maintain the licensure of the therapy while NMRC, on behalf of the Defense Health Agency (DHA), assists with funding and research. NMRC also functions as the chartered service product lead, managing costs, schedules and performance.
“NMRC is the capability developer and determines the contracting strategy, or industry engagement approach, to provide the Department of War technical direction, governing all aspects of the clinical development of the bacteriophage therapeutic,” said Dunn.
NMRC, headquarters of Navy Medicine Research & Development, is engaged in a broad spectrum of activity from basic science in the laboratory to field studies in austere and remote areas of the world to investigations in operational environments. In support of Navy, Marine Corps and joint U.S. warfighter health, readiness and lethality, researchers study infectious diseases, biological warfare detection and defense, combat casualty care, environmental health concerns, aerospace and undersea medicine, operational mission support and epidemiology.
All City Baby
4月前
Armata Pharmaceuticals Receives FDA Qualified Infectious Disease Product (QIDP) Designation for AP-SA02
Intravenous use as a QIDP for adjunct treatment of complicated bacteremia caused by Staphylococcus aureus
QIDP Designation provides for five years of market exclusivity and the potential for fast track and priority review
LOS ANGELES, Feb. 23, 2026 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a late clinical-stage biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections, today announced that the U.S. Food and Drug Administration (the "FDA") has granted AP-SA02, the Company's Staphylococcus aureus ("S. aureus") multi-phage product candidate, for intravenous use as a Qualified Infectious Disease Product ("QIDP") for adjunct treatment of complicated bacteremia caused by methicillin-sensitive S. aureus ("MSSA") or methicillin resistant S. aureus ("MRSA").
"The FDA's decision to grant QIDP designation to AP-SA02 underscores the urgent need for innovative antibacterial therapies to address serious and drug-resistant S. aureus infections," said Dr. Deborah Birx, Chief Executive Officer of Armata. "This designation recognizes the potential of AP-SA02 and supports our mission to advance bacteriophage-based therapies to patients with unmet medical needs through efficient, rigorously designed, randomized controlled clinical trials. We look forward to continuing to work closely with the FDA to prepare for the Phase 3 superiority study that we plan to initiate in the second half of this year."
To achieve QIDP designation, a drug candidate must be intended to treat serious or life-threatening infections, particularly those caused by bacteria and fungi that are resistant to treatment, or that treat qualifying resistant pathogens identified by the FDA. The QIDP designation makes AP-SA02 eligible to benefit from certain incentives for the development of new antibacterials provided under the Generating Antibiotic Incentives Now (GAIN) Act, including an additional five-year extension of Hatch-Waxman market exclusivity. Further, the QIDP designation makes AP-SA02 eligible for Fast Track status, which provides an opportunity for more frequent meetings and communication with the FDA, priority and rolling review, leading to potential accelerated approval of its Biologics License Application. The Company plans to submit to the FDA a request for Fast Track Designation for AP-SA02.
About AP-SA02
Armata is developing AP-SA02, a fixed multi-phage phage cocktail, for the treatment of complicated bacteremia caused by S. aureus, including MSSA and MRSA strains. The diSArm study (NCT05184764) was a Phase 1b/2a, multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of the safety, tolerability, and efficacy of intravenous AP-SA02 in addition to best available antibiotic therapy ("BAT") compared to BAT alone (placebo) for the treatment of adults with complicated S. aureus bacteremia. Positive results of the Phase 2a diSArm study were highlighted in a late-breaking oral presentation at IDWeek 2025™ in October 2025. The Phase 1b/2a clinical development of AP-SA02 was partially supported by a $26.2 million Department of Defense (DoD) award, received through the Medical Technology Enterprise Consortium (MTEC) and managed by the Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD) with funding from the Defense Health Agency and Joint Warfighter Medical Research Program. The Company plans to advance AP-SA02 into a Phase 3 superiority study in complicated S. aureus bacteremia, anticipated to initiate in the second half of 2026.
About Armata Pharmaceuticals, Inc.
Armata is a late clinical-stage biotechnology company focused on the development of high-purity pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, S. aureus, and other important pathogens. Armata is committed to advancing phage therapy with drug development expertise that spans bench to clinic including in-house phage-specific current Good Manufacturing Practices ("cGMP") manufacturing to support full commercialization.
https://investor.armatapharma.com/2026-02-23-Armata-Pharmaceuticals-Receives-FDA-Qualified-Infectious-Disease-Product-QIDP-Designation-for-AP-SA02
lesgetrich
4年前
Here's an interesting article on how a bacteriophage has helped save the abalone industry in California. Armata is researching using different bacteriophages to fight bacterial diseases in humans..
A good virus comes to the rescue of California’s abalone
‘A PARASITE OF A PARASITE’-‘Bacteria eater’ protects the treasured sea snails from a crippling disease...
...“The abalone would become weak and fall off and starve to death,” said Doug Bush, an aquaculture specialist at the Cultured Abalone Farm in Goleta. “We were just bucketing dead abalone out of here.”
Then about 15 years ago, as suddenly as the disease appeared, another mystery began confounding scientists.
“An abalone farmer sent me some samples and when I looked at them under the microscope, it looked like the bacteria were dying,” said Jim Moore, the now-retired head of the California Department of Fish and Wildlife’s Shellfish Health Laboratory at the Bodega Marine Lab. “I called him up and said, ‘Hey,
you must have sent me a sample that you treated with antibiotics.’ And he said no, and I thought that was really strange.”
At the same time, Friedman was noticing changes in wild black abalone around the Monterey Peninsula. Using electron microscopy techniques, she found a bacteriophage hijacking the pathogen.
“I thought it was really interesting and kind of exciting that you have this hyperparasite, a parasite of a parasite,” Friedman said of her discovery. “It’s sort of thought of as a natural therapy.”
Scientists found that the virus infects about 60% of an abalone’s withering syndrome bacteria, turning them into little bacteriophage factories. But little more was known, and they weren’t sure whether abalone would continue to die from the bacterial infection when stressed by warmer waters.
It wasn’t until years later when another marine heat wave hit between 2013 and 2016 that the protective effect became clear. Abalone farmers found that the problem of withering syndrome virtually disappeared thanks to the virus.
“We don’t view withering syndrome with the same lens as before — as an existential threat to the future of our business,” Bush said.
Beyond aiding abalone farms, the virus could also help wild abalone populations recover and survive in the coming years, particularly as climate change raises ocean temperatures.
“This is really good news for most abalone species,” said Kristin Aquilino, who raises white abalone at the Bodega Marine Lab to replenish wild populations.
Abalone continue to face a number of obstacles, including a devastating loss of their kelp forest habitat. White and black abalone are still listed as endangered, and there are still so few abalone left in the wild that it’s difficult for them to successfully reproduce.
But for now, the virus is keeping the once-deadly bacterial pathogen at bay.
“There are plenty of other issues,” said Seavey, the Monterey abalone farmer. “But that one has really gotten a lot easier to deal with.”
lesgetrich
6年前
New PR is out...
Armata Pharmaceuticals Announces Second Quarter 2020 Results and Provides General Corporate Update
MARINA DEL REY, Calif., Aug. 13, 2020 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced results for the second quarter of 2020 and provided a corporate and clinical update.
During the quarter, the Company announced a $15 million award from the U.S. Department of Defense, through the Medical Technology Enterprise Consortium (MTEC) with funding from the Defense Health Agency and Joint Warfighter Medical Research Program, for a three-year program to advance development of AP-SA02 in S. aureus bacteremia infections. Armata will use the award to partially fund a Phase 1b/2 randomized, double-blind, placebo-controlled, dose escalation clinical study. The Company expects to initiate the clinical trial next year.
"The highlight of the second quarter was our announcement of the $15 million award from the U.S. Department of Defense to advance AP-SA02, which we are developing as a potential treatment for Staphylococcus aureus bacteremia infections. In an ongoing effort to prudently manage our cash, we sought non-dilutive third-party funding to help advance this program, and we exceeded the amount that we were initially targeting. We are in the process of developing an efficient clinical plan for this promising candidate, and this award will now allow us to initiate a Phase 1b/2 clinical trial as expeditiously as possible," said Todd R. Patrick, Chief Executive Officer of Armata. "With respect to our lead program, subject to potential delays related to COVID-19, we believe we are on track to initiate our Phase 1b/2a clinical trial of AP-PA02 in Pseudomonas aeruginosa infections in cystic fibrosis patients later this year. Finally, we remain well capitalized with $19.8 million of cash on our balance sheet as of June 30, 2020."
Anticipated 2020 and 2021 Milestones:
Initiate a Phase 1b/2a clinical trial evaluating AP-PA02 as a potential treatment for Pseudomonas aeruginosa infections by the end of 2020
Initiate a Phase 1b/2 clinical trial evaluating AP-SA02 as a potential treatment for Staphylococcus aureus bacteremia infections in 2021
Continue to screen pathogens against the Company's proprietary phage library to identify additional high-quality bacteriophage product candidates and expand the pipeline.
Second Quarter Financial Results
Research and Development. Research and development expenses for the three months ended June 30, 2020 were approximately $2.6 million as compared to $3.1 million for the comparable period in 2019.
General and Administrative. General and administrative expenses for the three months ended June 30, 2020 were $2.0 million as compared to $2.1 million for the comparable period in 2019.
Loss from Operations. Loss from operations for the three months ended June 30, 2020 was $4.7 million as compared to $4.2 million for the comparable period in 2019.
Cash and Equivalents. As of June 30, 2020, Armata held $19.8 million of unrestricted cash and cash equivalents, as compared to $6.0 million as of December 31, 2019. Management believes the Company's existing resources will be sufficient to fund planned operations through at least the first half of 2021.
As of August 13, 2020, there were approximately 18.7 million shares of common stock outstanding.
About Armata Pharmaceuticals, Inc.
Armata is a clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. In addition, in collaboration with Merck, known as MSD outside of the United States and Canada, Armata is developing proprietary synthetic phage candidates to target an undisclosed infectious disease agent. Armata is committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage specific GMP manufacturing.
Forward Looking Statements
This communication contains "forward-looking" statements, including, without limitation, statements related to Armata's ability to meet expected milestones, expand its pipeline, and pursue additional potential partnerships, the expected use of proceeds from the $15 million grant, the expected impact of the COVID-19 pandemic on the Company's operations, Armata's ability to be a leader in the development of phage-based therapeutics, and statements related to the timing and results of clinical trials, including the anticipated initiation of clinical trials of AP-PA02 and AP-SA02, Armata's ability to develop new products based on bacteriophages and synthetic phages, Armata's expectations for performance of Armata's therapeutic candidates based on Armata's recent nonclinical work, and Armata's ability to continue to screen pathogens against Armata's proprietary phage library to identify additional high-quality bacteriophage product candidates and expand the pipeline. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon Armata's current expectations. Forward-looking statements involve risks and uncertainties. Armata's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the ability of Armata's lead clinical candidates, AP-PA02 and AP-SA02, to be more effective than previous candidates; Armata's ability to expedite development of AP-PA02; Armata's ability to advance its preclinical and clinical programs and the uncertain and time-consuming regulatory approval process; Armata's ability to develop products based on bacteriophages and synthetic phages to kill bacterial pathogens; the Company's expected market opportunity for its products; Armata's ability to sufficiently fund its operations as expected, including obtaining additional funding as needed; and any delays or adverse events within, or outside of, Armata's control, caused by the recent outbreak of COVID-19. Additional risks and uncertainties relating to Armata and its business can be found under the caption "Risk Factors" and elsewhere in Armata's filings and reports with the SEC, including in Armata's Annual Report on Form 10-K, filed with the SEC on March 19, 2020, and in its subsequent filings with the SEC. Armata expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Armata's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Media Contacts:
At Armata:
Steve Martin
Armata Pharmaceuticals, Inc.
ir@armatapharma.com
858-800-2492
Investor Relations:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
212-915-2569
...actual financial results follow. Go to the link above for the full text.
lesgetrich
6年前
Here's the PR...
Armata Pharmaceuticals Announces $15 Million Award from the U.S. Department of Defense (DoD) for Development of Bacteriophage Therapy to Treat S. aureus Bacteremia Infections
Non-dilutive funding to be used to advance the company's second phage-based therapeutic candidate in a Phase 1b/2 clinical study
MARINA DEL REY, Calif., June 17, 2020 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced that it has received a $15 million award for a three year program from the U.S. DoD through the Medical Technology Enterprise Consortium (MTEC) with funding from the Defense Health Agency and Joint Warfighter Medical Research Program. Armata will use the award to partially fund a Phase 1b/2, randomized, double-blind, placebo-controlled, dose escalation clinical study of Armata's therapeutic phage-based candidate, AP-SA02, for the treatment of complicated Staphylococcus aureus bacteremia infections.
"Today, I am pleased to announce that we have achieved our goal of receiving non-dilutive funding to support clinical development of our optimized phage candidate, AP-SA02, as a promising potential treatment for S. aureus bacteremia. We are excited to have exceeded the amount of funding we had originally targeted, which enables us to robustly examine the potential efficacy of our optimized phage candidate," stated Todd R. Patrick, Chief Executive Officer of Armata Pharmaceuticals. "This funding from the DoD validates the potential of phage-based therapeutics and helps us move AP-SA02 into clinical development while continuing to carefully manage our financial position. Drug-resistant S. aureus bacteremia infections carry mortality rates as high as 40%, reflecting the urgent need for novel and improved treatment options."
Mr. Patrick added, "This award from the DoD facilitates what will be our second clinical program in our development pipeline, enabling Armata to advance phage therapy in two distinct indications: our lead program, AP-PA02, will explore inhaled phage therapy in cystic fibrosis patients with Pseudomonas aeruginosa lung infections and is partially funded by the US Cystic Fibrosis Foundation, and AP-SA02, which will test intravenous phage therapy in S. aureus bacteremia and is partially funded by the DoD."
Thomas Dunn, Acting Program Manager Naval Advanced Medical Development, stated "Antibiotic resistance is a global challenge and has become more prevalent in recent years, threatening the lives of both warfighters and civilians. There is an imminent need for alternative therapies to help protect the population. Using Armata's targeted phage cocktail to treat Staphylococcus aureus bacteremia that are non-responsive to standard of care is a novel method that can potentially greatly reduce the number of these complicated, drug-resistant infections and help span the ever-growing bacteria / antibiotic resistance gap."
The primary objectives of the Phase 1b/2 bacteremia study will be to evaluate the safety and tolerability of AP-SA02 as an adjunct to best available antibiotic therapy, and to determine the appropriate dose or doses for future clinical trials of efficacy. Because of the impact of COVID-19 on the Company's development programs, Armata does not believe the clinical trial will initiate prior to mid-2021. The clinical trial of AP-PA02 targeting Pseudomonas aeruginosa is on target to enroll later this year.
About Bacteremia
Bacteremia is a bacterial infection of the bloodstream. A common diagnosis, the Centers for Disease Control and Prevention (CDC) estimates that up to 1.7 million people in the United States develop bacteremia each year. S. aureus is the most commonly identified pathogen in both hospital- and community-acquired blood stream infections. Annually in the United States there are approximately 200,000 hospitalizations for S. aureus bacteremia (SAB). Despite conventional antibiotics, mortality in SAB results in death of up to 40% of all cases and 57% of patients over the age of 85. Patients with comorbidities such as alcoholism, malignancy, diabetes, end-stage renal disease requiring hemodialysis, and immunosuppression are at even higher risk for death when SAB develops. Age-adjusted mortality assessments show that SAB mortality is higher than that of AIDS, tuberculosis, or viral hepatitis, and comparable to mortality rates for breast or prostate cancer. Outcomes are even poorer for SAB due to methicillin-resistant S. aureus (MRSA), classified as a serious threat to global health by the CDC and a high priority threat by the World Health Organization, with higher rates of complications and increased mortality as compared to methicillin-susceptible S. aureus (MSSA). Average hospital costs to patients with nosocomial SAB ranges between $40,000 (MSSA) and $114,000 (MRSA). Treatment failures are common in SAB, with highest rates due to MRSA. These failures can be attributed in part to poor penetration of some tissues by antibiotics, slow onset of bactericidal effects, emerging resistance patterns, and biofilm formation. While biofilms can render traditional antibiotics ineffective, phages may have the ability to penetrate the biofilm allowing rapid and efficient infection of the host and amplification at the site of infection. Daptomycin (approved in 2005; based on clinical cure rates of <50%) and vancomycin are the only two antibiotics with label indications in the United States for the treatment of SAB, and the emergence of drug-resistant S. aureus isolates, including to these two standard of care drugs, represents a major threat in terms of increasing morbidity, mortality and health care utilization.
About Armata Pharmaceuticals, Inc.
Armata is a clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage therapeutics for the treatment of antibiotic-resistant infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. In addition, in collaboration with Merck, known as MSD outside of the United States and Canada, Armata is developing proprietary synthetic phage candidates to target an undisclosed infectious disease agent. Armata is committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage specific GMP manufacturing.
Forward Looking Statements
This communication contains "forward-looking" statements, including, without limitation, statements related to Armata's ability to meet expected milestones, expand its pipeline, and pursue additional potential partnerships, the expected use of proceeds from the recent $15 million grant, Armata's ability to be a leader in the development of phage-based therapeutics, statements related to the timing and results of clinical trials, including the anticipated initiation of clinical trials of AP-PA02 and AP-SA02, expected impact of the COVID-19 pandemic on the Company's operations, Armata's ability to develop new products based on bacteriophages and synthetic phages, the timing and ability of Armata to obtain non-dilutive funding on acceptable terms, if at all, Armata's expectations for performance of Armata's therapeutic candidates based on Armata's recent nonclinical work, and Armata's ability to continue to screen pathogens against Armata's proprietary phage library to identify additional high-quality bacteriophage product candidates and expand the pipeline. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon Armata's current expectations. Forward-looking statements involve risks and uncertainties. Armata's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the ability of Armata's lead clinical candidates, AP-PA02 and AP-SA02, to be more effective than previous candidates; Armata's ability to expedite development of AP-PA02; Armata's ability to advance its preclinical and clinical programs and the uncertain and time-consuming regulatory approval process; Armata's ability to develop products based on bacteriophages and synthetic phages to kill bacterial pathogens; Armata's expected market opportunity for its products; Armata's ability to sufficiently fund its operations as expected, including obtaining additional funding as needed; and any delays or adverse events within, or outside of, Armata's control, caused by the recent outbreak of COVID-19. Additional risks and uncertainties relating to Armata and its business can be found under the caption "Risk Factors" and elsewhere in Armata's filings and reports with the SEC, including in Armata's Annual Report on Form 10-K, filed with the SEC on March 19, 2020, and in its subsequent filings with the SEC. Armata expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Armata's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Media Contacts:
At Armata:
Steve Martin
Armata Pharmaceuticals, Inc.
ir@armatapharma.com
858-800-2492
Armata Investor Relations:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
212-915-2569
lesgetrich
6年前
Here's more on the Innoviva agreement. Armata will effectively become a subsidiary of Innoviva...
IMLFF Form DEF-14A
At the closing of the second tranche (the “Second Closing”, and the issuance of Shares in the Second Closing, the “Second Placement”), subject to satisfaction of certain closing conditions, including the Company’s shareholders voting in favor of the transaction at this Special Meeting, Innoviva will purchase approximately 7.7 million shares of Common Stock and Warrants to purchase approximately 7.7 million shares of Common Stock for an aggregate purchase price of approximately $22.2 million.
At the First Closing, Innoviva and the Company entered into an investor rights agreement (the “Investor Rights Agreement”), which provides that, for so long as Innoviva and its affiliates hold at least 12.5% of the outstanding shares of Common Stock on a fully-diluted basis, Innoviva shall have the right to designate two (2) directors to the Board of Directors of the Company (the “Board”), and, for so long as Innoviva and its affiliates hold at least 8% but less than 12.5% of the outstanding shares of Common Stock on a fully-diluted basis, Innoviva shall have the right to designate one (1) director to the Board, subject to certain qualifications and conditions in the Investor Rights Agreement. In connection with the First Closing, on February 12, 2020, two of Armata’s Board members, Richard Bear and Michael Perry, resigned from the Board, and Innoviva appointed Sarah Schlesinger, M.D. and Odysseas Kostas, M.D. to fill the newly created vacancies on the Board. The Investor Rights Agreement also provides for participation rights for Innoviva to participate in future offerings of equity securities by the Company.
The Second Closing is expected to occur by the end of the first quarter of 2020, subject to the satisfaction of certain closing conditions referenced above. Following the Second Closing, Innoviva will become our largest shareholder, owning approximately 47% of the Company, assuming no exercise of the Warrants, and if Innoviva exercises the Warrants, it will own approximately 64% of the Company?—?either of which will result in a change of control of the Company under the rules of the NYSE American.
In addition, the Purchase Agreement provides that prior to the consummation of the Second Closing, Armata will effect an amendment to its Amended and Restated Articles of Incorporation, as amended, to renounce any interest or expectancy of the Company in, or in being offered an opportunity to participate in, any business opportunity that is presented to its directors, officers or shareholders.
lesgetrich
6年前
There's a new PR out...
Armata Pharmaceuticals Announces Closing of First Tranche of Recently Executed $25 Million Securities Purchase Agreement with Innoviva, Inc.
MARINA DEL REY, Calif., Feb. 13, 2020 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, today announced that it has completed the first closing under a recently executed Securities Purchase Agreement with Innoviva, Inc. (NASDAQ: INVA) ("Innoviva"), a company with a portfolio of royalties that include respiratory assets partnered with Glaxo Group Limited. In connection with the closing, Armata issued 993,139 common shares and warrants to purchase 993,139 common shares in exchange for net proceeds of approximately $2.8 million. The first closing occurred following the satisfaction of certain closing conditions, including the execution of voting agreements by greater than 50.1% of the existing common stockholders of Armata in support of the $25 million private placement financing transaction. In connection with the closing, Richard Bear and Michael S. Perry, D.V.M., Ph.D., resigned from Armata's Board of Directors and two individuals designated by Innoviva, Sarah Schlesinger, M.D. and Odysseas Kostas, M.D., were appointed to fill the newly created vacancies. Armata also announced that it has withdrawn its registration statement on Form S-1 that was previously filed with the SEC.
https://mma.prnewswire.com/media/884786/Armata_Logo.jpg
"We are very pleased to close the first tranche of this Securities Purchase Agreement with Innoviva, and, together with my fellow Directors, we welcome Drs. Kostas and Schlesinger to our Board," stated Todd R. Patrick, Chief Executive Officer of Armata. "These additional funds significantly strengthen our financial position and provide ample cash runway to pursue meaningful clinical and corporate milestones in 2020 and 2021. We are very fortunate to partner with Innoviva and we look forward to mutual success as we advance our emerging bacteriophage platform to treat the growing global health challenge of multi-drug resistant infections."
Pursuant to and subject to the terms and conditions of the Securities Purchase Agreement and related agreements, Innoviva will purchase a total of approximately 8.7 million newly issued shares of Armata's common stock, at a price of $2.87 per share, and warrants to purchase up to approximately 8.7 million additional shares of Armata's common stock, at an exercise price of $2.87 per share. The stock purchases will occur in two tranches, the first of which has now been completed. Upon the closing of the second tranche, which is expected to occur during the first quarter of 2020, subject to the satisfaction or waiver of certain closing conditions, including approval by Armata shareholders, Innoviva will purchase approximately 7.7 million additional shares of common stock and warrants to purchase approximately 7.7 million additional shares of common stock for an aggregate purchase price of $22.2 million.
Immediately following the closing of the second tranche, expected in the first quarter of 2020, Armata will have approximately 18.6 million shares of common stock and warrants exercisable for approximately 10.6 million shares of common stock outstanding. The Company expects the proceeds from the offering to provide sufficient cash resources to achieve meaningful clinical milestones in 2020 and 2021.
This release does not constitute an offer to sell or the solicitation of an offer to buy any security. The shares offered have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws and may not be offered or sold in the United States or any state thereof absent registration under the securities act and applicable state securities laws or an applicable exemption from registration requirements.
About Armata Pharmaceuticals, Inc.
Armata is a clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage therapeutics for the treatment of antibiotic-resistant infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. In addition, in collaboration with Merck, known as MSD outside of the United States and Canada, Armata is developing proprietary synthetic phage candidates to target an undisclosed infectious disease agent. Armata is committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage specific GMP manufacturing.
Forward Looking Statements
This communication contains "forward-looking" statements, including, without limitation, statements related to the anticipated benefits of the offering and related transactions, Armata's ability to meet expected milestones, expand its pipeline, pursue additional potential partnerships, statements related to clinical trials, including the anticipated initiation of a clinical trial of AP-PA02, and future milestones, including obtain topline data from the clinical trial of AP-PA02, obtain third party, non-dilutive funding to advance the Company's Staphylococcus aureus phage candidate, AP-SA02, into clinical trials, and file an IND to initiate clinical studies of AP-SA02. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon Armata's current expectations. Forward-looking statements involve risks and uncertainties. Armata's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to Armata's ability to advance its preclinical and clinical programs and the uncertain and time-consuming regulatory approval process; Armata's ability to develop products based on bacteriophages and synthetic phages to kill bacterial pathogens; Armata's expected market opportunity for its products; and Armata's ability to obtain stockholder approval of the offering transaction described herein; Armata's ability to complete the offering described herein and ability to sufficiently fund its future operations as expected. Additional risks and uncertainties relating to Armata and its business can be found under the caption "Risk Factors" and elsewhere in Armata's filings and reports with the SEC, including in Armata's Annual Report on Form 10-K, filed with the SEC on March 25, 2019, Armata's Proxy Statement on Schedule 14A, filed with the SEC on April 4, 2019, as amended, and Armata's subsequent filings with the SEC. Armata expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Armata's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Media Contacts:
At Armata:
Steve Martin
Armata Pharmaceuticals, Inc.
ir@armatapharma.com
858-800-2492
Armata Investor Relations:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
212-915-2569
At Innoviva:
Dan Zacchei / Alex Kovtun
Sloane & Company
212-446-9500
dzacchei@sloanepr.com / akovtun@sloanepr.com
https://c212.net/c/img/favicon.png?sn=LA18292&sd=2020-02-13 View original content to download multimedia:www.prnewswire.com/news-releases/armata-pharmaceuticals-announces-closing-of-first-tranche-of-recently-executed-25-million-securities-purchase-agreement-with-innoviva-inc-301004161.html
SOURCE Armata Pharmaceuticals, Inc.
timberwolf7
6年前
financing deal 'stimulates' buyers... wow
just checking my charts and once again, a 'trend' that was in my favor gets interrupted by 'PR'..
whats interesting about this one is, the financier is reportedly buying 8 Million shares at $2.87/sh, and yet the shares have spiked to nearly $5.5 on the news... unreal... but hey, IF I had shares, I would be selling right now and looking to rebuy back wherever this settles back down at...
So once again, a trend that was in my favor as the share price was sliding lower got interrupted. And given its 'trend' and that its still some time away from a PH 3 IF they have to do one... I was thinking under $2/sh for a buy in price... Oh well, the way it goes, now I watch and see...
ursuant to and subject to the terms and conditions of the securities purchase agreement and related agreements, Innoviva will purchase approximately 8.7 million newly issued shares of Armata's common stock, at a price of $2.87 per share, and warrants to purchase up to approximately 8.7 million additional shares of Armata's common stock, with an exercise price of $2.87 per share. The stock purchases are expected to occur in two tranches. At the closing of the first tranche, Innoviva will purchase approximately 1.0 million shares of common stock and warrants to purchase approximately 1.0 million shares of common stock for an aggregate purchase price of $2.8 million. At the closing of the second tranche, upon Armata stockholders voting in favor of the transaction, Innoviva will purchase approximately 7.7 million shares of common stock and warrants to purchase approximately 7.7 million shares of common stock for an aggregate purchase price of $22.2 million. Assuming the completion of the first closing, Innoviva will be entitled to appoint two directors to Armata's Board of Directors. It currently is expected that Innoviva will appoint Sarah Schlesinger. M.D. and Odysseas Kostas, M.D. to serve on Armata's Board of Directors.
Subject to the satisfaction of certain closing conditions, including, with respect to the second closing, the approval of Armata's stockholders, the transactions contemplated by the securities purchase agreement are expected to close during the first quarter of 2020.
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