NVUS Novus Therapeutics Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
OP0201 - C-006
Acute Otitis Media - children
|
Phase 2a
Phase 2a
|
Phase 2a data did not meet primary endpoint - June 1, 2020.
|
|
OP0201 C-001
Healthy volunteers
|
Phase 1
Phase 1
|
Phase 1 data released April 22, 2019. Safety and tolearbility objectives met.
|
|
OP0201- C-002
Healthy volunteers
|
Phase 1
Phase 1
|
Phase 1 data presented June 11, 2019, 1pm.
|
|
OP0201
Acute Otitis Media - adults
|
Phase 1
Phase 1
|
Phase 1 data released April 22, 2019. Safety and tolerability objectives met.
|
|
OP0201 - C-001
Healthy volunteers
|
Phase 1/2
Phase 1/2
|
Phase 1 data released April 22, 2019. Safety and tolerability objectives met.
|
|
Galeterone - ARMOR3-SV
Cancer - castration-resistant prostate cancer (CRPC)
|
Phase 3
Phase 3
|
Phase 3 trial discontinued July 2016 due to poor data
|
|
Galeterone - ARMOR2
Xtandi (enzalutamide) refractory metastatic castration-resistant prostate cancer (mCRPC)
|
Phase 2
Phase 2
|
Announced in August 2016 that Phase 2 trial enrollment has been discontinued.
|
Latest News
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Novus Therapeutics, Inc. ("Novus") (NASDAQ:NVUS), a clinical stage biotechnology company targeting the CD40L pathway to develop potential treatments for organ or cell-based transplant, autoimmune and neurodegenerative diseases, today announced that David-Alexandre C. Gros, M.D., Chief Executive Officer, will present a corporate overview to virtual audiences this week at the H.C. Wainwright & Co. 22nd Annual Global Investment Conference and at the Cantor Virtual Global Healthcare Conference.
Conferences Details
Event:
H.C. Wainwright 22nd Annual Global Investment Conference (virtual)
Date:
Wednesday, September 16th
Time:
3:30 p.m. ET
Event:
Cantor Virtual Global Healthcare Conference (virtual)
Date:
Thursday, September 17th
Time:
12:00 p.m. ET
Live webcasts of both presentations can be accessed by visiting the "Events and Presentations" tab of the investor section of the Novus website at http://ir.novustherapeutics.com/events-and-presentations/events. A replay of the webcasts will be archived for 30 days following the conference.
About Novus Therapeutics
Novus Therapeutics, Inc. is a clinical stage biotechnology company using its expertise in targeting the CD40L pathway to develop potential treatments for people requiring an organ or cell-based transplant, and for people with autoimmune and neurodegenerative disease. Novus is headquartered in Irvine, Calif. For more information, please visit the company's website at www.novustherapeutics.com. Follow Novus Therapeutics on social media: @Novus_Thera and LinkedIn.
Forward-Looking Statements
This press release contains forward‐looking statements that involves substantial risks and uncertainties. Any statements about the company's future expectations, plans and prospects, including statements about its strategy, future operations, development of its product candidates, and other statements containing the words "believes," "anticipates," "plans," "expects," "estimates," "intends," "predicts," "projects," "targets," "looks forward," "could," "may," and similar expressions, constitute forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, although not all forward‐looking statements include such identifying words. Forward‐looking statements include, but are not limited to statements regarding: risks related to market conditions; expectations regarding the timing for the commencement of future clinical trials; expectations regarding the success of clinical trials; the rate and degree of market acceptance and clinical utility of the company's products; the company's estimates regarding expenses and cash runway; and the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward‐looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company's actual results to differ significantly from the forward‐looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the SEC, which can be found at www.sec.gov. Any forward‐looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward‐looking statements, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200915006306/en/
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Acquisition includes lead clinical-stage compound AT-1501, a next generation anti-CD40L antibody, in development for organ and cellular transplantation, autoimmune diseases, and neurodegenerative diseases
Senior management team with extensive drug development and commercialization experience, including Dr. David-Alexandre "DA" C. Gros as CEO and Dr. Steven Perrin as President and CSO, to lead Novus
Company completes private placement financing with proceeds of $108 million to be used to advance AT-1501 Phase 2 clinical trials in up to four indications
Conference call tomorrow at 8:30 a.m. EDT
Novus Therapeutics, Inc. ("Novus") (NASDAQ:NVUS) today announced it has completed the acquisition of Anelixis Therapeutics, Inc. ("Anelixis"), a privately held clinical stage biotechnology company developing a next generation anti-CD40 Ligand (CD40L) antibody as a potential treatment for organ and cellular transplantation, autoimmune diseases, and neurodegenerative diseases. Concurrent with the acquisition of Anelixis, Novus entered into a definitive agreement for the sale of non-voting convertible preferred stock (the "Preferred Stock") in a private placement to a group of institutional accredited investors led by BVF Partners L.P., with participation from Cormorant Asset Management, Ecor1 Capital, Logos Capital, Fidelity Management and Research Company, Adage Capital Partners L.P., Woodline Partners LP, Ridgeback Capital, Janus Henderson Investors, and Samsara BioCapital, as well as additional investors. The private placement is expected to result in gross proceeds to Novus of approximately $108 million before deducting placement agent and other offering expenses. The proceeds from the private placement will be used to fund the Company's operations, including to advance Phase 2 clinical trials of AT-1501, a humanized IgG1 anti-CD40L antibody with high affinity for CD40L, in renal transplantation, islet cell transplantation, autoimmune nephritis, and amyotrophic lateral sclerosis (ALS).
"We are excited about AT-1501 and the potential to develop and commercialize the next generation anti-CD40L antibody, a well-validated target with broad therapeutic possibilities," said Keith A. Katkin, Chairman of the Board of Directors of Novus. "After exploring a range of strategic options to maximize shareholder value, we believe this acquisition represents the greatest value creation opportunity for Novus stockholders, and we are confident that we have the management and scientific leadership team to fully realize this opportunity for patients in need of new treatment options."
Leadership & Organization
In addition to the strategic acquisition and private placement, Novus announced its Board of Directors has previously appointed David-Alexandre "DA" C. Gros, M.D. to serve as Chief Executive Officer and Director. Dr. Gros joins Novus from Imbria Pharmaceuticals Inc., where he served as Co-Founder, Chief Executive Officer and Director. Prior to Imbria, Dr. Gros was President and Chief Operating Officer of Neurocrine Biosciences, Inc., Chief Business and Principal Financial Officer of Alnylam Pharmaceuticals, Inc., and Chief Strategy Officer of Sanofi, S.A. Before Sanofi, Dr. Gros held leadership positions in healthcare investment banking at Centerview Partners, LLC, and Merrill Lynch, Pierce, Fenner & Smith, Inc., and in healthcare consulting at McKinsey & Company. Dr. Gros earned a Doctor of Medicine from Johns Hopkins University School of Medicine, a Master of Business Administration from Harvard Business School, and a Bachelor of Arts from Dartmouth College.
"I am both thrilled and humbled to join the Novus management team and Board during this new phase of the company's evolution, as we prepare to initiate multiple Phase 2 trials for AT-1501" said Dr. Gros. "Through this acquisition and financing, we now have the scientific, organizational and financial resources to build upon a deep historical understanding of the CD40/CD40L pathway, as well as Anelixis' preclinical and Phase 1 data, to address the needs of people undergoing organ or cellular transplantation, or living with autoimmune and neurodegenerative diseases."
Joining Dr. Gros on the Novus management team and Board of Directors is Steven Perrin, Ph.D., Founder and Chief Executive Officer of Anelixis, who will take on the role of President and Chief Scientific Officer. Dr. Perrin brings 20 years of drug development experience to Novus, having held R&D positions at the Hoechst-Ariad Genomics Center, Aventis Pharmaceuticals, Inc., and Biogen Idec, Inc. Over the past decade, Dr. Perrin has worked with the ALS Therapy Development Institute to develop the world's largest ALS drug development program, bridging preclinical and clinical programs. Dr. Perrin received a Ph.D. in biochemistry from Boston University Medical Center, where he also started his career as Associate Professor of Medicine, and a Bachelor of Science from Boston College.
"The activation of CD40/CD40L signaling is critical to mediating antibody and cellular inflammatory response. We are developing antibodies to inhibit the activation of this pathway with the hope of offering new treatment modalities for people living with conditions such as autoimmune nephritis and ALS, or those requiring a potentially life-saving transplant," said Dr. Perrin. "I have dedicated my career to developing better medicines for these patients and their families, and I look forward to working with the team to advance these clinical programs."
Concurrent with the acquisition, former Anelixis Chairman of the Board Walter Ogier has been appointed to the Novus Board of Directors. Mr. Ogier has more than 30 years of experience developing therapeutic medical products ranging from pharmaceuticals to medical devices, stem and immune cell therapies, and gene therapies. He has served in multiple CEO roles including Genetix Pharmaceuticals, Inc. (now bluebird bio, Inc.) and Acetylon Pharmaceuticals, Inc., which Celgene Corporation acquired in 2016. In addition to Novus, he serves as a director of Biothera Pharmaceuticals, Inc., Thetis Pharmaceuticals, LLC, and Nemucore Medical Innovations, Inc., and as Board advisor to Kodikaz Therapeutic Solutions, Inc., and ME Therapeutics, Inc.
Novus Board members will also include Keith A. Katkin, Chairman of the Board; Gary A. Lyons; and John S. McBride. The company will continue to maintain its executive offices in Irvine, Calif. and will have research and development facilities in Boston, Mass.
About the Transactions
The acquisition of Anelixis was structured as a stock-for-stock transaction whereby all of Anelixis' outstanding equity interests were exchanged in a merger for a combination of shares of Novus common stock and shares of Preferred Stock. Concurrently with the acquisition of Anelixis, Novus entered into definitive agreements for a PIPE investment with existing and new investors to raise approximately $108 million in which the investors will be issued shares of Preferred Stock at a price of approximately $500 per share (or, $0.50 per share on an as-converted-to-common basis). The PIPE offering is expected to close on September 14, 2020. Subject to stockholder approval, each share of Preferred Stock will, at the option of the holder, be convertible into 1,000 shares of common stock, subject to certain beneficial ownership limitations set by each holder. The acquisition was approved by the Board of Directors of Novus and the equity holders of Anelixis.
Ladenburg Thalmann & Co. Inc. is serving as exclusive financial advisor and Gibson, Dunn & Crutcher LLP is serving as legal counsel to Novus. Goodwin Procter LLP is serving as legal counsel to Anelixis. SVB Leerink is serving as financial advisor and lead placement agent for the private placement, and Noble Life Science Partners, a division of Noble Capital Markets, Inc., is acting as co-placement agent.
Additional details are available in an updated corporate presentation that can be found online at www.novustherapeutics.com.
Webcast Details
Novus will host an audio webcast on Tuesday, September 15, 2020, at 8:30 a.m. EDT to discuss the acquisition. The live audio webcast will be accessible through a direct link and the investor section of www.novustherapeutics.com. To access via phone, please dial (833) 614-1390 (toll-free) or (914) 987-7111 (international) and provide the conference ID 4046285. Please visit the investor section of the Novus website at www.novustherapeutics.com for the archived webcast and for more information on the acquisition.
About AT-1501
AT-1501 is a humanized IgG1 anti-CD40L antibody with high affinity for CD40L, a well-validated target with broad therapeutic potential. The CD40/CD40L pathway plays a central role in generating pro-inflammatory responses in autoimmune disease, allograft transplant rejection, and neuroinflammation. In a Phase 1 safety study of healthy volunteers and patients with ALS, AT-1501 was well tolerated at all doses tested.
About Novus Therapeutics
Novus Therapeutics, Inc. is a clinical stage biotechnology company using its expertise in targeting the CD40L pathway to develop potential treatments for people requiring an organ or cell-based transplant, and for people with autoimmune and neurodegenerative disease. Novus is headquartered in Irvine, Calif. For more information, please visit the company's website at www.novustherapeutics.com.
Follow Novus Therapeutics on social media: @Novus_Thera and LinkedIn.
Notice of Issuance of Inducement Grants
Pursuant to their employment agreements, Drs. Gros and Perrin have been awarded options to purchase a total of 18,279 and 7,857 shares of Preferred Stock, respectively, subject to time-based vesting (the "Inducement Grants"). The Inducement Grants have an exercise price of $500 per share of Preferred Stock, which is equal to the price at which the Preferred Stock is being offered and sold in the PIPE financing and represents (on an as-converted basis) a premium of approximately 30% over the last reported closing price of the Novus common stock prior to grant. The Inducement Grants have been approved by the Novus Board of Directors and the Compensation Committee of the Board of Directors. The Inducement Grants will be issued outside of the Company's stockholder-approved equity incentive plans as an inducement grant in accordance with Nasdaq Listing Rule 5635(c)(4).
Forward-Looking Statements
This press release contains forward-looking statements that involves substantial risks and uncertainties. Any statements about the company's future expectations, plans and prospects, including statements about its strategy, future operations, development of its product candidates, and other statements containing the words "believes," "anticipates," "plans," "expects," "estimates," "intends," "predicts," "projects," "targets," "looks forward," "could," "may," and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, although not all forward-looking statements include such identifying words. Forward-looking statements include, but are not limited to statements regarding: risks related to market conditions; expectations regarding the timing for the commencement of future clinical trials; expectations regarding the success of clinical trials; the rate and degree of market acceptance and clinical utility of the company's products; the company's estimates regarding expenses and cash runway; and the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company's actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the SEC, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200914005852/en/
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Resolution of middle ear effusion in 56% of OP0201 vs. 38% of placebo patients (p=0.07)
Company engages financial advisors to explore strategic options
Novus Therapeutics, Inc. (NASDAQ:NVUS), a specialty pharmaceutical company focused on developing products for patients with disorders of the ear, nose, and throat, today announced topline results from the company's exploratory phase 2a clinical trial of OP0201 in acute otitis media (study C-006).
Study C-006 was a phase 2a, single center, double-blind, randomized, placebo-controlled, parallel group clinical trial to assess the safety, tolerability, and efficacy of 20 mg per day intranasal OP0201 as an adjunct therapy to oral antibiotic in the treatment of acute otitis media in infants and children 6 to 24 months of age. Subjects were treated twice-daily for 10 days and followed up to one month. Post-randomization visits occurred between days 4-6 (visit 2), days 12-14 (visit 3), and days 28-30 (visit 4). The primary efficacy endpoints included resolution of bulging tympanic membrane at visit 2 and resolution of middle ear effusion at visit 3.
"Although we did not achieve statistical significance for the primary efficacy endpoints, we are encouraged with the statistical trend that favored the OP0201 treatment group with regard to resolution of middle ear effusion," said Dr. Catherine Turkel, President and Head of Global R&D for Novus Therapeutics. "Middle ear effusion is a key diagnostic criterion for otitis media disorders, including acute otitis media. When middle ear effusion persists after an episode of acute otitis media, it may make children susceptible to more serious otitis media disorders, such as recurrent acute otitis media and/or chronic otitis media with effusion. These topline results, including evidence supporting the safety and tolerability in infants and children, support continued development of our surfactant-based nasal aerosol. We are grateful to the young patients, their parents/caregivers, and the investigators who supported this clinical trial," concluded Dr. Turkel.
Primary Efficacy Endpoints (Modified Intent-to-Treat Population)
Placebo
(N=46)OP0201
(N=54)Bulging tympanic membrane at visit 2
No bulging tympanic membrane (standard error)
47.3% (8.66)
51.0% (7.69)
p-value
p=0.62
Middle ear effusion at visit 3
No middle ear effusion (standard error)
37.9% (8.44)
55.9% (8.29)
p-value
p=0.07
Summary of Treatment-Emergent Adverse Events (TEAE) (Safety Population)
Placebo
(N=48)OP0201
(N=55)All Subjects
(N=103)Subjects with any TEAE
36 (75.0%)
48 (87.3%)
84 (81.6%)
Subjects with 1 or more TEAE
related to treatment
11 (22.9%)
17 (30.9%)
28 (27.2%)
TEAE resulting in interruption
or discontinuation of treatment
1 (2.1%)
0 (0.0%)
1 (1.0%)
Serious TEAE
1 (2.1%)
0 (0.0%)
1 (1.0%)
The company also today announced that the Board of Directors has initiated a process to explore strategic options intended to maximize shareholder value. The company has engaged financial advisors, including Ladenburg Thalmann & Co. Inc., to assist in the review and evaluation of strategic options. Such options may result in a financing to continue development of the surfactant-based nasal aerosol, a company sale, merger, asset sale, in-license, out-license, or other business transaction.
"We recognize that continued development of our surfactant-based nasal aerosol will require significant time and capital," said Gregory J. Flesher, CEO of Novus Therapeutics, Inc. "We must fund the company for several years in order to complete additional formulation and device development, initiate the next otitis media clinical trial, and ultimately deliver clinical data. Given our current valuation relative to our capital needs, and given the operational challenges with the ongoing COVID-19 pandemic, we believe that exploration of all options is the appropriate course of action," concluded Mr. Flesher.
There can be no assurance that the exploration of strategic options will result in the company entering or completing any transaction. Novus does not intend to make any further disclosures regarding this process unless and until a specific course of action is approved by the Board of Directors.
About Novus Therapeutics
Novus Therapeutics, Inc. (Novus) is a specialty pharmaceutical company focused on developing products for patients with disorders of the ear, nose, and throat. The Company has two platform technologies, each with the potential to be developed for multiple indications. Novus' lead program (OP0201) is a surfactant-based nasal aerosol drug-device combination product candidate being developed as a potential first-in-class treatment option for patients at risk for, or with, otitis media, which is middle ear inflammation and effusion with or without infection. Globally, otitis media affects more than 700 million adults and children every year, with over half of the cases occurring in children under five years of age. Otitis media is one of the most common disorders seen in pediatric practice, and in the U.S. is a leading cause of health care visits and the most frequent reason children are prescribed antibiotics or undergo surgery. Novus also has a foam-based drug delivery technology platform (OP01xx), which may be developed in the future to deliver drugs into the ear, nasal, and sinus cavities. For more information, please visit novustherapeutics.com.
Forward-Looking Statements
This press release contains forward‐looking statements that involves substantial risks and uncertainties. Any statements about the company's future expectations, plans and prospects, including statements about its strategy, future operations, development of its product candidates, and other statements containing the words "believes," "anticipates," "plans," "expects," "estimates," "intends," "predicts," "projects," "targets," "looks forward," "could," "may," and similar expressions, constitute forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, although not all forward‐looking statements include such identifying words. Forward‐looking statements include, but are not limited to statements regarding: risks related to market conditions, including the Company's ability to raise capital or successfully pursue a strategic transaction; expectations regarding the timing for the commencement and completion of product development and formulation, as well as future clinical trials; expectations regarding the success of clinical trials; the rate and degree of market acceptance and clinical utility of the company's products; the company's manufacturing capabilities and strategy; the company's intellectual property position and strategy; the company's ability to identify additional products or product candidates with significant commercial potential; the company's estimates regarding expenses, future revenue, capital requirements and needs for additional financing; developments relating to the company's competitors and industry; the impact of government laws and regulations; and the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward‐looking statements as a result of various important factors, including: the ability to develop a formulation suitable for future clinical trials; the sufficiency of the company's cash resources; the ability to obtain necessary regulatory and ethics approvals to commence additional clinical trials; whether data from early clinical trials will be indicative of the data that will be obtained from future clinical trials; whether the results of clinical trials will warrant submission for regulatory approval of any investigational product; whether any such submission will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies and, if we are able to obtain such approval for an investigational product, whether it will be successfully distributed and marketed. These risks and uncertainties, as well as other risks and uncertainties that could cause the company's actual results to differ significantly from the forward‐looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the SEC, which can be found at www.sec.gov. Any forward‐looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward‐looking statements, whether as a result of new information, future events or otherwise.
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Novus Therapeutics, Inc. (NASDAQ:NVUS), a specialty pharmaceutical company focused on developing products for patients with disorders of the ear, nose, and throat, today announced financial results for the quarter ended March 31, 2020.
Operational Highlights
- Raised gross proceeds of approximately $5.8 million through the exercise of outstanding warrants in January 2020
- Completed enrollment of OP0201 phase 2a clinical trial in acute otitis media (study C-006) in March 2020
Upcoming Milestones
- Topline results of OP0201 phase 2a clinical trial in acute otitis media (study C-006) are expected in early June 2020
"During the quarter, we accomplished two key objectives of extending our cash runway and completing enrollment of study C-006, our exploratory phase 2a clinical trial of OP0201 in infants and children with acute otitis media," said Gregory J. Flesher, CEO of Novus Therapeutics, Inc. "We now have cash through year-end 2020 and all patients have subsequently completed the trial. We look forward to sharing the topline result of study C-006 in the coming weeks," concluded Mr. Flesher.
Financial Results for the Three Months Ended March 31, 2020
The company reported a net loss of $8.2 million, or $0.47 per share, for the three months ended March 31, 2020, compared to a net loss of $4.9 million, or $0.52 per share, for the same period in 2019. The company had $11.8 million in cash and cash equivalents as of March 31, 2020.
Research and development (R&D) expenses were $1.6 million for the three months ended March 31, 2020, compared to $3.0 million for the same period in 2019. The decrease in R&D expenses were primarily attributed to reductions of $806,000 in clinical, $706,000 in CMC, $46,000 in travel and meeting expenses, and $3,000 in miscellaneous operating costs. The decrease was partially offset by increases of $17,000 in personnel costs, $85,000 in consulting costs, and $118,000 in stock-based compensation.
General and administrative (G&A) expenses were $1.7 million for the three months ended March 31, 2020, compared to $1.9 million for the same period in 2019. The decrease in G&A expenses were primarily attributed to reductions of $257,000 in public company costs, $107,000 in litigation costs, $20,000 in general operating costs, and $15,000 in travel and meeting expenses. The decrease was partially offset by increases of $136,000 in personnel costs and $107,000 in stock-based compensation.
During the quarter, the Company recognized a non-operating non-cash warrant inducement expense of $4.8 million.
About Study C-006
Study C-006 is a phase 2a, single center, double-blind, randomized, placebo-controlled, parallel group clinical trial to assess the safety, tolerability, and efficacy of 20 mg per day intranasal OP0201 as an adjunct therapy to oral antibiotic in the treatment of acute otitis media in infants and children aged 6 to 24 months. Subjects were treated twice-daily for 10 days and followed for up to 20 additional days after treatment has been completed (up to 30-days in total). The study was designed to detect a 25% treatment effect over placebo in at least one of the two primary efficacy endpoints. The primary efficacy endpoints include resolution of bulging tympanic membrane 4-6 days after initiation of treatment (visit 2) and resolution of middle ear effusion 12-14 days after initiation of treatment (visit 3). Please see clinicaltrials.gov for additional information (identifier NCT03818815).
About Novus Therapeutics
Novus Therapeutics, Inc. (Novus) is a specialty pharmaceutical company focused on developing products for patients with disorders of the ear, nose, and throat. The Company has two platform technologies, each with the potential to be developed for multiple indications. Novus' lead program (OP0201) is a surfactant-based nasal aerosol drug-device combination product candidate being developed as a potential first-in-class treatment option for patients at risk for, or with, otitis media (OM), which is middle ear inflammation and effusion with or without infection. Globally, OM affects more than 700 million adults and children every year, with over half of the cases occurring in children under five years of age. OM is one of the most common disorders seen in pediatric practice, and in the U.S. is a leading cause of health care visits and the most frequent reason children are prescribed antibiotics or undergo surgery. Novus also has a foam-based drug delivery technology platform (OP01xx), which may be developed in the future to deliver drugs into the ear, nasal, and sinus cavities. For more information, please visit novustherapeutics.com.
Forward-Looking Statements
This press release contains forward‐looking statements that involves substantial risks and uncertainties. Any statements about the company's future expectations, plans and prospects, including statements about its strategy, future operations, development of its product candidates, and other statements containing the words "believes," "anticipates," "plans," "expects," "estimates," "intends," "predicts," "projects," "targets," "looks forward," "could," "may," and similar expressions, constitute forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, although not all forward‐looking statements include such identifying words. Forward‐looking statements include, but are not limited to statements regarding: risks related to market conditions, the completion of the common stock and warrant financing, including the satisfaction of the closing conditions, and the use of anticipated proceeds; expectations regarding the timing for the commencement and completion of product development or clinical trials, including the ongoing OP0201 clinical trial; expectations regarding the success of clinical trials; the rate and degree of market acceptance and clinical utility of the company's products; the company's commercialization, marketing and manufacturing capabilities and strategy; the company's intellectual property position and strategy; the company's ability to identify additional products or product candidates with significant commercial potential; the company's estimates regarding expenses, future revenue, capital requirements and needs for additional financing; developments relating to the company's competitors and industry; and the impact of government laws and regulations. Actual results may differ materially from those indicated by such forward‐looking statements as a result of various important factors, including: the ability to develop commercially viable product formulations; the sufficiency of the company's cash resources; the ability to obtain necessary regulatory and ethics approvals to commence additional clinical trials; whether data from early clinical trials will be indicative of the data that will be obtained from future clinical trials; whether the results of clinical trials will warrant submission for regulatory approval of any investigational product; whether any such submission will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies and, if we are able to obtain such approval for an investigational product, whether it will be successfully distributed and marketed. These risks and uncertainties, as well as other risks and uncertainties that could cause the company's actual results to differ significantly from the forward‐looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the SEC, which can be found at www.sec.gov. Any forward‐looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward‐looking statements, whether as a result of new information, future events or otherwise.
NOVUS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
March 31,
December 31,
2020
2019
(Unaudited)
ASSETS
Current assets:
Cash
$
11,785
$
8,791
Prepaid expenses and other current assets
1,088
1,180
Total current assets
12,873
9,971
Property and equipment, net
3
5
Operating lease asset, net
272
316
Other assets
572
639
Total assets
$
13,720
$
10,931
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable
$
741
$
329
Current operating lease liability
184
180
Accrued expenses and other liabilities
953
813
Total current liabilities
1,878
1,322
Non-current operating lease liability
97
144
Total liabilities
1,975
1,466
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.001 par value, 5,000,000 shares authorized at March 31, 2020 and December 31, 2019; 3,796 and 0 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively
—
—
Common stock, $0.001 par value, 200,000,000 shares authorized at March 31, 2020 and December 31, 2019; 16,069,562 and 12,967,338 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively
16
13
Additional paid-in capital
77,488
67,034
Accumulated deficit
(65,759
)
(57,582
)
Total stockholders' equity
11,745
9,465
Total liabilities and stockholders' equity
$
13,720
$
10,931
NOVUS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
(Unaudited)
For the Three Months
Ended March 31,
2020
2019
Operating expenses
Research and development
$
1,648
$
2,989
General and administrative
1,730
1,886
Total operating expenses
3,378
4,875
Loss from operations
(3,378
)
(4,875
)
Other income (expense), net
30
(6
)
Warrant inducement expense
(4,829
)
—
Net loss and comprehensive loss
$
(8,177
)
$
(4,881
)
Net loss per share, basic and diluted
$
(0.47
)
$
(0.52
)
Weighted-average common shares outstanding, basic and diluted
17,267,123
9,427,073
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Data from the fully enrolled phase 2a efficacy study in infants and children with acute otitis media to be announced by early June 2020
Novus Therapeutics, Inc. (NASDAQ:NVUS), a specialty pharmaceutical company focused on developing products for patients with disorders of the ear, nose, and throat, today announced financial results for the fourth quarter and full-year ended December 31, 2019.
"We made steady progress in the OP0201 development program during 2019. During the year, the company generated data from three phase 1 safety studies, which established safety and tolerability of single and multiple doses of OP0201 in both healthy adult volunteers and in adults with acute otitis media. We also initiated our first phase 2a efficacy study in patients with acute otitis media. Finally, we completed a successful meeting with the U.S. FDA in which we gained alignment on study design and endpoints for a phase 2 study in patients with chronic otitis media with effusion," said Gregory J. Flesher, CEO of Novus Therapeutics.
"Looking ahead, we expect to announce data from the fully enrolled phase 2a efficacy study in infants and children with acute otitis media in the coming months," concluded Mr. Flesher.
Financial Results for the Three Months Ended December 31, 2019
The company reported a net loss of $4.1 million, or $0.32 per share, for the three months ended December 31, 2019, compared to a net loss of $4.6 million, or $0.49 per share, for the same period in 2018.
Research and development (R&D) expenses were $1.3 million for the three months ended December 31, 2019, compared to $2.7 million for the same period in 2018. The decrease in R&D expenses of $1.4 million is primarily attributed to a decrease of clinical and formulation development costs for OP0201 of $612,000 and $432,000, respectively, as well as savings in personnel costs of $431,000, stock-based compensation of $59,000, and travel and meetings expense of $36,000. The decreases were partially offset by an increase in consulting services of $163,000.
General and administrative (G&A) expenses were $1.0 million for the three months ended December 31, 2019, compared to $1.8 million for the same period in 2018. The decrease in G&A expenses of $870,000 is primarily attributed to a decrease of $556,000 in personnel costs, $439,000 in stock-based compensation, and costs associated with operating a publicly traded company of $141,000. The decreases were partially offset by an increase in litigation costs of $266,000.
Financial Results for the Year Ended December 31, 2019
Novus reported a net loss of $16.0 million, or $1.36 per share, for the year ended December 31, 2019, compared to a net loss of $14.1 million, or $1.56 per share, for the same period in 2018.
R&D expenses were $8.1 million for the year ended December 31, 2019, compared to $6.8 million for the same period in 2018. The increase in R&D expenses of $1.3 million for the year ended December 31, 2019 was primarily due to an increase in clinical development costs of $1.8 million and an increase in consulting costs of $131,000 related to the advancement of our OP0201 programs, as well as an increase in stock-based compensation of $94,000. The increases were offset by a decrease in formulation and device development costs of $474,000, and decreases in personnel and travel related costs of $163,000 and $112,000, respectively. As we advance our clinical development programs, R&D expenses are expected to increase.
G&A expenses were $6.1 million for the year ended December 31, 2019, compared to $7.2 million for the same period in 2018. The decrease in G&A expenses of $1.2 million for the year ended December 31, 2019 was primarily due to a reduction of $590,000 in administrative costs associated with operating a public company, as well as decreases in personnel costs and stock-based compensation of $163,000 and $330,000, respectively. Additionally, general operating costs decreased $87,000 and travel related expenses decreased $21,000. The decreases were offset by an increase in litigation costs of $4,000.
The company had approximately $8.8 million in cash and cash equivalents as of December 31, 2019, compared to approximately $10.8 million in cash and cash equivalents as of September 30, 2019.
In January 2020, the company received gross proceeds of approximately $5.8 million through the exercise of warrants that were issued in a private placement in May 2019. The company's cash and cash equivalents, including the cash received from warrants, is expected to fund operations through year end 2020.
About Novus Therapeutics
Novus Therapeutics, Inc. (Novus) is a specialty pharmaceutical company focused on developing products for patients with disorders of the ear, nose, and throat. The Company has two platform technologies, each with the potential to be developed for multiple indications. Novus' lead program (OP0201) is a surfactant-based nasal aerosol drug-device combination product candidate being developed as a potential first-in-class treatment option for patients at risk for, or with, otitis media (OM), which is middle ear inflammation and effusion with or without infection. Globally, OM affects more than 700 million adults and children every year, with over half of the cases occurring in children under five years of age. OM is one of the most common disorders seen in pediatric practice, and in the U.S. is a leading cause of health care visits and the most frequent reason children are prescribed antibiotics or undergo surgery. Novus also has a foam-based drug delivery technology platform (OP01xx), which may be developed in the future to deliver drugs into the ear, nasal, and sinus cavities. For more information, please visit novustherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements that involves substantial risks and uncertainties. Any statements about the company's future expectations, plans and prospects, including statements about its strategy, future operations, development of its product candidates, and other statements containing the words "believes," "anticipates," "plans," "expects," "estimates," "intends," "predicts," "projects," "targets," "looks forward," "could," "may," and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, although not all forward-looking statements include such identifying words. Forward-looking statements include, but are not limited to statements regarding: risks related to market conditions, the completion of the common stock and warrant financing, including the satisfaction of the closing conditions, and the use of anticipated proceeds; expectations regarding the timing for the commencement and completion of product development or clinical trials, including the ongoing OP0201 clinical trial; expectations regarding the success of clinical trials; the rate and degree of market acceptance and clinical utility of the company's products; the company's commercialization, marketing and manufacturing capabilities and strategy; the company's intellectual property position and strategy; the company's ability to identify additional products or product candidates with significant commercial potential; the company's estimates regarding expenses, future revenue, capital requirements and needs for additional financing; developments relating to the company's competitors and industry; and the impact of government laws and regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the ability to develop commercially viable product formulations; the sufficiency of the company's cash resources; the ability to obtain necessary regulatory and ethics approvals to commence additional clinical trials; whether data from early clinical trials will be indicative of the data that will be obtained from future clinical trials; whether the results of clinical trials will warrant submission for regulatory approval of any investigational product; whether any such submission will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies and, if we are able to obtain such approval for an investigational product, whether it will be successfully distributed and marketed. These risks and uncertainties, as well as other risks and uncertainties that could cause the company's actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the SEC, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
NOVUS THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
December 31,
2019
2018
ASSETS
Current assets:
Cash and cash equivalents
$
8,791
$
12,972
Prepaid expenses and other current assets
1,180
1,304
Total current assets
9,971
14,276
Property and equipment, net
5
14
Operating lease asset, net
316
—
Goodwill
—
1,867
Other assets
639
869
Total assets
$
10,931
$
17,026
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable
$
329
$
689
Current operating lease liability
180
—
Accrued expenses and other liabilities
813
1,845
Total current liabilities
1,322
2,534
Non-current operating lease liability
144
—
Total liabilities
1,466
2,534
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.001 par value, 5,000,000 shares authorized and none issued and outstanding at December 31, 2019 and 2018
—
—
Common stock, $0.001 par value, 200,000,000 shares authorized at December 31, 2019 and 2018; 12,967,338 and 9,422,143 shares issued and outstanding at December 31, 2019 and 2018, respectively
13
9
Additional paid-in capital
67,034
56,054
Accumulated deficit
(57,582
)
(41,571
)
Total stockholders' equity
9,465
14,492
Total liabilities and stockholders' equity
$
10,931
$
17,026
NOVUS THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
Year Ended
December 31,2019
2018
Operating expenses
Research and development
$
8,128
$
6,817
General and administrative
6,056
7,243
Goodwill impairment
1,867
—
Total operating expenses
16,051
14,060
Loss from operations
(16,051
)
(14,060
)
Other income (expense), net
40
(5
)
Net loss and other comprehensive loss
$
(16,011
)
$
(14,065
)
Net loss per share, basic and diluted
$
(1.36
)
$
(1.56
)
Weighted-average common shares outstanding, basic and diluted
11,793,125
9,005,352
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