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These 2 “Strong Buy” Penny Stocks Could Go Boom, Says Roth Capital
TipRanks · 2d ago
Applied Genetic Technologies (AGTC) Reports Q1 Loss, Misses Revenue Estimates
Applied Genetic Technologies (AGTC) delivered earnings and revenue surprises of -17.65% and -100.00%, respectively, for the quarter ended September 2020. Do the numbers hold clues to what lies ahead for the stock?
Zacks · 11/16 22:35
Applied Genetic Tech Q1 EPS $(0.60) Up From $(0.64) YoY
Applied Genetic Tech (NASDAQ:AGTC) reported quarterly losses of $(0.60) per share. This is a 6.25 percent increase over losses of $(0.64) per share from the same period last year.
Benzinga · 11/16 21:25
AGTC Announces Financial Results and Business Update for the Quarter Ended September 30, 2020
Applied Genetic Technologies Corporation (Nasdaq: AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, today announced financial results for the quarter ended September 30, 2020. The Company is also providing an update on its ongoing clinical trials in patients with X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM).
GlobeNewswire · 11/16 21:06
AGTC Announces Financial Results and Business Update for the Quarter Ended September 30, 2020
GAINESVILLE, Fla. and CAMBRIDGE, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Applied Genetic Technologies Corporation (Nasdaq: AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, today announced financial results for the quarter ended September 30, 2020. The Company is also providing an update on its ongoing clinical trials in patients with X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM). “The updated XLRP data that we reported last week provide evidence that our XLRP product candidate provides durable improvements in visual sensitivity and visual acuity over a wide dose range and has a favorable safety profile,” said Sue Washer, President and CEO of AGTC. “Data publicly reported by our competitors this weekend at the American Academy of Ophthalmology (AAO) Annual Meeting further increase our confidence that we have the industry-leading XLRP program. We are on track to initiate enrollment in the planned Phase 1/2 expansion trial (Skyline) in 4Q 2020 and the Phase 2/3 trial (Vista) in 1Q 2021. Additionally, new data from our ongoing ACHM trials have provided important insights for the potential development of our ACHM product candidates. We are pleased that we met our goal of reporting out data from all three ongoing clinical trials in 4Q 2020 and are now focused on advancing the Skyline and Vista trials for XLRP as rapidly as possible.”XLRP On November 11, 2020, the Company reported additional positive data from its Phase 1/2 clinical trial in patients with XLRP that indicated durable improvements observed in visual sensitivity and visual acuity over a wide dose range with a favorable safety profile out to month 12 in two of the dose groups. Based on comparison to publicly released data reported by competitors this weekend at the AAO Annual Meeting, the Company believes it has a best-in-class product that may provide significant benefit to patients with XLRP.ACHM Today the Company is reporting 12-month ACHM data in the original three dose groups (low, medium and high), as well as 6- to 9-month data at two higher dose groups (higher and highest groups in the January 2020 data release), and data for 6 pediatric subjects (three in each study; 12-17 years old) at the first of three planned dose levels. While some patients showed improvements in at least one measure of visual function, no consistent sustained improvements were observed based on current assessments within the dose groups tested. However, anecdotal statements and assessments from patient-reported outcome surveys continue to provide the Company with confidence that patients are subjectively experiencing improved vision. Based on the characteristics of ACHM, the Company continues to believe that longer treatment durations and/or focusing on younger patients may be necessary to fully realize the potential of this treatment. To this end, the Company intends to complete the planned enrollment of pediatric patients in the two highest dose groups of the ongoing ACHM clinical trials and has amended the study protocol to allow enrollment of patients as young as four years of age and to include additional assessments such as functional MRI (fMRI) and improved color brightness tests.Financial Results for the Three Months Ended September 30, 2020R&D Expenses: Research and development expenses were $11.6 million for the quarter ended September 30, 2020 compared to $8.6 million during the comparable period in the prior fiscal year. The increase of $3.0 million was primarily due to increased external XLRP spending (primarily related to Skyline and Vista activities) and increased external spending related to ACHM (primarily due to patient enrollment and deployment of the Company’s mobile vision center). These expenses were partially offset by a reduction in employee-related costs and decreased external research and discovery spending on other programs.G&A Expenses:   General and administrative expenses were $3.4 million for the quarter ended September 30, 2020 compared to $3.3 million during the comparable period in the prior fiscal year. The increase of $0.1 million was primarily due to higher fees from outside legal counsel in the 2020 period, partially offset by lower employee-related expenses and share-based compensation expense.Interest Expense: Interest expense increased by $0.3 million during the quarter ended September 30, 2020 when compared to the comparable period in the prior fiscal year due to the loan agreement that the Company entered into on June 30, 2020.Net Loss: The Company’s net loss was $15.4 million and $11.6 million for the quarters ended September 30, 2020 and 2019, respectively.Financial Guidance:   As of September 30, 2020, the Company’s cash, cash equivalents and investments totaled $66.6 million. We believe that these funds will be sufficient to allow the Company to generate data from its ongoing clinical programs, initiate the Skyline and Vista studies and fund currently planned research and discovery programs into the fourth quarter of calendar year 2021.About AGTC AGTC is a clinical-stage biotechnology company developing genetic therapies for people with rare and debilitating ophthalmic, otologic and central nervous system (CNS) diseases. AGTC is a leader in designing and constructing all critical gene therapy elements and bringing them together to develop customized therapies that address real patient needs. The Company’s most advanced clinical programs leverage its best-in-class technology platform to potentially improve vision for patients with an inherited retinal disease. AGTC has active clinical trials in X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM CNGB3 & ACHM CNGA3). Its preclinical programs build on the Company’s industry-leading AAV manufacturing technology and scientific expertise. AGTC is advancing multiple important pipeline candidates to address substantial unmet clinical need in optogenetics, otology and CNS disorders.About XLRP XLRP is an inherited condition that causes progressive vision loss in boys and young men. Characteristics of the disease include night blindness in early childhood and progressive constriction of the visual field. In general, XLRP patients experience a gradual decline in visual acuity over the disease course, which results in legal blindness around the 4th or 5th decade of life. AGTC was granted U.S. Food and Drug Administration (FDA) orphan drug designation in 2017, as well as European Commission orphan medicinal product designation in 2016, for its gene therapy product candidate to treat XLRP caused by mutations in the RPGR gene.About ACHM ACHM is an inherited retinal disease, which is present from birth and is characterized by the lack of cone photoreceptor function. The condition results in markedly reduced visual acuity, extreme light sensitivity causing day blindness, and complete loss of color discrimination. Best-corrected visual acuity in persons affected by ACHM, even under subdued light conditions, is usually about 20/200, a level at which people are considered legally blind.Forward-Looking Statements This release contains forward-looking statements that reflect AGTC's plans, estimates, assumptions and beliefs, including statements regarding the projected timing for its planned Vista (Phase 2/3 XLRP) and Skyline (Expanded Phase 1/2 XLRP) clinical trials, the timing for reporting data in both its Skyline and Vista trials and the potential of its ACHM clinical programs. Forward-looking statements include information concerning possible or assumed future results of operations, financial guidance, business strategies and operations, preclinical and clinical product development and regulatory progress, potential growth opportunities, potential market opportunities, the effects of competition and the impact of the COVID-19 pandemic, including the impact on its ability to enroll patients. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "anticipates," "believes," "could," "seeks," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" or similar expressions and the negatives of those terms. Actual results could differ materially from those discussed in the forward-looking statements, due to a number of important factors. Risks and uncertainties that may cause actual results to differ materially include, among others: gene therapy is still novel with only a few approved treatments so far; AGTC cannot predict when or if it will obtain regulatory approval to commercialize a product candidate or receive reasonable reimbursement; uncertainty inherent in clinical trials and the regulatory review process; risks and uncertainties associated with drug development and commercialization; the direct and indirect impacts of the ongoing COVID-19 pandemic on the Company’s business, results of operations, and financial condition; factors that could cause actual results to differ materially from those described in the forward-looking statements are set forth under the heading "Risk Factors" in AGTC’s most recent annual and subsequently filed quarterly reports filed with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent management's plans, estimates, assumptions and beliefs only as of the date of this release. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.  APPLIED GENETIC TECHNOLOGIES CORPORATION BALANCE SHEETS (Unaudited)           September 30,  June 30,  In thousands, except per share data 2020  2020  ASSETS         Current assets:         Cash and cash equivalents $31,570  $38,463  Investments  34,987   41,995  Prepaid and other current assets  1,984   2,506  Total current assets  68,541   82,964  Property and equipment, net  4,314   4,311  Intangible assets, net  1,136   1,098  Investment in Bionic Sight, LLC  8,067   8,096  Right-of-use assets – operating leases  3,337   3,422  Right-of-use asset – finance lease  69   80  Other assets  151   348  Total assets $85,615  $100,319  LIABILITIES AND STOCKHOLDERS’ EQUITY         Current liabilities:         Accounts payable $1,654  $1,355  Accrued and other liabilities  10,246   10,502  Lease liabilities – operating  1,063   1,058  Lease liability – finance  49   48  Total current liabilities  13,012   12,963  Lease liabilities – operating, net of current portion  3,898   4,070  Lease liability – finance, net of current portion  26   38  Long-term debt, net of debt discounts and deferred financing fees  9,759   9,677  Other liabilities  2,718   2,555  Total liabilities  29,413   29,303  Stockholders’ equity:         Preferred stock, par value $0.001 per share, 5,000 shares authorized; no shares issued and outstanding  —   —  Common stock, par value $0.001 per share, 150,000 shares authorized; 25,901 and 25,813 shares issued; 25,860 and 25,793 shares outstanding at September 30, 2020 and June 30, 2020, respectively  25   25  Additional paid-in capital  253,208   252,519  Treasury stock at cost; 41 and 20 shares at September 30, 2020 and June 30, 2020, respectively  (211)  (88) Accumulated deficit  (196,820)  (181,440) Total stockholders’ equity  56,202   71,016  Total liabilities and stockholders’ equity $85,615  $100,319    APPLIED GENETIC TECHNOLOGIES CORPORATION STATEMENTS OF OPERATIONS (Unaudited)     Three Months    Ended September 30,  In thousands, except per share data 2020  2019  Revenue:         Collaboration revenue $—  $—  Grant revenue  —   —  Total revenue  —   —  Operating expenses:         Research and development  11,626   8,642  General and administrative and other  3,436   3,348  Total operating expenses  15,062   11,990  Loss from operations  (15,062)  (11,990) Other income (expense), net:         Investment income, net  64   446  Interest expense  (332)  (2) Total other income (expense), net  (268)  444  Loss before provision for income taxes  (15,330)  (11,546) Provision for income taxes  21   21  Loss before equity in net losses of an affiliate  (15,351)  (11,567) Equity in net losses of an affiliate  (29)  (10) Net loss $(15,380) $(11,577) Weighted average shares outstanding:         Basic  25,818   18,212  Diluted  25,818   18,212  Net loss per common share:         Basic $(0.60) $(0.64) Diluted $(0.60) $(0.64)           IR/PR CONTACTS:  David Carey (IR) or Glenn Silver (PR) Lazar FINN Partners T: (212) 867-1768 or (646) 871-8485 david.carey@finnpartners.com or glenn.silver@finnpartners.comCorporate Contacts: Bill Sullivan Chief Financial Officer Applied Genetic Technologies Corporation T: (617) 843-5728 bsullivan@agtc.comStephen Potter Chief Business Officer Applied Genetic Technologies Corporation T: (617) 413-2754 spotter@agtc.com
GlobeNewswire · 11/16 21:05
After Yesterday's Decline of 8.14%, Applied Genetic Offers Investors Better Value
Applied Genetic (NASDAQ:AGTC) traded in a range yesterday that spanned from a low of $5.07 to a high of $5.35. Yesterday, the shares fell 8.1%, which took the trading range below the 3-day low of $5.21 on volume of 124,000 shares. Often times after large one-day declines, short-term traders may play for some degree of mean reversion.
Comtex SmarTrend(R) · 11/11 17:38
AGTC to Host Conference Call on November 11 at 8:00 am ET to Discuss XLRP 12-Month Data and Full 6-Month Data from Highest Dose Groups of its Ongoing Phase 1/2 Clinical Trial
Applied Genetic Technologies Corporation (Nasdaq: AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, today announced that it plans to release 12-month data for Groups 1 through 4 evaluating durability of effect and continued safety and interim data of Groups 5 and 6 evaluating safety and efficacy at higher doses for its Phase 1/2 clinical trial in patients with X-linked Retinitis Pigmentosa (XLRP) on November 11, 2020. AGTC management will host a conference call and webcast with accompanying slides to review the data and provide a general update on the XLRP trial beginning at 8:00am Eastern Time on the same date.
GlobeNewswire · 11/10 21:08
American Gilsonite to Post 3rd Quarter 2020 Financial Results and Announces Conference Call Details
, /PRNewswire/ -- American Gilsonite Company (the "Company" or "AGC"), the world's principal commercial miner and processor of uintaite, the unique mineral marketed under its trademark name "Gilsonite," today announced that it will post financial and operating results for the quarter ended to the Company's Intralinks site on .
PR Newswire - PRF · 10/29 13:00
AGTC to Participate in Cantor Fitzgerald Virtual Panel: Key Considerations for Gene Therapy Manufacturing and Platforms
Applied Genetic Technologies Corporation (Nasdaq: AGTC), a biotechnology company focused on developing adeno-associated virus (AAV) based gene therapies for the treatment of rare inherited diseases, today announced that Sue Washer, President & Chief Executive Officer, and Dave Knop, PhD, Vice President, Process Development and Manufacturing, will participate in the Cantor Fitzgerald "Key Considerations for Gene Therapy Manufacturing and Platforms" virtual panel at 10:00 a.m. ET on Wednesday, October 28, 2020.
GlobeNewswire · 10/21 11:00
AGTC to Present at Upcoming Virtual Conferences
Applied Genetic Technologies Corporation (Nasdaq: AGTC), a biotechnology company focused on developing adeno-associated virus (AAV) based gene therapies for the treatment of rare inherited diseases, today announced that management will participate in the following virtual conferences:
GlobeNewswire · 10/08 11:00
Could The Applied Genetic Technologies Corporation (NASDAQ:AGTC) Ownership Structure Tell Us Something Useful?
The big shareholder groups in Applied Genetic Technologies Corporation (NASDAQ:AGTC) have power over the company...
Simply Wall St. · 09/12 14:20
Applied Genetic Shares Up 55.0% Since SmarTrend's Buy Recommendation (AGTC)
SmarTrend identified an Uptrend for Applied Genetic (NASDAQ:AGTC) on March 24th, 2020 at $3.29. In approximately 6 months, Applied Genetic has returned 55.02% as of today's recent price of $5.10.
Comtex SmarTrend(R) · 09/10 18:01
Mid-Afternoon Market Update: Nasdaq Surges 300 Points; Slack Shares Plunge
Toward the end of trading Wednesday, the Dow traded up 2.32% to 28140.09 while the NASDAQ rose 2.87% to 11,159.42. The S&P also rose, gaining 2.44% to 3,413.24.
Benzinga · 09/09 18:30
Mid-Day Market Update: Dow Jumps Over 500 Points; Trillium Therapeutics Shares Spike Higher
Midway through trading Wednesday, the Dow traded up 1.90% to 28,024.77 while the NASDAQ rose 2.69% to 11,139.51. The S&P also rose, gaining 2.18% to 3,404.35.
Benzinga · 09/09 16:04
Intra-Cellular Therapies, Trillium Therapeutics leads gainers, Co-Diagnostics, Applied Genetic Technologies among losers
Gainers: Intra-Cellular Therapies (ITCI) +65%, Trillium Therapeutics (TRIL) +36%, Amryt Pharma (AMYT) +25%, BeyondSpring (BYSI) +18%, XTL Biopharmaceuticals (XTLB) +17%.Losers: Co-Diagnostics (CODX) -17%, Applied Genetic Technologies (AGTC) -16%, SCWorx (WORX) -10%, Innate Pharma (IPHA) -7%, PolarityTE (PTE) -5%.
Seekingalpha · 09/09 15:07
AGTC Provides Trial Design Update for its Phase 2/3 XLRP Clinical Trial, New Data on XLRP Higher Dose Group and Financial Results for the Fourth Quarter and Year Ended June 30, 2020
\- Planned Phase 2/3 trial expected to include approximately 60 patients and a responder analysis based on at least 7 decibel improvement in visual sensitivity in at least 5 loci across two active dose groups and one control group -\- Data from Group 5 supports use of higher dose level in Phase
GlobeNewswire · 09/09 12:00
Applied Genetic Tech Q4 EPS $(0.56) Misses $(0.48) Estimate
Applied Genetic Tech (NASDAQ:AGTC) reported quarterly losses of $(0.56) per share which missed the analyst consensus estimate of $(0.48) by 16.67 percent. This is a 3.45 percent increase over losses of $(0.58) per share
Benzinga · 09/09 11:34
Applied Genetic EPS misses by $0.09
Applied Genetic (AGTC): FQ4 GAAP EPS of -$0.56 misses by $0.09.Cash and cash equivalents of $38.5MPress Release
Seekingalpha · 09/09 11:04
Benzinga Pro's Stocks To Watch For Tues., Sept. 8, 2020: GM, LULU, XHB, AGTC, GNRC
Today's 5 Stock Ideas:  General Motors (GM) - Shares were up more than 7% in pre-market action Tuesday following news the company has formed a strategic partnership with electric vehicle
Benzinga · 09/08 12:20
The Week Ahead In Biotech: Focus On Mallinckrodt FDA Decision, Conference Presentations
After remaining steady in the first three sessions of the week ended Sept. 4, biotech stocks pulled back along with the broader market in a tech-induced sell-off.
Benzinga · 09/06 17:25
Webull provides a variety of real-time AGTC stock news. You can receive the latest news about AGTC through multiple platforms. This information may help you make smarter investment decisions.
About AGTC
Applied Genetic Technologies Corporation is a clinical-stage biotechnology company. The Company develops gene therapy products designed to manage the lives of patients with severe diseases in ophthalmology. As of March 31, 2016, its product candidates included treatments for X-linked retinoschisis (XLRS), over two forms of achromatopsia (ACHM) and X-linked retinitis pigmentosa (XLRP). As of March 31, 2016, the Company was engaged in developing three discovery programs, targeting three indications based on its adeno-associated virus vector technologies. XLRS is an inherited retinal degenerative disease caused by mutations in the retinoschisis1 (RS1) gene. Achromatopsia is an inherited condition that is associated with visual acuity loss, extreme light sensitivity resulting in daytime blindness, and reduced or complete loss of color discrimination, achromatopsia is caused by mutations in any of several genes. The Company is also developing Alpha-1 Antitrypsin Deficiency (Alpha 1).
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