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Atossa Genetics

IDMC-fulvestrant trial site change, new timelines

Flash note | Pharmaceuticals & healthcare | 11 Jan 2017

Atossa announced this week that it is transferring the site of its ongoing 30-pt Phase II study on intraductal catheter (IDMC) administered fulvestrant to the Montefiore Medical Center in New York City, from the Columbia University Medical Center where it had been initiated in March 2016. This move follows the relocation of the study’s primary investigator, Dr Sheldon M Feldman, from Columbia to Montefiore. Atossa believes this move will hasten patient recruitment, which it acknowledges had been slower than expected. It now expects to finish enrolment by August 2017, whereas it previously guided completion by March 2017.

Atossa Genetics

Atossa to raise up to $2.9m in equity offering

Flash note | Pharmaceuticals & healthcare | 02 Sep 2016

Atossa Genetics plans to raise up to $2.9m in an equity offering of 1.15m shares, priced at $2.50 per share (a 29% discount to the 30 August 2016 market close of $3.45). The proceeds should help fund Atossa's two active breast cancer therapeutic development programs, intraductal microcatheter (IDMC) administered fulvestrant and oral endoxifen.

Atossa Genetics

Funded into Q417, endoxifen now in Phase I

Update | Pharmaceuticals & healthcare | 30 May 2017

Atossa raised $4.4m in April 2017 in an equity raise consisting of common shares, Series A convertible preferred shares (SACPS), and warrants. We believe the proceeds should extend its cash runway into Q417 as it advances its 30-patient Phase II study on IDMC-delivering fulvestrant in patients scheduled for mastectomy or lumpectomy, and its 48-patient Phase I trial on endoxifen. We obtain an rNPV-based equity valuation of $9.3m.

Atossa Genetics

Multiple opportunities to address breast health

Outlook | Pharmaceuticals & healthcare | 07 Dec 2018

Atossa Genetics’s endoxifen programs are advancing in their respective breast health programs. The firm recently reported positive safety data from its Phase I study on topical endoxifen in men, and it completed enrolment for its Phase II endoxifen study in women with elevated mammographic breast density (MBD). It is also advancing an oral endoxifen formulation in women refractory to tamoxifen, and is applying its intraductal microcatheter (IDMC) with cancer drug fulvestrant. Our rNPV-derived equity valuation is $23.9m, or $3.66 per share.

Atossa Genetics

Atossa raises $13.4m in rights offering

Update | Pharmaceuticals & healthcare | 15 Jun 2018

Atossa’s previously announced rights offering closed on 30 May 2018, generating $13.3m in gross proceeds ($12.1m net) through the issue of 13,324 shares of Series B convertible preferred stock (SBCPS) and 3,784,016 warrants exercisable at $4.05 per share. We believe the funds raised could sustain operations into early 2020. Each SBCPS is immediately convertible into 284 common shares. Assuming the full conversion of all SBCPS into common shares, the number of Atossa’s fully diluted (FD) common shares outstanding has increased by 143% to 6.44m. While our rNPV ($24.4m) is largely unchanged, our per-share equity valuation has reduced to $5.87 per share (from $11.30 previously) due to the dilutive impact of the equity raise.

Atossa Genetics

Endoxifen to start Phase II studies shortly

Update | Pharmaceuticals & healthcare | 26 Apr 2018

Atossa Genetics is preparing to start Phase II studies of both its oral and topical endoxifen formulations in Q218. Endoxifen, an estrogen receptor (ER) antagonist, is being advanced in topical form to treat high mammographic breast density (MBD), and also as an oral drug to prevent cancer recurrence in women refractory to tamoxifen. The company plans to raise $20m in equity through a rights offering in May 2018, which we believe should fund the Phase II endoxifen trials through completion.

Atossa Genetics

Seeking to prevent or treat breast cancer

Outlook | Pharmaceuticals & healthcare | 16 Nov 2017

Atossa Genetics reported Phase I data on its topical endoxifen formulation and it is now developing this as a potential treatment for high mammographic breast density (MBD), which is associated with increased breast cancer risk. The firm is also developing oral endoxifen for patients refractory to tamoxifen, and its intraductal microcatheter (IDMC), combined with established cancer drug fulvestrant. After also considering the recent $5.5m equity raise (at $0.44 per share), our rNPV-derived equity valuation is $24.6m (from $9.3m previously), or $0.93 per share.

Atossa Genetics

Atossa to raise $4.0m in combined class offering

Flash note | Pharmaceuticals & healthcare | 30 Mar 2017

Atossa intends to raise $4.0m (gross proceeds), excluding over-allotments, in an equity offering of Class A and Class B units, consisting of 0.664m common shares (CS), 3,502 Series A convertible preferred shares (SACPS), and 5.33m common share warrants (CSW). The offering is expected to close on 3 April, subject to customary closing conditions, and we estimate that it will enable Atossa to fund its operations into Q417.

Atossa Genetics

Endoxifen complements Atossa's cancer focus

Update | Pharmaceuticals & healthcare | 30 Nov 2016

Atossa raised $2.875m in an equity raise in September 2016. We expect the proceeds to be allocated to Atossa’s two active pipeline programs: its 30-pt Phase II study on its intraductal microcatheter (IDMC) delivering fulvestrant to breast ducts in patients scheduled for mastectomy or lumpectomy, and its oral endoxifen candidate, expected to start human studies in 2017 as potential treatment for breast cancer patients refractory to tamoxifen. We obtain an rNPV-based equity valuation of $10.7m.

Atossa Genetics

One step forward, one step back

Update | Pharmaceuticals & healthcare | 27 May 2016

A Phase II study evaluating Atossa's intraductal microcatheter (IDMC) for the delivery of approved cancer drug fulvestrant to the breast, is ready for enrollment. The firm's other program, afimoxifene topical gel (AfTG), is now on hold, pending resolution of a contract dispute with licensor Besins Healthcare. AfTG is intended to provide transdermal selective estrogen receptor modulation (SERM) to the breast area, with fewer adverse events than oral SERMs. Our rNPV-derived equity valuation has declined to $5.4m (from $14.2m), mostly due to AfTG delays and uncertainty. With $3.2m net cash at Q116 and a Q116 burn rate of $3.0m, we expect Atossa to raise additional funding in coming weeks.

Atossa Genetics

Improving delivery of breast cancer therapeutics

Initiation | Pharmaceuticals & healthcare | 17 Feb 2016

Atossa is developing afimoxifene topical gel (AfTG), intended to provide transdermal selective estrogen receptor modulation (SERM) to the breast area while reducing the adverse events associated with oral SERM drugs. Atossa is also advancing its proprietary intraductal microcatheter (IDMC) intended to selectively introduce drug to breast ducts, potentially improving drug targeting for chemotherapy. It plans to combine its IDMC with established cancer drug fulvestrant and start a Phase II study in H116. Our rNPV-derived equity valuation is $14.2m.

Atossa Genetics

Aiming to stop cancer before it starts

QuickView | Pharmaceuticals & healthcare | 17 Nov 2015

Atossa is developing afimoxifene gel for atypical ductal hyperplasia (ADH), a condition affecting about 100,000 new US patients each year, and which leads to breast cancer within five years in 5-11% of cases (Coopey et al. 2011). A Phase II trial for intraductal fulvestrant should also start by YE15.