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BIO SmartBrief

Daily Dose Newsletter

Daily Dose Newsroom is a Daily Dose of Wall Street research and news in the Healthcare, Biotech, and Biomedical sectors.

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Wednesday
Mar142012

Advanced Cell therapy ($ACTC): Reverse Split Ahead: 1:20 and 1:80

Daily Dose Conclusion: Advanced Cell Therapy (OTCBB ACTC): Moving up from OTC BB to NASDQ is always good. This company sports a $200 million market cap and has liquidity so it logical to reverse split the stock. According to the 10K the company ended the year with $13 million and presented at Roth conference this week has a $15 million line they can draw upon.  A quick glance at the filling suggests the company has $21 million in losses last year.  Clinically its early days for ACTC and like every small cap biotech they will be needing funding to keep clinical programs moving forward. We will have to watch for next catalysts.

From the press Release: MARLBOROUGH, Mass. — March 14, 2012 – Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that on Monday, March 12 it filed with the Securities and Exchange Commission a proxy statement containing a shareholder proposal for a reverse split of its common stock.

The annual meeting of stockholders will be held on Thursday, April 26, at the Hyatt Regency Suites, Palm Springs, 285 N. Palm Canyon Dr., Palm Springs, Calif., 92262, on Thursday, April 26, 2012, at 9 a.m. PDT, to consider the following proposals: election of five directors, ratifying the appointment of the company’s public accounting firm, and a proposal to effect a reverse stock split of the company’s common stock, at a ratio between one-for-twenty and one-for-eighty, and to reduce the number of authorized shares of the company’s common stock in the same proportion as the reverse split, with the exact ratio to be determined by the board of directors.

 “This reverse stock split, which should better align the company’s capital structure with its stage of development, and an accompanying Nasdaq listing application, will represent a significant step toward creating long-term shareholder value and building ACT into a world-class player in the regenerative medicine space,” said Gary Rabin, chairman and CEO of ACT. “I hope that our stockholders understand how important it is to vote ‘For’ the reverse stock split. A Nasdaq listing will enable us to significantly broaden our shareholder base and attract institutional ownership, a process that can build on itself to position the company on very firm financial footing over the long term.”

Stockholders who have questions on how to vote or need assistance voting their shares should contact the company’s proxy solicitor InvestorCom, Inc. toll-free at (877) 972-0090.

Macular Degeneration (from the chairmen's Blog): As you are undoubtedly aware, last July we initiated the first-ever clinical trials using a cell therapy derived from human embryonic stem cells (hESCs) to treat various forms of macular degeneration.  The end goal for our clinical trials is to test whether or not the retinal pigment epithelial (RPE) cells we make from hESCs are capable of homing to sites of injury in the retina, replacing the native RPE cells that are lost to disease, and ultimately reestablishing the function of this layer of cells in protecting photoreceptors from cell death, i.e. slowing or halting progressive vision loss.  One of our ongoing trials is for Stargardt’s Macular Dystrophy (SMD, aka Stargardt’s Disease) and the other is for Dry Age-Related Macular Degeneration (Dry AMD).  Last month we also initiated a European clinical trial for Stargardt’s Disease.  That same week, we also published some exciting – albeit very preliminary data – relating to the patients treated last July, in The Lancet.

To date, we have treated one patient with Dry AMD (at UCLA), and a total of four patients with SMD (three at UCLA, and one at Moorfields Eye Hospital in London).  The recent treatment of the two SMD patients at UCLA represents the entire first cohort of patients for this initial dose of cells in the SMD trial.

We are pleased to have both trials underway and delighted with the results we have reported so far.  Clearly, though, the question arises: why does the Stargardt’s Disease trial appear to be moving along at a faster pace than the Dry AMD trial?  This has no doubt been of particular interest to our investors, upon whom the vast size of the potential market for Dry AMD is not lost; a projected market upwards of $25-30 Billion in the US and Europe alone.  I intend to briefly address this issue here.

Wednesday
Mar142012

Cleveland BioLabs: reports the Quarter & More... $CLBI

Cleveland BioLabs (CBLI): Revenues for 2011 were $9M, (versus $15M in 2010) this was a result of the difference in US biodefense revenues (contracts and grants).  Opearting expenses were high at $34M versus $26MM spent in 2010. R&D expenses for the year came in at $22.8MM, up 42% from the $16.1MM spent in 2010 in the year prior. This was directly related to additional (preclinical) animal studies and manufacturing of CBLB502 as well as preparations for human clinical work. G&A expenses were $11M. CBLI ended the year with $28M in cash which is strong for a biodefense company especially since the qtrly cash burn is modest at $3.6-4.2M.

BioDefense Moving Forward: As part of todays news the company announced that last last year the company received a confirmatory letter from the FDA.  The FDA did not have any objections to the development plan for CBLB502 in biodefense. Cleveland BioLabs will now respond to BARDA’s current open Broad Agency Announcement (BAA) by submitting a white paper by year end. A BARDA response should follow (90 days) followed by an invitation to submit a contract proposal.

Clinical Testing of CBLB502 in Oncology: Earlier this month the company announced that the first patient completed a series of five doses in the phase 1 trial evaluating CBLB502 in cancer patients. N=48 patients are expected to be enrolled across several arms to provide data on safety, tolerability, and PKA (dose simetry) as well as hints at efficacy. 

Wednesday
Mar142012

Presenting Companies at the 19th Annual Future Leaders in the Biotech Industry

Future Leaders in the Biotech Industry returns for its 19th meeting with a slate of companies positioned to meet the investment criteria that the current market demands.

The conference is organized by BioCentury & Thomson Reuters, with the Special Support of GOLD SPONSOR Rodman & Renshaw.
Contributing Sponsors: AstraZeneca, 
Ladenburg Thalmann, MLV & Co., OrbiMed Advisors, WBB Securities, and Yorkville Advisors. 

The Future Leaders Class of 2012 will showcase companies with a solid mix of innovative science and platform assets, plus later stage compounds with near-term commercial milestones. Features for this year’s slate include a track of epigenetics plays, fresh IPO stories, mature privates readying for IPO, companies with upcoming Phase III data sets and selected international companies with key value inflection points. 
The Presenting Companies are as follows:
  • Acadia Pharmaceuticals Inc. (NASDAQ:ACAD)
  • Acceleron Pharma Inc. 
  • Acetylon Pharmaceuticals Inc.
  • Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) 
  • Ambit Biosciences Corp. 
  • Anthera Pharmaceuticals Inc. (NASDAQ:ANTH) 
  • Ardea Biosciences Inc. (NASDAQ:RDEA)
  • Astex Pharmaceuticals Inc. (NASDAQ:ASTX) 
  • Avanir Pharmaceuticals Inc. (NASDAQ:AVNR) 
  • BioTime Inc. (NYSE-A:BTX) 
  • BioDelivery Sciences International Inc.(NASDAQ:BDSI) 
  • BioSante Pharmaceuticals Inc. (NASDAQ:BPAX)
  • Catabasis Pharmaceuticals Inc. 
  • Cempra Inc. (NASDAQ:CEMP)
  • ChemoCentryx Inc. (NASDAQ:CCXI) 
  • Chimerix Inc. 
  • Curis Inc. (NASDAQ:CEMP) 
  • Epizyme Inc. 
  • Essentialis Inc. 
  • Five Prime Therapeutics Inc. 
  • Forma Therapeutics Holdings LLC 
  • 4SC AG (Xetra:VSC) 
  • Geron Corp. (NASDAQ:GERN) 
  • Infinity Pharmaceuticals Inc. (NASDAQ:INFI) 
  • Omeros Corp. 
  • OncoGenex Pharmaceuticals Inc. (NASDAQ:OGXI) 
  • OncoMed Pharmaceuticals Inc. 
  • Oncothyreon Inc. (NASDAQ:ONTY) 
  • Pathway Therapeutics Inc. 
  • Prima BioMed Ltd. (ASX:PRR) 
  • Progenics Pharmaceuticals Inc. (NASDAQ:PGNX)
  • Puma Biotechnology Inc.
  • RaNA Therapeutics Inc. 
  • Relypsa Inc. 
  • Resverlogix Corp. (TSX:RVX) 
  • Rib-X Pharmaceuticals Inc. 
  • Roka Bioscience Inc. 
  • Sangamo BioSciences Inc. (NASDAQ:SGMO) 
  • Sucampo Pharmaceuticals Inc. (NASDAQ:SCMP)
  • SymBio Pharmaceuticals Ltd. (JASDAQ:4582) 
  • Threshold Pharmaceuticals Inc. (NASDAQ:THLD)
  • Transcept Pharmaceuticals Inc. (NASDAQ:TSPT) 
  • Trius Therapeutics Inc. (NASDAQ:TSRX) 
  • Verastem Inc. (NASDAQ:VSTM) 
  • Ziopharm Oncology Inc. (NASDAQ:ZIOP) 

For more information about the conference and the presenting companies, please go to www.biocentury.com/conferences and click "BioCentury Events." 

Wednesday
Mar142012

$ONTY: Oncothyreon initiates phase 1 trial of ONT-10

Oncothyreon ($ONTY) initiates phase 1 trial of ONT-10 ($4.80).

Oncothyreon is a biotechnology company dedicated to the development of oncology products that can improve the lives and outcomes of cancer patients. They are currently developing multiple therapeutic candidates designed to target cancer in specific and effective ways. The pipeline includes both synthetic vaccines and small molecules for a variety of cancer indications.

  • The company announced that the first patient has been enrolled in a Phase 1 trial of ONT-10
  • The Phase 1 trial is designed to evaluate the safety and immunogenicity of ONT-10 in patients with cancers which commonly express MUC1
  • The Phase 1 trial of ONT-10 consists of two parts
  • Part 1 will study a dose escalation schedule in up to 48 patients to determine the maximally tolerated and/or recommended dose of ONT-10 administered either once every other week or once every week over an 8 week period
  • Part 2 will further investigate the safety of ONT-10 at the maximally tolerated or recommended dose in up to 15 additional patients at the weekly and/or biweekly schedule

The ability of ONT-10 to induce both a humoral and a cellular immune response will be investigated in both parts of the study.

Daily Dose Conclusion: This is an interesting data point in the wake of StimuVax delays which were not perceived well by the marketplace.

Wednesday
Mar142012

5th Diabetes Drug Discovery and Development Conference April 19-20 in Boston

"Beyond HbA1c - Are There Better Endpoints for Clinical Trials"

To be discussed at the 5th Diabetes Drug Discovery and Development Conference in Boston, MA on April 19-20, 2012.

Deadline for 10% discount ends on March 19th. Register Today!

A highlight of the 5th Diabetes Drug Discovery and Development Conference, to be held on April 19-20, 2012 in Boston, MA, is the panel discussion "Beyond HbA1c - Are There Better Endpoints for Clinical Trials?" The panel will discuss various topics such as why HbA1c may not be an ideal endpoint for clinical trials and what would it take to achieve a new standardized endpoint for clinical trials.

Guests on the panel discussion include:

  • Lane Desborough, Product Strategist at Medtronic
  • Claudia Graham, Ph.D., MPH, Vice President of Marketing & Global Access at Dexcom
  • James F. List, Vice President of Metabolics, R&D, and Full Development Lead of Dapagliflozin, at Bristol-Myers Squibb
  • Solomon Steiner, Chief Executive Officer and Chairman, Founder, Perosphere
  • Helena W. Rodbard, MD, FACP, MACE, Medical Director, Endocrine and Metabolic Consultant

Join the discussion with other diabetes experts at the 5th Diabetes Drug Discovery and Development Conference. The conference will bring together the leading experts on diabetes from both industry and academia to discuss novel targets for diabetes, lessons learned from current clinical drug development, and business strategies and opportunities under the current regulatory landscape.

This conference is also part of the 2nd Diabetes Summit which consists of one other conference: 2nd Diabetes Partnering & Deal Making.

Register 2 people at the regular price, bring a 3rd person for free! Use discount code rcdvb.

Wednesday
Mar142012

Orgenesis licenses IP covering diabetes therapy - $ORGS

ORGS News Update:

Tel Hashomer Medical Research Infrastructure and Services Ltd. (Tel Hashomer, Israel) granted Orgenesis Inc. (OTCBB: ORGS) an exclusive license to develop and commercialize IP covering functional autologous insulin-producing cells (AIPC) regeneration technology as a therapy for diabetes. Tel Hashomer will receive an annual fee of $15,000, and is eligible for up to $3 million in milestones, plus a 3.5% royalty. Tel Hashomer is also eligible for 16% of all sublicensing fees. The AIPC technology involves the use of a patient's own liver cells to generate functional insulin-producing autologous cells, which can then be transplanted back into a patient's liver. Orgenesis gained $0.81 (117%) to $1.50 on Tuesday.

Daily Dose Comment: This is interesting news but our concern is that the AIPC technology will still be at risk from being destroyed by the same auto-immune reaction that wiped out the patients islet cells int he first place. We would focus on islet biosciences (using porcine islet cells encapsulated in an algenate) as a more compelling technology. We like this company born from the ashes of the old micro-islet.

 

Tuesday
Mar132012

CytRx ($CYTR): Oncology Value Play ? Cowen thinks so...

CytRx Corporation (NASDAQ: CYTR): An Oncology Focused Small Molecule Biotech Play:

The CytRx oncology pipeline includes three programs in clinical development for cancer indications: INNO-206, tamibarotene and bafetinib.

With its tumor-targeted doxorubicin conjugate INNO-206, CytRx has initiated an international Phase 2b clinical trial as a treatment for soft tissue sarcomas, is completing its ongoing Phase 1b/2 clinical trial and plans to initiate a Phase 2 trial for an undisclosed solid tumor indication in the first half of 2012.

CytRx's pipeline also includes tamibarotene, which it is testing in a double-blind, placebo-controlled, international Phase 2b clinical trial in patients with non-small-cell lung cancer, and which is in a clinical trial as a treatment for acute promyelocytic leukemia (APL).

The Company is evaluating bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib.

In 2011, CytRx completed its strategy of monetizing its non-core assets through the sale of its molecular chaperone technology to Denmark-based Orphazyme ApS in a transaction valued up to $120 million, the sale of its 19% interest in SynthRx to ADVENTRX Pharmaceuticals, and the disposition of its remaining shares of RXi Pharmaceuticals in a series of transactions that provided CytRx with approximately $17 million in non-dilutive financing.

Cowen Highlights their Investment Thesis: CyTRx: A three-compound oncology company (aka Innovive Pharmaceuticals but three years later, with different management, more data and a lot more cash). CYTR is financed through important data points that will provide answers questions about its pipeline

According to Cowen:  Three Phase II oncology compounds for a total EV of ~$30M make for a favorable risk/reward:

  • Compound #1: INNO-206: a targeted doxorubicin prodrug with platform potential...but, first, show me the data!
  • Compound #2: Tamibarotene: Trying to be ATRA 2.0; Issues: 1) APL is a miniscule market, 2) belief in NSCLC requires some extrapolation, and 3) weak IP position.
  • Compound #3: Bafetinib: a novel, oral, Bcr-Abl and Lyn kinase dual inhibitor; pathways involved are compelling, but safety and competition is a concern.

Tuesday
Mar132012

Aastrom (ASTM): Reports the Quarter, JMP Makes Positive Comments

Aastrom (ASTM): Reports the Quarter its great to have the cash but...

Highlights As follows:

  1. The company ended 2011 with cash of $5.5MM which, together with $40MM raised last week should fund current operations through mid 2013.
  2. The Phase III trial for ixmyelocel-T in critical limb ischemia (CLI) has begun. Enrollment will be monitores (this is a large trial, how long will it take ?).
  3. Aastrom is planning to move ahead with a phase IIb trial in dilated cardiomyopathy (DCM) by this summer. Reesults from the Phase 1b trial are expected this quarter.

Daily Dose Conclusion: Its great that Aastrom is financed but we convertible debt is atypical for Biotech's and raises the importance of the CLI trial. We believe the trial is highly powered and if all goes well will show good results but as mentioned previously, the "B" in binary just got a bit Bigger.  CLI is an unmet medical need. Aastrom does appear to have the jump on the field (versus Pluristem (PSTI) and Aldagen / Cytomedic