Advanced Life Sciences Holdings Inc. (ADLS)

[surf1944]

http://ir.advancedlifesciences.com/phoenix.zhtml?c=190126&p=irol-sec

[MDeal]

With the market potential of restanza and the board searching strategic alternatives $1.00 per share would be a very conservative estimate for purchasing this company.

[YearOfADLS]

bkstock,


The post in Raging Bull is from August, 2010.

This is how it breaks down:

In March, 2010, ADLS received guidance for their SPA from FDA.

In June, 2010, ADLS submits their SPA proposal to FDA based on that guidance.

In August, 2010, ADLS receives acceptance of SPA proposal from FDA.

ADLS only now has to complete the work. ADLS got their asses handed to them by the FDA before, for not adhering to CABP guidelines in the past. This, I can assure you, WILL NOT happen again. The company has not released anything new regarding their progress completing the SPA work. Suffice it to say that they require some pretty heavy funding before anything can be done. This funding may come soon in way of BARDA grant/contract or from the DOD, perhaps. Other companies are receiving very large grants that probably are not as deserving as ADLS, in my opinion.

Hope this helps. Hope we hear an update from ADLS, soon!

[bkstocks08]

ADLS submits final SPA to FDA for Restanza


Is this old? Has today's date on it but cannot find any filings or other sources

Link:

http://ragingbull.quote.com/mboard/boards.cgi?board=ADLS&read=2

[Dandawg71]

Yeah me too Surf...I've been buying at these super low prices to try and lower my basis. I feel like this company is destined for greatness and I hope my gut is right on this one.

[surf1944]

Bought back in & took the MOD position. ADLS will be much higher or near zero by the EOY.......

[Dandawg71]

No news is good news? Lets hope...

[Dandawg71]

I've got a positive outlook too but have yet to hear any news. What's all the buzz about?

[Dandawg71]

It certainly does...because Restanza just seems to trash the competition on every level. Its just a matter of time before we get approval or partnership/acquisition. Good news is imminent!

[dos equis]

positive outlook from other boards. anyone have any thoughts as to why?

[JV44]

Who knows...It almost feels like they dont want this one to make it...They = Govt or Corp...

[Dandawg71]

Anyone know when these additional trials for the SPA are supposed to start or if they have already begun? And does anyone have any prior experience with an SPA, like how long they traditionally take?

[Dandawg71]

Hey Drums thanks for the article...definitely will check it out. Yeah it sure is quiet on here. I'm very surprised the conference didn't stir up some excitement or possible M&A. Hopefully we'll hear something promising soon...

[odaydrums]

Hey Dawg..... No news that I know of. This board, while more pleasant than Yahoo, is pretty boring. You can check out the
Bio conference stuff if you've not already. They have a pretty good stuff. It gives you a glimpse of how that part of the biz
works. Heres one article that will get you there.

http://ebdgroup.com/partneringnews/2011/01/funding-the-future-it-takes-creativity/

[Dandawg71]

Hang in there ADLS longs! Anyone hear anything new? This board needs some excitement...

[kei]

i see... thank you for your input

[Dandawg71]

It certainly seems like good news because they swapped out a 10 million dollar loan agreement for a 5 million dollar one. So I assume things could be looking up for us...

[kei]

is this good news???

[JV44]

And its going up today with this news?

[surf1944]

21-Jan-2011

Entry into a Material Definitive Agreement, Termination of


Item 1.01 Entry into a Material Definitive Agreement.

On January 18, 2011, Advanced Life Sciences Holdings, Inc. (the "Company") entered into an Investment Agreement (the "Investment Agreement") with Dutchess Opportunity Fund, II, LP ("Dutchess"), for the sale of up to $5.0 million of shares of the Company's common stock over a two-year commitment period. Under the terms of the Investment Agreement, the Company may from time to time, in its discretion, sell newly-issued shares of its common stock to Dutchess at 95% of a recent average market price at the time of such issuance. In connection with the Investment Agreement, the Company paid to Dutchess a commitment fee of $50,000 by issuing 2,475,248 shares of its common stock and a document preparation fee in the form of a $15,000 cash payment.

The amount of each advance under the Investment Agreement is generally limited to the greater of $300,000 or two hundred percent (200%) of the average daily volume traded in the United States of the Company's common stock for the three
(3) consecutive trading days prior to the date the Company requests the advance, multiplied by the average of the three (3) daily closing prices immediately preceding the date of the advance notice. The Company is not obligated to utilize any of the $5.0 million available under the Investment Agreement and there are no minimum commitments or minimum use penalties. The total amount of funds that ultimately can be raised under the Investment Agreement over the two-year term will depend on the market price for the Company's common stock and the number of shares actually sold.

The Investment Agreement does not impose any restrictions on the Company's operating activities. During the term of the Investment Agreement, Dutchess is prohibited from engaging in any short selling or hedging transactions related to the Company's common stock.

Also on January 18, 2011, the Company and Dutchess entered into a Registration Rights Agreement (the "Registration Rights Agreement"), pursuant to which the Company agreed to register the resale by Dutchess of the shares of common stock issued under the Investment Agreement. In accordance with the terms of the Registration Rights Agreement, the Company filed a Registration Statement on Form S-1 (Registration No. 333-171748) with the Securities and Exchange Commission on January 18, 2011.

A copy of the Investment Agreement is attached hereto as Exhibit 4.1 and incorporated by reference herein. A copy of the Registration Rights Agreement is attached hereto as Exhibit 4.2 and incorporated by reference herein.



Item 1.02 Termination of a Material Definitive Agreement.

On January 17, 2011, the Company and YA Global Master SPV Ltd ("YA Master"), an affiliate of Yorkville Advisors, agreed to terminate the Standby Equity Distribution Agreement dated as of September 27, 2010 (the "SEDA"). Pursuant to the SEDA, the Company had the right from time to time in its discretion, to sell up to $10.0 million of newly issued shares of its common stock to YA Master at 95% of a recent average market price at the time of such issuance. The Company was not obligated to utilize any of the $10.0 million available under the SEDA and there were no minimum commitments or minimum use penalties. The total amount of funds that ultimately were raised under the SEDA was dependent on the market price for the Company's common stock and the number of shares actually sold. The Company raised $1.1 million and issued 52,133,074 shares of its common stock to YA Master under the SEDA prior to its termination. There were no fees paid in connection with the termination of the SEDA.

[shotei]

I posted the second article to show the connection between Hauer and the political party in power. With public backing and campaign donations he is able to keep his company as the main source of vaccine for the military even though it doesn't work all that well.

[Dandawg71]

Very interesting article Shotei...the second link doesn't seem to work though. Anyone left on this board? It is awful quiet...

[Dandawg71]

How come we haven't heard any news from this conference?

[shotei]

Please read post #1967

[Dandawg71]

I agree JV...certainly seems like another case of dirty politics. It just goes to prove "It's not what you know, it's who you know."

[JV44]

It stills kills me that ADLS has had a year and a half to conduct another Phase 3 trial and nothing...2011 should have been there year after 2009 fiasco...This drug is safe and has proven itself against Mild to moderate CAP...IMHO...Somebody doesnt like ADLS...Some company and or govt

[Dandawg71]

Would've responded sooner but ran out of posts yesterday. In response to any competition to Restanza...I do know of one company. A privately owned company, Achaogen has a broad spectrum antibiotic that treats the same things as Restanza with different chemistry. They have received a grant from BARDA too. However, they are in early stage 2 development...so it would appear that ADLS certainly has the jump on them.

[biomanbaba]

is cheap ugly? depends on whether you are buying or selling

[Stockrockdrummer]

Things looking ugly here or what??

[biomanbaba]

why do people call YA GLOBAL "duchess"...I have never understood the linkage

[Talc Moan]

S-1 filed today i just noticed.


http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=7658238

Shares being sold to Dutchess. Prob why we tanked today.

Dutchess is not a bad company to due financnig with.

Smitter SMTT

[Talc Moan]

Very True, A buyout trumps everthing.

Smitter SMTT

[biomanbaba]

I would rather see a BUYOUT by a larger fish here....would be better overall for shareholders,,,,except the insiders...their jobs might be on the line in a TAKEOVER

[Talc Moan]

I like the YA Global Master SPV Ltd deal for the financing.

Just starting to read all the filings.

Any thoughts???

Smitter SMTT

[Talc Moan]

Great questions,

I like what i see, and know i have alot of DD to catch up with everyone.

Smitter SMTT

[thinkingStone]

Agreed 100%.

[odaydrums]

Has anyone done DD on other broad spectrum antibiotics
in the pipeline? In other words who/what is Restanza's
competition? I know this increased Resistance to meds
by strains of bacteria and virus' are a big problem.
Restanza cant be the only one obviously.

[Dandawg71]

Indeed bioman! I'm with you...cheers bro

[biomanbaba]

In light of this guidance, Advanced Life Sciences is working with the FDA to finalize a SPA using a superiority design for the outpatient CABP indication. Clinical cure rate in a macrolide-resistant Streptococcus pneumoniae (MRSP) population will be the primary endpoint.

"We are pleased that the Agency provided clear guidance regarding our registration pathway for Restanza in the CABP and biodefense indications. Using clinical response in the MRSP population as the primary endpoint provides the most scientifically meaningful approach to demonstrate a clinical efficacy advantage against resistant strains of Streptococcus pneumoniae," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. "Based on the data we have accumulated in our extensive pre-clinical and clinical program to date, coupled with a thorough review of published literature on the clinical relevance of macrolide resistance, we believe that Restanza can show a superior efficacy advantage in patients who are resistant to marketed macrolide drugs. With reported macrolide resistance rates as high as 40 percent in the U.S., there is a pressing medical need for new drugs to treat CABP. Our goal is to finalize the SPA by the end of the third quarter of this year."

[biomanbaba]

they were robbed by the FDA last time. Every body and his momma knows this drug works well. It is just a matter of time till the FDA recognizes it.....no place else in the world can you get a piece of a blockbuster for 2 cents a share....ba ba ba booom

[Dandawg71]

Hey Drums...haven't made money YET! haha. I have managed to lower my basis considerably though. I just think restanza has the potential of blockbuster status(Huge moneymaker drug, not the failing movie rental company haha). I feel they were robbed out of FDA approval...having conducted trials for 4 years the FDA decided to change the guidelines a few months prior to the approval date. I feel that if they can remain solvent or acquire a partnership, FDA approval is certain. I will admit it is a gamble, however I am a betting man.

[odaydrums]

Just curious DDawg. Why do you "love" this company?
Have you managed to make make some money with it?
It's been more or less trending lower ( minus that
strange 120% spike 3-4 weeks ago ).Let me know

[Dandawg71]

Hey everyone...long time holder of ADLS...love the company, and love the positive attitudes on here. Hopefully we'll get some good news soon huh...

[Talc Moan]

I will begin to follow ADLS, and buy once i see how the 8k is digested with investors.

Smitter SMTT

[ozz collins]

8K out news http://ih.advfn.com/p.php?pid=nmona&article=46032344&symbol=ADLS

[xristosx]

no selling,,big news coming imho

[Stockrockdrummer]

The ask was at .04 on my curve which is higher than a while. Of course that may mean it was just above .035

[Stockrockdrummer]

Well I believe in them although I'm a little angered over the swings in the share price, seems so knob oreintated. Many are of course.

[biomanbaba]

the Govt likes this drug........re the support for Defence and anti bio warfare uses......at some point it gets approved......we dont know when or under what circumstances....at the current SP the price of a ticket to watch is cheap

CHICAGO, Nov. 9, 2010 /PRNewswire via COMTEX/ --

Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced that it has submitted a full proposal to the National Institute of Allergy and Infectious Diseases (NIAID) under BAA-NIAID-DMID-NIHAI2010097 Development Of Therapeutics For Biodefense. It is anticipated that one or more awards will be made from this solicitation and that the awards will be made on or about July 29, 2011.

(Logo: http://photos.prnewswire.com/prnh/20080218/ALSLOGO)

(Logo: http://www.newscom.com/cgi-bin/prnh/20080218/ALSLOGO)

"We are pleased to have submitted a full proposal to NIAID which, if awarded, could significantly advance the development of the intravenous (IV) formulation of Restanza(TM) (cethromycin) for the therapeutic treatment of bioterror pathogens as well as for the commercial indication of community acquired bacterial pneumonia," stated Michael T. Flavin, Ph.D., chief executive officer of Advanced Life Sciences. "In addition to the efficacy demonstrated by the oral form of Restanza for post-exposure prophylaxis of anthrax, plague and tularemia, the oral form of Restanza has also shown initial efficacy in treating anthrax infection where symptoms are present. This is significant because there are currently no agents approved by the FDA for the therapeutic treatment of anthrax, plague or tularemia and we believe that the increased bioavailability of the IV formulation of Restanza offers a promising option as a therapeutic treatment for these infections."

The Company's proposal requests $38 million over 5 years for the development of an IV formulation of its novel antibiotic, Restanza to therapeutically treat anthrax, tularemia and plague. In addition, the proposal includes pre-clinical development as well as funding for four Phase 1 clinical trials and a Phase 2 clinical trial to evaluate the safety and efficacy of IV Restanza in patients hospitalized with moderate-to-severe community acquired bacterial pneumonia (CABP).

The Company recently announced positive results from preclinical toxicology and pharmacokinetic studies of an IV formulation of Restanza. Restanza was administered intravenously as a single dose up to 60 mg/kg/day. Results from this GLP study show that the IV formulation of Restanza was well tolerated and generated 10-fold greater plasma exposure compared to oral administration.

About Restanza

Restanza is a novel, once-a-day, oral antibiotic that is in late stage development for the treatment of adults with mild-to-moderate community-acquired bacterial pneumonia ("CABP") and biodefense pathogens. It has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections and appears to be effective against penicillin-, macrolide- and fluoroquinolone-resistant bacteria. Restanza's demonstrated potency and ability to overcome bacterial resistance may be due to its mechanism of action resulting in specificity for its bacterial target. In addition to its utility in CABP, Restanza is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure and other high priority biodefense pathogens, including plague and tularemia. The FDA has designated Restanza as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, as well as for use in treating plague and tularemia, but the drug is not yet approved for these or any other indications.

[Stockrockdrummer]

I wish I knew why myself but it was down 18% at one point and down yesterday as well.