RegMed Investors’ (RMi) closing bell; a new ball game

May 9, 2018 5:40pm

Forget about the yesterday’s slide. Things are different in today’s game. The circumstances will change in the next session …

The bases are loaded but, eight (8) quarterly batters are on deck

Q1/18 AKA earnings:  Asterias Biosciences (NYSEMKT: AST) closed up +$0.05 with a -$0.04 net loss for Q1/18, Audentes Therapeutics (BOLD) closed up +$0.99 with a -$0.74 net loss for Q1, Stemline therapeutics (STML) closed up +$0.70 with a -$0.69 net loss for Q1 and Adverum Biotechnologies (ADVM) closed up +$0.30 with a -$0.30 net loss for Q1/18

Pre-open indications: 2 hits

End of day briefing; the “numbers” speak; what I do in 8-10 hours is reducing the content so you, the investor get to know what happened today in a 15 minute read to understand what you need to do tomorrow!

Henry’omics:

From Wednesday’s pre-open newsletter, “…who’s at bat and what’s on tap today? The IBB is pitching a +0.46% upside; Wednesday sets the tone for tomorrow’s batch of quarterly releases.”

Today’s moves … the ballpark was full and oversold; look for attendance to lessen as tomorrow’s quarterly results AKA earning appear!

Some sector “names” stocks kept the lights on: ONCE (post Q1 earnings), RGNX (post Q1 earnings), BLUE (after Tuesday’s slide), SLDB and IONS (post Q1 earnings)

While losers hid in the open – AXGN (after pricing offering at $41.00), GBT (post Q1 earnings), CLLS (post 11 earnings), MDXG, and CRSP (post Q1 earnings)

The advance/decline line scenario of 45 covered companies:   

• The open started positive with an ADL of 23/19 and 3 flat;
• The mid-day stayed positive with an A/DL of 28/15 and 2 flats;
• The close concluded positive with an A/DL of 34/12 and 2 flats;

Pre-open indications – 2 hits:

• Applied Genetic technologies (AGTC) closed down -$0.05 – hit;
• AxoGen (AXGN) closed down -$1.25 – hit;

MY working five (5) trend lines:

… The greatest volume to the downside:  MDXG. AXGN, CRSP, GBT and VSTM

… Upside volume was weighted to:  SGMO, BLCM, BLCM, IONS and VCEL

… Biggest $ downside:  AXGN (-$1.25), GBT (-$1.20), CLLS (-$0.82), MDXG (-$0.60) and CRSP (-$0.47)

… Best moves to the $ upside:  ONCE (+$6.25), RGNX (+$5.35), BLUE (+$3.25), SLDB (+$2.89) and IONS (+$2.27)

… Flats:  CUR, RENE.L and PSTI

The month of May:

• Wednesday closed POSITIVE with 12 decliners, 24 advancers and 2 flats;
• Tuesday closed NEGATIVE with 28 decliners, 16 advancers and z flats;
• Monday (May 7) closed POSITIVE with 15 decliners, 29 advancers and 1 flat;
• Friday closed POSITIVE with 8 decliners, 34 advancers and 3 flat
• Thursday closed NEGATIVE with 29 decliners, 11 advancers and 5 flats;
• Wednesday closed POSITIVE with 15 decliners, 22 advancers and 8 flats;
• Tuesday (May 1) closed POSITIVE with 15 decliners, 25 advancers and 5 flats;

Q1/18 financial results i.e. earning – the LPS (loss-per-share) skirmish:

Asterias Biosciences (NYSEMKT: AST) …

Platform development:

• Cancer Research UK released the first cGMP clinical grade lot of AST-VAC2. This lot will provide initial clinical trial material for subjects enrolling in the first-in-human P1 study evaluating AST-VAC2 in NSCLC. This initial clinical trial, which is being sponsored and managed by Cancer Research UK, will examine the safety and tolerability of AST-VAC2 in NSCLC subjects as the study’s primary endpoints. Secondary and tertiary endpoints of the study include evaluations of the immunogenicity of AST-VAC2 in NSCLC subjects. The partnership between AST and Cancer Research UK is being conducted under Cancer Research UK’s Clinical Development Partnerships (CDP) scheme, which allows the first clinical trial of AST-VAC2 to be initiated without significant Asterias resources being allocated to the trial or the manufacturing of the product. On completion of the clinical trial, AST will have an exclusive first option to acquire the data from the trial,
• Initiated the process to open enrollment in the first site for the AST-VAC2 trial in NSCLC; the study will enroll up to 24 subjects into one of two cohorts, depending on the stage of each subject’s NSCLC,
• In February, AST reported additional results from the company’s ongoing P1/2a SCiStar study that continued to support AST-OPC1’s positive safety profile and its potential to durably engraft and help restore upper extremity motor function improvement to individuals with severe cervical spinal cord injuries.

The “Numbers”:

Net loss was $2.3 million, or $0.04 per share compared to a net loss of $6.3 million, or $0.13 per share, for Q1/17,

• Ended Q with net cash used in operating activities was $3.9 million compared to $7.2 million for Q1/17,
• Total revenues were $500 K which were comprised of license revenues and royalty revenues on product sales by licensees,

Cash, cash equivalents, and available-for-sale securities totaled $18.8 million                    

“Runway”: mid 2019

Audentes Therapeutics (BOLD) …

Platform development:

• Completed dosing of three additional patients as an expansion of the first dose cohort of ASPIRO, the P1/2 clinical study of AT132 for the treatment of X-Linked Myotubular Myopathy (XLMTM),
• Plan to report additional interim data from ASPIRO during an oral presentation at the 21st Annual Meeting of the American Society of Gene and Cell Therapies (ASGCT) on May 16, 2018,
• Initial proof of concept established with twelve-week data from the first subject enrolled in VALENS, the P1/2 clinical study of AT342 for the treatment of Crigler-Najjar Syndrome; plan to escalate to higher dose and enroll the next patient in the coming weeks

The “Numbers”:

Net loss was $25.6 million or -$0.74 per share compared to $18.1 million or -$0.83 per share for Q1/17,

Cash, cash equivalents, and short-term investments of $326.1 million,

“Runway”: second half of 2020

Stemline Therapeutics (STML) …

Platform development:

In April, initiated a rolling Biologics License Application (BLA) submission for SL-401, and expect to complete the rolling submission in 2Q18.

• SL-401 is also being evaluated in clinical trials in additional indications including myeloproliferative neoplasms (MPN) [focused on chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF)], acute myeloid leukemia (AML), and multiple myeloma.
• Evaluating possible registration-directed trial designs in CMML and MF given the results observed to date. Updates relating to these programs are expected later this year.
• SL-801: the P1 trial in patients with advanced solid tumors is ongoing, and dose escalation continues. Data from the SL-801 trial were selected for presentation at the upcoming ASCO meeting in June.
• SL-701: the P2 trial in patients with second-line glioblastoma has completed. Data from the SL-701 trial were selected for presentation at the upcoming ASCO meeting in June.

The “numbers”:

Net loss of $18.4 million or $0.69 per share, compared with a net loss of $14.6 million, or $0.67 per share for Q1/17,

Ended with $106.2 million in cash, cash equivalents and investments, as compared to $66.2 million in Q1/17,

“Runway”: Q1/2020

Adverum Biotechnologies (ADVM) …

Platform development:

• In May 2018, announced long-term preclinical efficacy data on ADVM-022 gene therapy in a non-human primate model of wet age-related macular degeneration (wAMD). After 13 months, a single intravitreal injection of ADVM-022 was found to be safe and statistically significant (p<0.0001) in preventing the development of Grade IV lesions compared to the vehicle control group. The efficacy at 13 months was consistent with earlier-reported data, demonstrating that ADVM-022 induced long-term efficacy that was comparable to aflibercept, an anti-Vascular Endothelial Growth Factor (VEGF) standard-of-care therapy. ADVM-022 was well tolerated, with no serious adverse events,
• In late April 2018, dosed the first patient in Cohort 2 in the ADVANCE P1/2 trial for ADVM-043 in alpha-1 antitrypsin (A1AT) deficiency and continues to enroll patients,

The “numbers”:

Net loss attributable to common stockholders was $17.2 million, or $0.30 per share, for the three months ended March 31, 2018, compared to $16.1 million, or $0.38 per share for Q1/17,

• Revenue from collaborative research was $200 K,

Cash, cash equivalents and marketable securities were $247 million compared to $190.5 million as of 12/31/2017. In February 2018, Adverum raised $64.5 million in net proceeds from a public offering of common stock.

“Runway”: Q4/19

Daily analytics:

Stocks rose on Wednesday as energy shares jumped on the back of a strong rally in oil prices. The move higher follows President Donald Trump's decision to pull the U.S. out of the Iran nuclear deal.

• The Dow closed 0.74% higher rising 182.33 points to 24,542.54
• The S&P 500 closed 0.9 % higher +25.87 points at 2,697.79,
• The NASDAQ advanced 1% or 73 points to close at 7,339.91.

The CBOE Volatility Index (VIX) widely considered the best gauge of fear in the market,

• Wednesday traded at 13.41, down -8.84%
• Tuesday traded at 14.71, down -0.27%
• Monday traded at 14.75, down -0.14%
• Friday traded at 14.77, down -7.11 %
• Thursday traded at 15.90 , down -0.44% …
• Last Wednesday traded at 15.97, up +3.10 %

The iShares Russell 2000 (IWM) indicated:

• Wednesday was up +0.56%
• Tuesday +0.78%
• Monday was up +0.84%
• Friday +1.22%
• Thursday -0.55%
• Last Wednesday +0.36%

The iShares NASDAQ Biotechnology (IBB) indication:

• Wednesday was up +1.35%
• Tuesday -0.57%%
• Monday was up +0.64%
• Friday +1.06%
• Thursday -1.36%
• Last Wednesday -1.32%

The count in May - decliners versus gainers:

……. look at the differences in decliners:

• Wednesday’s decliners ranged from -0.38% <HSGX -$0.01> to -7.49% <MDXG -$0.60 > in 12 equities;
• Tuesday’s decliners ranged from -0.18% <BMRN -$0.16 > to -9.85% <SGMO -$1.60 > in 28 equities;
• Monday’s decliners ranged from -0.25% < RGNX -$0.10> to -5.67% <SLDB -$1.07> in 15 equities;
• Friday’s decliners ranged from -0.28% <XON -$0.05 > to -16.14% <ADVM -$1.025 > in 8 equities;
• Thursday’s decliners ranged from -0.08% <BMRN -$0.07> to -4.97% <SGMO -$0.85 > in 29 equities;
• Last Wednesday’s decliners ranged from -0.11% <XON -$0.02 > to -4.40% < BMRN -$3.79> in 15 equities;

Versus

… Look at the percentage’s (%) and spreads …

• Wednesday’s gainers ranged from +0.24% <VSTM +$0.01> to +16.77% <SLDB +$2.89 > in 34 equities;
• Tuesday’s gainers ranged from +0.11% <XON +$0.02 > to +7.96% <GBT +$3.60 > in 16 equities;
• Monday’s gainers ranged from +0.17% <BLUE +$0.30 > to +7.85% <BCLI +$0.27 > in 29 equities;
• Friday’s gainers ranged from +0.17% <SAGE +$0.25 > to +17.20% <SLDB +$2.77 > in 34 equities;
• Thursday’s gainers ranged from +0.45% <BTX +$0.01 > to +8% <AST +$0.10 > in 11 equities;
• Last Wednesday’s gainers ranged from +0.26% <IONS +$0.11 > to +5.66% <SLDB +$0.83 > in 22 equities;

Opinions expressed are those of the author and are subject to change, and not intended to be a forecast of future events, a guarantee of future results, nor investment advice.

Whether information or intelligence is good, bad or somewhere in between; I put into context what is relevant and useful for investors.  All investments are subject to risks. Investors should consider investment objectives.

Henry McCusker, the editor and publisher of RegMed Investors does not hold or have positions in securities referred to in this publication.