Larimar Therapeutics Inc (LRMR)

[Wildbilly]

Q1 ZFGN: $234 mln cash at quarter end.

Top 2 holders, Kolchinsky & Edelman initiated their stake in Q3 2014

From The Filing

Quarter Highlighted by Accelerated Enrollment in bestPWS Clinical Trial?Six Month Data Now Expected in Early Q1 2016

Company on Track to Report Data from Ongoing ZAF-203 Clinical Trial in Late 2015/Very Early 2016

Ends Quarter with Cash and Marketable Securities of $234 Million Following Recent Follow-on Offering

BOSTON, Mass., May 12, 2015 ? Zafgen, Inc. (Nasdaq: ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced its first quarter 2015 financial results.

Z afgen Q1 2015 Business Highlights

Announced an accelerated rate of patient enrollment in recent months in the bestPWS (Beloranib Efficacy Safety and Tolerability in PWS) clinical trial in patients with a rare genetic disorder, Prader-Willi syndrome (PWS) and has reached the original patient recruitment target of 102 patients. Enrollment closeout is expected to be completed in the near term and the total patients in the trial will slightly exceed the original 102 patient goal. Release of top line results is now expected to occur early in the first quarter of 2016.

Based on constructive ongoing dialogue with the U.S. Food and Drug Administration (FDA), the Company has finalized its plan regarding the statistical analysis of primary efficacy endpoints for the bestPWS clinical trial. Both hyperphagia-related behaviors and body weight will be co-primary efficacy endpoints and will be evaluated at a significance level of p-value less than 0.05. With 102 patients enrolled, the trial is adequately powered to demonstrate these effects of beloranib.

Enrolled approximately two-thirds of a target 150 patients in the Phase 2b clinical trial (ZAF-203) to establish the long-term weight loss benefits of MetAP2 inhibitor treatment with beloranib in patients with severe obesity complicated by type 2 diabetes, which began randomized treatment in December 2014. The Company remains on track to release six-month interim data in this subset of patients in late 2015 or very early 2016.

In January 2015, announced positive results from a Phase 2 clinical trial of beloranib in patients with hypothalamic injury-associated obesity (HIAO), a rare, severe, and difficult-to-treat form of obesity. The Company also announced new weight loss and safety data from this Phase 2 clinical trial of beloranib in HIAO at the Endocrine Society Annual Meeting (ENDO 2015). Results from this trial showed that after four weeks of treatment, patients randomized to beloranib lost on average 3.40 kg of body weight vs. 0.25 kg on average for patients randomized to placebo (p=0.01). Results from the open-label extension phase of the trial suggested no apparent waning of the effect of beloranib over eight weeks of treatment.

Raised approximately $130 million through a follow-on public offering in January 2015 which included the full-exercise of the underwriters? option to purchase additional shares of common stock.

?We are very pleased with our accomplishments for the first quarter of 2015. We are thrilled to have seen a high rate of enrollment at our most recently-opened bestPWS clinical trial sites, which will enable us to release six month data from our first pivotal Phase 3 clinical trial early in the first quarter of 2016,? said Dr. Thomas Hughes, Chief Executive Officer of Zafgen. ?We are grateful to the patients and their families for their enthusiasm and commitment to making the bestPWS trial possible.?

?With enrollment progressing well in our Phase 2b trial (ZAF-203) in patients with severe obesity complicated by type 2 diabetes, we remain on track to release important six month interim data in late 2015 or very early 2016,? said Dr. Dennis Kim, Chief Medical Officer of Zafgen. ?The ZAF-203 trial will provide our first look at the effects of beloranib treatment on both body weight and glycemic control in the setting of type 2 diabetes, an important and difficult to treat co-morbidity of obesity.?

?We were pleased to have completed our recent follow-on offering in January 2015, bringing in total net proceeds of approximately $130 million and ending the current quarter with a total cash position of approximately $234 million,? said Patricia Allen, Chief Financial Officer of Zafgen. ?This is an incredibly productive and exciting time for Zafgen and we are investing this capital in the development of beloranib in multiple indications, along with advancing our ZAF-839 program in nonalcoholic steatohepatitis, or NASH, and our second-generation molecules in obesity. We are also expanding our organization to deliver on our multiple development programs and establish our commercial operations in anticipation of approval of beloranib in Prader-Willi syndrome.?

First Quarter 2015 Financial Results

Cash and Cash Equivalents and Marketable Securities

As of March 31, 2015, the Company had cash and cash equivalents and marketable securities totaling $234.2 million.

In January 2015, the Company sold an aggregate of 3,942,200 shares of common stock through an underwritten public offering at $35.00 per share, before underwriting discounts, which included the full-exercise of the underwriters? option to purchase an additional 514,200 shares of common stock at $35.00 per share. The net proceeds to the Company were approximately $129.6 million.

Net Loss

The Company reported a net loss for the first quarter of 2015 of $13.5 million, or $0.53 per share, compared to a $4.5 million net loss, or $6.18 per share, for the first quarter of 2014. The

weighted average common shares (basic and diluted) outstanding used to compute net loss per share were 25,615,282 for the first quarter of 2015, compared to 729,391 for the first quarter of 2014.

Research and Development Expenses

Research and development expenses for the first quarter of 2015 were $10.2 million, compared to $3.3 million for the first quarter of 2014. The increase in research and development expenses for the quarter ended March 31, 2015 as compared to the first quarter of 2014 was primarily due to increased costs associated with the advancement of the Company?s beloranib program, ZGN-839 and other early stage development programs (consisting of our second-generation MetAP2 inhibitors).

General and Administrative Expenses

General and administrative expenses for the first quarter of 2015 were $3.0 million, compared to $1.2 million for the first quarter of 2014. The increase in general and administrative expenses for the quarter ended March 31, 2015 as compared to the first quarter of 2014 was primarily due to increased personnel related costs, increased public company costs, increased travel and other related costs, and increased professional fees.

2015 Financial Guidance

The Company continues to expect that its cash and cash equivalents and marketable securities balance will be greater than $145.0 million at December 31, 2015.

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